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Dienstag, 31.07.2018 13:05 von GlobeNewswire | Aufrufe: 235

Shire plc : 2nd Quarter Results

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Shire Delivers Q2 2018 Product Sales Growth of 6% and Continued Regulatory and Pipeline Progress

Product sales grew to $3.8 billion driven by Immunology, recently launched products, and international expansion

Innovative pipeline continued to advance with 7 programs in registration and 16 in Phase 3

U.S. Food and Drug Administration (FDA) approval received for state-of-the-art plasma manufacturing facility

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Kurse

Shire

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$0.9 billion in net operating cash flow enabled continued debt pay-down

July 31, 2018 - Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG), the leading global biotech company focused on rare diseases, announces unaudited results for the three months ended June 30, 2018.

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

"Shire continued to deliver on its key priorities of commercial execution, pipeline advancement, debt pay-down, and portfolio optimization during the second quarter. We drove product sales growth of 6% over the prior year period led by the strong performance of our Immunology franchise, continued uptake of our recently launched products, and expansion in international markets.

"During the quarter, our Board reached an agreement with the Takeda Board on the terms of a recommended offer for Takeda to acquire Shire. The acquisition is expected to close in H1 2019, subject to shareholder approval of both companies and additional regulatory approvals. In the meantime, we remain resolutely focused on execution as these results demonstrate.

"We also achieved important regulatory milestones and continued to advance our robust late stage pipeline. We received U.S. FDA approval for CINRYZE for pediatric use and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for VEYVONDI in Europe. In addition, we gained U.S. FDA approval for our state-of-the-art plasma manufacturing facility near Covington, Georgia supporting the continued growth of our immunoglobulin portfolio."

Financial Highlights

	Q2 2018	Reported Growth	Non GAAP CER⁽¹⁾
Product sales⁽²⁾	$3,809 million	+6%	+4%
Total revenues⁽²⁾	$3,920 million	+5%	+3%

Operating income from continuing operations	$830 million	+108%
Non GAAP operating income⁽¹⁾	$1,492 million	+0%	-1%

Net income margin⁽³⁾⁽⁴⁾	16%	+10ppc
Non GAAP EBITDA margin^(1)(3)(4)	42%	-1ppc

Net income	$616 million	+156%
Non GAAP net income⁽¹⁾	$1,186 million	+4%

Diluted earnings per ADS⁽⁵⁾	$2.01	+154%
Non GAAP diluted earnings per ADS⁽¹⁾⁽⁵⁾	$3.88	+4%	+2%

Net cash provided by operating activities	$940 million	-23%
Non GAAP free cash flow⁽¹⁾	$756 million	-29%

⁽¹⁾The Non GAAP financial measures included within this release are explained on pages 27 - 28, and are reconciled to the most directly comparable financial measures prepared in accordance with U.S. GAAP on pages 20 - 23.

⁽²⁾In Q2 2018, we returned to a single segment approach to managing our business. This decision was precipitated by our Board's acceptance of Takeda's offer to acquire Shire and reflects our focus on the performance of the entire business as it operates in this current environment.

⁽³⁾Percentage point change (ppc).

⁽⁴⁾Calculated as a percentage of total revenues.

⁽⁵⁾Diluted weighted average number of ordinary shares of 917.5 million.

Product sales growth

Achieved product sales growth of 6% driven primarily by Immunology, Internal Medicine, and Ophthalmics. Excluding the impact of Established Brands, defined on page 8, product sales increased 10%.
Delivered growth of recently launched products of 67%, primarily due to ADYNOVATE, CUVITRU, GATTEX, and XIIDRA.
Strong demand for our Immunology products which delivered 13% growth, including significant contributions from our subcutaneous immunoglobulin portfolio.

Operating performance

Generated Non GAAP diluted earnings per ADS of $3.88, an increase of 4%, as Q2 2018 benefited from higher product sales, partially offset by lower gross margins as Q2 2017 reflected favorability from the timing of changes in the costs to manufacture certain products.
Reported Non GAAP EBITDA margin of 42%, a slight decline from Q2 2017, with continued benefit from operating efficiencies in SG&A offset by lower gross margins as explained above.

