- AbbVie on Thursday reported sales of its flagship product Humira fell by more than 5% in the first quarter of 2019 compared with the same period a year ago. A steep decline of nearly 28% in Europe thanks to the entry of biosimilars drove the sales setback, although CEO Richard Gonzalez said the European sales trends were consistent with the company's internal forecasts.
- Skyrizi, the psoriasis drug that received U.S. approval this week, will not help offset Humira declines in the second quarter, although AbbVie expects it to achieve sales of $150 million for the full year 2019.
- Nonetheless, AbbVie raised its full-year earnings-per-share guidance by 1% to $7.36, crediting the "strength of the underlying business." It is the third time in seven years of existence the company has raised guidance in the first quarter.
As Humira (adalimiumab) goes, so goes AbbVie. And it may require quite a few new products to replace the rheumatoid arthritis giant, which earned just shy of $20 billion in sales in 2018.
Investors did not take the news of sales declines from Humira biosimilars well when the signs first became apparent at the end of 2018. The decline has now become clear and is now pulling down product sales globally.
Even a 7% year-over-year increase in quarterly U.S. sales, to $3.2 billion, couldn't offset the 28% tumble in international sales, which dropped to $1.2 billion. Globally, Humira sales fell about 6% to $4.4 billion, leading to a slight 1% decline in total AbbVie sales to $7.8 billion.
A brighter spot for AbbVie was strong growth from its blood cancer drugs Imbruvica (ibrutinib) and Venclexta (venetoclax). These two products together broke the $1 billion mark for the first quarter, representing 53% growth.
Gonzalez said the company believes its forecasts of European Humira biosimilar declines have matched reality, giving it the confidence to raise the full-year guidance. As long as Humira retains its U.S. exclusivity, sales should continue to grow and help to reduce the impact of European erosion.
That won't last forever, of course, with multiple biosimilars set for U.S. launches in 2023. Pipeline projects will need to start pulling their weight by then. Thus the Food and Drug Administration's decision on Skyrizi (risankizumab) was closely watched, and even more so, AbbVie's expectations on sales.
The Illinois-based company has predicted Skyrizi will earn $5 billion in sales by that key 2023 date. For 2019, AbbVie is forecasting $150 million in sales, mostly in the second half of the year as it plans to give away the product during the early launch period until formulary access can be gained.
It will be going up against a number of new psoriasis drugs, including Johnson & Johnson's Tremfya (guselkumab) and Eli Lilly's Taltz (ixekizumab).
A second product AbbVie's immunology pipeline is upadacitinib, a rheumatoid arthritis pill, which is expected to secure an FDA approval later this year. Rheumatoid arthritis is a competitive space with several products — including Humira — losing patent protection in coming years, so it will also have a fight on its hands as AbbVie tries to replace that Humira revenue.