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Shire's Replenished Portfolio Drives Excellent Quarterly Performance
Date:4/29/2010

DUBLIN, April 29, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company, announces results for the three months to March 31, 2010.

    Financial Highlights

                                                      Q1 2010(1)

    Product sales                                $718 million     -5%

    Product sales from core products(2)          $626 million    +36%

    Total revenues                               $816 million       -

    Non GAAP operating income                    $265 million    -19%

    US GAAP operating income                     $218 million     -4%
    Non GAAP diluted earnings per ADS                   $1.01    -21%
    US GAAP diluted earnings per ADS                    $0.89    -23%

    (1) Percentages compare to equivalent 2009 period.
    (2) Core products represent Shire's products excluding ADDERALL XR.
    Angus Russell, Chief Executive Officer, commented:

"This was an excellent first quarter performance with our core product sales up 36% and cash generation increasing 19% to $278 million. Despite the impact of authorised generic ADDERALL XR, total reported revenues in the quarter were at 2009 levels, reflecting our success in replenishing our portfolio with products providing strong growth and robust intellectual property. Across the business we saw significant developments: VYVANSE now has approximately a 14% share of the US ADHD market, our two recently launched products VPRIV and INTUNIV are performing well and in the EU REPLAGAL is now the leading Fabry treatment, with an estimated 60% market share.

We are investing in our growing international presence and building on our recent product launches. We are also progressing our pipeline and we expect to deliver further newsflow on our early projects later this year. Our core products are leveraging our existing infrastructure and we will continue to expand our operating margins.

Our performance in the first quarter reinforces our confidence in growing both revenue and earnings in the full year 2010 compared to 2009, and we re-iterate our aspirational target of mid-teens revenue growth on average between 2009 and 2015."

    FINANCIAL SUMMARY
    First Quarter 2010 Unaudited Results

                            Q1 2010                         Q1 2009
                                           Non                            Non
                US GAAP   Adjustments     GAAP  US GAAP   Adjustments    GAAP
                     $M            $M       $M       $M            $M      $M
    Revenues        816             -      816      818             -     818
    Operating
    income          218            47      265      226           101     327

    Diluted
    earnings
    per ADS       $0.89         $0.12    $1.01    $1.16         $0.12   $1.28

The Non GAAP financial measures included within this release are explained on pages 19 and 20, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 17 and 18.

    - Product sales from core products were up 36% to $626 million (2009:
      $460 million). On a constant exchange rate ("CER") basis, which is a
      Non GAAP measure, core product sales were up 33%. Growth in core
      product sales was achieved by strong performance throughout the
      portfolio including:

    - VYVANSE(R) (up 32% to $154 million, CER: up 32%);

    - ELAPRASE(R) (up 22% to $101 million, CER: up 17%);

    - REPLAGAL(R) (up 69% to $68 million, CER: up 60%);

    - LIALDA/MEZAVANT(R) (up 29% to $64 million, CER: up 28%); and

    - Recently launched INTUNIV(R) ($35 million) and VPRIV(R) ($6 million).

    - Product sales including ADDERALL XR(R) were down 5% to $718 million
      (CER: down 7%), as the decline in ADDERALL XR sales compared to Q1 2009
      (down 69% to $92 million) offset the strong core product sales growth.
      The decline in ADDERALL XR product sales was expected, as Q1 2009 was
      the last quarter of ADDERALL XR exclusivity prior to the launch of
      authorized generic versions by Teva Pharmaceuticals USA Inc. ("Teva")
      in April 2009 and Impax Laboratories Inc. ("Impax") in October 2009.

    - Total revenues of $816 million remained at 2009 levels (CER: down 2%;
      2009: $818 million) as higher royalty income (primarily received on
      Impax's sales of authorized generic ADDERALL XR) offset lower product
      sales.

    - Non GAAP operating income decreased by 19% to $265 million (2009: $327
      million) as a result of increased investment in research and
      development ("R&D") and higher selling, general and administrative
      ("SG&A") costs in support of recent product launches. On a US GAAP
      basis, operating income decreased by 4% to $218 million
      (2009: $226 million). US GAAP operating income in Q1 2009 included
      costs of $65 million on termination of the Women's Health development
      agreement with Duramed Pharmaceuticals Inc. ("Duramed").

    - Cash generation, which is a Non GAAP measure, continues to be strong
      and increased by 19% to $278 million in Q1 2010 (2009: $234 million).
      The increase in cash generation in 2010 resulted from higher cash
      receipts from gross product sales and royalties, partially offset by
      higher cash payments on the increased investment in R&D and SG&A.
      Cash balances (including cash equivalents and restricted cash) at
      March 31, 2010 were $684 million (December 31, 2009: $532 million).

2010 OUTLOOK

The first quarter's performance has increased our confidence in growing both revenues and earnings for the full year 2010 compared to 2009, including the effect of US Healthcare Reform.

Whilst our core portfolio will continue to deliver strong year on year growth, revenues from ADDERALL XR product sales and from total royalties are anticipated to be lower in the last three quarters of 2010 compared to their very strong performance in the first quarter. Given our confidence in our outlook, we have decided to make some targeted increases in investment in our international infrastructure, our recent product launches and in progressing our pipeline to support longer-term growth. As a result, we anticipate that R&D and SG&A spending in 2010 will be at the top end of our previously stated guidance of 5-10% growth year on year.

With the expected growth in 2010 we reiterate our aspirational target of mid-teens revenue growth on average between 2009 and 2015.

