AbbVie NYSE:ABBV Stock Report

European Commission Approves Abbvie's Rinvoq® (Upadacitinib) as an Oral Treatment for Adults with Active Non-Radiographic Axial Spondyloarthritis

Second quarter 2022 earnings: EPS misses analyst expectations

Second quarter 2022 results: EPS: US$0.52 (up from US$0.42 in 2Q 2021). Revenue: US$14.6b (up 4.5% from 2Q 2021). Net income: US$924.0m (up 23% from 2Q 2021). Profit margin: 6.3% (up from 5.4% in 2Q 2021). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 76%. Over the next year, revenue is forecast to stay flat compared to a 40% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has increased by 30% per year, which means it is tracking significantly ahead of earnings growth.

Abbvie Submits Regulatory Applications to U.S. Food and Drug Administration and European Medicines Agency for Upadacitinib (Rinvoq®) in Crohn's Disease

AbbVie announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ®, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active Crohn's disease. The applications to the FDA and EMA are supported by data from three Phase 3 clinical trials, including two induction studies (U-EXCEED & U-EXCEL) and one maintenance study (U-ENDURE). Across all three studies, significantly more patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response, with clinical remission measured by the Crohn's Disease Activity Index (CDAI) or by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP). Additionally, more patients receiving upadacitinib 45 mg once daily at week 12 in the induction studies or 15 mg and 30 mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission per CDAI and per SF/AP compared to placebo among patients taking corticosteroids at baseline. The safety results of upadacitinib in U-EXCEED, U-EXCEL and U-ENDURE were generally consistent with the known safety profile of upadacitinib, with no new safety risks observed. About Crohn's Disease: Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain. It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery. Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.10 About the U-EXCEED and U-EXCEL Induction and U-ENDURE Maintenance Studies: The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of upadacitinib 45 mg once daily as induction therapy, and upadacitinib 15 mg and 30 mg once daily as maintenance therapy in adults with moderately to severely active Crohn's disease. Topline results from U-EXCEED and U-EXCEL induction studies were announced in December 2021 and February 2022, respectively, and topline results from the U-ENDURE maintenance study were announced in May 2022. These studies include assessments of efficacy, safety and tolerability of upadacitinib. More information on these trials can be found at www.clinicaltrials.gov (NCT03345836, NCT03345849, NCT03345823). About upadacitinib (RINVOQ®): Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs. JAK-2, JAK-3 and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. The use of upadacitinib in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities. RINVOQ® (upadacitinib) U.S. Use and Important Safety Information: RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated; Adults with active psoriatic arthritis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated; Adults with moderate to severe ulcerative colitis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active ankylosing spondylitis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, or ankylosing spondylitis. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended. RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.