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Donnerstag, 16.02.2017 13:00 von PR Newswire | Aufrufe: 141

SHIRE PLC - Shire reports full year 2016 results with record revenue

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PR Newswire

London, February 16

Shire reports full year 2016 results with record revenue; positioned for continued strong growth driven by best-in-class rare disease pipeline

Key growth contributions from all therapeutic areas

Baxalta integration progressing ahead of schedule; Shire now the world leader in rare diseases

February 16, 2017 – Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the year ended December 31, 2016.

Financial Highlights	Full Year 2016⁽¹⁾	Growth⁽¹⁾	Non GAAP CER⁽¹⁾⁽²⁾
Product sales	$10,886 million	+78%	+79%
Product sales excluding legacy Baxalta	$6,998 million	+15%	+15%
Total revenues	$11,397 million	+78%	+78%

Operating income from continuing operations	$963 million	(32%)
Non GAAP operating income⁽²⁾	$4,417 million	+59%	+57%

Net income margin⁽³⁾⁽⁴⁾	3%	(17ppc)
Non GAAP EBITDA margin⁽²⁾⁽⁴⁾	39%	(4ppc)

Net income	$327 million	(75%)
Non GAAP net income⁽²⁾	$3,391 million	+47%

Diluted earnings per ADS⁽⁵⁾	$1.27	(81%)
Non GAAP diluted earnings per ADS⁽²⁾⁽⁵⁾	$13.10	+12%	+11%

Net cash provided by operating activities	$2,659 million	+14%
Non GAAP cash generation⁽²⁾	$3,464 million	+43%
Non GAAP free cash flow⁽²⁾	$2,103 million	(5%)

⁽¹⁾ Results include Baxalta Inc. (Baxalta) (acquired on June 3, 2016) and Dyax Corp. (Dyax) (acquired on January 22, 2016), unless otherwise noted. Percentages compare to equivalent 2015 period. ⁽²⁾ The Non GAAP financial measures included within this release are explained on pages 28 – 29, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 22 – 24. ⁽³⁾ US GAAP net income as a percentage of total revenues. ⁽⁴⁾ Percentage point change (ppc). ⁽⁵⁾ Diluted weighted average number of ordinary shares 776.2m.

Financial Highlights

• Delivered product sales growth of 78% to $10.9 billion, driven by record legacy Shire product sales and inclusion of legacy Baxalta sales since June 2016.

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• Achieved combined pro forma sales growth of 11% (12% at Non GAAP CER); 15% sales growth (15% at Non GAAP CER) for legacy Shire and 6% pro forma sales growth (8% at Non GAAP CER) for legacy Baxalta.

• Generated Non GAAP diluted earnings per ADS of $13.10 (11% Non GAAP CER growth), at top end of financial guidance.

• Delivered strong Non GAAP cash generation in Q4 2016 enabling a $0.9 billion reduction in Non GAAP net debt.

Product and Pipeline Highlights

• Expanded commercial portfolio with 4 new product launches: XIIDRA, ONIVYDE, VONVENDI and CUVITRU.

• Delivered strong performance for XIIDRA in dry eye disease, capturing 19% U.S. market share within four months since launch.

• Progressed pipeline of innovative, novel therapies with approximately 20 programs in Phase 3 or registration.

• Received Prescription Drug User Fee Act (PDUFA) date of June 20, 2017 for SHP465 in Attention Deficit Hyperactivity Disorder (ADHD); completed enrollment for SHP643 in prophylaxis of Hereditary Angioedema (HAE) with results expected in the first half of 2017.

Integration Highlights

• Completed Dyax integration.

• Progressed Baxalta integration with operating expense synergy initiatives ahead of schedule and legacy Baxalta products transitioning quickly onto Shire’s commercial platform.

Flemming Ornskov, M.D., M.P.H., Shire Chief Executive Officer, commented:

“2016 was a transformational year for Shire as we became the world leader in rare diseases. Our innovative portfolio and sharp focus on commercial excellence enabled us to generate double digit pro forma top-line growth, with reported sales of $10.9 billion, while materially advancing the pipeline, successfully integrating Dyax and progressing the Baxalta integration ahead of schedule.

“In August we launched XIIDRA in the U.S. with an exceptional new drug launch, demonstrating our strength in commercial excellence and capturing 19% of market share within four months. This marks an outstanding entry into ophthalmics and we aim to further build a leadership position in this therapeutic area.