PRODUCT LAUNCHES

Subject to obtaining the relevant regulatory/governmental approvals, future product launches in the next 12 months will include:

    - VPRIV(TM) for the treatment of Type 1 Gaucher disease in the
      EU;

    - REPLAGAL for the treatment of Fabry disease in the US;

    - MEZAVANT for the treatment of ulcerative colitis in certain
      EU and RoW countries;

    - FIRAZYR(R) for the symptomatic treatment of acute attacks of hereditary
      angiodema ("HAE") in certain European and Latin American countries; and

    - EQUASYM(R) for the treatment of ADHD in certain EU
      countries.


    FIRST QUARTER 2010 AND RECENT PRODUCT AND PIPELINE DEVELOPMENTS
    Products
    VPRIV - for the treatment of Type 1 Gaucher disease in the US

    - On February 26, 2010 the U.S. Food and Drug Administration
      ("FDA") granted marketing approval for VPRIV, a human cell line derived
      enzyme replacement therapy ("ERT") for the long-term treatment of Type
      1 Gaucher disease in pediatric and adult patients. The FDA designated
      VPRIV for Priority Review and granted marketing approval in just six
      months. VPRIV offers patients and their physicians a new treatment
      option at a critical time, as the supply of a previously approved ERT
      for Gaucher disease is uncertain and remains disrupted.

    VYVANSE - for the treatment of ADHD

    - On February 1, 2010 Shire announced the Canadian
      availability of VYVANSE, the first and only prodrug therapy approved
      for ADHD treatment in Canada. This is the first launch of VYVANSE
      outside the US.

    - On March 4, 2010 the United States District Court for the
      District of Columbia (the "District Court") upheld the FDA's decision
      that VYVANSE is entitled to five year market exclusivity in the US.
      The five-year exclusivity period for VYVANSE expires on February 23,
      2012 and precludes generic manufacturers from submitting an Abbreviated
      New Drug Application ("ANDA") to the FDA until that time, or until
      February 23, 2011 should a generic applicant challenge the US patents
      covering VYVANSE, which remain in effect until June 29, 2023. Actavis
      Elizabeth LLC ("Actavis") has appealed the District Court's ruling to
      the US Court of Appeals for the DC Circuit. No hearing date has been
      set.

    INTUNIV - for the treatment of ADHD

    - On March 16, April 5, and April 26, 2010 Shire received
      Paragraph IV Notice Letters from Teva, Actavis and Anchen
      Pharmaceuticals, Inc. ("Anchen") respectively, advising of the filing
      of ANDAs for generic versions of 1mg, 2mg, 3mg, and 4mg guanfacine
      hydrochloride extended release tablets, INTUNIV. INTUNIV is protected
      by three FDA Orange Book listed patents. The three patents expire in
      2015, 2020 and 2022, respectively. Teva's Paragraph IV Notice Letter
      was only directed to the patents expiring in 2020 and 2022. On April
      22, Shire filed a lawsuit against Teva in the US District Court for the
      District of Delaware for the infringement of these patents. Actavis's
      and Anchen's Paragraph IV Notice Letters were directed to all three
      Orange Book listed patents. Shire is currently reviewing the details
      of Actavis's and Anchen's Paragraph IV Notice Letters.

    REPLAGAL - for the treatment of Fabry disease

    - On April 14, 2010 Mt. Sinai School of Medicine of New York
      University sought to initiate lawsuits in Sweden and Germany alleging
      that REPLAGAL infringes Mt. Sinai's European Patent No. 1 942 189,
      granted April 14, 2010. Mt. Sinai is seeking an injunction against the
      use of REPLAGAL in these jurisdictions until expiration of the patent
      on November 30, 2013. Shire will defend its right to commercialize
      REPLAGAL in these countries and will vigorously oppose the validity of
      this patent.

    Pipeline
    REPLAGAL - for the treatment of Fabry disease in the US

    - On February 24, 2010 Shire announced its receipt of Fast Track
      designation from the FDA for REPLAGAL, an ERT for Fabry disease.
      Shire filed a Biologics License Application ("BLA") for REPLAGAL in
      December 2009, and in Q1 2010 the FDA requested additional
      pharmacokinetic comparability data. As a result of this request,
      Shire withdrew its December BLA filing, and, at the suggestion of the
      FDA, requested and received Fast Track designation. Shire immediately
      initiated the rolling submission of the REPLAGAL BLA, and expects to
      submit the requested pharmacokinetic data around mid-year. REPLAGAL is
      currently approved for the treatment of Fabry disease in 45 countries
      and has been available to US patients since December 2009 under an
      FDA-approved treatment protocol filed at the request of FDA. The
      Company is also supporting emergency Investigational New Drug requests
      in the US. The REPLAGAL early access program was put in place as a
      result of the supply disruption of the only currently marketed
      treatment for Fabry disease in the US.

HGT-2310 - for the treatment of Hunter syndrome with central nervous system symptoms, idursulfase-IT (intrathecal delivery)

    - HGT 2310 is in development as an ERT delivered intrathecally for Hunter
      syndrome patients with central nervous system symptoms. The Company
      initiated a Phase I/II clinical trial in the first quarter of 2010.
      This product has been granted orphan designation in the US.

    LIALDA/MEZAVANT - for the treatment of diverticulitis

    - LIALDA/MEZAVANT is being investigated as a treatment to prevent
      recurrent attacks of diverticulitis. Phase 3 worldwide clinical trials
      investigating the use of the product for the treatment of
      diverticulitis were initiated in 2007 and are ongoing. Enrollment in
      these trials has completed and data is estimated to be available in
      2012.

