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Shire plc : Shire reports strong Q2 2017 operating results and cash flow

Released 12:00 03-Aug-2017

Shire plc : Shire reports strong Q2 2017 operating results and cash flow

Shire reports strong Q2 2017 operating results and cash flow; updates full year guidance

Q2 product sales growth of 7% on a combined pro forma basis; generated $1.2 billion operating cash flow

Over-delivered Year 1 Baxalta integration cost synergies, recognizing $400 million vs $300 million target
  
Exploring strategic review of Neuroscience franchise, including potential of independent public listing

Significant pipeline progress with SHP643 (lanadelumab); Phase 3 topline data demonstrates potential to change treatment paradigm for patients with HAE; U.S. approval of MYDAYIS for patients with ADHD; September launch planned

  
August 3, 2017 - Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the three months ended June 30, 2017.

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

"During the second quarter, we delivered strong top-line growth of 7% on a pro forma basis, generating product sales of $3.6 billion. Our Immunology franchise grew by 18%, and we saw significant contributions across our broad and diverse portfolio. Shire remains ahead of schedule to deliver at least $700 million in cost synergies from the Baxalta integration by Year 3. The Q2 performance resulted in strong operating cash flow of $1.2 billion and enabled us to reduce Non GAAP net debt by $880 million in the quarter.

"We also continue to drive the late-stage clinical pipeline. In Q2 we announced positive topline data from our Phase 3 pivotal trial of SHP643 in HAE, and anticipate submission of the BLA in late 2017 or early 2018. MYDAYIS, a once-daily treatment for patients with ADHD, received US FDA approval and will be launched in September.

"We are at an exciting inflection point, with both our rare disease and neuroscience businesses performing strongly and each having significant growth potential over the coming years. The strength and scale of our business provides us with the opportunity to further optimize our franchise portfolio - one of our key priorities communicated earlier this year. By year end, we expect to complete a formal evaluation of the full range of strategic options for the neuroscience franchise, including the potential for its independent public listing.

"As we enter the second half of 2017, we are focused on generating strong organic growth while continuing to deliver on our key priorities - launching more than 80 products globally by leveraging our expanded commercial platform, progressing our late-stage pipeline, integrating Baxalta, and paying down debt. We have updated our 2017 full year guidance and remain very confident about Shire's long-term prospects."


Financial Highlights

  Q2 2017(1) Growth(1) Non GAAP CER(1)(2)
Product sales $3,592 million +55% +56%
Product sales excluding legacy Baxalta $1,882 million +7%  
Total revenues $3,746 million +54% +56%
       
Operating income from continuing operations $399 million +315%  
Non GAAP operating income(2) $1,492 million +53% +54%
       
Net income margin(3)(4) 6% 13ppc  
Non GAAP EBITDA margin(2)(4) 43% 1ppc  
       
Net income $240 million N/M  
Non GAAP net income(2) $1,135 million +47%  
       
Diluted earnings per ADS(5) $0.79 N/M  
Non GAAP diluted earnings per ADS(2)(5) $3.73 +10% +11%
       
Net cash provided by operating activities $1,223 million +107%  
Non GAAP free cash flow(2) $1,064 million +130%  

(1) Results include Baxalta Inc. (Baxalta) (acquired on June 3, 2016), unless otherwise noted. Percentages compare to equivalent 2016 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 913 million.

Product sales growth

Earnings growth
·     Generated Non GAAP earnings per ADS of $3.73, underscoring continued focus on commercial excellence and operating efficiency.
·       Continued to progress Baxalta integration, while delivering $400 million in cost synergies in year 1 - exceeding our target of $300 million - which contributed to a Non GAAP EBITDA margin of 43% for the quarter; on-track to achieve at least $700 million in synergies by year 3.

Strong cash flow
·       Strong operating cash flow enabled $880 million reduction in Non GAAP net debt since March 31, 2017; remain on-track to achieve our year-end debt target.

Product and Pipeline Highlights

Regulatory updates
·       Received U.S. Food and Drug Administration (FDA) approval of MYDAYIS, a new once-daily treatment option for symptom control in Attention Deficit Hyperactivity Disorder (ADHD) patients 13 years and older.
·       Granted European Union (EU) Conditional Marketing Authorization for NATPAR (Parathyroid Hormone) for the treatment of patients with Chronic Hypoparathyroidism.
·       Received European Medicines Agency (EMA) validation of VEYVONDI [von Willebrand factor (Recombinant)] Marketing Authorization Application for treatment of von Willebrand Disease (VWD).
·       Submitted Investigational New Drug (IND) application to FDA for gene therapy candidate SHP654 for the treatment of hemophilia A.

Clinical and business development updates
·     Reported positive topline data for SHP643 (lanadelumab), which was acquired with Dyax Corp. (Dyax), an investigational treatment that reduced Hereditary Angioedema (HAE) monthly attack rate by 87% versus placebo in a Phase 3 26-week pivotal trial.
·     Entered into an agreement with Parion Sciences to develop and commercialize SHP659 (formerly known as P-321), an investigational epithelial sodium channel (ENaC) inhibitor for the potential treatment of Dry Eye Disease in adults.
·       Expanded broad antibody research platform through license agreement with Novimmune S.A. to develop and commercialize an innovative, differentiated bi-specific antibody in pre-clinical development for the treatment of hemophilia A and hemophilia A patients with inhibitors.


FINANCIAL SUMMARY - SECOND QUARTER 2017 COMPARED TO SECOND QUARTER 2016

Revenues

Operating results

Earnings per share (EPS)

Cash flows

Debt


OUTLOOK

Following the strong performance in the first half of the year, we are updating our guidance for 2017.

The guidance incorporates accelerated synergy capture as well as an updated view on our product sales, primarily due to a new generic LIALDA competitor. We have also revised our depreciation estimate to be $450 - $500 million, based on updates resulting from the Baxalta integration, and we have lowered our capital expenditure forecast to $800 - $900 million.