“With multiple product launches planned in 2017, we remain focused on execution and expect to generate strong top- and bottom-line growth. Our pipeline has never been stronger with multiple programs in Phase 3 or registration. We remain extremely optimistic about Shire’s long-term growth prospects.”

FINANCIAL SUMMARY - FULL YEAR 2016 COMPARED TO FULL YEAR 2015

Revenues

• Product sales increased 78% (79% at Non GAAP CER) to $10,886 million (2015: $6,100 million), primarily due to including $3,887 million of legacy Baxalta sales.

• Product sales excluding legacy Baxalta increased 15% (15% at Non GAAP CER) with all legacy Shire franchises exhibiting double digit growth, with Genetic Diseases up 12%, Neuroscience up 13% and Internal Medicine up 17%. In addition, we launched XIIDRA in August 2016 and our Ophthalmology franchise contributed sales of $54 million.

• Royalties and other revenues increased 61% to $511 million, as the second half of 2016 benefited from additional revenue acquired with Baxalta, primarily related to contract manufacturing activities.

Operating results

• Operating income decreased 32% to $963 million (2015: $1,420 million), primarily due to the impact of acquisition accounting, including higher amortization of inventory fair value adjustments and acquired intangible assets, combined with higher integration and acquisition costs, partially offset by lower impairment charges related to research and development (R&D) programs.

• Non GAAP operating income increased 59% to $4,417 million (2015: $2,786 million), primarily due to including Baxalta's operating income and higher revenue from legacy Shire products.

• Non GAAP EBITDA margin decreased to 39% (2015: 43%). The decrease was primarily due to the impact of lower margin product franchises acquired with Baxalta and XIIDRA launch and promotional costs.

Earnings per share (EPS)

• Diluted earnings per American Depositary Shares (ADS) decreased 81% to $1.27 (2015: $6.59). The decrease was primarily due to lower operating income resulting from the impact of acquisition accounting and higher integration and acquisition costs, combined with the impact of additional shares issued as consideration for the Baxalta transaction.

• Non GAAP diluted earnings per ADS increased 12% to $13.10 (2015: $11.68), as higher Non GAAP operating income more than offset the impact of additional shares issued as consideration for the Baxalta transaction.

Cash flows

• Net cash provided by operating activities increased 14% to $2,659 million (2015: $2,337 million), primarily due to strong cash receipts from higher sales, partially offset by higher tax and interest payments, costs related to the Baxalta integration and a payment associated with the termination of a biosimilar collaboration acquired with Baxalta.

• Non GAAP cash generation, increased 43% to $3,464 million (2015: $2,422 million), primarily due to strong cash receipts from higher sales, partially offset by costs related to the Baxalta integration and a payment associated with the termination of a biosimilar collaboration acquired with Baxalta.

• Non GAAP free cash flow, decreased 5% to $2,103 million (2015: $2,222 million), despite the strong increase in net cash provided by operating activities noted above, as continued investment in manufacturing operations resulted in an increase in capital expenditures of $531 million.

Debt

• Non GAAP net debt at December 31, 2016 was $22,439 million (December 31, 2015: $1,459 million), representing aggregate long and short term borrowings of $22,614 million, and other debt, primarily capital leases, of $354 million, partially offset by cash and cash equivalents of $529 million. The increase in net debt is primarily due to debt used to fund the acquisitions of Baxalta and Dyax and borrowings assumed from Baxalta.

OUTLOOK

We expect 2017 to be another strong year for Shire, building on our excellent financial performance in 2016.

In addition to the guidance in the table below, we are providing depreciation and capital expenditure 2017 guidance following the Baxalta acquisition on June 3, 2016. We expect depreciation expense to be $400 - $450 million and capital expenditure to be approximately $1 billion in 2017 reflecting our larger footprint and important investments to support our growth aspirations.

The Non GAAP diluted earnings per ADS forecast assumes a weighted average number of 914 million fully diluted ordinary shares outstanding for 2017.

Our US GAAP diluted earnings per ADS outlook reflects anticipated amortization, integration and reorganization costs.

Full Year 2017	US GAAP Outlook	Non GAAP Outlook⁽¹⁾
Total product sales	$14.5 - $14.8 billion	$14.5 - $14.8 billion
Royalties & other revenues	$600 - $700 million	$600 - $700 million
Gross margin as a percentage of total revenue	67.0% - 69.0%	74.5% - 76.5%
Combined R&D and SG&A	$5.2 - $5.5 billion	$5.0 - $5.3 billion
Net interest/other	$500 - $600 million	$500 - $600 million
Effective tax rate	~11%	16% - 17%
Diluted earnings per ADS⁽²⁾	$6.95 - $7.55	$14.60 - $15.20

⁽¹⁾ For a list of items excluded from Non GAAP Outlook, refer to pages 28 - 29 of this release.

