Ionis (IONS) and their partner Biogen (BIIB) recently announced strong 3Q results for Spinraza sales of $468 million easily beating the consensus estimate of $445 million, explains John McCamant, editor of The Medical Technology Stock Letter.
During the latest conference call, management pointed out they are seeing durable and persistent treatment across all SMA subtypes. Spinraza penetration within the US adult market remains low at 15% (up from 10% in Q2).
Ex-US, Spinraza saw 29% Q/Q patient growth (12% Q/Q rev growth) driven by launches in over 30 countries including Germany, Italy, Japan, Brazil, Spain, France and Australia.
In Q3, Biogen received regulatory approval in five additional countries, filed for regulatory approvals in two more, and secured formal reimbursement in additional four countries including Canada. Hence, Spinraza’s blockbuster launch continues with some additional momentum.
Ionis recently reported compelling new data on danvatirsen , a Generation 2.5 antisense therapy targeting signal transducer and activator of transcription 3 (STAT3), in combination with durvalumab, AstraZeneca’s anti-PD-L1 antibody, in recurrent metastatic head and neck cancer.
The combo resulted in 7% of patients achieving a complete tumor response and 23% achieving either a partial or complete tumor response. AstraZeneca (AZN) is currently evaluating danvatirsen in a range of cancer types as part of a broader oncology partnership.
Overall, Spinraza has quickly become a blockbuster drug with sales already annualizing at $1.9 billion. Growth is virtually assured with a large number of ex-US countries still coming online leading to long-term consensus estimates of $2.5-3 billion.
The danvatirsen/durvalumab combo data is impressive as head and neck cancer is a very difficult to treat cancer. The PD-L1 combo treatment space will be a huge market opportunity with PD-L1 monotherapy (estimated $35 billion) only able to address about 35% of the potential market currently. IONS remains a buy under $55.