    OTHER FIRST QUARTER AND RECENT DEVELOPMENTS
    US Healthcare Reform

    - During the quarter, President Obama signed into law Healthcare Reform,
      with the goal of expanding healthcare access to millions of Americans
      currently without health insurance and lowering the overall costs of
      healthcare. Healthcare Reform will affect Shire in a number of
      ways, including a limited impact coming from the changes to the
      calculation of Medicaid rebates effective from this quarter, and from
      Shire's share of the industry wide excise tax starting in 2011.
      We are pleased with the expansion of healthcare coverage to previously
      uninsured patients and believe this should provide a positive benefit
      for Shire. Furthermore, we are also pleased with Healthcare
      Reform providing certainty regarding regulatory exclusivity for
      biologics. Healthcare Reform did not materially impact Shire's results
      in the first quarter of 2010, and we believe Shire is well placed to
      manage the changes Healthcare Reform will bring in future periods.

    BOARD CHANGES

    - On March 15, 2010 Bill Burns was appointed to the Board as a
      Non Executive Director with immediate effect. Mr Burns has also been
      appointed a member of Shire's Remuneration Committee.

Dial in details for the live conference call for investors 14:30 BST/9:30 EDT on April 29, 2010:

    UK dial in: 0844-800-3850 or 01296-311-600

    US dial in: 1-866-8048688 or 1-718-3541175

    International dial in: +44(0)1296-311-600

    Password/Conf ID: 327562

    Live Webcast: http://www.shire.com/shireplc/en/investors

    ADDITIONAL INFORMATION
    The following additional information is included in this press release:

                                              Page
    Overview of Q1 2010 Financial               6
    Results
    Financial Information                      10
    Notes to Editors                           19
    Safe Harbor Statement                      19
    Explanation of Non GAAP Measures           19
    Trademarks                                 20


    OVERVIEW OF Q1 2010 FINANCIAL RESULTS
    1. Product sales

For the three months to March 31, 2010 product sales decreased by 5% to $718.2 million (2009: $756.0 million) and represented 88% of total revenues (2009: 92%). On a CER basis product sales decreased 7% compared to 2009.

Sales of core products increased by 36% to $626.4 million (2009: $460.2 million), up 33% on a CER basis.

    Product Highlights

                                                                    Exit
                                                                   Market
                                               Growth             Share(1)
    Product              Sales $M   Sales       CER     US Rx(1)

    VYVANSE                 154.4     +32% 1     +32%       +32%        14%
    ELAPRASE                100.8     +22% 1     +17%     n/a(2)     n/a(2)
    REPLAGAL                 68.0     +69% 1     +60%     n/a(3)     n/a(3)
    LIALDA / MEZAVANT        63.6     +29% 1     +28%       +23%        19%
    PENTASA(R)               58.2     +14%       +14%        -6%        15%
    FOSRENOL(R)              47.1     +18% 1     +14%       -12%         7%
    INTUNIV                  34.5      n/a 1      n/a        n/a         2%
    VPRIV                     5.8      n/a 1      n/a        n/a        n/a
    FIRAZYR                   2.2    +340% 1    +313%     n/a(3)     n/a(3)
    OTHER                    91.8     +15% 1     +11%        n/a        n/a
    Core product sales      626.4      36% 1      33%
    ADDERALL XR              91.8     -69% 1     -70%       -60%         8%
    Total product sales     718.2      -5% 1      -7%

(1) Data provided by IMS Health National Prescription Audit ("IMS NPA"). Exit market share represents the US market share in the week ending March 26, 2010.

(2) IMS NPA Data not available.

(3) Not sold in the US in Q1 2010, or awaiting approval in the US.

VYVANSE - ADHD

The increase in VYVANSE product sales was driven by increased US prescription demand compared to Q1 2009, 10% growth in the US ADHD market and price increases.

ELAPRASE - Hunter syndrome

The growth in sales of ELAPRASE was driven by increased volumes across all regions where ELAPRASE is sold. On a CER basis sales grew by 17% (79% of ELAPRASE sales are made outside of the US).

REPLAGAL - Fabry disease

The growth in REPLAGAL product sales in Q1 2010 over 2009 was driven by an increase in demand due to significant switching of patients to REPLAGAL in the EU, attributable in part to supply shortages of a competitor product. Sales increased 60% on a CER basis (REPLAGAL is sold primarily in Euros and Pounds sterling).

LIALDA/MEZAVANT - Ulcerative colitis

Strong product sales of LIALDA/MEZAVANT continued in Q1 2010 driven by increased US prescription demand compared to Q1 2009 and price increases. The US oral mesalamine market was flat year on year.

PENTASA - Ulcerative colitis

Product sales of PENTASA increased in Q1 2010 compared to Q1 2009 primarily due to price increases.

FOSRENOL - Hyperphosphatemia

Product sales increased as FOSRENOL grew its share of existing markets outside the US. Product sales also grew in the US due to price increases and growth in non-retail demand which offset the decline in US retail prescription demand.

INTUNIV - ADHD

In line with Shire's revenue recognition policy for launch shipments, initial stocking shipments in November 2009 were deferred and are being recognised into revenue in line with end-user prescription demand. At March 31, 2010 deferred revenues on the balance sheet represented gross sales of $18.8 million.

VPRIV - Gaucher disease

Product sales were primarily generated on a pre-approval basis via patient early access programs in the EU throughout Q1 2010 and in the US after February 26, 2010 when approval was received from the FDA.

FIRAZYR - HAE

Product sales of FIRAZYR increased as volumes grew across European markets. FIRAZYR is the first new product for HAE in Europe in 30 years and has orphan exclusivity for acute attacks of HAE in adults in the EU until 2018.

ADDERALL XR - ADHD

ADDERALL XR product sales decreased in 2010 compared to 2009 as Q1 2009 represented the final quarter of exclusivity prior to the launch of authorized generic versions by Teva and Impax in April and October 2009, respectively. The launch of authorized generic versions resulted in a lower prescription demand in 2010 compared to 2009 resulting in a corresponding reduction in ADDERALL XR's share of the US ADHD market (8% for Q1 2010 compared to 21% in Q1 2009).