⁽²⁾ See page 24 for a reconciliation between US GAAP diluted earnings per ADS and Non GAAP diluted earnings per ADS.

FINANCIAL SUMMARY - FOURTH QUARTER 2016 COMPARED TO FOURTH QUARTER 2015

Financial Highlights	Q4 2016	Growth	Non GAAP CER
Product sales	$3,621 million	+123%	+124%
Product sales excluding legacy Baxalta	$1,839 million	+13%	+14%
Total revenues	$3,806 million	+122%	+122%

Operating income from continuing operations	$729 million	+104%
Non GAAP operating income	$1,395 million	+83%	+79%

Net income margin	12%	(4ppc)
Non GAAP EBITDA margin	38%	(5ppc)

Net income	$457 million	+63%
Non GAAP net income	$1,025 million	+74%

Diluted earnings per ADS	$1.51	+6%
Non GAAP diluted earnings per ADS	$3.37	+13%	+11%

Net cash provided by operating activities	$1,153 million	+51%
Non GAAP cash generation	$1,289 million	+58%
Non GAAP free cash flow	$906 million	+28%

Revenues

• Product sales increased 123% (124% at Non GAAP CER) to $3,621 million (Q4 2015: $1,624 million), primarily due to including $1,782 million of legacy Baxalta sales.

• Product sales excluding legacy Baxalta, increased 13% (14% at Non GAAP CER) with strong growth from our Genetic Diseases and Internal Medicine franchises, each up 17%. In addition, our Ophthalmology franchise contributed sales of $40 million.

• Royalties and other revenues increased 101% to $185 million, primarily due to including $41 million of contract manufacturing revenue acquired with Baxalta.

Operating results

• Operating income increased 104% to $729 million (Q4 2015: $357 million), primarily due to including Baxalta's operating income, higher revenue from legacy Shire products and lower R&D program impairment charges, partially offset by higher amortization of acquired intangible assets and XIIDRA promotional costs.

• Non GAAP operating income increased 83% to $1,395 million (Q4 2015: $764 million), primarily due to including Baxalta's operating income and higher revenue from legacy Shire products, partially offset by XIIDRA promotional costs.

• Non GAAP EBITDA margin decreased to 38% (Q4 2015: 43%). The decrease was primarily due to the impact of lower margin product franchises acquired with Baxalta and XIIDRA promotional costs.

Earnings per share (EPS)

• Diluted earnings per ADS increased 6% to $1.51 (Q4 2015: $1.42), as higher US GAAP operating income more than offset the impact of additional shares issued as consideration for the Baxalta transaction.

• Non GAAP diluted earnings per ADS increased 13% to $3.37 (Q4 2015: $2.97), as higher Non GAAP operating income more than offset the impact of additional shares issued as consideration for the Baxalta transaction.

Cash flows

• Net cash provided by operating activities increased 51% to $1,153 million (Q4 2015: $762 million), primarily due to strong cash receipts from higher sales, partially offset by costs related to the Baxalta integration and higher tax and interest payments.

• Non GAAP cash generation, increased 58% to $1,289 million (Q4 2015: $813 million), primarily due to strong cash receipts from higher sales, partially offset by costs related to the Baxalta integration.

• Non GAAP free cash flow, increased 28% to $906 million (Q4 2015: $709 million), primarily due to the increase in net cash provided by operating activities, partially offset by an increase in capital expenditures of $194 million.

RECENT DEVELOPMENTS

Products

ADYNOVATE for the treatment of hemophilia A

• On December 27, 2016, Shire announced that the U.S. Food and Drug Administration (FDA) approved ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age.

• The FDA also approved ADYNOVATE for use in surgical settings for both adult and pediatric patients.

CUVITRU for the treatment of primary immunodeficiency disorders

• On November 16, 2016, Shire announced the U.S. launch of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] to treat adult and pediatric patients (two years of age and older) with primary immunodeficiency.

• Global expansion is ongoing. CUVITRU was launched in Switzerland in January 2017. Shire expects to initiate further launches and additional global regulatory submissions for CUVITRU in 2017.