Cash flow

Strong free cash flow enabled a $1,414 million reduction in Non GAAP net debt since December 31, 2017.

FINANCIAL SUMMARY - SECOND QUARTER 2018 COMPARED TO SECOND QUARTER 2017

Revenues

Delivered total revenues of $3,920 million representing growth of 5%.
Product sales increased 6% to $3,809 million (Q2 2017: $3,592 million), driven by Immunology, up 13%, Internal Medicine, up 61%, and Ophthalmics, up 75%. Excluding the impact of Established Brands, product sales increased 10%.
Royalties and other revenues decreased 28% to $111 million (Q2 2017: $154 million), due to lower SENSIPAR royalties and the reclassification of ADDERALL XR from royalty revenue to product sales and other changes as required under the new revenue accounting standard.

Operating results

Operating income increased 108% to $830 million (Q2 2017: $399 million), due to a decline in integration and acquisition costs and lower expense related to the unwind of inventory fair value adjustments. Q2 2017 also reflected costs related to R&D license arrangements which did not recur in Q2 2018.
Non GAAP operating income was unchanged at $1,492 million (Q2 2017: $1,492 million), primarily due to increased product sales, partially offset by lower gross margins due to Q2 2017 favorability from the timing of changes in the costs to manufacture certain products.
Non GAAP EBITDA margin was slightly down to 42% (Q2 2017: 43%), primarily due to lower gross margin partially offset by benefits from ongoing cost reduction initiatives and operating expense synergies.

Earnings per share (EPS)

Diluted earnings per American Depository Share (ADS) increased 154% to $2.01 (Q2 2017: $0.79), due to a decline in integration and acquisition costs and lower expense related to the unwind of inventory fair value adjustments. Q2 2017 also reflected costs related to R&D license arrangements which did not recur in Q2 2018.
Non GAAP diluted earnings per ADS increased 4% to $3.88 (Q2 2017: $3.73) as increased product sales were offset by lower gross margins.

Cash flows

Net cash provided by operating activities decreased 23% to $940 million (Q2 2017: $1,223 million), primarily driven by tax payments during the quarter of $380 million (Q2 2017: $153 million), due to higher taxable income and timing of tax payments.
Non GAAP free cash flow decreased 29% to $756 million (Q2 2017: $1,064 million), primarily due to the decrease in net cash provided by operating activities noted above. Non GAAP free cash flow includes capital expenditures of $184 million (Q2 2017: $179 million).

Debt

Non GAAP net debt as of June 30, 2018 decreased $1,414 million since December 31, 2017, to $17,655 million (December 31, 2017: $19,069 million). A combination of Shire's Non GAAP free cash flow and existing cash balances were utilized to repay debt during the year. Non GAAP net debt represents aggregate long and short term borrowings of $17,568 million, and capital leases of $347 million, partially offset by cash and cash equivalents of $260 million.

OUTLOOK

Our 2018 guidance, which continues to include our Oncology franchise, remains unchanged. Guidance will be updated to remove the Oncology franchise after the close of the sale to Servier S.A.S. (Servier), which is expected in Q3 2018. Similarly, our 2020 guidance remains unchanged and will be updated to remove the Oncology franchise after the close of this pending sale.

The Non GAAP diluted earnings per ADS forecast assumes a weighted average number of 915 million fully diluted ordinary shares outstanding for 2018.

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

Risks associated with this outlook include the potential uncertainty resulting from the announcement by Takeda Pharmaceutical Company Limited (Takeda) on May 8, 2018 of a recommended offer for Shire under the U.K. Takeover Code.