    Despite price increases taken since Q1 2009, product sales in 2010
declined at a faster rate than US prescription demand due to increased sales
deductions as a percentage of branded ADDERALL XR gross sales, representing
61% of gross revenues in Q1 2010 (2009: 37%). Sales deductions in Q1 2010
included the effect of a change in estimate of inventory in the wholesaler
pipeline, which decreased sales deductions as a percentage of gross sales by
8 percentage points.
    2. Royalties

                                                    Year on year growth
                                 Royalties to
    Product                        Shire $M      Royalties          CER

    3TC(R) and Zeffix(R)    1.00     36.6           -6%             -7%
    ADDERALL XR             1.00     40.8           n/a             n/a
    Other                   1.00     17.9           52%             47%
    Total                   1.00     95.3           88%             86%

Royalty income increased by 88% in Q1 2010 compared to 2009 due to royalties received on sales of Impax's authorized generic version of ADDERALL XR, which commenced in October 2009. This increase more than offset the decline in royalties received from GlaxoSmithKline ("GSK") on 3TC, down 9%, due to competition from other treatments. Royalties received from GSK on ZEFFIX were slightly increased over 2009. Other royalties increased by 52%, principally due to higher royalties on sales of FOSRENOL in Japan.

    3. Financial details
    Cost of product sales

                                                % of              % of
                                             product           product
                                Q1 2010        sales  Q1 2009    sales
                                     $M                    $M
    Cost of product sales (US     101.9          14%     83.6      11%
    GAAP)
    Costs associated with the
    transfer of manufacturing
    from Owings Mills              (7.2)                    -
    Depreciation                   (2.5)                 (3.6)
    Cost of product sales (Non     92.2          13%     80.0      11%
    GAAP)

Non GAAP cost of product sales as a percentage of product sales increased in Q1 2010 compared to the same period in 2009 due to changes to the product mix following the launch of authorized generic versions of ADDERALL XR by Teva and Impax in April and October 2009, and the inclusion of lower margin sales of the authorized generic to Teva and Impax which depressed gross margins for ADDERALL XR.

    Research and development ("R&D")

                                              % of                  % of
                                           product               product
                              Q1 2010        sales  Q1 2009        sales
                                   $M                    $M
    R&D (US GAAP)               131.0          18%    185.9          25%
    Women's Health exit costs       -                (65.0)
    Depreciation                (3.7)                 (4.0)
    R&D (Non GAAP)              127.3          18%    116.9          15%

Non GAAP R&D increased in absolute terms by $10.4 million in 2010 over 2009 due to continued increased investment in R&D programs, in part as a result of acceleration of the REPLAGAL and VPRIV programs. As a percentage of core product sales, Non GAAP R&D decreased by 5 percentage points to 20% (2009: 25%).

    Selling, general and administrative ("SG&A")

                                            % of              % of
                                         product           product
                                Q1 2010    sales  Q1 2009    sales
                                     $M                $M
    SG&A (US GAAP)                359.9      50%    318.9      42%
    Intangible asset             (34.6)            (32.5)
    amortization
    Depreciation                 (16.3)            (14.8)
    SG&A (Non GAAP)               309.0      43%    271.6      36%

Non GAAP SG&A increased in 2010 compared to 2009 due in part to increased selling and marketing costs incurred in support of recently launched products. As a percentage of core product sales, Non GAAP SG&A decreased by 10 percentage points to 49% (2009: 59%).

Reorganization costs

For the three months to March 31, 2010 Shire recorded reorganization costs of $5.0 million (2009: $2.2 million) principally relating to the transfer of manufacturing from its Owings Mills facility.

Interest expense

For the three months to March 31, 2010 the Company incurred interest expense of $9.0 million (2009: $11.0 million). Interest expense principally relates to the coupon and deferred issue costs on Shire's $1,100 million 2.75% convertible bonds due 2014.

    Other income/(expense), net

                                    Q1 2010  Q1 2009
                                         $M       $M
    Other income, net (US GAAP)        10.8     50.3
    Gain on sale of investments      (11.1)   (55.2)
    Other expense, net (Non GAAP)     (0.3)    (4.9)

Non GAAP other expense, net in 2010 was lower than the same period in 2009 due to foreign exchange losses in 2009 that were not repeated in 2010.

In the first quarter of 2010 Shire recognised a gain of $11.1 million (2009: $55.2 million) relating to the disposal of its investment in Virochem Pharma Inc. ("Virochem") in March 2009. At the time of the disposal, an element of the consideration was held in escrow for twelve months pending any warranty claims and breaches of representations made by Virochem and by all selling shareholders, including Shire. The remaining consideration was released from escrow in March 2010, resulting in a gain of $11.1 million being recognized in Q1 2010.

Taxation

The effective rate of tax for the three months to March 31, 2010 was 24% (2009: 19%), and the effective tax rate on Non GAAP income was 26% (2009: 24%).

The Non-GAAP effective tax rate in 2010 is higher than the same period in 2009 due to unfavourable changes in profit mix and the recording of valuation allowances in 2010 in relation to loss carry forward amounts which were not recorded in Q1 2009.

