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Shire Reports Record Full-year Revenue and Strong Double Digit Growth in Non GAAP Diluted Earnings per ADS

Vivien Diniz
Feb. 11, 2016 10:29AM PST
Life Science Investing

Shire (LSE:SHP, NASDAQ:SHPG) announced its unaudited results for the year to December 31, 2015.

Shire (LSE:SHP, NASDAQ:SHPG) announced its unaudited results for the year to December 31, 2015.
According to the press release, the full year and recent highlights include:

  • Delivered product sales growth of 10% excluding INTUNIV (14% on a Non GAAP CER basis) driven by the strong performance from VYVANSE®, CINRYZE®, FIRAZYR®, LIALDA®/MEZAVANT®, and the inclusion of GATTEX®/REVESTIVE® and NATPARA®.

  • Achieved Non GAAP diluted earnings per ADS growth of 10% (14% on a Non GAAP CER basis), exceeding our upgraded guidance provided in Q2 2015, while investing in future growth drivers.

  • Expanded commercial portfolio with NPS-acquired products, GATTEX/REVESTIVE and NATPARA, and launch of VYVANSE in the Binge Eating Disorder (“BED”) adult indication.

  • Significantly progressed pipeline, now with 14 programs either in Phase 3 or Phase 3 ready.

  • Advanced ophthalmic portfolio with the US Food and Drug Administration (“FDA”) acceptance of lifitegrast New Drug Application (“NDA”) resubmission on February 4, 2016 with a Prescription Drug User Fee Act (“PDUFA”) date of July 22, 2016, and the acquisition of Foresight Therapeutics, Inc.; SHP607 Phase 2 topline data in Retinopathy of Prematurity expected in mid-2016.

  • Closed the acquisitions of NPS in February 2015 and Dyax Corp. (“Dyax”) in January 2016.

  • Reached merger agreement with Baxalta Incorporated (“Baxalta”), which at closing would create the global leader in rare diseases; expected to deliver over $20 billion in annual revenues by 2020.

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

In 2015, we significantly advanced our strategy to become a leading global biotechnology company focused on rare diseases and other specialty conditions.  We executed significant acquisitions to deliver best-in-class therapies in our core therapeutic areas, further strengthened our position in rare diseases, and advanced our innovative dry eye treatment, lifitegrast, including the recent FDA acceptance of our NDA resubmission.
As we transformed our business in 2015, we also achieved record full year revenue and strong Non GAAP diluted earnings per ADS growth. I am particularly pleased with our top and bottom-line growth, delivered while we continued our investment in future growth drivers.  Importantly, we again demonstrated our ability to accelerate the growth of rare disease assets that we have acquired, most recently with NPS.

Click here to view the full press release. 

rare disease fda acceptance food and drug administration new drug application
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