AbbVie (ABBV) is scheduled to report the results of its fourth fiscal quarter before the market open on January 25, with a conference call scheduled for 9:00 am EDT. What to watch for: 1. 2018 GUIDANCE: With its third quarter report on November 2, AbbVie raised its FY18 adjusted EPS view to $7.90-$7.92 from $7.76-$7.86. At the time of the report, the consensus estimate was $7.88. On the company’s Q3 earnings conference call in early November, the drug company said it anticipates Q4 EPS in the range of S $1.89-$1.91 versus a consensus of $1.96. Soon after the earnings report in November, Piper Jaffray analyst Christopher Raymond said he was maintaining a Neutral rating on AbbVie after the company’s Q3 earnings results, which Raymond noted were better than expected. However, the analyst was cautious given management’s indication of growing headwinds, which he believes “portend a meaningful downward revision to FY19 consensus.” Additionally, Raymond said he sees AbbVie “married to the prospects of Humira,” which he believes now faces international headwinds competing with four biosimilars. 2. LOOKING BEYOND HUMIRA: On October 19, Mylan (MYL) announced that it initiated the commercial launch of Hulio, a biosimilar to AbbVie’s Humira, across major markets in Europe. The product, which is approved for all adalimumab indications, will be available to patients as soon as possible, Mylan said in a statement. The European Commission approved Hulio in September. According to an article written by Dan Stanton for BioProcess International, Mike Severino, AbbVie’s vice chairman and president, said new product launches will offset any losses from biosimilar competition. “We expect revenue from our non-Humira growth platform, including our durable base business and innovative new products, will grow to more than $35B in 2025”, said the AbbVie executive during a recent presentation at the 37th JP Morgan Healthcare Conference. 3. PIPELINE: At a recent conference 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. On November 21, 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 who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. Additionally, on December 20, AbbVie 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. The NDA and MAA are supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five Phase 3 studies. Just last week, AbbVie announced that its Phase 3 study of ibrutinib did not meet its primary endpoint.
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