ONIVYDE for the treatment of pancreatic cancer

• ONIVYDE was launched in Germany and Austria during Q4 2016. This follows the October 18, 2016 announcement that the European Commission had approved ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate) for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine-based therapy. Additional launches are planned in 2017.

Pipeline

SHP465 for the treatment of ADHD

• On January 19, 2017, Shire announced that the FDA has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, for the treatment of ADHD. The FDA is expected to provide a decision on or around June 20, 2017.

NATPAR for the treatment of hypoparathyroidism

• The CE Mark for the NATPAR auto-injector device was granted and submitted to the Committee for Medicinal Products for Human Use in January 2017. This completes the European Union (EU) submission. A decision on EU approval is anticipated in Q2 2017.

VONVENDI for the treatment of adults affected by von Willebrand disease (VWD)

• On December 2, 2016, Shire announced positive topline results from a Phase 3 clinical trial of VONVENDI [von Willebrand factor (Recombinant)] to treat bleeds in elective surgical settings for adults with severe VWD. The results will form the basis of a supplemental NDA to the FDA.

Legal Proceedings

DERMAGRAFT

• Shire entered into a final settlement agreement with the Department of Justice, announced in January 2017, in the amount of $350 million, plus interest. Shire paid $345.5 million of the settlement amount in January 2017 and anticipates the remaining payment will be made in Q2 2017. The agreement resolves the civil investigations conducted by the Department of Justice, including multiple U.S. Attorney’s Offices and relevant federal and state agencies. Shire established a reserve for the expected settlement, $340 million in Q2 2016 and an additional $10 million in Q3 2016.

VANCOCIN

• On February 7, 2016, the U.S. Federal Trade Commission filed a Complaint against Shire alleging that ViroPharma Incorporated (ViroPharma) engaged in conduct in violation of U.S. antitrust laws arising from a citizen petition ViroPharma filed in 2006 related to Food & Drug Administration’s policy for evaluating bioequivalence for generic versions of VANCOCIN. The Complaint seeks equitable relief, including an injunction and disgorgement. At this time, Shire is unable to predict the outcome or duration of this case.

Facilities

• On December 6, 2016, Shire received planning permission for its new state-of-the-art biologics manufacturing facility in Piercetown, County Meath, Ireland.

• On November 22, 2016, Shire announced that it will expand its operations in Cambridge, Massachusetts, establishing a rare disease innovation hub and increasing its footprint in the heart of Kendall Square. Shire and BioMed Realty signed a lease at 500 Kendall Street. Shire anticipates occupancy in Q1 2019.

Board Changes

On January 3, 2017, Shire announced the appointment of Ian Clark to the Board of Directors.

Dividend

In respect of the six months ended December 31, 2016, the Board resolved to pay an interim dividend of 25.70 U.S. cents per Ordinary Share (2015: 22.16 U.S. cents per Ordinary Share).

Dividend payments will be made in Pounds Sterling to holders of Ordinary Shares and in U.S. Dollars to holders of ADSs. A dividend of 20.64⁽¹⁾ pence per Ordinary Share (2015: 15.32 pence) and 77.10 U.S. cents per ADS (2015: 66.48 U.S. cents) will be paid on April 25, 2017 to shareholders on the register as at the close of business on March 10, 2017.

Together with the first interim payment of 4.63 U.S. cents per Ordinary Share (2015: 4.21 U.S. cents per Ordinary Share), this represents total dividends for 2016 of 30.33 U.S. cents per Ordinary Share (2015: 26.37 U.S. cents per Ordinary Share), an increase of 15% in U.S. Dollar terms.

Holders of Ordinary Shares are notified that, in order to receive UK sourced dividends via Shire’s Income Access Share arrangements (“IAS Arrangements”), they need to have submitted a valid IAS Arrangements election form to the Company’s Registrar, Equiniti, by no later than 5pm (BST) on March 24, 2017. Holders of Ordinary Shares are advised that:

• any previous elections made using versions of the IAS Arrangements election form in use prior to February 16, 2016, and any elections deemed to have been made prior to April 28, 2016, are no longer valid; and

• if they do not elect, or have not elected using the newly formatted IAS Arrangements election forms published on or after February 16, 2016, to receive UK sourced dividends via Shire’s IAS Arrangements, their dividends will be Irish sourced and therefore incur Irish dividend withholding tax, subject to applicable exemptions.

Internet links to the newly formatted IAS Arrangements election forms can be found at:

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