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$AMGN expects to continue making long-term investments now, while also being able to return excess capital to its shareholders in the form of growing dividends and share buybacks. Based on confidence and the long-term outlook for the business is enhanced by the benefits of tax reform, $AMGN has lifted its share repurchase authorization by $10Bil.
With improved clarity on tax reform, $AMGN expects to invest on order of $2.5Bil in CapEx in the U.S. over the next 5 years. $AMGN sees tax reform benefiting in other areas as well. Amgen Ventures will also make close to $300MM available for new investments in biotech, digital healthcare information companies.
$AMGN said Repatha is exactly the type of innovation needed to bring down the risk of cardiovascular disease. The company expects Repatha to be the important growth driver for many years to come. $AMGN will continue to work to ensure that patients gain access to this therapy worldwide especially for other therapies that have not proven effective.
$AMGN entered 2018 in a strong position and confident about its long-term outlook. $AMGN expects the franchises, which have come off patent in nephrology and oncology, to remain competitive. The brands that $AMGN expects to drive future growth led of course by Repatha, Prolia, and KYPROLIS, with Aimovig and the biosimilars coming close behind.
$AMGN expects to invest about $3.5Bil in capital expenditures over the next 5 years, with about 75% of that investment in the U.S., up from about 50% in recent years. The construction and validation work is expected to add 220 jobs to the local economy. Also, $AMGN expects this new facility to employ up to 300 highly skilled full-time employees.
$AMGN's Enbrel sales for 4Q17 decreased 13% due to lower unit demand and net selling price. Neulasta sales were flat as lower unit demand was offset by favorable changes in accounting estimates. Aranesp sales fell 7% due to lower unit demand, favorable prior year changes in accounting estimates and unfavorable changes in foreign exchange rates.
$AMGN's BoD authorized an additional $10Bil of share repurchases. This authorization is in addition to the existing $4.4Bil in share repurchase authorization as of Dec. 31, 2017. Cash returned to shareholders totaled $6.5Bil in 2017 through dividends and share repurchases.
$AMGN slipped to a loss in 4Q17 from a profit last year, due to the inclusion of a $6.1Bil charge related to the impacts of the U.S. corporate tax reform. Net loss was $4.26Bil or $5.89 per share compared to a profit of $1.94Bil or $2.59 per share a year ago. Revenue fell 3% to $5.8Bil. Non-GAAP EPS were flat at $2.89.
$AMGN gets US FDA's approval for the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
$AMGN said the final analysis of Phase 3 ASPIRE trial showed KYPROLIS combined with dexamethasone and lenalidomide reduced the risk of death among patients with relapsed or refractory multiple myeloma by 21% and extended survival by nearly eight months, compared with patients treated with the two drugs alone.
FDA accepts to review $LLY's Galcanezumab, an injectionable drug for the treatment of migraine. Rivals $NVS and $AMGN already filed their migraine drug with FDA in July 2017, while $TEVA is also expected to join the race. Lilly's pain portfolio also includes Tanezumab, developed in partnership with $PFE, for the treatment of osteoarthritis.
$AMGN announced five new subgroup analyses from the Repatha cardiovascular outcomes study (FOURIER). The study showed the addition of Repatha to statin therapy improved clinical outcomes with significant reduction of cardiovascular events in high-risk patients with peripheral artery disease and in patients with a history of heart attack.
$AMGN said its growth brands, including Prolia, Repatha, KYPROLIS and BLINCYTO are all exhibited solid unit volume growth in 3Q17. Looking ahead to next year, the company expects to begin tackling another significant unmet medical need in migraine, as it continues to receive positive feedback on Aimovig.
$AMGN upped its FY17 adjusted earnings forecast to $12.50 to $12.70 per share from its earlier view of $12.15 to $12.65. The company sees GAAP earnings in the range of $10.96 to $11.20 per share, with revenue ranging between $22.7Bil and $23Bil.
$AMGN reported a flat profit of $2Bil, or $2.76 per share, for 3Q17 compared to a year ago, as the world's largest biotech drugmaker saw a 1% dip in revenue. The company, which is in the process of refreshing its product portfolio, saw its product sales dropping 1% with sales declining in some of its established products.
$AMGN has entered into a neuroscience research collaboration with Boston Children's Hospital, which aims at identifying novel pain targets based on human genetic analyses. The one-year collaboration will focus on patients with genetic anomalies of pain sensitivity.