10-QPeriod: Q1 FY2023

AbbVie Inc. Quarterly Report for Q1 Ended Mar 31, 2023

Filed May 5, 2023For Securities:ABBV

Summary

AbbVie Inc. reported first-quarter 2023 results with net revenues of $12.2 billion, a decrease of 9.7% on a reported basis and 8.3% on a constant currency basis compared to the prior year. This decline was primarily driven by the impact of direct biosimilar competition for Humira following its loss of exclusivity in the U.S. at the end of January 2023, leading to a 25.2% decrease in Humira sales globally. Despite the revenue decline, AbbVie demonstrated growth in key products such as Skyrizi (up 44.7%) and Rinvoq (up 47.5%), indicating successful expansion of its newer growth drivers. The company also reported significant R&D expenses, including a $630 million impairment charge related to an intangible asset, and a substantial increase in other expenses due to a $1.9 billion change in the fair value of contingent consideration liabilities, largely favorable. Diluted earnings per share significantly decreased to $0.13 from $2.51 in the prior year, impacted by these non-recurring charges and the amortization of intangibles.

Financial Statements
Beta
Revenue$12.22B
Cost of Revenue$3.99B
Gross Profit$8.24B
SG&A Expenses$3.04B
Operating Expenses$9.46B
Operating Income$2.77B
Interest Expense$553.00M
Net Income$239.00M
EPS (Basic)$0.13
EPS (Diluted)$0.13
Shares Outstanding (Basic)1.77B
Shares Outstanding (Diluted)1.78B

Key Highlights

  • 1Net revenues declined by 9.7% to $12.2 billion, primarily due to Humira's loss of exclusivity in the U.S. and subsequent biosimilar competition.
  • 2Growth in immunology products Skyrizi and Rinvoq was strong, increasing 44.7% and 47.5% respectively, signaling their increasing contribution to revenue.
  • 3Diluted EPS dropped significantly to $0.13 from $2.51 in Q1 2022, heavily impacted by a $1.8 billion unfavorable change in fair value of contingent consideration, a $630 million intangible asset impairment, and substantial amortization expenses.
  • 4Operating earnings decreased by 41.2% to $2.8 billion, reflecting the lower revenues and increased R&D expenses.
  • 5AbbVie continued robust investment in R&D, with expenses increasing 53% to $2.3 billion, including a significant intangible asset impairment charge.
  • 6The company maintained a strong cash flow from operations, generating $4.2 billion, while also returning cash to shareholders through $2.7 billion in dividends and $1.6 billion in share repurchases.

Frequently Asked Questions

The primary reason for the decrease in net revenues is the loss of exclusivity for Humira in the United States in January 2023, leading to the introduction of biosimilar competition. This resulted in a substantial decline in Humira sales globally.

AbbVie is pursuing strategies to maintain broad formulary access for Humira and manage the impact of biosimilar erosion. The company is also focusing on the growth of its newer immunology products, Skyrizi and Rinvoq, which are demonstrating strong performance.

The significant decrease in diluted EPS to $0.13 from $2.51 in the prior year was primarily due to several factors including a substantial increase in 'Other expense (income), net' ($1.8 billion charge from the change in fair value of contingent consideration liabilities), a $630 million intangible asset impairment charge, and ongoing amortization of intangible assets related to past acquisitions.

Yes, the filing highlights progress in the immunology segment with positive Phase 3 results for Skyrizi in ulcerative colitis and an EC approval for Rinvoq in Crohn's disease. In oncology, AbbVie initiated a Phase 3 trial for epcoritamab. For neuroscience, the FDA issued a Complete Response Letter for ABBV-951, requesting more information on the device, and approved Qulipta for chronic migraine prevention.