OREANDA-NEWS. Shire plc (“Shire”) (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the three months ended June 30, 2016, inclusive of the Baxalta transaction that closed on June 3, 2016.

Financial Highlights Q2 2016(1) Growth(1) Non GAAP CER(1)(2)
Product sales $2,322 million +57% +58%
Product sales excluding Baxalta products $1,763 million +19% +20%
Total revenues $2,429 million +56% +57%
US GAAP operating income from continuing operations $96 million (27%)  
Non GAAP operating income(2) $972 million +58% +57%
US GAAP net income margin(3) (7) % (17pps)(4)  
Non GAAP EBITDA margin(2) 40% +1pps  
US GAAP net loss ($162 million) (202%)  
Non GAAP net income(2) $773 million +48%  
US GAAP diluted losses per ADS ($0.71) (188%)  
Non GAAP diluted earnings per ADS(2) $3.38 +29% +28%
US GAAP net cash provided by operating activities $591 million +31%  
Non GAAP cash generation(2) $853 million +69%  
Non GAAP free cash flow(2) $464 million +7%  

(1) Results include Baxalta Inc. (“Baxalta”) (acquired on June 3, 2016) and Dyax Corp. (“Dyax”) (acquired on January 22, 2016). 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 22 – 23.
(3) US GAAP net income as a percentage of total revenues.
(4) Percentage point change (“pps”).

Q2 2016 and Recent Highlights:

  • Strong topline growth delivered across the business; legacy Shire product sales increased 19% in Q2 2016, legacy Baxalta product sales increased 12% on a pro forma basis in Q2 2016.
  • Achieved significant progress on the Baxalta integration with upgraded guidance; operating cost synergy expectations increased by 40% to at least $700 million in year three post close.
  • Obtained FDA approval of Shire’s first medicine in ophthalmics, XIIDRA (lifitegrast ophthalmic solution) 5%; U.S. launch expected in Q3 2016.
  • Strong pipeline progress across many late stage product candidates:
    • Received a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) recommending marketing authorization for ONIVYDE for treatment of adult patients with metastatic adenocarcinoma of the pancreas who have progressed following gemcitabine-based therapy.
    • Completed decentralized procedure to support European approval of CUVITRU, expanding therapeutic options within our Immunology portfolio.
    • Reported encouraging topline efficacy and safety data for SHP465 in adults with ADHD supporting an FDA resubmission planned by the end of 2016.
    • Expanded our gastrointestinal portfolio with in-licensing from Pfizer of late-stage asset, SHP647 (formerly known as PF-00547659), for the potential treatment of moderate-to-severe Inflammatory Bowel Disease (“IBD”).

Flemming Ornskov, M.D., M.P.H., Chief Executive Officer, commented:

“The second quarter marked an important milestone in Shire’s history, as we completed the combination with Baxalta to create the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. While closing this transformative deal and making significant progress on integration, we have delivered strong double-digit revenue growth from our legacy Shire franchises, and for the first time our results reflect a significant contribution from the legacy Baxalta franchises – allowing us to upgrade our guidance for full year 2016.

“In addition, we have advanced key assets in development and have a robust, innovative clinical pipeline with approximately 40 programs focused on areas of significant unmet medical need. We were pleased to receive approval from the FDA for XIIDRA, the first FDA-approved treatment for the signs and symptoms of dry eye disease and the first product in our developing franchise in ophthalmics. We also received a positive CHMP opinion for ONIVYDE, and completed the decentralized procedure to support European approval of CUVITRU, expanding therapeutic options within our Immunology portfolio. Lastly, we are on track for an FDA resubmission for SHP465 later this year to strengthen our ADHD product offerings.

“Baxalta integration activities continue to progress very well and, with our new operating structure in place, we are raising our operating cost synergy expectations by 40% to at least $700 million in year three post close. This would not have been possible without the commitment of all our employees, who have worked tirelessly in recent months to help drive efficiencies across the business, so that we can continue to deliver best-in-class therapies to patients around the world. We remain resolutely focused on achieving our goals, and I am very confident that Shire will continue to deliver strong growth as we integrate Baxalta and advance our combined portfolio of products.”

 

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.