2019-04-24 13:04:51 | Fly Intel: What to watch in AbbVie earnings reportAbbVie (ABBV) is scheduled to report the results of its first fiscal quarter before the market open on April 25, with a conference call scheduled for 9:00 am EDT. What to watch for: 1. 2019 GUIDANCE: With its fourth quarter report on January 25, AbbVie said it sees first quarter earnings per share of $2.05-$2.07 on revenue of approximately $7.7B. At the time, analysts were modeling Q1 EPS of $2.03 on revenue of $8B. AbbVie also gave a first glimpse of its 2019 outlook with its Q4 report, saying it saw revenue growth of approximately 1% and FY19 EPS coming in at $8.65-$8.75. Analysts had estimated FY19 EPS of $8.71 per share at the time. HUMIRA FRANCHISE: In its extensive product portfolio, Humira is AbbVie's blockbuster. Humira, which is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and psoriasis, accounts for nearly $20B in global sales. AbbVie has been preoccupied with the looming patent cliff set to start impacting its sales in the U.S. Global Humira sales increased only 0.5% on a reported basis in Q4, or 1.4% operationally, excluding the impact from foreign exchange. Internationally, Humira sales declined 14.8% operationally, due to direct biosimilar competition in certain international markets. In late 2018, Mylan (MYL) announced that it initiated the commercial launch of Hulio, a biosimilar to AbbVie's Humira, across major markets in Europe. PIPELINE: At a conference last year, AbbVie said it expects non-Humira sales to grow more than $35B in 2025. The company noted recently that its portfolio has the potential to address more than 80% of the hematologic malignancies market. In 2018, AbbVie announced that the FDA had granted accelerated approval to Venclexta in combination with azacitidine, or decitabine, or low-dose cytarabine, for the treatment of newly diagnosed acute myeloid leukemia in adults. AbbVie also announced that it has submitted a New Drug Application to the FDA and a marketing authorization application to the European Medicines Agency for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis. This Tuesday, AbbVie announced that the FDA approved Skyrizi, an interleukin-23 inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Skyrizi is expected to be available in the U.S. in early May. | |
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