Exhibit 99.1
Press Release
SHIRELOGOA09.JPG
Shire reports 8% pro forma product sales and strong earnings growth resulting in record operating cash flow for full year 2017
Strong growth driven by Immunology, recently launched products, and global expansion
Improved operating margin and operating cash flow of $4.3 billion enabled achievement of debt target
Significantly advanced innovative pipeline with 15 programs in late-stage development
February 14, 2018 – Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the twelve months ended December 31, 2017 .
Flemming Ornskov, M.D., M.P.H., Shire Chief Executive Officer, commented:
“Shire delivered 8% pro forma product sales growth to $14.4 billion in 2017, an increase of over $1 billion. Of particular note are the strong performance of our Immunology franchise and the significant contribution from recently launched products, as well as growth in international markets. We increased Non GAAP diluted earnings per ADS by 16%, realizing cost synergies ahead of plan.
“2018 is a year of continued focus on commercial execution and targeted investment in our manufacturing infrastructure, new product launches, and pipeline to drive future growth. We expect to deliver mid-single digit product sales growth in 2018 after absorbing the anticipated impact of generics.
“The mid-term outlook for growth is positive driven by our Immunology franchise, multiple near-term launches, and international markets. We are committed to achieving our projected revenue target of $17 - $18 billion in 2020.
“Based on current assumptions, we expect Non GAAP diluted earnings per ADS growth to be lower than top line growth in 2018, mainly due to costs incurred from the start-up of our new U.S. plasma manufacturing site, intensifying genericization, and lower royalties. With the already disclosed manufacturing and SG&A cost reduction initiatives, we are on track to achieve mid-forties Non GAAP EBITDA margin by 2020.”
Product and Pipeline Highlights
Regulatory updates
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Accelerated international expansion and growth, including 126 product approvals globally and 50 product launches at the country level.
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Received two FDA Fast Track Designations, two Orphan Drug Designations, and one Breakthrough Therapy Designation.
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Filed for FDA approval of a new plasma manufacturing facility near Covington, Georgia to support our growing Immunology franchise, and received FDA approval for the technology transfer of the CINRYZE drug product manufacturing process to Vienna, Austria.
Clinical and business development updates
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Advanced pipeline including nine Phase 3 studies completed in 2017 with several key readouts expected in 2018.
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Entered into agreements with Novimmune, MicroHealth and Rani Therapeutics focused on advancing innovation for patients suffering from hemophilia. Parion Sciences focused on Dry Eye Disease and with AB Biosciences focused on autoimmune disorders.
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
Financial Highlights
Full Year 2017 (1)
Growth (1)
Non GAAP CER (1)(2)
Product sales (3)
$14,449 million
+33%
+33%
Product sales excluding legacy Baxalta
$7,461 million
+7%
+6%
Total revenues
$15,161 million
+33%
Non GAAP total revenues (4)
$15,086 million
+32%
+32%
Operating income from continuing operations
$2,455 million
+155%
Non GAAP operating income (2)
$5,997 million
+36%
+36%
Net income margin (5)(6)
28%
25ppc
Non GAAP EBITDA margin (2)(6)
43%
2ppc
Net income
$4,272 million
+1,205%
Non GAAP net income (2)
$4,604 million
+36%
Diluted earnings per ADS (7)
$14.05
+1,006%
Non GAAP diluted earnings per ADS (2)(7)
$15.15
+16%
+16%
Net cash provided by operating activities
$4,257 million
+60%
Non GAAP free cash flow (2)
$3,431 million
+63%