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Why Abbvie Inc. Slumped 13% In September
What: The large cap biopharma company is investing heavily in R&D to offset risk tied to the looming patent expiration of Humira. Humira generates more than $12 billion in annual sales. Humira accounts for 63% of year-to-date revenue. Expansion into hepatitis C offers billion dollar potential. Competitor Gilead Sciences reports positive phase 3 data for its pan-genotype hepatitis C drug on September 21. Shares dropped 12.8% in September. Source Juno Therapeutics
So what: Humira is AbbVie’s top selling therapy. Sales of $6.6 billion through the first six months of 2015. Patent protection ends on Humira in 2016. AbbVie launched Viekira Pak for hepatitis C in Q1 2015 Viekira Pak Q2 sales tracking at an annualized $1.5 billion pace.
So what continued:
So what continued: Gilead Sciences announces positive data for next-generation, pan-genotype hepatitis C therapy. 99% overall cure rate, including 98% rate in genotype 1. Could reduce demand for Viekira Pak in genotype 1 patients. Robust efficacy across genotypes 1 to 6. Could remove need for genotype testing. Could outmaneuver AbbVie’s pan-genotype next generation therapy: ABT-493 + ABT-530.
Now what: Humira patent risk looms, but efforts underway on next-generation autoimmune drugs. ABT-494: Advancing into late stage trials by year end. 82% of rheumatoid arthritis patients achieved a 20% or greater improvement in symptoms in phase 2 trials. In anti-TNF (such as Humira) non-responders, 71% achieved a 20% or greater improvement. Safety profile potentially better than Humira with most common adverse event being headache. Oral dosing rather than injection dosing like Humira.
Now what continued: Significant opportunity in oncology. Acquired Pharmacyclics in May to get Imbruvica. Fast growing drug with billion dollar annual sales potential. Venetoclax potential regulatory filing by year end. Relapsed/refractory CLL with 17p deletion genetic mutation. Elotuzumab filed for approval. Decision expected in February 2016. Improved progression free survival when added to standard of care.
Now what continued: Absent a Humira successor, significant risk remains. Continue to monitor progress on oncology pipeline. Look for insight into timeline for next-generation pan-genotype HCV therapies during Q3 EPS report. Recent decline may offer opportunity if company can execute on its plan to overcome Humira risk. Underweight in portfolios until clarity exists.