STOCKS TELEGRAPH

Tag: OPK stock

  • OPKO Health, Inc. (OPK) Stock Dipping in Premarket Following Earnings Release

    OPKO Health, Inc. (OPK) Stock Dipping in Premarket Following Earnings Release

    OPKO Health, Inc. (OPK) is a global biotherapeutics and diagnostics company focused on the establishment of industry-leading positions in rapidly growing markets. The company leverages its marketing proficiency and innovative and exclusive technologies

    The price of OPK stock in regular trades on February 24, 2022, was $3.23 with an increase of 8.39%. The stock decelerated by 13.6% at the last check in the premarket on February 25, 2022,

    OPK: Key Financials

    On February 24, 2022, OPK released its financials for three months, and the fourth quarter ended December 31, 2021. Some of the crucial points are discussed below.

    Revenue

    Revenue in Q4 2021 was observed to be $401.3 million versus $494.6 million in the fourth quarter of 2020. The company observed a decrease of $93.3 million in revenue year-over-year.

    EPS

    Basic and diluted net loss in the fourth quarter of 2021 was $73.8 million or $0.11 per share versus a net income of $32.3 million, or $0.05 per share in the same period of 2020. The company observed a decline in its earnings over the year.

    OPK: Events and Happenings

    On February 15, 2022, OPK updated the grant of marketing approval for the NGENLA or somatrogon by the European Commission. It is used to treat children from 3 years of age with growth disorder due to inadequate growth hormone secretion. On February 03, 2022, OPK reported that Vifor Fresenius Medical Care Renal Pharma had begun the commercial-scale launch of RAYALDEE in Germany.

    On January 21, 2022, OPK announced the issuance of a Complete Response Letter by the FDA for the Biologics License Application for somatrogon. Pfizer assessed the agency’s comments and will work with it to determine a suitable path forward. On January 20, 2022, OPK and Pfizer Japan Inc. informed that NGENLA Injection 24 and 60 mg Pens, had been authorized by the Japanese Ministry of Health, Labor, and Welfare.

    On January 18, 2022, OPK and Sema4 updated on their entry into a definitive contract for Sema4 to purchase OPK’s subsidiary, GeneDx, Inc. On January 5, 2022, OPK reported its management’s presence at the Virtual 40th Annual J.P. Morgan Healthcare Conference on January 10-13, 2022.

    Conclusion

    OPK stock is 26% down the past year. The company’s stock again declined in Friday’s premarket session as it announced its financials. The company’s financials observed a decline in its revenue and EPS over the year. For the upcoming quarter, the company’s revenue guidance is $317.2 million and EPS is -$0.02.

  • OPKO Health Inc. (OPK) stock Plummets Further After Hours on FDA’s CRL for Somatrogon

    OPKO Health Inc. (OPK) stock Plummets Further After Hours on FDA’s CRL for Somatrogon

    On January 21, OPKO Health Inc. (OPK) and Pfizer Inc. announced receiving a Complete Response Letter for somatrogon’s Biologics License Application. Consequently, OPK stock suffered a blow in the after-hours.

    During regular trading, the stock lost 2.75% at its closing price of $4.24 on Friday. Following the announcement, the stock plunged further to reach $3.75 in the after-hours. Hence, OPK lost a further 11.56% at an after-hours volume of 639K shares.

    The biopharmaceutical and diagnostics company, OPKO Health Inc. has a market capitalization of $2.89 billion. Currently, the company has 681.34 million shares outstanding in the market.

    Somatrogon

    Somatrogon is an investigational recombinant human growth hormone for the treatment of GHD (growth hormone deficiency) in pediatric patients. GHD is a rare disease in which the pituitary gland secretes an inadequate amount of the growth hormone. Thus causing a delay in puberty, restricted growth, and many other physical and associated mental problems as well.

    Previously, in 2014, OPK and Pfizer had entered into a worldwide agreement for developing and commercializing somatrogon for GHD. According to the agreement, clinical development is OPK’s responsibility while registration and commercialization are Pfizer’s.

    Recent Developments Regarding Somatrogon

    Pfizer has submitted regulatory applications for somatrogon to several countries around the world for review. Recently, NGENLA® (somatrogon) inj. Was approved by Japan’s Ministry of Health, Labor, and Welfare for treatment of growth failure in pediatric patients due to growth hormone. Moreover, in 2021, NGENLA® was also approved by Health Canada and Australia’s Therapeutic Goods Administration. Furthermore, a decision from European Commission is expected soon, based on EMA’s CHMP’s recent positive opinion.

    CRL regarding Somatrogon

    As per Friday’s announcement, FDA has issued a CRL for somatrogon’s Biologics License Application BLA). Currently, Pfizer is assessing the comments of the FDA and plans to work with the agency for the best course forward.

    OPK’s Recent Participation

    Recently, OPK participated in the 40th Annual J.P. Morgan Healthcare Conference which took place from January 10 to 13, 2022. Further, the company’s management hosted a one-on-one meeting with investors along with a fireside chat on January 12, at the conference.

    OPK’s Financial Data

    On October 28, the company declared its financial results for the third quarter of 2021.

    In the third quarter of 2021, consolidated total revenues reported were $385.8 million against $428.1 million in Q3 of 2020.

    Additionally, OPK ended the quarter with cash, cash equivalents, and marketable securities of $148.6 million.