Press Release
AbbVie Reports Full-Year 2015 and Fourth-Quarter Financial Results
Published: Jan 29, 2016 7:47 a.m. ET
- Reports Full-Year Adjusted EPS of $4.29, Up 29.2 Percent; GAAP EPS of $3.13- Delivers Full-Year Adjusted Net Revenues of $22.819 Billion, Up 22.1 Percent on an Operational Basis; GAAP Net Revenues of $22.859 Billion, Up 14.5 Percent- Expanded Adjusted Operating Margin to 42.3 Percent in 2015, Up 610 Basis Points; Adjusted Gross Margin of 82.9 Percent, Up 280 Basis Points- Reports Fourth-Quarter Adjusted EPS of $1.13, Up 27 Percent; GAAP EPS of $0.92- Reports Fourth-Quarter Adjusted Net Revenues of $6.360 Billion, Up 24.4 Percent on an Operational Basis; GAAP Net Revenues of $6.40 Billion, Up 17.4 Percent- Revenue Growth in the Quarter Reflects 16.0 Percent Global Operational Sales Growth from HUMIRA; Reported Global HUMIRA Sales Increased 10.5 Percent- Fourth-Quarter Global IMBRUVICA Net Revenue was $343 Million; Fourth-Quarter Global VIEKIRA Sales were $554 Million- Confirms 2016 Adjusted EPS Guidance Range of $4.90 to $5.10, Reflecting Strong Double-Digit Growth Versus 2015
NORTH CHICAGO, Ill., Jan. 29, 2016 /PRNewswire/ -- AbbVie ABBV, -2.21% today announced financial results for the fourth quarter and full year ended Dec. 31, 2015.
"AbbVie delivered strong performance in 2015, exceeding original sales, margin expansion, and earnings projections for the year," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We achieved significant growth in 2015, and expect to continue building on that momentum in 2016 with another year of strong performance."
Fourth-Quarter Results
•Worldwide adjusted net revenues were $6.360 billion in the fourth-quarter, up 18.4 percent. On an operational basis, adjusted net revenues increased 24.4 percent, excluding a 6.0 percent unfavorable impact from foreign exchange rate fluctuations.
•Global HUMIRA sales increased 16.0 percent on an operational basis, excluding the impact of foreign exchange. Exceptional U.S. HUMIRA growth of 20.7 percent was driven by continued momentum across all three major market categories - rheumatology, dermatology and gastroenterology. International HUMIRA sales growth was also strong in the fourth quarter, up 9.7 percent on an operational basis. Reported international HUMIRA sales growth in the quarter was reduced by 13.1 percent due to unfavorable foreign exchange.
•Fourth-quarter global IMBRUVICA net revenue was $343 million, with U.S. sales of $295 million and international profit sharing of $48 million for the quarter.
•Total company revenue growth was also driven by $554 million in global VIEKIRA sales in the quarter, as well as strong operational growth from Duodopa, Creon and Lupron.
•Adjusted gross margin ratio in the fourth quarter was 80.5 percent, excluding intangible asset amortization and other specified items. On a GAAP basis, the gross margin ratio was 77.0 percent.
•Adjusted selling, general and administrative (SG&A) expense was 23.9 percent of net revenues in the fourth quarter. On a GAAP basis, SG&A was 27.1 percent of net revenues.
•Adjusted research and development (R&D) expense was 15.9 percent of net revenues in the quarter, reflecting funding actions in support of our mid- and late-stage pipeline. On a GAAP basis, R&D was 16.8 percent of net revenues.
•Adjusted operating margin in the fourth quarter was 40.1 percent, compared to 35.8 percent in fourth-quarter 2014. On a GAAP basis, the operating margin was 33.0 percent.
•Net interest expense was $199 million. The adjusted tax rate in the quarter was 21.6 percent and 21.1 percent on a GAAP basis.
•Adjusted diluted earnings per share, excluding intangible asset amortization expense and other specified items, were $1.13 in the fourth quarter, up 27 percent. Diluted earnings per share were $0.92 on a GAAP basis.
Key Events from the Fourth Quarter
•AbbVie submitted a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA®) to the U.S. Food and Drug Administration (FDA) for use in treatment-naïve chronic lymphocytic leukemia (CLL) patients, based on results from the Phase 3 RESONATE™-2 study. These data, published in The New England Journal of Medicine (NEJM), found that IMBRUVICA significantly decreased the risk of progression or death (progression-free survival, PFS) and significantly decreased the risk of death (overall survival, OS) versus chlorambucil in treatment-naïve patients 65 years and older with CLL.
•AbbVie submitted a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for venetoclax in patients with relapsed/refractory (R/R) CLL in patients with chromosome 17p deletion to the FDA and European Medicines Agency (EMA), respectively. Priority review status was granted by the FDA and validation provided by the EMA for these submissions based on results from a Phase 2, open-label trial that found treatment with venetoclax demonstrated a 79.4 percent overall response rate (ORR) as monotherapy treatment, including patients that achieved complete remission.
•AbbVie has now received three FDA Breakthrough Therapy Designations for venetoclax. The first designation was received early last year for the treatment of patients with R/R CLL with chromosome 17p deletion. The second designation for venetoclax was received earlier this month for combination therapy with rituximab for patients with R/R CLL, including those with chromosome 17p deletion. A third designation was received this week for venetoclax in combination with hypomethylating agents (HMAs) in patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy).
•AbbVie submitted a sNDA to the FDA for labeling considerations based on safety and efficacy results from the Phase 3 HELIOS trial of IMBRUVICA in patients with R/R CLL. The trial found that treatment with IMBRUVICA plus bendamustine and rituximab, versus placebo plus rituximab, significantly reduced the risk of disease progression or death by 80 percent and significantly improved ORR compared to placebo plus rituximab in previously-treated CLL/SLL patients.
•The FDA accepted AbbVie's sNDA and granted priority review for VIEKIRA PAK without ribavirin in patients with genotype 1b (GT1b) chronic hepatitis C virus infection (HCV) and compensated cirrhosis (Child-Pugh A). The application was supported by data from the TURQUOISE-III study, which showed 100 percent sustained virologic response at 12 weeks post-treatment (SVR12) in this patient