Non GAAP EPS has been upgraded by raising the midpoint of our guidance range by 10 cents to $15.00, driven by cost discipline and accelerated synergy capture.

The 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 has been updated to reflect ongoing integration activities, which has accelerated the recognition of synergies, and the change in fair value of contingent consideration for SHP643 (lanadelumab) resulting from the positive topline Phase 3 results.

Full Year 2017 US GAAP Outlook Non GAAP Outlook(1)
Total product sales $14.3 - $14.6 billion $14.3 - $14.6 billion
Royalties & other revenues $600 - $700 million $600 - $700 million
Gross margin as a percentage of total revenue(2) 67.5% - 69.5% 74.5% - 76.5%
Combined R&D and SG&A $5.3 - $5.5 billion $4.9 - $5.1 billion
Net interest/other $500 - $600 million $500 - $600 million
Effective tax rate ~7% 16% - 17%
Diluted earnings per ADS(3) $5.65 - $6.05 $14.80 - $15.20

(1) For a list of items excluded from Non GAAP Outlook, refer to pages 28 - 29 of this release.
(2) Gross margin as a percentage of total revenues excludes amortization of acquired intangible assets.
(3) See page 24 for a reconciliation between US GAAP diluted earnings per ADS and Non GAAP diluted earnings per ADS.


RECENT DEVELOPMENTS

Corporate Strategy

Shire to assess strategic options for its Neuroscience franchise

Business Development

Shire enters into a licensing agreement for Novimmune bi-specific antibody

Products

FIRAZYR for the treatment of HAE in Japan

VEYVONDI for the treatment of adults affected by VWD

MYDAYIS for the treatment of ADHD

INTUNIV for the treatment of ADHD in Japan

Pipeline

SHP654 for the treatment of hemophilia A

SHP643 for the treatment of HAE

SHP647 for the treatment of ulcerative colitis

SHP680 for the treatment of multiple neurological conditions

Board Changes

In accordance with Shire's normal succession planning, the Company announces that the following Non-Executive Directors will retire from the Board with effect from the conclusion of the 2018 Annual General Meeting ("AGM"):

Al Stroucken, Non-Executive Director, will assume the position of Chairman of the Remuneration Committee effective August 3, 2017. Anne Minto will continue to serve as a member of the Remuneration Committee to enable a period of transition until her retirement from the Board. Anne will fully support Al in the shareholder consultation process ahead of the publication of the new Directors' Remuneration Policy that will be put forward for shareholder approval at the 2018 AGM. The Board, supported by the Nomination & Governance Committee, will continue to evaluate Board and committee membership, including succession plans for the roles of Senior Independent Director and Chairman of the Science & Technology Committee, and will announce further changes once finalized.

Dividend

In respect of the six months ended June 30, 2017, the Board resolved to pay an interim dividend of 5.09 U.S. cents per Ordinary Share (2016: 4.63 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 3.85(1) pence per Ordinary Share (2016: 3.51 pence) and 15.27 U.S. cents per ADS (2016: 13.89 U.S. cents) will be paid on October 20, 2017, to shareholders on the register as of the close of business on September 8, 2017.

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 22, 2017. Holders of Ordinary Shares are advised that:

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 1.3221.


ADDITIONAL INFORMATION

The following additional information is included in this press release:

  Page
   
Overview of Second Quarter 2017 Financial Results 9
   
Financial Information 14
   
Non GAAP Reconciliations 22
   
Notes to Editors 25
   
Forward-Looking Statements 26
   
Non GAAP Measures 28
   
Trademarks 29

For further information please contact:

Investor Relations    
  Ian Karp ikarp@shire.com +1 781 482 9018
  Robert Coates rcoates@shire.com +44 1256 894874
       
Media    
  Lisa Adler lisa.adler@shire.com +1 617 588 8607
  Debbi Ford debbi.ford@shire.com +1 617 949 9083

Dial in details for the live conference call for investors at 14:00 BST / 9:00 EDT on August 3, 2017:

UK dial in: 0808 237 0030 or 020 3139 4830
US dial in: 1 866 928 7517 or 1 718 873 9077
International Access Numbers: Click here
Password/Conf ID: 96350792#
Live Webcast: Click here

The quarterly earnings presentation will be available today at 13:00 BST / 8:00 EDT on:

- Shire.com Investors section

- Shire's IR Briefcase in the iTunes Store


OVERVIEW OF SECOND QUARTER 2017 FINANCIAL RESULTS COMPARED TO SECOND QUARTER 2016

  1. Product sales

Product sales increased 55% to $3,592 million (Q2 2016: $2,322 million), primarily due to the inclusion of a full quarter of legacy Baxalta sales in Q2 2017. Excluding legacy Baxalta, product sales increased 7%.

(in millions)               Total Sales
Year on year growth
Product sales by franchise   U.S. Sales   International Sales   Total Sales   Reported Non GAAP CER
                   
HEMOPHILIA   $ 383.1     $ 360.8     $ 743.9     N/M N/M
INHIBITOR THERAPIES   76.1     144.6     220.7     N/M N/M
Hematology total   459.2     505.4     964.6     N/M N/M
                   
CINRYZE   164.7     11.2     175.9     +2 % +2 %
ELAPRASE   39.8     121.2     161.0     +5 % +5 %
FIRAZYR   118.1     19.3     137.4     +1 % +1 %
REPLAGAL   -     122.1     122.1     +3 % +6 %
VPRIV   37.3     50.6     87.9     -0 % +2 %
KALBITOR   20.6     -     20.6     +16 % +16 %
Genetic Diseases total   380.5     324.4     704.9     +2 % +3 %
                   
IMMUNOGLOBULIN THERAPIES   407.9     102.6     510.5     N/M N/M
BIO THERAPEUTICS   75.9     96.3     172.2     N/M N/M
Immunology total   483.8     198.9     682.7     N/M N/M
                   
