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The FDA approved $ABBV’s Mavyret to treat adults with chronic hepatitis C virus across all major genotypes (GT1-6). It is an 8-week treatment for patients without cirrhosis and who are new to treatment. Up to 95% of HCV patients in the U.S. may be eligible for the new cure, including those with compensated cirrhosis and limited treatment options.
$ABBV expects 1Q18 adjusted EPS of $1.77-1.79 excluding about $0.31 as specified items. $ABBV anticipates 1Q18 operational revenue growth approaching the mid-teens. Holding exchange rates constant at current levels, the company would expect foreign exchange to have a favorable impact on reported sales growth of 3% in 1Q18.
On the topline in 2018, $ABBV expects revenue approaching $32Bil, which reflects favorable impact from foreign currency of roughly 1.5%. Included in this are the assumptions for the company's key products. Humira will maintain its strong position as the front-line therapy across therapeutic segments and continues to be an important growth driver.
$ABBV's ongoing Phase 3 studies in small-cell lung cancer also continue to advance, with the Tahoe study in second-line setting and the Meru trial in front-line patients both now well underway. $ABBV is also evaluating Rova-T with Opdivo and with Opdivo and Yervoy in mid-stage combination study with potential to start seeing data later in the year.
This year, $ABBV will launch major label expansion for Vebclexta in relapsed/refractory cancer type chronic lymphocytic leukemia as well as elagolix in endometriosis. Endometriosis is painful disorder in which tissue that normally lines inside of uterus grows outside.
In 2018, $ABBV plans to accelerate pension funding by $750MM as well as enhancing non-executive employee compensation. $ABBV is also planning one-time shareable contribution of about $350MM to select not-for-profit organizations, supporting initiatives such as the Puerto Rico rebuilding efforts, children's healthcare access programs, and charities.
Over next 5 years, $ABBV plans to invest about $2.5Bil in capital projects in the U.S. and the company is currently evaluating additional expansion of its U.S. facilities. The company also plans to accelerate pension funding by $750MM, as well as enhance non-executive employee compensation.
$ABBV expects FY18 EPS of $6.45-6.55. The company lifted its 2018 adjusted EPS guidance to $7.33-7.43 from $6.37-6.57, to reflect the impact of U.S. tax reform and stronger operating performance. $ABBV sees adjusted effective tax rate to increase to 13% over next 5 years as a result of increased domestic income and investment.
$ABBV reported a drop in 4Q17 earnings due to about $4.5Bil of tax charge arising from enactment of the Tax Cuts and Jobs Act. Net income fell to $52MM or $0.03 per share from $1.4Bil or $0.85 per share last year. Net revenue grew 14% to $7.74Bil. Adjusted EPS increased 23.3% to $1.48.
Biotech company $ENTA swung to 4Q17 profit on higher revenue, driven by milestone payments totaling $65MM received following $ABBV's U.S. approval of MAVYRET and EU approval of MAVIRET. Net income was $36.5MM or $1.86 per share in the quarter compared to a net loss of $1.8MM, or $0.09 loss per share a year earlier. Revenue jumped to $75.9MM.
As $ABBV posted 3Q17 results, it now sees full-year gross margin as a percentage of sales at 80.5% and operating margin at 42.5%. AbbVie also expects full-year net interest expense of approximately $1Bil with an adjusted tax rate of about 19%.
As $ABBV posted 3Q17 results, it updated its GAAP diluted EPS guidance for FY17 to $4.27-4.29. AbbVie now expects to deliver adjusted diluted EPS for the full year of $5.53-5.55. The drug giant now sees global HUMIRA sales to approach $21Bil in 2020.
With worldwide net revenues jumping 8.8% to about $7.0Bil in 3Q17, $ABBV saw net earnings inch up 2% to $1.6Bil or $1.01 per diluted share. Global HUMIRA sales saw a 15% hike while global IMBRUVICA net revenues surged 37% in the quarter.
$ABBV announced that the Japanese Ministry of Health, Labor and Welfare has approved MAVIRET, a once-daily, treatment for adults with chronic hepatitis C virus infection. The treatment was also recently granted marketing authorization by the European Commission and approved by the US FDA.