XML 43 R30.htm IDEA: XBRL DOCUMENT v3.22.0.1
Subsequent Events
12 Months Ended
Dec. 31, 2021
Subsequent Events [Abstract]  
Subsequent Events Subsequent Events
In February 2022, the European Commission approved the next-generation long-acting recombinant human growth hormone NGENLA (Somatrogon), a once-weekly injection to treat children and adolescents from as young as 3 years of age with growth disturbance due to insufficient secretion of growth hormone.
In January 2022, Pfizer, Inc. and OPKO announced that the FDA issued a Complete Response Letter for the BLA for Somatrogon. Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of GHD in pediatric patients. Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.
In January 2022, Pfizer, Inc. and OPKO announced that the long-acting growth hormone injection, NGENLA® (Somatrogon) Inj. 24 mg Pens and 60 mg Pens, has been approved by the Ministry of Health, Labour and Welfare in Japan for the treatment of GHD in pediatric patients. Somatrogon has also been approved in the Canada and Japan under the brand name NGENLA.
In January 2022, Sema4 and OPKO announced they have signed GeneDx Merger Agreement, pursuant to which Sema4 has agreed to acquire GeneDx, a leader in genomic testing and analysis, from OPKO, subject to satisfaction of customary closing conditions. The GeneDx Transaction is expected to close in the second quarter of 2022.
Under the terms of the agreement, Sema4 has agreed to acquire GeneDx for an upfront payment of $150 million in cash together with 80.0 million shares of Sema4 Common Stock, subject to a customary purchase price adjustment mechanism providing for a normalized level of working capital and that GeneDx be free of debt at closing of the GeneDx Transaction. Additionally, Sema4 agreed to pay OPKO up to an additional $150 million revenue-based milestones over the next two years (which may be paid in Sema4 Common Stock, cash or a combination thereof in Sema4’s discretion, subject to GeneDx
achieving certain revenue targets). Based on the closing stock price of Sema4 as of January 14, 2022, the total upfront consideration is approximately $473 million, and the total aggregate consideration including potential milestones is approximately $623 million. As of December 31, 2021, the assets and liabilities of GeneDx are reflected in the consolidated balance sheet as held for sale.We have reviewed all subsequent events and transactions that occurred after the date of our December 31, 2021 Consolidated Balance Sheet date, through the time of filing this Annual Report on Form 10-K.