    FINANCIAL INFORMATION
    TABLE OF CONTENTS

                                                          Page

    Unaudited US GAAP Statement of Financial Position       11

    Unaudited US GAAP Consolidated Statements of
    Operations                                              12

    Unaudited US GAAP Consolidated Statements of Cash
    Flows                                                   14

    Selected Notes to the Unaudited US GAAP Financial
    Statements
    (1) Earnings per share                                  15
    (2) Analysis of revenues                                16

    Non GAAP reconciliation                                 17

    Unaudited US GAAP results for the three months to March 31, 2010
Consolidated Balance Sheets

                                                       March 31, December 31,
                                                            2010         2009
                                                              $M           $M
    ASSETS
    Current assets:
    Cash and cash equivalents                              657.5        498.9
    Restricted cash                                         26.8         33.1
    Accounts receivable, net                               620.7        597.5
    Inventories                                            215.6        189.7
    Deferred tax asset                                     114.1        135.8
    Prepaid expenses and other current assets              131.0        115.2

    Total current assets                                 1,765.7      1,570.2

    Non-current assets:
    Investments                                            109.6        105.7
    Property, plant and equipment, net                     668.5        676.8
    Goodwill                                               373.2        384.7
    Other intangible assets, net                         1,729.6      1,790.7
    Deferred tax asset                                      80.9         79.0
    Other non-current assets                                11.2         10.4

    Total assets                                         4,738.7      4,617.5

    LIABILITIES AND EQUITY
    Current liabilities:
    Accounts payable and accrued expenses                  929.2        929.1
    Deferred tax liability                                   3.3          2.9
    Other current liabilities                               36.5         88.0

    Total current liabilities                              969.0      1,020.0

    Non-current liabilities:
    Convertible bonds                                    1,100.0      1,100.0
    Other long-term debt                                    43.7         43.6
    Deferred tax liability                                 321.3        294.3
    Other non-current liabilities                          247.7        247.1

    Total liabilities                                    2,681.7      2,705.0

    Shareholders' equity:
    Common stock of 5p par value; 1,000 million
    shares authorized; and 562.1 million shares
    issued and outstanding (2009: 1,000 million
    shares authorized; and 561.5 million shares
    issued and outstanding)                                 55.6         55.6
    Additional paid-in capital                           2,697.9      2,677.6
    Treasury stock: 15.7 million shares (2009: 17.8
    million)                                             (311.8)      (347.4)
    Accumulated other comprehensive income                 107.3        149.1
    Accumulated deficit                                  (492.0)      (622.4)

    Total shareholders' equity                           2,057.0      1,912.5

    Total liabilities and equity                         4,738.7      4,617.5

Unaudited US GAAP results for the three months to March 31, 2010 Consolidated Statements of Operations

    3 months to March 31,                                   2010        2009
                                                              $M          $M
    Revenues:
    Product sales                                          718.2       756.0
    Royalties                                               95.3        50.6
    Other revenues                                           2.7        11.2
    Total revenues                                         816.2       817.8

    Costs and expenses:
    Cost of product sales(1)                               101.9        83.6
    Research and development                               131.0       185.9
    Selling, general and administrative(1)                 359.9       318.9
    Reorganization costs                                     5.0         2.2
    Integration and acquisition costs                        0.6         1.4
    Total operating expenses                               598.4       592.0

    Operating income                                       217.8       225.8

    Interest income                                          0.4         0.6
    Interest expense                                       (9.0)      (11.0)
    Other income, net                                       10.8        50.3
    Total other income, net                                  2.2        39.9

    Income from continuing operations before income
    taxes and equity in losses of equity method
    investees                                              220.0       265.7
    Income taxes                                          (53.6)      (49.5)
    Equity in losses of equity method investees, net
    of taxes                                               (0.5)       (0.1)
    Income from continuing operations, net of tax          165.9       216.1

    Loss from discontinued operations (net of income
    tax expense of $nil and $nil respectively)                 -       (2.6)
    Net income                                             165.9       213.5

    Add: Net loss attributable to noncontrolling
    interest in subsidiaries                                   -         0.1
    Net income attributable to Shire plc                   165.9       213.6

(1) Cost of product sales includes amortization of intangible assets relating to favorable manufacturing contracts of $0.4 million for the three months to March 31, 2010 (2009: $0.4 million). Selling, general and administrative costs include amortization of intangible assets relating to intellectual property rights acquired of $34.6 million for the three months to March 31, 2010 (2009: $32.5 million).

Unaudited US GAAP results for the three months to March 31, 2010 Consolidated Statements of Operations (continued)

    3 months to March 31,                    2010      2009

    Earnings per ordinary share - basic
    Earnings from continuing operations     30.5c     40.1c
    Loss from discontinued operations           -    (0.5c)
    Earnings per ordinary share - basic     30.5c     39.6c

    Earnings per ADS - basic                91.5c    118.8c

    Earnings per ordinary share -
    diluted
    Earnings from continuing operations     29.7c     38.9c
    Loss from discontinued operations           -    (0.4c)
    Earnings per ordinary share -           29.7c     38.5c
    diluted

    Earnings per ADS - diluted              89.1c    115.5c

    Weighted average number of shares:
                                         Millions  Millions
    Basic                                   543.9     539.2
    Diluted                                 586.1     577.2

Unaudited US GAAP results for the three months to March 31, 2010 Consolidated Statements of Cash Flows

    3 months to March 31,                                       2010     2009
                                                                  $M       $M
    CASH FLOWS FROM OPERATING ACTIVITIES:
    Net income                                                 165.9    213.5
    Adjustments to reconcile net income to net cash
    provided by operating activities:
            Loss from discontinued operations                      -      2.6
            Depreciation and amortization                       64.3     55.3
            Share based compensation                            14.1     15.8
            Gain on sale of non-current investments           (11.1)   (55.2)
            Other                                                5.2      3.3
    Movement in deferred taxes                                  52.2     33.7
    Equity in losses of equity method investees                  0.5      0.1

