On November 1, 2016 Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) reported unaudited results for the three months ended September 30, 2016 (Press release, Shire, NOV 1, 2016, View Source [SID1234516161]).

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Financial Highlights Q3 2016(1) Growth(1) Non GAAP CER(1)(2)
Product sales $3,315 million +110% +111%
Product sales excluding Baxalta products $1,769 million +12% +13%
Total revenues $3,452 million +109% +109%
US GAAP operating loss from continuing operations ($406 million) (189%)
Non GAAP operating income(2) $1,254 million +73% +71%
US GAAP net income margin(3)(4) (11%) (38ppc)
Non GAAP EBITDA margin(2)(4) 38% (5ppc)
US GAAP net loss ($387 million) (185%)
Non GAAP net income(2) $962 million +50%
US GAAP diluted losses per ADS ($1.29) (156%)
Non GAAP diluted earnings per ADS(2) $3.17 (2%) (3%)
US GAAP net cash provided by operating activities $526 million (6%)
Non GAAP cash generation(2) $830 million +41%
Non GAAP free cash flow(2) $395 million (27%)

(1)Results include Baxalta Inc. (Baxalta) (acquired on June 3, 2016) and Dyax Corp. (Dyax) (acquired on January 22, 2016), unless otherwise noted. Percentages compare to equivalent 2015 period.
(2)The Non GAAP financial measures included within this release are explained on pages 27 – 28, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 21 – 23.
(3)US GAAP net income as a percentage of total revenues.
(4) Percentage point change ("ppc").

Financial highlights

Very strong launch results for XIIDRA; 64,732 scripts written through October 21, with a market share of 16%.
Product sales growth of 110% in Q3 2016 to $3.3 billion, driven by record legacy Shire product sales and the inclusion of legacy Baxalta franchises.
Underlying growth in Q3 2016 hematology and immunology businesses largely in line with overall market trends; pro forma sales growth of legacy Baxalta products impacted by the timing of large orders.
Q3 2016 year to date growth for legacy Shire product sales was 15% (16% on a Non GAAP CER basis) and legacy Baxalta was 7% on a pro forma basis (8% on a Non GAAP CER pro forma basis), in line with our expectations.
Baxalta integration

Operating expense synergy initiatives ahead of schedule, including manufacturing footprint optimization review.
Sharp focus on transitioning legacy Baxalta products onto Shire’s commercial platform and operating execution.
Issued $12.1 billion aggregate principal debt at a weighted average interest rate of 2.6%; net proceeds used to fully repay bridge facility for financing Baxalta transaction.
Pipeline progress

Pipeline continuing to deliver with U.S. Food and Drug Administration (FDA) approval of CUVITRU, and European Commission (EC) Marketing Authorization for ONIVYDE accompanied by Orphan Drug Designation.
Fully enrolled Phase 3 study for SHP643 in prophylaxis of hereditary angioedema with results expected in the first half of 2017.
FDA resubmission of SHP465 for the treatment of ADHD on track to be made in Q4 2016.
Flemming Ornskov, M.D., M.P.H., Shire Chief Executive Officer, commented:

"During the third quarter, we made rapid progress integrating our new company while delivering record quarterly product sales growth and remaining on track to meet our full year Non GAAP guidance. The launch of XIIDRA is off to a very strong start, and we are using this momentum to build a leadership position in pharmaceutical ophthalmics. Commercial execution remains a top priority across the business. Also, our robust pipeline is continuing to advance, and we look forward to highlighting key programs during our upcoming Investor Day. The changes we are applying to the legacy Baxalta business are similar to the One Shire initiative we undertook in 2013-2014, which set off a period of strong growth and profitability. I am highly confident about Shire’s future growth prospects."