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Shire (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the year to December 31, 2014.
|Financial Highlights||Full Year 2014||Growth(1)|
|Product sales||$5,830 million||+23%(2)(3)|
|Total revenues||$6,022 million||+22%|
|Non GAAP operating income||$2,593 million||+39%|
|US GAAP operating income||$1,698 million||-2%|
|Non GAAP EBITDA margin (excluding royalties & other revenues)(4)||44%||+6 pps(5)|
|US GAAP net income margin(6)||57%||+44 pps|
|Non GAAP diluted earnings per ADS||$10.60||+38%|
|US GAAP diluted earnings per ADS||$17.28||+390%|
|Non GAAP cash generation||$2,402 million||+35%|
|Non GAAP free cash flow||$2,529 million||+94%|
|US GAAP net cash provided by operating activities||$4,228 million||+189%|
(1) Results and percentages compare to the full financial year 2013.
(2) Product sales from continuing operations, including ViroPharma Incorporated (“ViroPharma”) acquired January 24, 2014, and excluding the DERMAGRAFT business sold on January 17, 2014. Product sales excluding products acquired with ViroPharma were up 11% in 2014.
(3) On a Constant Exchange Rate (“CER”) basis, which is a Non GAAP measure, product sales were up 23%.
(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.
The Non GAAP financial measures included within this release are explained on page 32 of the full release, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 24 - 29 of the full release.
2014 was a transformational year for Shire as we delivered on our strategy by achieving record revenues and Non GAAP diluted earnings per ADS, and developing the strongest pipeline in our history. We also successfully executed on value-enhancing M&A and generated strong cash flows which will enable us to continue investing in drivers of growth.
In 2014 Shire delivered value through commercial excellence across our product portfolio. Bolstered by demand for therapies in our expanded Hereditary Angioedema (HAE) portfolio, sales by our Rare Diseases business unit grew by 46%(2). CINRYZE grew 30%(3) on a pro-forma basis and contributed sales
(1) NPS Pharma acquisition expected to close in Q1 2015, subject to satisfaction of customary closing conditions.
(2) On a pro-forma basis including Cinryze sales in 2013 and prior to acquisition in 2014, growth was 18%.
(3) 2013 Cinryze product sales as reported by ViroPharma.
of $503 million, and FIRAZYR saw a 55% increase with $364 million in sales. Neuroscience and GI also contributed to our strong results, with VYVANSE sales up 18% and LIALDA sales up 20%.
We significantly enhanced our pipeline in 2014, and now have 21 distinct programs in clinical development. Importantly, our pipeline is advancing, most recently with the US approval of VYVANSE for Binge Eating Disorder (BED) in adults. VYVANSE is the first product approved for BED that will help address this condition which affects an estimated 2.8 million adults in the US. In addition, positive results from a second phase 2 maribavir study in patients with disease which is resistant or refractory to the standard of care CMV therapy showed that maribavir, at all doses, was effective at lowering CMV to below the limits of assay detection.
The acquisition of ViroPharma contributed significantly to our growth this year, and the Lumena acquisition materially expanded our Gastrointestinal (GI) pipeline. Recently we announced plans to acquire NPS Pharma, a rare disease focused biopharmaceutical company. The transaction, expected to close in the first quarter of 2015, will enhance our growth profile and enable us to apply our GI and rare disease expertise to deliver two therapies – GATTEX for short bowel syndrome and NATPARA for hypoparathyroidism – to patients.
Following an exceptional 2014, we expect to deliver further growth in 2015 despite significant foreign currency headwinds, the loss of exclusivity for INTUNIV, and the inclusion of CINRYZE in our 2014 results. In 2015, Shire is well-positioned on our journey to become a leading global biotech as we complete our One Shire reorganization with the expected benefits of profitability and efficiency, and advance pivotal regulatory and clinical milestones that will contribute to $10 billion in product sales by 2020.
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Dial in details for the live conference call for investors at 14:00 BST / 09:00 EDT on February 12, 2015:
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The quarterly earnings presentation will be available today at 13:00 BST / 08:00 EDT on:
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Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
Statements included in this announcement that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
and other risks and uncertainties detailed from time to time in Shire’s filings with the US Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
(1) The safe harbors for forward-looking statements under the Private Securities Litigation Reform Act of 1995 are not applicable to forward-looking statements, if any, in connection with Shire’s tender offer for NPS Pharma.
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