The drugmaker on Wednesday reported net income of $2.36 billion, or 92 cents per share, up from $1.83 billion, or 69 cents per share, a year earlier. Merck stock had rallied about 75% since mid-2015, and that was up more than 50% over the past two years. Led by highly innovative products, including KEYTRUDA (pembrolizumab), Lynparza (olaparib), Lenvima (lenvatinib mesylate), GARDASIL (Human Papillomavirus Vaccine, Recombinant), BRIDION (sugammadex), ZERBAXA (ceftolozane and tazobactam), and BRAVECTO (fluralaner), as well as its leading diabetes business and other key products, Merck will continue to benefit from broad commercial scale and remains committed to ensuring continued access to its innovative medicines across the globe. This is the first regulatory approval of a medicine for the treatment of NF1 PN, a rare and debilitating genetic condition. Organon has been an important part of Merck since the 2009 Schering-Plough acquisition. In 2019 the drug took over as the No. Mizuho analyst Mara Goldstein wrote to investors that the spinoff should drive higher revenue and dividend growth and increase profit margins. With Merck separating the businesses and with Keytruda already accounting for about one-fourth of the company’s total revenues, the so-called NewCo Merck likely will increase Merck’s dependence on that blockbuster cancer drug. For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. Also in June, FDA approved Keytruda as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation. The company forecast adjusted annual net income of $5.62 to $5.77 per share, for all of 2020, and revenue ranging from $48.8 billion to $50.3 billion. The maneuver culminates a steady shift of Merck’s business the past several years from a primary care drugmaker with more than 160 products, to a company which will have half as many, focused on its surging but young oncology business, and growing sales of its vaccine, hospital products and veterinary medicines. According to company leaders, this decrease was a result of continued pricing pressure in the United States, partially offset by higher demand in most international markets. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced its intention to spin-off products from its Women’s Health, trusted Legacy Brands, and Biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company. Cancer blockbuster Keytruda, one of the top new oncology drugs that boost the immune system to hunt and kill cancer cells, led sales, bringing in $3.11 billion in the quarter. During the fourth quarter, Merck paid $2.7 billion for ArQule, a company developing treatments for B-cell cancers, and won approval for Ervebo, the first vaccine against the Ebola virus. Results from the PROfound trial showed Lynparza reduced the risk of disease progression or death by 66 percent and improved radiographic progression-free survival to a median of 7.4 months versus 3.6 months with enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations, the primary endpoint and a subpopulation of HRR gene mutations. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. ORR is defined as the percentage of patients with confirmed complete or partial response of at least 20 percent tumor volume reduction. 1 oncologic in the world by sales, and No. As a result, Merck expects to optimize its resources, grow faster, and achieve meaningful operating margin expansion over time through increased productivity and efficiency. Drugmaker Merck beat Wall Street’s fourth-quarter profit expectations, but investors weren’t as happy with the biggest move Merck’s made in years: deciding to spin off its women’s health division and other operations with $6.5 billion in annual revenues. Net income was up by more than half, from $6.19 billion to $9.78 billion, and diluted earnings per share rose by $1.49 to $3.81 for the year. In the first half of 2020, Keytruda sales rose another 36.1 percent to $6.67 billion. Kenneth Frazier, Merck’s chairman and CEO. The company assumes no duty to update the information to reflect subsequent developments. FDA accepted and granted priority review for a new sBLA seeking accelerated approval for Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), based on the Phase III KEYNOTE-355 trial. In July, FDA accepted two new supplemental biologics license applications for Keytruda. Merck & Co. Inc. unveiled plans Wednesday to spin off products from its women’s health and biosimilars businesses, along with certain legacy brands, into a … The maneuver culminates a steady shift of Merck's business the past several years from a primary care drugmaker with more than 160 products, to a company which will have half as many, focused on its surging but young oncology business, and growing sales of its vaccine, hospital products and veterinary medicines. Merck's stock closed Wednesday down $2.53, or 2.9%, at $85.83, while broader markets were all up.