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Shire Continues to Deliver Excellent Growth From Core Products
Date:10/30/2009

DUBLIN, October 30 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.

    Q3 2009 Financial Highlights

                                                               Q3 2009(1)

    Product sales                                        $603 million    -15%

    Product sales from core products(2)                  $532 million    +20%
    Product sales growth from core products at
    constant exchange rates(2)(3)                                        +23%

    Total revenues                                       $667 million    -14%

    Non GAAP operating income                            $134 million    -52%
    US GAAP operating income                              $92 million    -25%
    Non GAAP diluted earnings per ADS                           $0.49    -58%
    US GAAP diluted earnings per ADS                            $0.33  +$0.52

    (1) Figures compare Q3 2009 results with the same period in 2008.

    (2) Core products represent Shire's products excluding ADDERALL XR.

    (3) Sales growth at constant exchange rates ("CER"), which is a Non GAAP
        measure, is calculated after restating Q3 2009 results using Q3 2008
        average foreign exchange rates.

Angus Russell, Chief Executive Officer, commented:

"Shire continues to deliver excellent growth from its core products, which were up 20% over an exceptionally strong Q3 2008. This performance reflects our transformation in the past few years into a global biopharmaceutical company with a proven differentiated strategy and a balanced portfolio of new products which is protected by strong exclusivity and patent protection.

The growth of our core products and continued pro-active cost management are positioning us well to deliver on our unchanged guidance framework for 2009 and our aspiration of growing sales in the mid-teens range on average between 2009 and 2015.

Following US approval of INTUNIV, our new ADHD treatment, we are preparing for the US launch next week. INTUNIV adds a new choice of treatment for physicians and patients within our market-leading branded portfolio of ADHD products. We have also continued to grow VYVANSE's market share which is now 13.4%, benefiting from both the 'back to school' season and strong 10% ADHD market growth. These results reinforce our confidence that VYVANSE will grow to become a leading product in this market.

Our HGT business continues to deliver; a New Drug Application for velaglucerase alfa, for Gaucher disease, was filed with the FDA at the end of August. Velaglucerase alfa is available ahead of its commercial launch in the US via a treatment protocol and elsewhere on a pre-approval access basis. We are supporting the Fabry disease community with a stronger uptake of REPLAGAL in Europe. In the US a treatment protocol has been approved, enabling immediate access to the drug. In addition we plan to file a Biologics License Application with the FDA for REPLAGAL by the end of the year.

We continue to invest in our R&D pipeline. This quarter we announced a research collaboration with Santaris Pharma A/S, a leading player in RNA-based therapeutics, to develop its proprietary Locked Nucleic Acid technology in a range of rare diseases, thereby enabling us to build on our already strong competitive position in this area."

    Third Quarter 2009 Unaudited Results

                             Q3 2009                     Q3 2008

                        US   Adjust-               Non   Adjust-      Non
                      GAAP    ments   GAAP(1)  US GAAP    ments    GAAP(1)
                        $M       $M       $M        $M       $M        $M

    Revenues           667        -      667       779        -       779
    Operating income    92       42      134       123      156       279
    Net income/(loss)   60       29       89       (35)     251       216
    Diluted earnings
    /(loss) per ADS    33c      16c      49c      (20c)    137c      117c

    Note: Average exchange rates for Q3 2009 were $1.64:GBP1.00 and
          $1.43:EUR1.00, (Q3 2008: $1.89:GBP1.00 and $1.52:EUR1.00).

    (1) The Non GAAP financial measures included above are explained on pages
        26 and 27, together with an explanation of why Shire's management
        believes that these measures are useful to investors. For a
        reconciliation of these Non GAAP financial measures to the most
        directly comparable financial measures prepared in accordance with
        US GAAP, see pages 22 to 25.

    FINANCIAL SUMMARY

    Third Quarter 2009 (see page 7 for full Financial Results)

    - Product sales from core products were up 20% (up 23% at CER) to $532
      million, driven by continued strong growth from:

      - VYVANSE(R) (up 34% to $129 million);
      - LIALDA(R)/MEZAVANT(R) (up 62% to $65 million);
      - ELAPRASE(R) (up 16% to $91 million, up 20% at CER); and
      - REPLAGAL(R) (up 8% to $48 million, up 15% at CER).

