In the fourth quarter of 2018, Merck’s (MRK) leading oncology asset, Keytruda, earned revenues of $2.15 billion, a YoY rise of 66% on a reported basis and 69% on CC (constant currency) basis.
In fiscal 2018, Keytruda reported revenues of $7.17 billion, a YoY rise of 88% on a reported and CC basis. According to the fourth-quarter conference call, Keytruda reported a robust uptake across multiple indications such as newly diagnosed non-small cell lung cancer (NSCLC), head and neck cancer, bladder cancer, melanoma, squamous NSCLC, and microsatellite instability (or MSI)-high cancers around the world. According to the fourth-quarter conference call, the FDA has currently approved Keytruda in 15 indications across ten tumor types as well as for all MSI-high tumors.
In international markets, the demand for Keytruda monotherapy is mainly driven by PD-L1 high expressing newly diagnosed NSCLC patients. Merck is currently focused on launching Keytruda-chemotherapy in the first-line metastatic non-squamous NSCLC indication based on Keynote-189 trial data. According to the fourth-quarter conference call, while Merck has already secured reimbursement in Germany for its Keytruda-chemotherapy combination regimen, the company says it will focus on securing reimbursement in the remaining European markets in fiscal 2019.
In January 2019, Merck issued a press release announcing Keytruda’s regulatory approval in Japan in five new indications of which three were for advanced NSCLC, one was for melanoma, and one was for MSI-high tumors.
In the fourth quarter, Merck managed to secure FDA approvals for Keytruda in an additional three indications. On October 30, 2018, Merck issued a press release announcing FDA approval for the combination of Keytruda with Carboplatin and either Paclitaxel or Nab-Paclitaxel in the newly diagnosed squamous NSCLC indication based on results of the Phase KEYNOTE-407 trial. On November 9, 2018, the company issued a press release announcing FDA approval for Keytruda monotherapy in the second-line hepatocellular carcinoma indication. On December 19, 2018, the FDA issued a press release announcing accelerated approval for Keytruda in recurrent locally advanced and the metastatic Merkel cell carcinoma indication.
Next, we’ll look at the performance of Merck’s vaccines and hospital and specialty businesses in greater detail.