Merck Reports Strong H1 2019 Results: Keytruda Generates Nearly $5 Billion in Global Sales

On July 30, Merck & Co., Inc. (MSD) announced its financial results for the first half of 2019. Global sales revenue reached $22.575 billion, with the pharmaceutical business contributing $20.123 billion, representing an 11% increase compared to the first half of 2018. Excluding the negative impact of foreign exchange fluctuations, global sales grew by 15%. Among these, Keytruda, one of the core products, generated $4.903 billion in revenue during the first half of the year.

Since 2014, a total of nine PD-1/PD-L1 drugs have been approved for market launch globally. The global market size for this class of drugs exceeded $16 billion in 2018 (including approximately $800 million in revenue for Ono).

Based on quarterly sales data, Keytruda first surpassed Opdivo in Q2 2018. In the subsequent quarters, Opdivo’s revenue plateaued, whereas Keytruda and Tecentriq maintained robust growth rates. By Q2 2019, Keytruda’s quarterly revenue had significantly outpaced that of Opdivo, exceeding it by $811 million.

Comparison of Quarterly Sales Performance of Several PD-1/PD-L1 Products

In its semi-annual report, MSD noted that Keytruda received new approvals in the first half of the year for first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC), and for metastatic small cell lung cancer (SCLC) with disease progression following prior therapy.

Meanwhile, based on the results of the pivotal KEYNOTE-426 trial, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Keytruda in combination with axitinib as first-line treatment for advanced renal cell carcinoma (RCC).

Furthermore, the FDA has accepted for review six additional supplemental Biologics License Applications (sBLAs) for Keytruda to update its dosing frequency, including a every-six-weeks (Q6W) administration schedule option for certain monotherapy indications. The FDA has set a PDUFA date of February 18, 2020.

The following are the approved indications for Keytruda, Opdivo, and Tecentriq.

Source: PharmCube