Shire announces third quarter earnings and reiterates full year guidance

Strong commercial execution and pipeline progression

October 23, 2015 – Shire (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the three months to September 30, 2015.

⁽¹⁾ Percentages compare to equivalent 2014 period.
⁽²⁾ On a Constant Exchange Rate (“CER”) basis, which is a Non GAAP measure.
⁽³⁾ Non GAAP earnings before interest, tax, depreciation and amortization (“EBITDA”) as a percentage of product sales, excluding royalties and other revenues.
⁽⁴⁾ Percentage point change (“PPS”).
⁽⁵⁾ US GAAP net income as a percentage of total revenues.

The Non GAAP financial measures included within this release are explained on pages 30 - 31, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 22 - 28.

Highlights:

• Q3 product sales growth of 7% excluding INTUNIV (12% on a Non GAAP CER basis) driven by strong performance from VYVANSE® and the Hereditary Angioedema (“HAE”) portfolio, CINRYZE® and FIRAZYR®.
• NPS Pharmaceuticals’ (“NPS”) products continue to benefit from Shire’s rare disease and gastrointestinal expertise, with the strong US launch of NATPARA® and GATTEX®/REVESTIVE® performing well.
• Strength of intellectual property surrounding VYVANSE affirmed; Court of Appeals for the Federal Circuit upholds lower court’s summary judgment ruling that certain claims of the patents protecting VYVANSE are valid and infringed, preventing Abbreviated New Drug Application (“ANDA”) defendants from launching generic versions of VYVANSE until patent expirations in 2023.
• Pipeline continues to advance, with European approval for INTUNIV and US Fast Track designation for the study of CINRYZE in antibody-mediated rejection (“AMR”) for transplant recipients. Multiple Phase 3 trials expected to start Q4 2015/early-to-mid 2016, including SHP620 for cytomegalovirus (“CMV”) infection in transplant patients, SHP621 for Eosinophilic Esophagitis (“EoE”), and CINRYZE in AMR. 
• On October 16, 2015, the US Food and Drug Administration (“FDA”) issued a complete response letter requesting an additional clinical study to support the new drug application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults. An additional Phase 3 study, OPUS-3, has recently been completed, and topline results are expected before year-end; if positive, data from OPUS-3 will be used to support resubmission in the first quarter of 2016.
• Acquisition of Foresight Biotherapeutics further demonstrates Shire’s commitment to building a leadership position in ophthalmology, with the potential for SHP640 (formerly FST-100) to become the first agent to treat both viral and bacterial conjunctivitis.
• Shire continues to believe the proposed Baxalta acquisition represents a highly strategic combination to create a global rare diseases leader delivering an expected $20 billion in sales by 2020, with an opportunity to create significant shareholder value.

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

“In the third quarter, Shire maintained momentum while advancing the pipeline and investing for the future. VYVANSE again performed strongly in the adult market and we continued to demonstrate leadership in rare diseases, with the growth of our HAE assets, CINRYZE and FIRAZYR, and the strong performance of the recently launched NPS products NATPARA and GATTEX/REVESTIVE. These recent launches and our ongoing success enable us to invest in future growth drivers, including several programs that are preparing to enter Phase 3 in the months ahead.  As we progress our ambition to be a rare diseases leader, we continue to believe the proposed acquisition of Baxalta represents a highly strategic combination, delivering an expected $20 billion in sales by 2020 and a world-leading rare diseases portfolio. Based on the strength of our core business, we are reiterating our recently upgraded full year Non GAAP diluted EPS guidance of mid-to-high single digit growth.”

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 BST / 09:00 EDT on October 23, 2015:

The quarterly earnings presentation will be available today at 13:00 BST / 08:00 EDT on:

- Shire.com Investors section

- Shire's IR Briefcase in the iTunes Store