    - Product sales including ADDERALL(R) XR, were down 15% to $603 million,
      as ADDERALL XR product sales declined by 74%, or $198 million to
      $71 million.

    - Non GAAP operating income decreased by 52%, or $145 million, to $134
      million due to the lower ADDERALL XR revenues in Q3 2009 and increased
      investment in research and development, which were partially offset
      by higher revenues from core products and lower selling, general and
      administrative costs. On a US GAAP basis operating income in Q3 2009
      was $92 million, compared to $123 million in 2008 (2008 included the
      impact of a $121 million in-process R&D charge relating to the
      acquisition of Jerini AG ("Jerini")).

    - Non GAAP diluted earnings per ADS were down 58% to $0.49 (Q3 2008:
      $1.17), and on a US GAAP basis diluted earnings per ADS were $0.33
      (Q3 2008: $(0.20)).

    - During the first three quarters of 2009 Shire has generated Non GAAP
      diluted earnings per ADS of $2.38 ($1.74 on a US GAAP basis).


    THIRD QUARTER HIGHLIGHTS AND RECENT DEVELOPMENTS

    Products

    VYVANSE - for the treatment of Attention Deficit and Hyperactivity
    Disorder ("ADHD")

    - Following a review of governing statutory and regulatory
      standards and public comments, the US Food and Drug Administration
      ("FDA") has affirmed its prior decision to grant five-year New Chemical
      Entity ("NCE") exclusivity to lisdexamfetamine dimesylate. The
      five-year exclusivity period for VYVANSE expires on February 23, 2012.
      As a consequence of this decision, the FDA appropriately refused to
      file the Abbreviated New Drug Application submitted by Actavis
      Elizabeth, LLC ("Actavis") for generic lisdexamfetamine dimesylate in
      January 2009. VYVANSE is covered by US patents which remain in effect
      until June 29, 2023.

    INTUNIV(TM) - for the treatment of ADHD in children and adolescents in
    the US

    - On September 3, 2009 Shire announced that it received approval from
      the FDA for INTUNIV Extended Release Tablets for the treatment of ADHD
      in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily
      non-scheduled formulation of guanfacine, is the first selective
      alpha-2A adrenergic receptor agonist approved for the treatment of
      ADHD.

    - Once-daily INTUNIV is expected to be widely available in US pharmacies
      in November 2009 and will come in four dosage strengths (1 mg, 2 mg,
      3 mg, and 4 mg). INTUNIV will be marketed in the US by the existing
      Shire ADHD sales team of nearly 600 representatives.

    FOSRENOL(R) - for the treatment of pre-dialysis chronic kidney disease
    ("CKD") in the EU

    - Shire has received approval through the European Mutual Recognition
      Procedure for an extension to the current indication for FOSRENOL as a
      treatment to control hyperphosphataemia in CKD patients who are not on
      dialysis and with a serum phosphorus level greater than or equal to
      1.78mmol/L (5.5mg/dL).

    Pipeline

    Velaglucerase alfa - for the treatment of Gaucher disease

    - On July 30, 2009 Shire began the rolling submission with the FDA under
      Fast Track designation of a New Drug Application ("NDA") for
      velaglucerase alfa, its enzyme replacement therapy in development for
      the treatment of Type 1 Gaucher disease. On September 1, 2009 Shire
      reported that it had completed its NDA submission. Velaglucerase alfa
      is available ahead of its commercial launch, in the US via a treatment
      protocol and elsewhere on a pre-approval basis, to 300-600 patients in
      2009 and will be available to several hundred more in 2010.

    REPLAGAL - for the treatment of Fabry disease

    - On October 21, 2009 Shire announced plans to file a Biologics License
      Application with the FDA for REPLAGAL (agalsidase alfa), its enzyme
      replacement therapy for Fabry disease, by the end of the year. The
      Company also announced that a treatment protocol for REPLAGAL, filed at
      the request of the FDA, has been approved, and that Shire will support
      emergency Investigational New Drug requests, in view of the announced
      supply restriction of the only currently marketed treatment for Fabry
      disease in the US.

    FIRAZYR(R) - for the treatment of hereditary angioedema ("HAE")

    - In September 2009 Shire initiated a clinical trial to investigate the
      safety of self-administration of FIRAZYR.

