Continued advancement toward goal of becoming a leading global biotechnology company
April 30, 2015 – Shire (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the three months to March 31, 2015.
| Financial Highlights | Q1 2015 | Growth(1) | CER(2) |
| Product sales | $1,423 million | +9% | +13% |
| Total revenues | $1,488 million | +11% | +15% |
| Non GAAP operating income | $683 million | +16% | +19% |
| US GAAP operating income from continuing operations | $475 million | +55% | |
| Non GAAP EBITDA margin (excluding royalties & other revenues)(3) | 46% | +1pps(4) | |
| US GAAP net income margin(5) | 28% | +11pps | |
| Non GAAP diluted earnings per ADS | $2.84 | +20% | +24% |
| US GAAP diluted earnings per ADS | $2.08 | +77% | |
| Non GAAP cash generation | $516 million | +56% | |
| Non GAAP free cash flow | $542 million | +135% | |
| US GAAP net cash provided by operating activities | $562 million | +128% |
(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 page 25, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 19 - 22 of the full release.
Highlights:
- Strong product sales growth of 9% (13% on a CER basis) to $1.4 billion, driven by performance of VYVANSE®, CINRYZE®, FIRAZYR® and LIALDA®/MEZAVANT®.
- Non GAAP earnings per ADS up 20% (up 24% on a CER basis).
- Acquisition of NPS Pharmaceuticals, Inc. ("NPS") completed and integration progressing according to plan.
- Commercial portfolio strengthened through the addition of GATTEX®/REVESTIVE® and NATPARA® from NPS and the launch of VYVANSE for Binge Eating Disorder in adults.
- Pipeline progressed, with the most significant developments being Priority Review for lifitegrast and agreement with the FDA on the regulatory path for SHP465. Shire now has its broadest and deepest pipeline in its history.
Flemming Ornskov, M.D., Shire's Chief Executive Officer, commented:
During the first quarter, Shire continued to exemplify the characteristics of a leading biotechnology company, delivering strong revenue growth and cash generation, while materially advancing our innovative pipeline and boosting our future growth profile through the acquisition of NPS. Our continued financial performance driven by the strength of our commercial operations, focus on efficiency, and breadth of our innovative pipeline are indicators of our bright future. We remain confident in delivering Non GAAP diluted earnings per ADS growth in the mid-single digits in 2015 (high single digit growth on a CER basis).
For further information please contact:
Investor Relations
Sarah Elton-Farr
[email protected]
+44 1256 894157
Media
Michele Galen
[email protected]
+1 781 482 1867
Brooke Clarke
[email protected]
+44 1256 894 829
Dial in details for the live conference call for investors at 14:00 BST / 09:00 EDT on April 30, 2015:
UK dial in: 0808 237 0030 or 0203 139 4830
US dial in: 1 866 928 7517 or 1 718 873 9077
International Access Numbers: Click here
Password/Conf ID: 54094197#
Live Webcast: Click here
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
NOTES TO EDITORS
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 are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein 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:
- Shire's products may not be a commercial success;
- product sales from ADDERALL XR and INTUNIV are subject to generic competition;
- the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for Shire's products may affect future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire's products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire's products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
- the manufacture of Shire's products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
- the actions of certain customers could affect Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire's revenues, financial condition or results of operations;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire's activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including Shire's ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire's revenues, financial condition or results of operations;
- Shire faces intense competition for highly qualified personnel from other companies and organizations. Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect Shire's ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
- failure to achieve Shire's strategic objectives with respect to the acquisition of NPS Pharmaceuticals Inc. may adversely affect Shire's financial condition and results of operations; and
other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including those risks outlined in "Item 1A: Risk Factors" in Shire's Annual Report on Form 10-K for the year ended December 31, 2014.