VYVANSE   460.1     58.1     518.2     +0 % +0 %
ADDERALL XR   67.2     4.2     71.4     -30 % -30 %
MYDAYIS   15.7     -     15.7     N/A N/A
Other Neuroscience   5.2     24.9     30.1     -16 % -12 %
Neuroscience total   548.2     87.2     635.4     -3 % -2 %
                   
LIALDA/MEZAVANT   187.5     20.3     207.8     +7 % +8 %
PENTASA   83.3     -     83.3     +14 % +14 %
GATTEX/REVESTIVE   63.7     11.6     75.3     +69 % +70 %
NATPARA   34.5     -     34.5     +73 % +73 %
Other Internal Medicine   31.2     52.2     83.4     -6 % -3 %
Internal Medicine total   400.2     84.1     484.3     +15 % +16 %
                   
Oncology total   45.8     16.7     62.5     N/M N/M
                   
Ophthalmology total   57.4     -     57.4     N/A N/A
                   
Total product sales   $ 2,375.1     $ 1,216.7     $ 3,591.8     +55 % +56 %
                   

Hematology
Hematology, acquired with Baxalta in June 2016, reported product sales of $965 million. Hematology includes sales of recombinant and plasma-derived hemophilia products (primarily factor VIII and factor IX) and inhibitor therapies. Pro forma Q2 2017 growth in Hematology was approximately 1%. U.S. sales growth in Hemophilia, which benefited from stocking in the quarter, was partially offset by overall hematology performance in our international markets due to the timing of large orders.

Genetic Diseases
Genetic Diseases product sales increased 2%. Growth was primarily driven by our lysosomal storage diseases (LSD) portfolio.

ELAPRASE sales increased by 5%, while REPLAGAL sales increased by 3%. Both products benefited from an increase in the number of patients on therapy.

Immunology
Immunology, acquired with Baxalta in June 2016, reported product sales of $683 million. Immunology includes sales of antibody-replacement immunoglobulin and bio therapeutics therapies. Pro forma Q2 2017 growth in Immunology was approximately 18% (20% at Non GAAP CER) as the franchise benefited from growth in both immunoglobulin therapies and bio therapeutics. The U.S. benefited from growth in demand for our subcutaneous portfolio. International experienced growth across most regions with some benefit due to the timing of large orders.

Neuroscience
Neuroscience product sales decreased 3%, primarily driven by ADDERALL XR.

ADDERALL XR sales decreased 30%, primarily due to additional generic competition since August 2016. VYVANSE sales growth was impacted by destocking in the second quarter of 2017 compared to stocking in the same period in the prior year.

MYDAYIS, approved by the FDA on June 20, 2017, contributed $16 million of product sales related to launch stocking.

Internal Medicine
Internal Medicine product sales increased 15%, with strong growth from GATTEX/REVESTIVE and NATPARA.

GATTEX/REVESTIVE and NATPARA continued to perform well with sales increasing 69% and 73%, respectively, primarily due to an increase in the numbers of patients on therapy.

During Q2 2017, a generic version of LIALDA was approved by the FDA; Shire expects generic competition to negatively impact future LIALDA product sales.

Oncology
Oncology, acquired with Baxalta in June 2016, reported sales of $63 million. Oncology includes sales of ONCASPAR and ONIVYDE, the latter of which was approved in the EU on October 18, 2016 and has contributed to international growth in 2017.

Ophthalmology
Ophthalmology product sales relate to XIIDRA, which was made available to patients starting on August 29, 2016. XIIDRA contributed $57 million of product sales with 13% prescription growth since Q1 2017.

Baxalta pro forma product sales growth
The following table presents Q2 2017 reported legacy Baxalta product sales compared with Q2 2016 pro forma legacy Baxalta sales.

(in millions)       Pro forma
Year on year growth
Product sales by franchise   U.S. Sales   International Sales   Total Sales   Reported Non GAAP CER
                   
HEMOPHILIA   $ 383.1     $ 360.8     $ 743.9     +3 % +5 %
INHIBITOR THERAPIES   76.1     144.6     220.7     -7 % -5 %
Hematology total   459.2     505.4     964.6     +1 % +2 %
                   
IMMUNOGLOBULIN THERAPIES   407.9     102.6     510.5     +19 % +20 %
BIO THERAPEUTICS   75.9     96.3     172.2     +18 % +20 %
Immunology total   483.8     198.9     682.7     +18 % +20 %
                   
Oncology total   45.8     16.7     62.5     +18 % +20 %
                   
Total   $ 988.8     $ 721.0     $ 1,709.8     +8 % +9 %
                   
  1. Royalties and other revenues
(in millions)       Year on year growth
    Revenue   Reported Non GAAP CER
SENSIPAR royalties   $ 46.4     +30 % +31 %
ADDERALL XR royalties   13.4     +158 % +157 %
FOSRENOL royalties   12.1     +6 % +7 %
3TC and ZEFFIX royalties   8.2     -32 % -32 %
Other royalties and revenues   73.9     +73 % +77 %
Total royalties and other revenues   $ 154.0     +44 % +46 %
           

Royalties and Other Revenues increased 44%, primarily due to the inclusion of a full quarter of contract manufacturing revenue acquired with Baxalta.

  1. Financial details

Cost of sales

(in millions)   Q2 2017   % of total revenues   Q2 2016   % of total revenues
Cost of sales (US GAAP)   $ 1,108.9     30 %   $ 778.1     32 %
Expense related to the unwind of inventory fair value adjustments   (145.0 )       (280.7 )    
Depreciation   (67.0 )       (22.4 )    
Non GAAP cost of sales   $ 896.9     24 %   $ 475.0     20 %
                 

Cost of sales as a percentage of total revenues decreased to 30% primarily due to lower expense related to the unwind of inventory fair value adjustments.

Non GAAP cost of sales as a percentage of total revenues increased to 24%, primarily due to the impact of a full quarter of lower margin product franchises acquired with Baxalta.