    Changes in operating assets and liabilities:
            Increase in accounts receivable                   (10.8)  (151.0)
            Increase in sales deduction accrual                 64.9    121.9
            Increase in inventory                             (24.2)    (9.5)
            Increase in prepayments and other current
            assets                                            (18.1)   (12.3)
            (Increase)/decrease in other assets                (0.6)      3.4
            Decrease in accounts and notes payable and
            other liabilities                                (116.1)   (39.8)
    Returns on investment from joint venture                       -      4.9
    Cash flows used in discontinued operations                     -    (2.6)
    Net cash provided by operating activities(A)               186.2    184.1

    CASH FLOWS FROM INVESTING ACTIVITIES:
    Movements in restricted cash                                 6.3    (6.9)
    Purchases of subsidiary undertakings and
    businesses, net of cash acquired                               -   (74.1)
    Purchases of property, plant and equipment                (43.6)   (42.0)
    Purchases of intangible assets                                 -    (6.0)
    Proceeds from disposal of long-term
    investments                                                  2.0     19.2
    Proceeds from disposal of property, plant
    and equipment                                                0.1      0.4
    Returns from equity investments                                -      0.2
    Net cash used in investing activities(B)                  (35.2)  (109.2)

    CASH FLOWS FROM FINANCING ACTIVITIES:
    Payment under building financing obligation                (0.7)    (0.7)
    Proceeds from exercise of options                            1.5      0.1
    Tax benefit of stock based compensation                      4.8        -
    Net cash provided by/(used in) financing
    activities(C)                                                5.6    (0.6)

    Effect of foreign exchange rate changes on
    cash and cash equivalents(D)                                 2.0    (1.4)

    Net increase in cash and cash equivalents(A)
    +(B) +(C) +(D)                                             158.6     72.9
    Cash and cash equivalents at beginning of
    period                                                     498.9    218.2
    Cash and cash equivalents at end of period                 657.5    291.1

    Unaudited US GAAP results for the three months to March 31, 2010
    Selected Notes to the Financial Statements
    (1) Earnings per share

    3 months to March 31,                  2010       2009
                                             $M         $M

    Income from continuing operations     165.9      216.1
    Loss from discontinued operations         -      (2.6)
    Noncontrolling interest in
    subsidiaries                              -        0.1

    Numerator for basic EPS               165.9      213.6
    Interest on convertible bonds,
    net of tax(1)                           8.4        8.4

    Numerator for diluted EPS             174.3      222.0

    Weighted average number of
    shares:
                                       Millions   Millions
    Basic(2)                              543.9      539.2
    Effect of dilutive shares:
    Stock options(3)                        9.0        5.3
    Convertible bonds 2.75% due
    2014(1)                                33.2       32.7

    Diluted                               586.1      577.2

    (1) Calculated using the "if-converted" method.

(2) Excludes shares purchased by the Employee Share Ownership Trust ("ESOT") and presented by Shire as treasury stock.

(3) Calculated using the treasury stock method.

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

    3 months to March 31,                      2010           2009
                                      No. of shares  No. of shares
                                        Millions(1)    Millions(1)
    Stock options out of the money             16.1           16.6

(1) For the three month periods ended March 31, 2010 and 2009, certain stock options have been excluded from the calculation of diluted EPS because their exercise prices exceeded Shire plc's average share price during the calculation period.

    Unaudited US GAAP results for the three months to March 31, 2010
    Selected Notes to the Financial Statements
    (2) Analysis of revenues

    3 months to March 31,             2010       2009      2010        2010
                                                              %  % of total
                                        $M         $M    change     revenue
    Net product sales:
    Specialty Pharmaceuticals
    ("Speciality")
    ADHD
    ADDERALL XR                       91.8      295.8      -69%         11%
    VYVANSE                          154.4      116.6       32%         19%
    DAYTRANA                          18.4       19.9       -7%          2%
    EQUASYM                            2.4 1        -       n/a         <1%
    INTUNIV                           34.5 1        -       n/a          4%
                                     301.5      432.3      -30%         37%
    GI
    PENTASA                           58.2       51.2       14%          7%
    LIALDA / MEZAVANT                 63.6       49.4       29%          8%
                                     121.8      100.6       21%         15%
    General products
    FOSRENOL                          47.1       39.8       18%          6%
    CALCICHEW                          9.4        9.6       -2%          1%
    CARBATROL                         20.1       18.1       11%          2%
    REMINYL/REMINYL XL                12.5        7.4       69%          2%
    XAGRID                            23.3       20.1       16%          3%
                                     112.4       95.0       18%         14%

    Other product sales                5.7        4.6       24%          1%
    Total Specialty product
    sales                            541.4      632.5      -14%         66%

    Human Genetic Therapies ("HGT")
    ELAPRASE                         100.8       82.8       22%         12%
    REPLAGAL                          68.0       40.2       69%          8%
    VPRIV                              5.8 1        -       n/a          1%
    FIRAZYR                            2.2        0.5      340%         <1%
    Total HGT product sales          176.8      123.5       43%         22%

    Total product sales              718.2      756.0       -5%         88%

    Royalties:
    3TC and ZEFFIX                    36.6       38.8       -6%          4%
    ADDERALL XR                       40.8 1        -       n/a          5%
    Other                             17.9       11.8       52%          2%
    Total royalties                   95.3       50.6       88%         11%

    Other revenues                     2.7       11.2      -76%         <1%

    Total Revenues                   816.2      817.8        0%        100%

    Unaudited results for the three months to March 31, 2010
    Non GAAP reconciliation

                        US GAAP             Adjustments
                                             Acquisitions
                                Amortization            &
                          March      & asset  integration
    3 months to,       31, 2010  impairments   activities
                                         (a)          (b)
                             $M           $M           $M
    Total revenues        816.2            -            -

    Costs and
    expenses:
    Cost of product
    sales                 101.9            -            -
    Research and
    development           131.0            -            -
    Selling, general
    and administrative    359.9       (34.6)            -
    Reorganization
    costs                   5.0            -            -
    Integration and
    acquisition costs       0.6            -        (0.6)
    Depreciation              -            -            -
    Total operating
    expenses              598.4       (34.6)        (0.6)

