Shire announces Full Year 2015 Results

Shire delivers record full-year revenue and strong double digit growth in Non GAAP diluted earnings per ADS

Transformational M&A achieved through NPS and Dyax acquisitions and the announced combination with Baxalta

Positioned for future growth with most robust pipeline in Shire’s history

February 11, 2016 – Shire (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the year to December 31, 2015.

⁽¹⁾ Results and percentages compare to the full financial year 2014.
⁽²⁾ On a Constant Exchange Rate (“CER”) basis, which is a Non GAAP measure.
⁽³⁾ Product sales including NPS Pharmaceuticals Inc. (“NPS”) acquired on February 21, 2015.
⁽⁴⁾ Non GAAP earnings before interest, tax, depreciation and amortization (“EBITDA”) as a percentage of product sales, excluding royalties and other revenues.
⁽⁵⁾ Percentage point change (“pps”).
⁽⁶⁾ US GAAP net income as a percentage of total revenues.
⁽⁷⁾ US GAAP net income margin, diluted earnings per American Depositary Share (“ADS”) and net cash provided by operating activities in 2014 benefited from the receipt of a $1,635 million break fee in relation to the terminated offer for Shire by AbbVie Inc. (“AbbVie”).

The Non GAAP financial measures included within this release are explained on page 33 - 34, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 24 - 30.

Full Year & Recent Highlights:

• 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.

Our continued focus on innovation has resulted in Shire entering 2016 with the most robust pipeline in its history, now with 14 programs either in Phase 3 or Phase 3 ready, and with the acquisition of Dyax and the planned combination with Baxalta, we are positioned for global leadership in rare diseases.

We expect to deliver strong results in 2016 as we anticipate generating double digit topline growth and a 7% to 10% increase in Non GAAP diluted earnings per ADS, while continuing to invest behind lifitegrast, Dyax and our pipeline. Our 2016 Outlook includes the effect of the Dyax acquisition but excludes the effect of the announced combination with Baxalta.”

Download the PDF for the full release

For further information please contact:

Dial in details for the live conference call for investors at 14:00 GMT / 09:00 EST on February 11, 2016:

The quarterly earnings presentation will be available today at 13:00 GMT / 08:00 EST on:

- Shire.com Investors section

- Shire's IR Briefcase in the iTunes Store