R&D

(in millions)   Q2 2017   % of total revenues   Q2 2016   % of total revenues
R&D (US GAAP)   $ 542.4     14 %   $ 294.8     12 %
Impairment of IPR&D intangible assets   (20.0 )       (8.9 )    
Costs relating to license arrangements   (123.7 )       -      
Depreciation   (12.8 )       (5.8 )    
Non GAAP R&D   $ 385.9     10 %   $ 280.1     12 %
                 

R&D increased by $248 million, or 84%, primarily due to milestone and upfront payments associated with license arrangements, and the inclusion of a full quarter of Baxalta costs.

Non GAAP R&D increased by $106 million, or 38%, primarily due to the inclusion of a full quarter of Baxalta costs. Non GAAP R&D expense as a percentage of total revenues decreased 2 percentage points.
SG&A

(in millions)   Q2 2017   % of total revenues   Q2 2016   % of total revenues
SG&A (US GAAP)   $ 899.1     24 %   $ 675.3     28 %
Legal and litigation costs   (7.6 )       (1.6 )    
Depreciation   (40.9 )       (19.7 )    
Non GAAP SG&A   $ 850.6     23 %   $ 654.0     27 %
                 

SG&A increased by $224 million, or 33%, primarily due to the inclusion of a full quarter of Baxalta related costs and increased XIIDRA marketing costs.

Non GAAP SG&A increased by $197 million, or 30%, primarily due to the inclusion of a full quarter of Baxalta related costs and increased XIIDRA marketing costs. Non GAAP SG&A as a percentage of total revenues decreased 4 percentage points.

Amortization of acquired intangible assets

Shire recorded amortization of acquired intangible assets of $434 million (Q2 2016: $213 million). The increase is primarily related to amortization on the intangible assets acquired with the Baxalta transaction.

Integration and acquisition costs

In Q2 2017, Shire recorded integration and acquisition costs of $344 million. Integration costs of $193 million, primarily related to Baxalta, including employee severance and acceleration of stock compensation, third-party professional fees and expenses associated with facility consolidations. Additionally, integration and acquisition costs included a net charge of $151 million, relating to the change in fair value of contingent consideration, primarily related to SHP643 which was acquired from Dyax in 2016.

In Q2 2016, Shire recorded integration and acquisition costs of $363 million. Integration and acquisition costs related to the Baxalta and Dyax transactions were $417 million, and included costs relating to investment banking and other transaction-related fees, as well as integration costs related to employee severance and acceleration of stock compensation, and third-party professional fees. These costs were partially offset by a net credit of $58 million relating to the change in fair value of contingent consideration.

Other expense, net

(in millions)   Q2 2017       Q2 2016    
Other expense, net (US GAAP)   $ (137.7 )       $ (79.6 )    
Amortization of one-time upfront borrowing costs for Baxalta and Dyax   1.7         25.9      
Gain on sale of long term investments   (13.2 )       -      
Non GAAP Other expense, net   $ (149.2 )       $ (53.7 )    
                 

Other expense, net increased by $58 million, primarily due to higher interest expense incurred on borrowings used to fund the acquisitions of Dyax and Baxalta.

Non GAAP Other expense, net increased by $96 million, primarily due to higher interest expense as noted above.

Taxation

(in millions)       Effective
tax rate
      Effective
tax rate
    Q2 2017   Q2 2016  
Income tax expense (US GAAP)   $ (24.3 )   9 %   $ 70.9     (427 %)
Tax effect of adjustments   (187.6 )       (215.8 )    
Non GAAP Income tax expense   $ (211.9 )   16 %   $ (144.9 )   16 %
                 

The effective tax rate on US GAAP income in Q2 2017 was 9% (Q2 2016: -427%) and on a Non GAAP basis was 16% (Q2 2016: 16%).

The effective rate in Q2 2017 on US GAAP income from continuing operations is low primarily due to the combined impact of the relative quantum of profit before tax for the period by jurisdiction and the reversal of deferred tax liabilities from the Baxalta acquisition, as well as acquisition and integration costs in higher tax territories.

Discontinued operations

The loss from discontinued operations in Q2 2017 was $1 million, net of taxes, associated with the divested DERMAGRAFT business. The loss in Q2 2016 was $249 million, net of taxes of $101 million, primarily due to the establishment of legal contingencies related to the divested DERMAGRAFT business.


FINANCIAL INFORMATION

TABLE OF CONTENTS

  Page
   
Unaudited US GAAP Consolidated Balance Sheets 15
   
Unaudited US GAAP Consolidated Statements of Operations 16
   
Unaudited US GAAP Consolidated Statements of Cash Flows 18
   
Selected Notes to the Unaudited US GAAP Financial Statements  
(1) Earnings per share 20
(2) Analysis of revenues 21
   
Non GAAP reconciliations 22

Unaudited US GAAP Consolidated Balance Sheets
(in millions, except par value of shares)

  June 30, 2017   December 31, 2016
ASSETS      
Current assets:      
Cash and cash equivalents $ 263.7     $ 528.8  
Restricted cash 34.2     25.6  
Accounts receivable, net 2,755.2     2,616.5  
Inventories 3,325.3     3,562.3  
Prepaid expenses and other current assets 778.5     806.3  
Total current assets 7,156.9     7,539.5  
       
Non-current assets:      
Investments 197.0     191.6  
Property, plant and equipment (PP&E), net 6,554.5     6,469.6  
Goodwill 19,482.1     17,888.2  
Intangible assets, net 33,434.3     34,697.5  
Deferred tax asset 132.2     96.7  
Other non-current assets 233.9     152.3  
       
Total assets $ 67,190.9     $ 67,035.4  
       
LIABILITIES AND EQUITY      
Current liabilities:      
Accounts payable and accrued expenses $ 3,842.0     $ 4,312.4  
Short term borrowings and capital leases 3,204.9     3,068.0  
Other current liabilities 389.6     362.9  
Total current liabilities 7,436.5     7,743.3  
       
Non-current liabilities:      
Long term borrowings and capital leases 18,355.1     19,899.8  
Deferred tax liability 7,788.0     8,322.7  
Other non-current liabilities 2,346.2     2,121.6  
       
