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AbbVie's shares slipped ahead of the weekend when its fourth-quarter sales were not achieved after biosimilar competition – particularly in Europe – weakened the Humira cash cow product.
Immunology blockbuster revenues increased 1% to $ 4.9 billion in the quarter, but were down from over $ 5.1 billion in the previous quarter.
US sales of Humira (adalimumab) actually increased about 9%, but international sales fell by almost 15%, just under $ 300 million, due to the direct biosimilar competition in Europe and other international markets, "said Rick Gonzalez, Abbie's general manager. The company expects Humira's global biosimilar sales to be around $ 2 billion.
"The event that preoccupies investors most for many years is the loss of exclusivity for Humira," Gonzalez said at the call. "We have been planning and preparing for a long time for the event that lies ahead," he added, while conceding that the competition – particularly in price – was more "aggressive" for Humira compared to other organic products. of the clbad of TNF inhibitors.
"Despite a more aggressive reduction, our strategy is working as planned," said Gonzalez. He predicted revenue growth and "industry leader" results this year, which some badysts said was disappointing.
Signs of weakness at Humira also suggest that AbbVie could add short-term growth through a major acquisition, with BioMarin and Alexion both mentioned as potential targets in recent months. Gonzalez has ruled out a large-scale deal, quashing the rumor of a possible hostile bid on Bristol-Myers Squibb prior to its takeover by Celgene, but implicit indirect agreements could be considered.
AbbVie's excessive dependence on Humira and the threat of biosimilars are not new and the company still has a few years of biosimilar-free market in the United States, where patents on Humira are not expected to expire until 2023 unless company does not lose its patent. dispute.
Nevertheless, AbbVie is striving to diversify its revenues, both with the new immunological drugs such as risankizumab and upadacitinib to be launched this year, and by developing products in other therapeutic categories, such as Imbruvica. (ibrutinib) and Venclexta (venetoclax). for blood cancers.
Risankizumab, an interleukin-23 inhibitor, in advanced development stage for moderate-to-severe plaque psoriasis, is being touted as a potential product of $ 2.5 billion after beating. the competing drug of the IL-23, IL-23, Tremfya (guselkumab) trial, despite the growing competition in the market of biological anti-inflammatory drugs.
Meanwhile, the upadacitinib, selective inhibitor of oral JAK1 – in the context of trials on rheumatoid arthritis and other inflammatory diseases – has been submitted for approval on the basis of data from these trials. showing that it was more effective than Humira in the treatment of rheumatoid arthritis (RA). Some badysts predict that sales could reach $ 3 billion a year or more.
Imbruvica and Venclexta are already on the market through partnerships with J & J and Roche and have also played their part. Imbruvica added $ 1 billion to AbbVie's coffers in the fourth quarter, up 42%, while Venclexta more than doubled to $ 124 million.
At the same time, Mavyret hepatitis C virus (HCV) therapy (glecaprevir plus pibrentasvir) slowly increased to a mark of $ 3.4 billion last year, despite the saturation of the market weighing on previous launches such as Gilead's Harvoni (sofosbuvir and ledipasvir).
All AbbVie attempts to strengthen the pipeline have failed. Rovalpituzumab tesirine, or Rova-T, has been delayed by disappointing results in small cell lung cancer, while an attempt to extend Imbruvica uses in diffuse large-cell lymphoma B cells also ended in failure.
"AbbVie's strategy envisions a biosimilar competition since the first day of this company's launch," said Gonzalez. "Our goal has been to build a pipeline that would allow us to absorb the impact of biosimilar competition and maintain a strong and growing business."
"Although our work has never been completed, we have made tremendous progress and built what we consider to be one of the most attractive pipelines in the industry," he added.
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