    Operating income      217.8         34.6          0.6

    Interest income         0.4            -            -
    Interest expense      (9.0)            -            -
    Other
    income/(expenses),
    net                    10.8            -            -
    Total other
    income/(expense),
    net                     2.2            -            -
    Income from
    continuing
    operations before
    income taxes and
    equity in losses
    of equity method
    investees             220.0         34.6          0.6
    Income taxes         (53.6)        (9.7)        (0.1)
    Equity in losses
    of equity method
    investees, net of
    tax                   (0.5)            -            -
    Net income
    attributable to
    Shire plc             165.9         24.9          0.5
    Impact of
    convertible debt,
    net of tax              8.4            -            -
    Numerator for
    diluted EPS           174.3         24.9          0.5
    Weighted average
    number of shares
    (millions) -
    diluted               586.1            -            -
    Diluted earnings
    per ADS               89.1c        12.8c         0.3c


    Table Continued


                               Divestments,                 Non GAAP
                            reorganizations
                             & discontinued   Reclassify    March 31,
    3 months to,                 operations depreciation         2010
                                        (c)          (d)
                                         $M           $M           $M
    Total revenues                        -            -        816.2

    Costs and expenses:
    Cost of product sales             (7.2)        (2.5)         92.2
    Research and
    development                           -        (3.7)        127.3
    Selling, general and
    administrative                        -       (16.3)        309.0
    Reorganization costs              (5.0)            -            -
    Integration and
    acquisition costs                     -            -            -
    Depreciation                          -         22.5         22.5
    Total operating
    expenses                         (12.2)            -        551.0

    Operating income                   12.2            -        265.2

    Interest income                       -            -          0.4
    Interest expense                      -            -        (9.0)
    Other
    income/(expenses), net           (11.1)            -        (0.3)
    Total other
    income/(expense), net            (11.1)            -        (8.9)
    Income from continuing
    operations before
    income taxes and equity
    in losses of equity
    method investees                    1.1            -        256.3
    Income taxes                      (3.1)            -       (66.5)
    Equity in losses of
    equity method
    investees, net of tax                 -            -        (0.5)
    Net income attributable
    to Shire plc                      (2.0)            -        189.3
    Impact of convertible
    debt, net of tax                      -            -          8.4
    Numerator for diluted
    EPS                               (2.0)            -        197.7
    Weighted average number
    of shares (millions) -
    diluted                               -            -        586.1
    Diluted earnings per
    ADS                              (1.0c)            -       101.2c

The following items are included in Adjustments:

(a) Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($34.6 million) and tax effect of adjustment;

(b) Acquisitions and integration activities Costs associated with the acquisition of EQUASYM ($0.6 million) and tax effect of adjustments;

(c) Divestments, reorganizations and discontinued operations: Accelerated depreciation ($6.1 million), dual running costs ($1.1 million) and reorganization costs ($5.0 million) primarily for the transfer of manufacturing from Owings Mills; gain on disposal of investment in Virochem ($11.1 million); and tax effect of adjustments; and

(d) Depreciation: Depreciation of $22.5 million included in Cost of product sales, R&D costs and SG&A costs for US GAAP separately disclosed for the presentation of Non GAAP earnings.

    Unaudited results for the three months to March 31, 2009
    Non GAAP reconciliation

                        US GAAP             Adjustments
                                             Acquisitions
                                Amortization            &
                          March      & asset  integration
    3 months to,       31, 2009  impairments   activities
                                         (a)          (b)
                             $M           $M           $M
    Total revenues        817.8            -            -

    Costs and
    expenses:
    Cost of product
    sales                  83.6            -            -
    Research and
    development           185.9            -            -
    Selling, general
    and administrative    318.9       (32.5)            -
    Reorganization
    costs                   2.2            -            -
    Integration and
    acquisition costs       1.4            -        (1.4)
    Depreciation              -            -            -
    Total operating
    expenses              592.0       (32.5)        (1.4)

    Operating income      225.8         32.5          1.4

    Interest income         0.6            -            -
    Interest expense     (11.0)            -            -
    Other income, net      50.3            -            -
    Total other
    expense, net           39.9            -            -
    Income from
    continuing
    operations before
    income taxes and
    equity in losses
    of equity method
    investees             265.7         32.5          1.4
    Income taxes         (49.5)        (9.9)        (0.2)
    Equity in losses
    of equity method
    investees, net of
    tax                   (0.1)            -            -
    Income from
    continuing
    operations, net of
    tax                   216.1         22.6          1.2
    Loss from
    discontinued
    operations            (2.6)            -            -
    Net income            213.5         22.6          1.2
    Add: Net loss
    attributable to
    noncontrolling
    interest in
    subsidiaries            0.1            -            -
    Net income
    attributable to
    Shire plc             213.6         22.6          1.2
    Impact of
    convertible debt,
    net of tax              8.4            -            -
    Numerator for
    diluted EPS           222.0         22.6          1.2
    Weighted average
    number of shares
    (millions) -
    diluted               577.2            -            -
    Diluted earnings
    per ADS              115.5c        11.7c         0.6c


    Table Continued

                                                                   Non GAAP
                              Divestments,
                           reorganizations
                            & discontinued          Reclassify    March 31,
    3 months to,                operations        depreciation         2009
                                       (c)                 (d)
                                        $M                  $M           $M
    Total revenues                       -                   -        817.8