Total liabilities 35,925.8     38,087.4  
       
Equity:      
Common stock of 5p par value; 1,500 shares authorized; and 915.3 shares issued and outstanding (2016: 1,500 shares authorized; and 912.2 shares issued and outstanding) 81.5     81.3  
Additional paid-in capital 24,951.2     24,740.9  
Treasury stock: 8.4 shares (2016: 9.1 shares) (283.0 )   (301.9 )
Accumulated other comprehensive income/(loss) 200.1     (1,497.6 )
Retained earnings 6,315.3     5,925.3  
Total equity 31,265.1     28,948.0  
       
Total liabilities and equity $ 67,190.9     $ 67,035.4  

Unaudited US GAAP Consolidated Statements of Operations
(in millions)

  3 months ended June 30,   6 months ended June 30,
  2017   2016   2017   2016
               
Revenues:              
Product sales $ 3,591.8     $ 2,322.1     $ 7,004.1     $ 3,949.4  
Royalties & other revenues 154.0     107.0     314.0     189.0  
Total revenues 3,745.8     2,429.1     7,318.1     4,138.4  
               
Costs and expenses:              
Cost of sales 1,108.9     778.1     2,435.9     1,026.7  
Research and development 542.4     294.8     921.7     511.9  
Selling, general and administrative 899.1     675.3     1,788.0     1,150.2  
Amortization of acquired intangible assets 434.1     213.0     798.1     347.6  
Integration and acquisition costs 343.7     363.0     459.7     454.1  
Reorganization costs 13.6     11.0     19.1     14.3  
Loss/(gain) on sale of product rights 4.8     (2.3 )   (0.7 )   (6.5 )
Total operating expenses 3,346.6     2,332.9     6,421.8     3,498.3  
               
Operating income from continuing operations 399.2     96.2     896.3     640.1  
               
Interest income 1.1     1.6     4.2     2.6  
Interest expense (141.3 )   (87.2 )   (283.6 )   (131.9 )
Other income/(expense), net 2.5     6.0     7.0     (2.5 )
Total other expense, net (137.7 )   (79.6 )   (272.4 )   (131.8 )
               
Income from continuing operations before income taxes and equity in earnings/(losses) of equity method investees 261.5     16.6     623.9     508.3  
Income taxes (24.3 )   70.9     (31.1 )   (11.2 )
Equity in earnings/(losses) of equity method investees, net of taxes 4.3     (0.9 )   3.5     (1.0 )
Income from continuing operations, net of taxes 241.5     86.6     596.3     496.1  
               
(Loss)/gain from discontinued operations, net of taxes (1.2 )   (248.7 )   19.0     (239.2 )
               
Net income/(loss) $ 240.3     $ (162.1 )   $ 615.3     $ 256.9  

Unaudited US GAAP Consolidated Statements of Operations (continued)
(in millions, except per share amounts)

  3 months ended June 30,   6 months ended June 30,
  2017   2016   2017   2016
Earnings/(loss) per Ordinary Share - basic              
Earnings from continuing operations $ 0.27     $ 0.12     $ 0.66     $ 0.78  
(Loss)/gain from discontinued operations -     (0.36 )   0.02     (0.38 )
Earnings/(loss) per Ordinary Share - basic $ 0.27     $ (0.24 )   $ 0.68     $ 0.40  
Earnings/(loss) per ADS - basic $ 0.80     $ (0.71 )   $ 2.04     $ 1.21  
               
Earnings/(loss) per Ordinary Share - diluted              
Earnings from continuing operations $ 0.26     $ 0.12     $ 0.65     $ 0.77  
(Loss)/earnings from discontinued operations -     (0.36 )   0.02     (0.37 )
Earnings/(loss) per Ordinary Share - diluted $ 0.26     $ (0.24 )   $ 0.67     $ 0.40  
Earnings/(loss) per ADS - diluted $ 0.79     $ (0.71 )   $ 2.02     $ 1.20  
               
Weighted average number of shares:              
Basic 906.4     682.8     905.3     637.3  
Diluted 912.7     682.8     912.3     640.1  

Unaudited US GAAP Consolidated Statements of Cash Flows
(in millions)

  3 months ended June 30,   6 months ended June 30,
  2017   2016   2017   2016
CASH FLOWS FROM OPERATING ACTIVITIES:              
Net income/(loss) $ 240.3     $ (162.1 )   $ 615.3     $ 256.9  
Adjustments to reconcile net income/(loss) to net cash provided by operating activities:              
Depreciation and amortization 554.8     260.9     1,041.7     429.8  
Share based compensation 53.7     176.5     106.4     194.8  
Amortization of deferred financing fees 3.6     30.1     6.8     50.1  
Expense related to the unwind of inventory fair value adjustments 145.0     280.7     625.4     293.5  
Change in deferred taxes (157.8 )   (319.1 )   (293.3 )   (329.2 )
Change in fair value of contingent consideration 151.2     (56.4 )   147.7     (45.0 )
Impairment of PP&E and intangible assets 53.6     8.9     53.6     8.9  
Other, net (12.0 )   (3.1 )   14.8     (17.6 )
Changes in operating assets and liabilities:              
Increase in accounts receivable (146.2 )   (80.1 )   (181.5 )   (181.0 )
Increase/(decrease) in sales deduction accrual 39.6     (7.2 )   57.1     66.4  
Increase in inventory (19.8 )   (84.2 )   (171.6 )   (116.4 )
Decrease in prepayments and other assets 90.4     48.7     104.6     26.5  
Increase/(decrease) in accounts payable and other liabilities 226.4     497.3     (445.1 )   342.7  
Net cash provided by operating activities 1,222.8     590.9     1,681.9     980.4  
               
CASH FLOWS FROM INVESTING ACTIVITIES:              
Purchases of PP&E and long term investments (178.6 )   (127.5 )   (391.1 )   (179.1 )
Purchases of businesses, net of cash acquired -     (11,783.4 )   -     (17,476.2 )
Proceeds from sale of investments 40.6     -     40.6     -  
Movements in restricted cash (0.1 )   2.4     (8.6 )   67.2  
Other, net 2.0     (2.2 )   3.2     3.3  
Net cash used in investing activities (136.1 )   (11,910.7 )   (355.9 )   (17,584.8 )

