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Opko Health, Inc.
8/3/2023
Good day and welcome to the Opco Health Second 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 star then 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.
Yvonne Briggs Thank you, Operator. Good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today's call to discuss Opelko Health's financial results for the second 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 materially affect the company's expected results. These 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, 2022, and its subsequently filed SEC reports. This conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 3, 2023. 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 of OPCO, will then provide an overview of OPCO's pharmaceutical business as well as bioreference health. After that, Adam Logel, Opco's CFO, will review the company's second quarter financial results, and then we'll open 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. In June, we were pleased to announce what we had been expecting for more than a year, FDA approval of Anglena, Our long-acting, once-weekly human growth hormone analog to treat pediatric patients age three and older. Our global commercial partner, Pfizer, has indicated it expects Angela to become available this month for prescribing in the U.S. This approval triggered a $90 million milestone payment from Pfizer and leads to a profit-sharing arrangement that Adam will discuss in more detail. That decision by the FDA adds to Angela's approvals in over 40 countries, with commercial launches today in over 18, including the major markets of Japan, Germany, France, Spain, and the United Kingdom. Pfizer expects to launch Angela in another 18 or more countries during the remainder of this year, covering all priority international markets by year end. With U.S. approval, we expect to see significant ramp-up in sales for NGINLA as market penetration continues to expand globally. With Pfizer's global commercial infrastructure and longstanding experience in this particular market segment, we couldn't have a better partner. On another front, we continue to advance the sophisticated science of our MODX unit toward clinical trials. MODIC's novel approaches are validated by the exclusive worldwide collaboration with Merck that we announced in March to develop our multivalent nanoparticle Epstein-Barr virus vaccine. Our strategy was to secure a large pharmaceutical partner to develop the EBV vaccine, and we have a great one in Merck. Despite the significant prevalence of this virus, and its potential to cause head and neck, stomach, and other cancers, as well as multiple sclerosis, there are currently no FDA-approved vaccines for EBV. At BioReference Health, we continue to drive cost control efforts in parallel with work to enhance innovation and productivity. We look forward to our diagnostic segments returning to profitability in the near future. Our international operations continue to perform well, with both our Ibero-American and FinTech businesses demonstrating profitability and growth this past quarter. With that brief overview, I'll turn the call over to Elias to provide further discussion and commentary on our pharmaceutical and diagnostic businesses.
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