    Costs and expenses:
    Cost of product
    sales                                -               (3.6)         80.0
    Research and
    development                     (65.0)               (4.0)        116.9
    Selling, general and
    administrative                       -              (14.8)        271.6
    Reorganization costs             (2.2)                   -            -
    Integration and
    acquisition costs                    -                   -            -
    Depreciation                         -                22.4         22.4
    Total operating
    expenses                        (67.2)                   -        490.9

    Operating income                  67.2                   -        326.9

    Interest income                      -                   -          0.6
    Interest expense                     -                   -       (11.0)
    Other income, net               (55.2)                   -        (4.9)
    Total other expense,
    net                             (55.2)                   -       (15.3)
    Income from
    continuing
    operations before
    income taxes and
    equity in losses of
    equity method
    investees                         12.0                   -        311.6
    Income taxes                    (15.2)                   -       (74.8)
    Equity in losses of
    equity method
    investees, net of
    tax                                  -                   -        (0.1)
    Income from
    continuing
    operations, net of
    tax                              (3.2)                   -        236.7
    Loss from
    discontinued
    operations                         2.6                   -            -
    Net income                       (0.6)                   -        236.7
    Add: Net loss
    attributable to
    noncontrolling
    interest in
    subsidiaries                         -                   -          0.1
    Net income
    attributable to
    Shire plc                        (0.6)                   -        236.8
    Impact of
    convertible debt,
    net of tax                           -                   -          8.4
    Numerator for
    diluted EPS                      (0.6)                   -        245.2
    Weighted average
    number of shares
    (millions) - diluted                 -                   -        577.2
    Diluted earnings per
    ADS                             (0.3c)                   -       127.5c

The following items are included in Adjustments:

(a) Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($32.5 million), and tax effect of adjustment;

(b) Acquisitions & integration activities: Integration and transaction related costs in respect of the acquisition of Jerini and EQUASYM ($1.4 million) and tax effect of adjustments;

(c) Divestments, reorganizations and discontinued operations: Costs associated with agreement to terminate development of Women's Health products with Duramed ($65.0 million); reorganization costs for the transition of manufacturing from Owings Mills ($2.2 million); gain on disposal of the investment in Virochem ($55.2 million); discontinued operations in respect of Jerini businesses held for sale ($2.6 million); and tax effect of adjustments; and

(d) Depreciation: Depreciation of $22.4 million included in Cost of product sales, R&D costs and SG&A costs for US GAAP separately disclosed for the presentation of Non GAAP earnings.

Unaudited results for the three months to March 31, 2010

Non GAAP reconciliation

The following table reconciles US GAAP net cash provided by operating activities to Non GAAP cash generation:

    3 months to March 31,                           2010        2009
                                                      $M          $M
    Net cash provided by operating activities      186.2       184.1
    Tax and interest payments, net                  90.1        51.2
    Foreign exchange on cash                         2.0       (1.4)
    Non GAAP cash generation                       278.3       233.9

    Notes to Editors
    SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder, human genetic therapies and gastrointestinal diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

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, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of Shire's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure new products for commercialization and/or development; government regulation of Shire's products; Shire's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on Shire's products; Shire's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; Shire's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission.

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 from continuing operations before income taxes and earnings of equity method investees ("Effective tax rate on Non GAAP income"); Non GAAP cost of product sales; Non GAAP research and development; Non GAAP selling, general and administrative; Non GAAP other income; and Non GAAP cash generation. These Non GAAP measures exclude the effect of certain cash and non-cash items, both recurring and non-recurring, that Shire's management believes are not related to the core performance of Shire's business.

These Non GAAP financial measures are used by Shire's management to make operating decisions because they facilitate internal comparisons of Shire's performance to historical results and to competitors' results. 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 measures are presented in this press release as Shire's management believe that they will provide investors with a means of evaluating, and an understanding of how Shire's management evaluates, Shire's performance and results on a comparable basis that is not otherwise apparent on a US GAAP basis, since many one-time, infrequent or non-cash items that Shire's management believe are not indicative of the core performance of the business may not be excluded when preparing financial measures under US GAAP.

These Non GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with US GAAP.

The following items, including their tax effect, have been excluded from both Q1 2010 and 2009 Non GAAP earnings, and from our 2010 outlook:

    Amortization and asset impairments:

    - Intangible asset amortization and impairment charges; and

    - Other than temporary impairment of investments.


    Acquisitions and integration activities:

    - Upfront payments and milestones in respect of in-licensed and acquired
      products;

    - Costs associated with acquisitions, including transaction costs, and
      fair value adjustments on contingent consideration and acquired
      inventory; and

    - Costs associated with the integration of companies.

    Divestments, re-organizations and discontinued operations

    - Gains and losses on the sale of non-core assets;

    - Costs associated with restructuring and re-organization activities;

    - Termination costs;

    - Costs associated with the introduction of the new holding company; and

    - Income / (losses) from discontinued operations.

Depreciation, which is included in Cost of product sales, Research and development and Selling, general and administrative costs in our US GAAP results, has been separately disclosed for the presentation of 2009 and 2010 Non GAAP earnings. A reconciliation of Non GAAP financial measures to the most directly comparable measure under US GAAP is presented on pages 17 and 18.

Sales growth at CER, which is a Non GAAP measure, is computed by restating 2010 results using average 2009 foreign exchange rates for the relevant period.

Average exchange rates for Q1 2010 were $1.56:GBP1.00 and $1.38:EUR1.00 (2009: $1.44:GBP1.00 and $1.31:EUR1.00).

TRADEMARKS

All trademarks defined as (R) and (TM) used in this press release are trademarks of Shire plc or companies within the Shire group except for 3TC(R) and ZEFFIX(R) which are trademarks of GSK, PENTASA(R) which is a trademark of Ferring A/S Corp, and REMINYL(R), REMINYL
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SOURCE Shire plc
Copyright©2010 PR Newswire.
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