Unaudited US GAAP Consolidated Statements of Cash Flows (continued)
(in millions)

  3 months ended June 30,   6 months ended June 30,
  2017   2016   2017   2016
CASH FLOWS FROM FINANCING ACTIVITIES:              
Proceeds from revolving line of credit, long term and short term borrowings 710.0     12,590.0     2,111.9     18,895.0  
Repayment of revolving line of credit, long term and short term borrowings (1,702.2 )   (505.2 )   (3,527.9 )   (1,500.3 )
Payment of dividend (234.7 )   (130.2 )   (234.7 )   (130.2 )
Debt issuance costs -     (18.5 )   -     (112.3 )
Proceeds from exercise of options 37.4     -     79.5     0.1  
Other, net (3.9 )   11.0     (24.0 )   11.9  
Net cash (used in)/provided by financing activities (1,193.4 )   11,947.1     (1,595.2 )   17,164.2  
               
Effect of foreign exchange rate changes on cash and cash equivalents 1.4     (2.9 )   4.1     (1.9 )
               
Net (decrease)/increase in cash and cash equivalents (105.3 )   624.4     (265.1 )   557.9  
Cash and cash equivalents at beginning of period 369.0     69.0     528.8     135.5  
Cash and cash equivalents at end of period $ 263.7     $ 693.4     $ 263.7     $ 693.4  

Selected Notes to the Unaudited US GAAP Financial Statements

  1. Earnings Per Share (EPS)

(in millions)

  3 months ended June 30,   6 months ended June 30,
  2017   2016   2017   2016
Income from continuing operations $ 241.5     $ 86.6     $ 596.3     $ 496.1  
(Loss)/gain from discontinued operations (1.2 )   (248.7 )   19.0     (239.2 )
Numerator for EPS $ 240.3     $ (162.1 )   $ 615.3     $ 256.9  
               
Weighted average number of shares:              
Basic 906.4     682.8     905.3     637.3  
Effect of dilutive shares:              
Share based awards to employees 6.3     -     7.0     2.8  
Diluted 912.7     682.8     912.3     640.1  

The share equivalents not included in the calculation of the diluted weighted average number of shares are shown below:

Share based awards to employees 13.2     8.3     10.3     4.4  

Selected Notes to the Unaudited US GAAP Financial Statements

(2) Analysis of revenues
(in millions)

  3 months ended June 30,   6 months ended June 30,
  2017   2016   2017   2016
Product sales by franchise              
               
HEMOPHILIA $ 743.9     $ 275.6     $ 1,394.3     $ 275.6  
INHIBITOR THERAPIES 220.7     74.0     441.2     74.0  
Hematology 964.6     349.6     1,835.5     349.6  
               
CINRYZE 175.9     173.0     401.8     337.2  
ELAPRASE 161.0     154.0     301.6     277.6  
FIRAZYR 137.4     136.7     265.9     265.0  
REPLAGAL 122.1     118.4     231.8     221.6  
VPRIV 87.9     88.0     167.7     171.6  
KALBITOR 20.6     17.7     32.3     28.1  
Genetic Diseases 704.9     687.8     1,401.1     1,301.1  
               
IMMUNOGLOBULIN THERAPIES 510.5     138.2     1,008.8     138.2  
BIO THERAPEUTICS 172.2     51.3     350.1     51.3  
Immunology 682.7     189.5     1,358.9     189.5  
               
VYVANSE 518.2     517.7     1,081.9     1,026.9  
ADDERALL XR 71.4     101.8     136.3     200.6  
MYDAYIS 15.7     -     15.7     -  
Other Neuroscience 30.1     35.7     54.8     57.8  
Neuroscience 635.4     655.2     1,288.7     1,285.3  
               
LIALDA/MEZAVANT 207.8     193.7     382.9     361.7  
PENTASA 83.3     72.9     152.4     136.9  
GATTEX/REVESTIVE 75.3     44.5     144.3     96.2  
NATPARA 34.5     19.9     64.2     35.5  
Other Internal Medicine 83.4     88.7     159.3     173.3  
Internal Medicine 484.3     419.7     903.1     803.6  
               
Oncology 62.5     20.3     120.8     20.3  
               
Ophthalmology 57.4     -     96.0     -  
               
Total product sales 3,591.8     2,322.1     7,004.1     3,949.4  
               
Royalties and other revenues              
               
SENSIPAR royalties 46.4     35.6     85.3     73.5  
ADDERALL XR royalties 13.4     5.2     25.9     11.0  
FOSRENOL royalties 12.1     11.4     20.7     20.6  
3TC and ZEFFIX royalties 8.2     12.1     22.7     27.1  
Other Royalties and revenues 73.9     42.7     159.4     56.8  
Total royalties and other revenues 154.0     107.0     314.0     189.0  
               
Total revenues $ 3,745.8     $ 2,429.1     $ 7,318.1     $ 4,138.4  

Non GAAP reconciliations
(in millions)

Reconciliation of US GAAP net income to Non GAAP EBITDA and Non GAAP operating income:

