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Opko Health, Inc.
10/29/2025
Good afternoon and welcome to the Opco Health Third Quarter 2025 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance during the conference call, you may signal an operator by pressing star 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 telephone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. I would like to now turn the conference over to Yvonne Briggs. Please go ahead.
Thank you, Operator, and good afternoon. This is Yvonne Briggs with Alliance Advisors IR. Thank you all for joining today's call to discuss Oplico Health's financial results for the third quarter of 2025. 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 risk and uncertainties that can 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, 2024, and subsequently filed SEC reports. Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, today, October 29, 2025. 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 Zerhouni, Vice Chairman and President, will then provide an overview of BioReference Health and OPCO's therapeutic segment. After that, Adam Logel, Opco's CFO, will review the company's third quarter financial results and discuss Opco's financial outlook. And then we'll open the call to questions. Now I'd like to turn the call over to Dr. Frost.
And thank you for joining us today. During the third quarter, Opco Health continued to execute well against our strategic priorities. It completed the sale of bio-reference health oncology division, and related testing services. This transaction is a significant milestone designed to streamline our lab business and ensure profitable growth. The sale provided $192.5 million at the closing and $32.5 million in a performance-based earn-out. By reference, it's now focused on our core clinical testing operations in the New York, New Jersey region and driving adoption of our 4K score test nationwide. We're devoting a portion of the sale proceeds to our stock repurchase program, reinforcing our commitment to increasing shareholder value. So far, during 2025, we've repurchased $25.1 million worth of stock. As of September 30th, we had $126 million remaining under this program. On the pharmaceutical side, we're advancing our pipeline of innovative therapeutics with four candidates now in the clinic and several more in the pre-IND stage. We're pleased to have significant partnerships that provide non-dilutive funding to support the development process for several of these programs. This morning, we announced a research collaboration and a license agreement with Regeneron, a leader and innovator in antibody-based therapies. This program will leverage MODX's MSTAR platform with Regeneron's proprietary binders to discover and develop multispecific antibodies that allow us to explore several indications of mutual interests. Currently, MODX has three programs and phase one clinical trials. Our most recent candidate, MDX2004, a multispecific immune rejuvenator, entered the clinic last month. Our most advanced immuno-oncology medicine, MDX2001, is a T-cell engager enhancer directed at two tumor antigens, CMET and TROP2, found on a variety of solid tumors. An abstract on this program was presented at the recent ESMO meeting in Berlin, Germany. It has advanced to its fifth cycle of escalation, which is approximately tenfold higher than the initial starting dose with acceptable safety and tolerability. Based on the outcome of these studies, we anticipate further Phase 1b expansion cohorts for next year. Our EBV vaccine, being developed in partnership with Merck, has advanced for immunogenicity, safety, and tolerability evaluation in Phase I human trials. Enrollment in this ongoing trial is progressing well, and the data will inform the Phase II trial design. Our next immuno-oncology candidate, MDX2003, a tetraspecific T-cell engager expander that targets B-cell leukemia and lymphoma. We expect this compound to enter the clinic early next year after appropriate regulatory review. Finally, MDX2301 is our bispecific tetravalent antibody designed to prevent and treat COVID infections. Funded by BARDA, we expect Phase 1 safety and immunogenicity studies to begin early next year. The MODX multispecific COVID antibody neutralizes all known strains of the virus, including the most recent variants. It is designed to confer broad protection against evolving outbreaks, particularly for subjects with underlying immune impairment, such as cancer patients, diabetics, and the elderly, thus having great medical value, potentially, and global health impact. Our collaboration with BARDA continues to advance the development of broadly protected multispecific antibodies for both COVID and influenza viruses. We're progressing our development of OPK88006 for the treatment of MASH and obesity for both subcutaneous and oral administration. We have partnered with Enterobio for the development of the oral formulation. The subcutaneous program is expected to enter the clinic in early 2026 with the oral formulation to follow later that year. Our international operations, including Opco Health, eBureau America, and Ergen Pharma, continue to provide steady sales growth and meaningful cash flow to assist in funding our R&D efforts. Overall, we remain highly committed to maximizing shareholder value. Through strategic actions such as the sale of select bioreference assets, the execution of our share repurchase program, the advancement of the MODX portfolio products and clinical trials, and a new MODX R&D alliance, we are focusing our operations to provide growth opportunities while returning capital to investors. We are confident in our strategic direction, our team, and our ability to deliver on our milestones. With that overview, I'll turn the call over to Elias. Elias?
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