Opko Health, Inc.

Good day and welcome to the Opco Health fourth quarter 2023 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 Yvonne Briggs.

Please go ahead. Thank you, Operator. Good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today's call to discuss Opco Health's financial results for the fourth quarter of 2023. 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, will be subject to risks and uncertainties that can severely affect the company's expected 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 2023, and in subsequently filed SEC reports. This conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 27, 2024. 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. Before we begin, let me review the format for today's call. Dr. Philip Frost, Chairman and Chief Executive Officer, will open the call. Dr. Elias Zerhouni, Vice Chairman and President, will then provide an overview of Opco's pharmaceutical business, as well as bioreference health. After that, Adam Logo, Opco's CFO, will review the company's fourth quarter financial results, and then will open up the call to questions. Now I'd like to turn the call over to Dr. Frost.

Good afternoon, and thank you for joining us today. 2023 was a year of significant achievement for Opco, and we expect continued progress in 2024. In 2023, NGENLA, our long-acting growth hormone therapy, was approved by the FDA for sale in the US, the largest growth hormone market in the world. Pfizer, our global commercial partner, has now launched NGENLA in over 40 markets worldwide, And we're optimistic about Pfizer's ability to convert users to the weekly injection from the daily to further penetrate this growing $5.5 billion market. MODX made great strides last year, in particular in executing its strategy to secure important collaborations to advance its multi-specific biologics platform into the clinic. These collaborations provide non-dilutive funding to advance a unique pipeline to commercial realization. Specifically, last March, we announced an exclusive worldwide license and collaboration agreement with Merck to develop MODX's nanoparticle vaccine candidate against Epstein-Barr virus. We received a sizable upfront payment and are eligible for milestone and royalty payments. In September, MODX was awarded a contract from the Biomedical Advanced Research and Development Authority, known as BARDA, to develop novel multi-specific antibodies against viruses that cause specific antibodies to treat and prevent COVID-19. And additional funding may be available to develop multi-specific antibodies targeting other viral pathogens, such as influenza. Elias will provide more detail on those programs. Stands of reality are drug to treat chronic kidney disease patients with elevated parathyroid hormone and low vitamin D levels. grew 13% last year, and we're expecting further progress this year. We're gathering data which indicate that reality may slow chronic kidney disease progression. Some of you have been asking about my long-time enthusiasm for our once-weekly auxinthamodulin product to treat type 2 diabetes and obesity. You'll remember that we had completed a successful phase 2 trial achieving significant weight loss, lowering of serum cholesterol and triglycerides, and lowered A1C levels. We delayed a Phase III trial when other products appeared which provided greater weight loss. Noting the great commercial success of these products, we decided to have a closer look at ours. The polyethylene glycol PEG added to our base peptide to increase its half-life is large and bulky, and increased the viscosity of the injection, which limited the maximum dose administered, which is related to the amount of weight loss. We have now found a substitute for PEG, which makes our molecule size similar to those on the market. With guarded optimism, we're in early stages of preclinical evaluation of this product. Switching to our international business, APCOA Iberoamerica, Finetec, and Ergen are all doing well. Turning to BioReference Health, our team has worked hard to improve our cost structure and enhance revenue. In addition to our expense reduction efforts, BioReference has been aiming to drive growth in higher value segments with new tests, larger customers, and better insurance reimbursement. We are laser focused on returning this segment to profitability in the near term, and again, Elias will provide more detail. With that overview, I'll turn it over to Elias.