  3 months ended June 30,   6 months ended June 30,
  2017     2016     2017     2016  
US GAAP net income/(loss) $ 240.3     $ (162.1 )   $ 615.3     $ 256.9  
Add back/(deduct):              
Loss/(gain) from discontinued operations, net of tax 1.2     248.7     (19.0 )   239.2  
Equity in (earnings)/losses of equity method investees, net of taxes (4.3 )   0.9     (3.5 )   1.0  
Income taxes 24.3     (70.9 )   31.1     11.2  
Other expense, net 137.7     79.6     272.4     131.8  
US GAAP operating income from continuing operations 399.2     96.2     896.3     640.1  
Add back/(deduct) Non GAAP adjustments:              
Expense related to the unwind of inventory fair value adjustments 145.0     280.7     625.4     293.5  
Impairment of acquired intangible assets 20.0     8.9     20.0     8.9  
Costs relating to license arrangements 123.7     -     123.7     -  
Legal and litigation costs 7.6     1.6     7.6     16.6  
Amortization of acquired intangible assets 434.1     213.0     798.1     347.6  
Integration and acquisition costs 343.7     363.0     459.7     454.1  
Reorganization costs 13.6     11.0     19.1     14.3  
Loss/(gain) on sale of product rights 4.8     (2.3 )   (0.7 )   (6.5 )
Depreciation 120.7     47.9     243.6     82.2  
Other Non GAAP adjustments -     -     (4.0 )   -  
Non GAAP EBITDA 1,612.4     1,020.0     3,188.8     1,850.8  
Depreciation (120.7 )   (47.9 )   (243.6 )   (82.2 )
Non GAAP operating income $ 1,491.7     $ 972.1     $ 2,945.2     $ 1,768.6  
               
Net income margin(1) 6 %   (7 )%   8 %   6 %
Non GAAP EBITDA margin(2) 43 %   42 %   44 %   45 %
               
(1) Net income as a percentage of total revenues.
(2) Non GAAP EBITDA as a percentage of total revenues.

Reconciliation of revenues to Non GAAP gross margin:

  3 months ended June 30,   6 months ended June 30,
  2017     2016     2017     2016  
Revenues $ 3,745.8     $ 2,429.1     $ 7,318.1     $ 4,138.4  
Cost of sales (US GAAP) (1,108.9 )   (778.1 )   (2,435.9 )   (1,026.7 )
US GAAP gross margin 2,636.9     1,651.0     4,882.2     3,111.7  
Add back Non GAAP adjustments:              
Expense related to the unwind of inventory fair value adjustments 145.0     280.7     625.4     293.5  
Depreciation 67.0     22.4     139.1     30.7  
Non GAAP gross margin $ 2,848.9     $ 1,954.1     $ 5,646.7     $ 3,435.9  
Non GAAP gross margin % (1) 76.1 %   80.4 %   77.2 %   83.0 %
               
(1) Non GAAP gross margin as a percentage of total revenues.

Non GAAP reconciliations
(in millions, except per ADS amounts)

Reconciliation of US GAAP net income to Non GAAP net income:

  3 months ended June 30,   6 months ended June 30,
  2017   2016   2017     2016  
US GAAP net income/(loss) $ 240.3     $ (162.1 )   $ 615.3     $ 256.9  
Expense related to the unwind of inventory fair value adjustments 145.0     280.7     625.4     293.5  
Impairment of acquired intangible assets 20.0     8.9     20.0     8.9  
Costs relating to license arrangements 123.7     -     123.7     -  
Legal and litigation costs 7.6     1.6     7.6     16.6  
Amortization of acquired intangible assets 434.1     213.0     798.1     347.6  
Integration and acquisition costs 343.7     363.0     459.7     454.1  
Reorganization costs 13.6     11.0     19.1     14.3  
Loss/(gain) on sale of product rights 4.8     (2.3 )   (0.7 )   (6.5 )
Amortization of one-time upfront borrowing costs for Baxalta and Dyax 1.7     25.9     3.5     44.1  
(Gain)/loss on sale of long term investments (13.2 )   -     (13.2 )   6.0  
Loss/(gain) from discontinued operations 1.9     349.6     (29.9 )   334.6  
Other Non GAAP adjustments -     -     (4.0 )   -  
Tax effect of adjustments (188.3 )   (316.7 )   (387.6 )   (365.7 )
Non GAAP net income $ 1,134.9     $ 772.6     $ 2,237.0     $ 1,404.4  

Reconciliation of US GAAP diluted earnings per ADS to Non GAAP diluted earnings per ADS:

  3 months ended June 30,   6 months ended June 30,
  2017   2016   2017     2016  
US GAAP diluted earnings/(losses) per ADS $ 0.79     $ (0.71 )   $ 2.02     $ 1.20  
Expense related to the unwind of inventory fair value adjustments 0.48     1.23     2.06     1.38  
Impairment of acquired intangible assets 0.07     0.04     0.07     0.04  
Costs relating to license arrangements 0.41     -     0.41     -  
Legal and litigation costs 0.02     0.01     0.02     0.08  
Amortization of acquired intangible assets 1.42     0.94     2.62     1.63  
Integration and acquisition costs 1.12     1.59     1.51     2.13  
Reorganization costs 0.04     0.05     0.06     0.07  
Loss/(gain) on sale of product rights 0.02     (0.01 )   -     (0.03 )
Amortization of one-time upfront borrowing costs for Baxalta and Dyax 0.01     0.11     0.01     0.21  
(Gain)/loss on sale of long term investments (0.04 )   -     (0.04 )   0.03  
Loss/(gain) from discontinued operations 0.01     1.53     (0.10 )   1.56  
Other Non GAAP adjustments -     -     (0.01 )   -  
Tax effect of adjustments (0.62 )   (1.40 )   (1.27 )   (1.72 )
Non GAAP diluted earnings per ADS $ 3.73     $ 3.38     $ 7.36     $ 6.58  

Non GAAP reconciliations
(in millions, except per ADS amounts)

Reconciliation of US GAAP net cash provided by operating activities to Non GAAP free cash flow:

  3 months ended June 30,   6 months ended June 30,
  2017   2016   2017   2016
Net cash provided by operating activities $ 1,222.8     $ 590.9     $ 1,681.9     $ 980.4  
Capital expenditure (178.6 )   (127.5 )   (391.1 )   (179.1 )
Up-front payments for in-licensed products 20.0     -     20.0     -  
Non GAAP free cash flow $ 1,064.2     $ 463.4     $ 1,310.8     $ 801.3  

Non GAAP net debt comprises:

