Opko Health, Inc.

Good day and welcome to the OpChair Health 3rd Quarter 2022 Financial Results Conference Call. All participants will be on the list on the menu. Should you need any 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 telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I'll now let you turn the conference over to Ms. Yvonne Briggs. Please go ahead.

Thank you, Operator, and good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today's call to discuss Opco Health financial results for the third quarter of 2022. 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. 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, 2021, and subsequently filed SEC reports. This conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, today, November 8, 2022. 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 of today's call. Dr. Philip Frost, Chairman and Chief Executive Officer, will open the call. Dr. Elias Zahouni, Vice Chairman and President of Opco, will then provide an overview of Opco's pharmaceutical business, as well as bioreference laboratories. After that, Adam Logel, Opco's CFO, will review the company's third 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 today's call to discuss our third quarter financial results and business progress. Starting with Opco Health's pharmaceutical business, we're pleased with the launches to date of Engendla, or Sumatragon, by our commercial partner, Pfizer. Engendla is our once-weekly injectable growth hormone product that's expected to ease a patient's burden versus the standard daily injections. Pfizer has launched in Japan and other countries, including Germany, Canada, Australia, and Australia, and Genla is now offered through the Pharmaceutical Benefits Scheme, which is Australia's national drug subsidy program. Although it's still very early in the launch of just a few territories, and Genla is starting to experience significant sequential quarter growth, which Adam will review in a moment. Additionally, there are several pricing approvals pending in other European countries, which should occur soon. In the US, I can assure you We're working diligently with Pfizer to resolve the FDA's comments regarding Sometragon's BLA submission. As you know, it's Pfizer's position not to disclose any further information regarding the FDA's comments in the complete response letter, ongoing discussions with the agency, or strategy to advance the regulatory process. Yet, they have publicly stated their commitment to the product in the U.S. market. As soon as we are able, we will provide an update with additional information on the regulatory status of Simetragon in the U.S. We're pleased with the progress of our licensing partners for several of our development stage drug candidates. LeaderMed, our joint venture partner in China, is expected to initiate a Phase III trial of oxyntamodulin for the treatment of obesity and type 2 diabetes early next year. LeaderMed is also planning a clinical trial of our Factor VII CTP, a novel long-acting coagulation factor to treat hemophilia. We look forward to the results from these clinical studies as we plan to leverage the data for regulatory approval in countries outside of China. The MODX team is enthusiastic and motivated to advance the pipeline of the combined company and to leverage the MODX proprietary technology platform focused on multi-specific antibodies. Their unique platform technology represents a significant opportunity to provide better therapy and outcomes for a wide variety of patients, and we continue to advance our discussions with potential partners. We'll keep you updated on our progress. Dr. Elias Zerhouni has immersed himself in all aspects of our business and has spent significant time onsite at bioreference laboratories to provide oversight leadership of the diagnostic operations and strategy. Elias will provide further details on the lab and its performance following his commentary on the pharmaceutical business. With that brief review, I'll now turn the call over to Elias.