Press Release
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Shire Delivers 7% Product Sales Growth and Robust Pipeline Progress in Q1 2018
Growth driven by Immunology, recently-launched products, and international expansion
Innovative pipeline progresses with 15 programs in Phase 3 and 7 programs in registration including lanadelumab
Delivers Non GAAP diluted earnings per ADS of $3.86 , up 6% year-on-year; GAAP diluted earnings per ADS were $1.81 , up 47%
$1.0 billion in net operating cash flow enabled continued debt pay down
April 26, 2018 – Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG), the leading global biotech company focused on rare diseases, announces unaudited results for the three months ended March 31, 2018 .
Flemming Ornskov, M.D., M.P.H., Shire Chief Executive Officer, commented:
“Shire is off to a good start in 2018 delivering on our key priorities of commercial execution, pipeline progression, debt pay down , and portfolio optimization. We generated product sales growth of 7% in the first quarter reaching $3.6 billion with important contributions from our Immunology franchise, recently-launched products, and international markets. We delivered $1.0 billion in net operating cash flow allowing us to remain on track towards our debt pay down target.
“We continue to advance our innovative pipeline with seven programs in registration including lanadelumab, the first monoclonal antibody being evaluated to prevent hereditary angioedema attacks, with the potential to change the treatment paradigm for this serious and sometimes life threatening rare disease.
“As part of the ongoing review of our portfolio, we recently announced an agreement for the sale of our Oncology franchise for $2.4 billion allowing us to unlock embedded value and sharpen our focus."
Product and Pipeline Highlights
Regulatory updates
•
Advanced lanadelumab with accelerated approval pathways underway in the U.S. (PDUFA date of August 26, 2018), Europe, and Canada.
•
Gained FDA acceptance for additional key filings: CINRYZE sBLA for pediatric use, including Priority Review; prucalopride NDA; and Calaspargase Pegol BLA.
•
Achieved marketing approval of XIIDRA (lifitegrast ophthalmic solution 5%) in Canada and ADYNOVI in E.U.
•
Obtained Breakthrough Therapy Designation for maribavir for cytomegalovirus (CMV) infection in transplant patients from FDA.
Clinical and business development updates
•
Agreed to divest Oncology franchise to Servier S.A.S. for $2.4 billion.
•
Formed pre-clinical research collaboration to evaluate a potential enzyme replacement therapy using NanoMedSyn’s proprietary synthetic derivatives.
Note: Growth rates are on a reported basis unless mentioned otherwise.
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Financial Highlights
Q1 2018
Reported Growth
Non GAAP CER (1)
Product sales Rare Disease (2)
$2,719 million
+10%
+6%
Product sales Neuroscience (2)
$918 million
-2%
-4%
Total product sales
$3,637 million
+7%
+3%
Total revenues
$3,766 million
+5%
+2%
Rare Disease contribution margin (2)
$1,367 million
+2%
•Rare Disease reported contribution margin of $1,367 million , or 48% , and Neuroscience reported contribution margin of $770 million , or 82% .