    Amicus collaboration for the development of pharmacological chaperones

    - On November 7, 2007 Shire licensed from Amicus Therapeutics Inc.
      ("Amicus") the rights to three pharmacological chaperone compounds in
      markets outside of the US: AMIGAL (HGT-3310) for Fabry disease,
      PLICERA (HGT-3410) for Gaucher Disease and HGT-3510 (formerly referred
      to as AT2220) for Pompe disease which were in clinical development.
      The parties have mutually agreed to terminate the collaboration and to
      return all rights for the three products to Amicus.

    Alba collaboration for the development of SPD 550

    - On October 16, 2009 and following review of Phase 2 data, Shire
      informed Alba Therapeutics Corporation ("Alba") of its intent to
      terminate the collaboration. Effective November 15, 2009 Shire will
      return to Alba all rights to SPD 550 (larazotide cetate for celiac
      disease), also known as AT-1001. In December 2007 Shire had acquired
      rights to SPD550 in markets outside of the US and Japan.

    Business

    Research Collaboration with Santaris Pharma A/S ("Santaris") on Locked
    Nucleic Acid ("LNA") Drug Platform

    - On August 24, 2009 Shire announced that it had entered into a research
      collaboration with Santaris, to develop its proprietary LNA technology
      in a range of rare diseases. LNA technology has the benefit of
      shortened target validation and proof of concept, potentially
      increasing the speed and lowering the cost of development. As part of
      the joint research project Santaris will design, develop and deliver
      pre-clinical LNA oligonucleotides for Shire-selected orphan disease
      targets, and Shire will have the exclusive right to further develop
      and commercialize these candidate compounds on a worldwide basis.

    Legal proceedings

    - On September 23, 2009 the Company received a subpoena from the US
      Department of Health and Human Services Office of Inspector General in
      coordination with the US Attorney for the Eastern District of
      Pennsylvania, seeking production of documents related to the sales and
      marketing of ADDERALL XR, DAYTRANA(R) and VYVANSE. Shire is cooperating
      and responding to this subpoena.

    - On October 19, 2009 Teva Pharmaceuticals USA, Inc. ("Teva") filed suit
      against Shire claiming that Shire is in breach of its supply contract
      for the authorized generic version of ADDERALL XR. Shire has been
      supplying Teva with authorized generic ADDERALL XR since April 1,
      2009. Shire's ability to supply this product, however, is limited by
      quota restrictions that the US Drug Enforcement Administration places
      on amphetamine, which is the product's active ingredient.

2009 OUTLOOK

We are reiterating our previously announced guidance framework for Non GAAP diluted earnings per ADS for 2009, which remains unchanged from that provided in our Q3 2008 earnings release. At that time, and in subsequent earnings releases, we provided details of the effect of changes in foreign exchange rates on the earnings guidance. Specifically, our plans for 2009, supporting Non GAAP diluted earnings per ADS for 2009 in the range of $3.00 to $3.40, were based on average actual foreign exchange rates (EUR1:$1.52, GBP1:$1.95) for the ten months to October 2008. During the first three quarters of 2009 we have already achieved Non GAAP diluted earnings per ADS of $2.38.

We identified that each 10c movement in the EUR:$ and GBP:$ exchange rates impacts Shire's Non GAAP diluted earnings per ADS by $0.10 and $0.01 respectively. Based on the following exchange rate scenarios, which are not forecasts, the impact on our base guidance would be:

                                      Euro fx    GBP fx    Non GAAP diluted
                                       rate        rate    earnings per ADS
                                                               range(1)

    Base guidance                      $1.52      $1.95     $3.00 to $3.40
    As advised at Q2 2009              $1.37      $1.56     $2.80 to $3.20
    At average rate for nine months
    to September 2009 & September
    average rate for Q4 2009           $1.39      $1.56     $2.83 to $3.23

    (1) Our guidance framework for Non GAAP diluted earnings per ADS is not
        prepared in accordance with US GAAP. Non GAAP diluted earnings per
        ADS excludes 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. A list of
        these items can be found on pages 26-27.


