IO growth trends
Despite intense competition from multiple IO therapies such as Merck’s Keytruda, Roche Holdings’ Tecentriq, Pfizer and Merck’s Bavencio, AstraZeneca’s Imfinzi, and Regeneron and Sanofi’s Libtayo, Bristol-Myers Squibb’s Opdivo has managed to maintain its leadership position in the majority of approved indications. The drug secured 16 regulatory approvals within the first four years of its launch and is protected by IP (intellectual property) estate until the beginning of fiscal 2028.
In its first-quarter earnings conference call, Bristol-Myers Squibb highlighted Opdivo’s increasing share in the adjuvant melanoma indication, upcoming readouts from metastatic settings in renal and gastric cancers, and upcoming NSCLC (non-small cell lung cancer) readouts as key growth areas for the drug in future years. In the first quarter, Opdivo reported $1.80 billion in revenues, while the drug earned $6.74 billion in revenues in fiscal 2018. Yervoy reported $348 million in revenues in the first quarter and $1.33 billion in revenues in fiscal 2018.
According to an investor presentation, at the end of fiscal 2018, Bristol-Myers Squibb’s IO therapies, which include Opdivo and Yervoy used as monotherapies or in combination regimens, accounted for 28% of the market share in the second-line NSCLC indication and 68% of the market share in the third-line plus SCLC (small cell lung cancer) indication. Bristol-Myers Squibb was also the leader in the first-line melanoma indication as well as the adjuvant melanoma indication with a market share of 60% and 77%, respectively. Bristol-Myers Squibb was the leader in first-line and second-line renal cell carcinoma indications with a market share of 44% and 52%, respectively. Finally, the company’s IO therapies accounted for an 18% share in the post platinum head and neck cancer indication and a 57% share in the second-line HCC (hepatocellular carcinoma) indication.
Revlimid growth trends
The acquisition of Celgene is expected to reduce overreliance of Bristol-Myers Squibb on its IO franchise while extending its leadership in the hematology segment. Celgene’s flagship product, Revlimid, reported revenues of $2.58 billion in the first quarter and is expected to report revenues of $10.8 billion in fiscal 2019. The drug continues to demonstrate double-digit YoY revenue growth backed by solid gains in market share and duration of treatment as maintenance therapy in MM (multiple myeloma) as well as the increasing use of triplet regiments in front-line MM. The drug is expected to lose its patent exclusivity in fiscal 2023.