Full Year 2018	U.S. GAAP Outlook	Non GAAP Outlook⁽¹⁾
Total revenue⁽²⁾	$15.4 - $15.9 billion	$15.4 - $15.9 billion
Gross margin as a percentage of total revenue⁽³⁾	71.0% - 73.0%	73.5% - 75.5%
Combined R&D and SG&A	$5.2 - $5.4 billion	$4.9 - $5.1 billion
Net interest/other	$450 - $550 million	$450 - $550 million
Effective tax rate	15% - 17%	16% - 18%
Diluted earnings per ADS⁽⁴⁾	$7.30 - $7.90	$14.90 - $15.50

⁽¹⁾ For a list of items excluded from Non GAAP Outlook, refer to pages 27 - 28 of this release.

⁽²⁾ Management is providing guidance for total revenue. Total revenue is comprised of total product sales and royalties & other revenues. Pursuant to a change in U.S. GAAP related to accounting for revenue, certain revenue formerly classified as royalties are now recorded as product sales.

⁽³⁾ Gross margin as a percentage of total revenues excludes amortization of acquired intangible assets.

⁽⁴⁾ See page 23 for a reconciliation between U.S. GAAP diluted earnings per ADS and Non GAAP diluted earnings per ADS.

RECENT DEVELOPMENTS

Corporate

On May 8, 2018, the Boards of Takeda and Shire announced that they had reached agreement on the terms of a recommended offer pursuant to which Takeda will acquire the entire issued and to be issued ordinary share capital of Shire. The acquisition is expected to close in H1 2019, subject to a number of conditions, including receipt of regulatory clearances and approval by the shareholders of both companies.

Business Development

Sale of Oncology franchise

On April 16, 2018, Shire announced it had entered into a definitive agreement with Servier to sell its Oncology franchise for $2.4 billion. Activities to conclude the sale are on track and the closing of the transaction is expected to occur in Q3 2018.

Products

VEYVONDI for adults with von Willebrand disease (VWD)

On July 2, 2018, Shire announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion recommending the granting of a marketing authorization in the European Union (EU) for VEYVONDI, for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults (age 18 and older) with VWD.

CINRYZE for the prevention of attacks in pediatric HAE patients

On June 21, 2018, Shire announced that the FDA had approved a label expansion for CINRYZE, making it available to help prevent angioedema attacks in children aged 6 years and older with HAE.

XIIDRA for the treatment of the signs and symptoms of dry eye disease

In June 2018, Shire withdrew from the decentralized procedure for XIIDRA's European Marketing Authorization Application and is targeting Q4 2018 for resubmission through a centralized procedure.

Pipeline

SHP626, an investigational treatment for adults with nonalcoholic steatohepatitis (NASH) with liver fibrosis

In June 2018, Shire announced that the phase 2 clinical study of SHP626 has been discontinued. Shire is evaluating other options for the program.

Facilities

On June 21, 2018, Shire announced that the FDA had approved its submission for the production of GAMMAGARD LIQUID at its new plasma manufacturing facility near Covington, Georgia. The facility will add approximately 30% capacity to Shire's internal network once fully operational. Commercial production began in January 2018 and shipments commenced shortly after approval.

Dividend

In respect of the six months ended June 30, 2018, the Board resolved to pay an interim dividend of 5.60 U.S. cents per Ordinary Share (2017: 5.09 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 4.26⁽¹⁾ pence per Ordinary Share (2017: 3.85 pence) and 16.80 U.S. cents per ADS (2017: 15.27 U.S. cents) will be paid on October 19, 2018, to shareholders on the register as of the close of business on September 7, 2018.

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 September 21, 2018. 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:

http://investors.shire.com/shareholder-information/shareholder-forms.aspx

⁽¹⁾ Translated using a GBP:USD exchange rate of 1.3147.

ADDITIONAL INFORMATION

The following additional information is included in this press release:

	Page

Overview of Second Quarter 2018 Financial Results	8

Financial Information	12

Non GAAP Reconciliations	20

Notes to Editors	24

Forward-Looking Statements	25

Non GAAP Measures	27

Trademarks	28

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