  June 30, 2017   December 31, 2016
Cash and cash equivalents $ 263.7     $ 528.8  
Long term borrowings (excluding capital leases) (18,011.3 )   (19,552.6 )
Short term borrowings (excluding capital leases) (3,198.1 )   (3,061.6 )
Capital leases (350.6 )   (353.6 )
Non GAAP net debt $ (21,296.3 )   $ (22,439.0 )

Reconciliation of full year 2017 US GAAP diluted earnings per ADS Outlook to Non GAAP diluted earnings per ADS Outlook:

    Full Year 2017 Outlook
    Min       Max
US GAAP diluted earnings per ADS   $ 5.65         $ 6.05  
Expense related to the unwind of inventory fair value adjustments       2.42    
Impairment of acquired intangible assets       0.07    
Costs relating to licensing arrangements       0.46    
Legal and litigation costs       0.04    
Amortization of acquired intangible assets       5.64    
Integration and acquisition costs       2.98    
Reorganization costs       0.10    
Amortization of one-time upfront borrowing costs for Baxalta and Dyax       0.02    
Loss from discontinued operations       (0.10)    
Gain on sale of long term investments       (0.01)    
Other Non-GAAP adjustments       (0.04)    
Tax effect of adjustments       (2.43)    
Non GAAP diluted earnings per ADS   $ 14.80         $ 15.20  

 
NOTES TO EDITORS

Stephen Williams, Deputy Company Secretary, is responsible for arranging the release of this announcement.

Inside Information

This announcement contains inside information.

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

www.shire.com


THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, 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, the following:

a further list and description of risks, uncertainties and other matters can be found in Shire's most recent Annual Report on Form 10-K and in Shire's subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in "ITEM 1A: Risk Factors", and in subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire's website.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.


NON GAAP MEASURES

This press release contains financial measures not prepared in accordance with US GAAP. These measures are referred to as "Non GAAP" measures and include: Non GAAP operating income; Non GAAP net income; Non GAAP diluted earnings per ADS; effective tax rate on Non GAAP income before income taxes and (losses/earnings) of equity method investees (effective tax rate on Non GAAP income); Non GAAP CER; Non GAAP cost of sales; Non GAAP gross margin; Non GAAP R&D; Non GAAP SG&A; Non GAAP other expense; Non GAAP free cash flow, Non GAAP net debt, Non GAAP EBITDA and Non GAAP EBITDA margin.

The Non GAAP measures exclude the impact of certain specified items that are highly variable, difficult to predict, and of a size that may substantially impact Shire's operations. Upfront and milestone payments related to in-licensing and acquired products that have been expensed as R&D are also excluded as specified items as they are generally uncertain and often result in a different payment and expense recognition pattern than ongoing internal R&D activities. Intangible asset amortization has been excluded from certain measures to facilitate an evaluation of current and past operating performance, particularly in terms of cash returns, and is similar to how management internally assesses performance. The Non GAAP financial measures are presented in this press release as Shire's management believes that they will provide investors with an additional analysis of Shire's results of operations, particularly in evaluating performance from one period to another.

Shire's management uses Non GAAP financial measures to make operating decisions as they facilitate additional internal comparisons of Shire's performance to historical results and to competitor's results, and provides them to investors as a supplement to Shire's reported results to provide additional insight into Shire's operating performance. Shire's Remuneration Committee uses certain key Non GAAP measures when assessing the performance and compensation of employees, including Shire's executive directors.

The Non GAAP financial measures used by Shire may be calculated different from, and therefore may not be comparable to, similarly titled measures used by other companies - refer to the section "Non GAAP Financial Measure Descriptions" below for additional information. In addition, these Non GAAP financial measures should not be considered in isolation as a substitute for, or as superior to, financial measures calculated in accordance with US GAAP, and Shire's financial results calculated in accordance with US GAAP and reconciliations to those financial statements should be carefully evaluated.

Non GAAP Financial Measure Descriptions

Where applicable the following items, including their tax effect, have been excluded when calculating Non GAAP earnings and from our Non GAAP outlook:

Amortization and asset impairments:

Acquisitions and integration activities:

Divestments, reorganizations and discontinued operations:

Legal and litigation costs:

Additionally, in any given period Shire may have significant, unusual or non-recurring gains or losses which it may exclude from its Non GAAP earnings for that period. When applicable, these items would be fully disclosed and incorporated into the required reconciliations from US GAAP to Non GAAP measures.

Depreciation, which is included in Cost of sales, R&D and SG&A costs in our US GAAP results, has been separately disclosed for presentational purposes.

Free cash flow represents net cash provided by operating activities, excluding up-front and milestone payments for in-licensed and acquired products, but including capital expenditure in the ordinary course of business.

Non GAAP net debt represents cash and cash equivalents less short and long term borrowings, capital leases and other debt.

A reconciliation of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented on pages 22 to 24.

Non GAAP CER growth is computed by restating 2017 results using average 2016 foreign exchange rates for the relevant period.

Average exchange rates used by Shire for the three months ended June 30, 2017 were $1.28:£1.00 and $1.09:€1.00 (2016: $1.45:£1.00 and $1.13:€1.00). Average exchange rates used by Shire for the six months ended June 30, 2017 were $1.26:£1.00 and $1.08:€1.00 (2016: $1.44:£1.00 and $1.11:€1.00).


TRADEMARKS

We own or have rights to trademarks, service marks or trade names that we use in connection with the operation of our business. In addition, our names, logos and website names and addresses are owned by us or licensed by us. We also own or have the rights to copyrights that protect the content of our solutions. Solely for convenience, the trademarks, service marks, trade names and copyrights referred to in this press release are listed without the ©, ® and (TM) symbols, but we will assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks, trade names and copyrights. In addition, this press release may include trademarks, service marks or trade names of other companies. Our use or display of other parties' trademarks, service marks, trade names or products is not intended to, and does not imply a relationship with, or endorsement or sponsorship of us by, the trademark, service mark or trade name.




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Shire plc via Globenewswire


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Shire plc : Shire reports strong Q2 2017 operating results and cash flow - RNS