Opko Health, Inc.

Good day, ladies and gentlemen, and welcome to the Opco Health, Inc. 4th Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Ms. Yvonne Briggs with LHA.

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 2021. 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 could 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 in subsequently filed SEC reports. Importantly, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 24, 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 for today's call. Dr. Philip Frost, Chairman and Chief Executive Officer, we'll open the call. Steve Rubin, OPCO's Executive Vice President, will provide a business update and pipeline review. And then Dr. John Cohen will discuss bioreference laboratories. After that, Adam Logel, OPCO's CFO, will review the company's fourth 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 fourth quarter financial results and business update. 2021 was a record year for Opco Health with revenue of more than $1.7 billion. Starting with our pharmaceutical division, we were pleased to announce NGENLA approval in several major markets, including the European Union and Japan, as well as in Canada and Australia. Angela is the brand name for somatotrogin for the treatment of pediatric growth hormone deficiency. Pfizer launched Angela in Canada on February 16th, and we look forward to launches in other territories as they receive pricing determinations. In the U.S., we were disappointed with the FDA's issuance of a complete response letter. However, Pfizer and Opco are evaluating the FDA's comments, and will work with the FDA to better understand their requirements for a path forward. Both Pfizer and Opco are committed to bringing this product and its benefits to growth hormone deficient children globally. Since the start of the pandemic, the bioreference laboratories team has responded to the nation's needs with efficiency and innovative testing services. As a result, bioreference exceeded sales expectations for the quarter, and closed out a record year with $1.6 billion in revenue. For the past two years, BioReference has effectively managed its resources and pivoted its operations to be prepared with testing capacity. Moreover, the addition of our digital health service, Scarlet Health, has made it more convenient for patients requiring both COVID and routine tests, and we expect Scarlet to be a growth driver in the future. John will provide further details on bioreference and its performance in a moment. As part of our strategy to unlock the value of Opco's assets and maximize value for shareholders, we entered into a definitive agreement to sell GeneDx to Semaphore for $150 million in cash and 80 million Semaphore shares upon the closing of the transaction. We're also entitled to receive up to $150 million of potential milestones. Catherine Stuhland, CEO of GeneDx, will become co-CEO of the combined companies. With a significant equity stake in Semaphore at closing, our co-shareholders will continue to participate in the growing genomics market without significant investment of capital. V4 Forcenius, our commercial partner for Rialdi in Europe and other markets outside the U.S., launched the product in Germany earlier this month. This is the first launch of Rialdi outside the United States, and we're enthusiastic about rollout plans, with a launch in Switzerland anticipated next. In December, we announced top-line results for our Phase II clinical trial with Rialdi, in COVID-19 patients. The preliminary data demonstrated that improving vitamin D status with oral reality results in earlier resolution of respiratory symptoms. Last time, I mentioned in OpcoGem, our small Latin American business. It finished the year with record sales and profits and is now planning to expand into Ecuador and from its unit in Spain into France. As I've stated in the past, we believe the market doesn't adequately value Opco's assets presently. The GeneDx transaction is one step towards better recognition of actual value. I'll now turn the call over to Steve Rubin, who will provide further commentary on our pharmaceutical business.