The FINANCIAL — Amgen on April 21 announced financial results for the first quarter of 2015. Key results include:
Total revenues increased 11 percent versus the first quarter of 2014 to $5,033 million, with 12 percent product sales growth driven primarily by Enbrel (etanercept), Prolia (denosumab), EPOGEN (epoetin alfa), Sensipar (cinacalcet) and XGEVA (denosumab). Unfavorable changes in foreign exchange rates impacted total revenue and product sales growth by 2 percentage points, according to Amgen.
Adjusted EPS grew 33 percent versus the first quarter of 2014 to $2.48 driven by higher revenues and lower operating expenses. Adjusted operating income increased 32 percent to $2,449 million.
GAAP EPS were $2.11 compared to $1.40 and GAAP operating income was $2,022 million compared to $1,364 million.
The Company generated $1.2 billion of free cash flow compared to $1.0 billion in the first quarter of 2014.
First Quarter 2015 Product Sales Performance
Total product sales increased 12 percent for the first quarter of 2015 versus the first quarter of 2014. The increase was driven primarily by ENBREL, Prolia, EPOGEN, Sensipar and XGEVA. Growth for the quarter was due to price and higher unit demand.
Neulasta (pegfilgrastim) sales increased 4 percent year-over-year driven primarily by price. NEUPOGEN (filgrastim) sales decreased 15 percent year-over-year driven primarily by the impact of competition in the United States (U.S.).
ENBREL sales increased 13 percent year-over-year driven by price.
XGEVA sales increased 22 percent year-over-year driven by higher unit demand.
Prolia sales increased 39 percent year-over-year driven by higher unit demand.
EPOGEN sales increased 16 percent year-over-year due primarily to price and, to a lesser extent, higher unit demand.
Aranesp (darbepoetin alfa) sales increased 4 percent year-over-year driven by higher unit demand in international markets.
Sensipar/Mimpara sales increased 24 percent year-over-year driven by higher unit demand, favorable changes in inventory levels, and price.
Nplate (romiplostim) sales increased 12 percent year-over-year driven by higher unit demand.
Vectibix (panitumumab) sales increased 18 percent year-over-year driven by higher unit demand.
Kyprolis (carfilzomib) sales increased 59 percent year-over-year driven by higher unit demand.
Operating Expense and Tax Rate Analysis, on an Adjusted Basis
Cost of Sales margin improved 0.6 points.
Research & Development (R&D) expenses decreased 14 percent in the first quarter of 2015 driven by savings from transformation and process improvement efforts.
Selling, General & Administrative (SG&A) expenses increased 1 percent in the first quarter of 2015 as increased commercial expenses for new product launches were enabled by savings from transformation and process improvement efforts.
Tax Rate for the first quarter of 2015 increased due to changes in the geographic mix of earnings, offset partially by the favorable impact of a state tax audit settlement.
Cash Flow and Balance Sheet Discussion
The Company generated $1.2 billion of free cash flow in the first quarter of 2015 versus $1.0 billion in the first quarter of 2014.
The Company’s second quarter 2015 dividend of $0.79 per share declared on March 4, 2015, will be paid on June 5, 2015, to all stockholders of record as of the close of business on May 14, 2015.
During the first quarter, the Company repurchased 2.9 million shares of common stock at a total cost of $0.5 billion. The Company has $3.4 billion remaining under its stock repurchase authorization.
2015 Guidance
For the full year 2015, the Company now expects:
Total revenues in the range of $20.9 billion to $21.3 billion and adjusted EPS in the range of $9.35 to $9.65. Previously, the Company expected total revenues in the range of $20.8 billion to $21.3 billion and adjusted EPS in the range of $9.05 to $9.40.
Adjusted tax rate to be in the range of 18 percent to 19 percent. This excludes the benefit of the federal R&D tax credit, which has not yet been extended for 2015.
Capital expenditures to be approximately $800 million.
The Company provided the following information on selected product and pipeline programs:
Corlanor
The Company discussed the U.S. Food and Drug Administration (FDA) approval to reduce the risk of hospitalization for worsening heart failure in patients with chronic heart failure.
Repatha
The Company discussed the recent submission of an application seeking marketing approval for the treatment of high cholesterol to the Ministry of Health, Labour and Welfare in Japan.
Omecamtiv mecarbil
The Company announced that results from its oral Phase 2 study in patients with heart failure are expected in the second half of 2015.
Kyprolis
The Company discussed the priority review designation granted by the FDA for the relapsed multiple myeloma indication in the U.S. The Company also discussed the upcoming presentation of the Phase 3 ENDEAVOR study results at a meeting of the American Society of Clinical Oncology (ASCO) and the initiation of a Phase 3 study with weekly dosing.
Talimogene laherparepvec
The Company discussed the upcoming FDA Advisory Committee meeting on April 29 to discuss a Biologics License Application (BLA) for treatment of metastatic melanoma. The Company also announced the completion of enrollment in a Phase 1b study in combination with pembrolizumab in metastatic melanoma.
Vectibix
The Company discussed the recent approval for use in combination with FOLFIRI in RAS wild type first-line metastatic colorectal cancer in the European Union (EU).
Brodalumab
The Company announced that it plans to submit a BLA in the U.S. and a Marketing Authorization Application (MAA) in the EU for moderate-to-severe plaque psoriasis mid-year in 2015. The Company also announced the termination of a Phase 2 asthma study due to futility.
AMG 416
The Company announced that it plans to submit a BLA in the U.S. and a MAA in the EU for secondary hyperparathyroidism in the second half of 2015.
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