AbbVie Dips as Stalled FDA Action on Rinvoq Worries Investors

(Bloomberg) -- AbbVie Inc.’s shares fell on Friday as the company faced analysts’ questions about its immune therapy Rinvoq that’s hoped to replace potential losses from key drugs due to biosimilar competition.

Rinvoq, approved to treat rheumatoid arthritis, has faced regulatory setbacks in recent months as the company seeks expanded clearance for related conditions, psoriatic arthritis and ankylosing spondylitis. Its Food and Drug Administration application has been delayed as safety concerns about the drug’s class have arisen, though the company said Friday it expects to receive the additional clearances in the next few months.

Rinvoq is one of the drugs whose sales are seen compensating in the coming years as international sales of Humira fall due to biosimilar copies. Six biosimilars have been cleared for U.S. launch in 2023. In a call with investors on Friday, Chairman and Chief Executive Officer Richard Gonzalez said the drugmaker expects Rinvoq, along with the plaque psoriasis drug Skyrizi, to buffer Humira’s potential domestic losses.

“They’re rapidly growing, and they’re doing exactly what we hoped they would do,” he said. The company is set to increase its focus on the “next-generation assets” as the drugmaker relies on its newly diversified portfolio to sustain growth, he said.

AbbVie said earlier this year that it expects the two drugs to bring in more than $15 billion in sales by 2025. The shares fell 1.5% as of 12:04 p.m. in New York.

The company otherwise posted second-quarter strong results, as the impact of the pandemic on non-Covid care waned. Revenue was $14 billion, a 34% increase from the year-earlier period that beat Wall Street’s projection. Adjusted profit for the quarter rose to $3.11 a share, beating analysts’ average expectation of $3.08. AbbVie raised its 2021 profit outlook to $12.52 to $12.62 a share, up from a previous range that topped out at $12.57.

U.S. sales of Humira rose 7.1% this quarter to $4.26 billion, although international sales fell due to biosimilar competition. The drugmaker’s second-top-grossing drug, cancer therapy Imbruvica, continued its upward trend with $1.38 billion in sales, a 7.2% year-over-year increase.

Growth was helped by the company’s buyout of Allergan, acquired for $63 billion last year. The company’s neuroscience and aesthetics units delivered double-digit sequential growth, with demand for the anti-wrinkle drug Botox rebounding from pandemic lows to $584 million.

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