    PRODUCT LAUNCHES

    Subject to obtaining the relevant regulatory/governmental approvals,
    product launches planned over the next two years include:

    - INTUNIV for the treatment of ADHD in children and
      adolescents in the US in November 2009 (already approved);

    - Velaglucerase alfa for the treatment of Gaucher disease in
      the US and the EU in 2010;

    - REPLAGAL for the treatment of Fabry disease in the US in 2010;

    - MEZAVANT for the treatment of ulcerative colitis; launches
      will continue in certain EU and RoW countries in 2009 and 2010;

    - FIRAZYR for the symptomatic treatment of acute attacks of HAE; launches
      will continue in certain European and Latin American countries during
      2009 and 2010;

    - DAYTRANA for the treatment of ADHD in adolescents in the US in 2010;

    - EQUASYM(R) for the treatment of ADHD; launches will continue in certain
      EU countries during 2009 and 2010; and

    - VYVANSE for the treatment of ADHD, in ex-US and ex-EU regions starting
      in 2010, and in the EU in 2011.

BOARD CHANGES

The Shire Board announces that Mr David Stout will be joining the Board as a non executive director with effect from October 31, 2009. Mr Stout brings significant pharmaceutical industry experience to the Shire Board, having spent many years at both GSK and prior to that Schering-Plough. Most recently, he was President of Pharmaceutical Operations at GSK. In this role he had responsibility for GSK's pharmaceutical operations in the United States, Europe, Japan and all other International Markets. Mr Stout was also responsible for global manufacturing and global Biologics (vaccines) at GSK.

The Shire Board also announces that Mr David Mott will be stepping down from the Shire Board on the expiry of his term of office on October 30, 2009.

Matt Emmens, Chairman of Shire commented;

"We are delighted to welcome David Stout to the Shire Board. He brings with him extensive international experience in the pharmaceutical industry, which we believe will be of great value to Shire as it continues its growth trajectory and becomes a more global company.

We would also like to thank David Mott for his valuable contribution to the Shire Board over the last few years."

Dial in details for the live conference call for investors 14:00 GMT/ 10:00 ET on October 30, 2009:

    UK dial in: 0800-077-8492 or 0-1296-311-600
    US dial in: 1-866-804-8688 or 1-718-354-1175
    International dial in: +44(0)1296-311-600

    Password/Conf ID: 891 799#

    Live Webcast: http://www.shire.com/shire/InvestorRelations/index.jsp?tn=2
    OVERVIEW OF FINANCIAL RESULTS
    1. Introduction
    Summary of Q3 2009

Revenues from continuing operations for the three months to September 30, 2009 decreased by 14% to $667.0 million (2008: $778.6 million), due to the decline in branded ADDERALL XR product sales in Q3 2009 following the launch of an authorized generic version by Teva in April 2009. However, core product sales increased by 20% to $531.6 million (2008: $443.8 million).

Non GAAP operating income for the three months to September 30, 2009 decreased by 52% to $133.6 million (2008: $278.6 million). Increased revenues from core products, combined with lower selling, general and administrative expenses achieved through the Company's continued focus on cost management partially offset the impact of lower revenues from ADDERALL XR and increased investment in research and development, in part reflecting the Santaris collaboration up-front costs and the acceleration of the velaglucerase program.

US GAAP operating income from continuing operations for the three months to September 30, 2009 decreased by 25% to $91.8 million (2008: $122.9 million). US GAAP operating income in Q3 2008 included an in-process R&D ("IPR&D") charge of $120.5 million on the acquisition of Jerini in 2008. Excluding this charge the decline in US GAAP operating income in the third quarter of 2009 principally resulted from lower ADDERALL XR revenues following genericization in the second quarter of 2009.

Net cash provided by operating activities decreased by 52% to $134.0 million for the three months to September 30, 2009 (2008: $279.4 million). The cash provided by operating activities was lower in Q3 2009 than the same period in 2008 due to lower sales receipts following the genericization of ADDERALL XR and cash inflows from forward exchange contracts in Q3 2008, which more than offset lower payments on operating costs.

Cash, cash equivalents and restricted cash at September 30, 2009 totaled $372.0 million (December 31, 2008: $247.4 million), an increase of $124.6 million. Cash provided by operating activities of $390.0 million in the nine months to September 30, 2009 have been partially offset by investments in property, plant and equipment at the HGT campus in Lexington, the acquisition of EQUASYM from UCB S.A. and the dividend payment.

2. Product sales

For the three months to September 30, 2009 product sales decreased by 15% to $602.5 million (2008: $712.5 million) and represented 91% of total revenues (2008: 92%). Excluding ADDERALL XR, product sales from core products increased by 20% to $531.6 million (2008: $443.8 million).

    Product Highlights

                                                                          US
                                                                     Average
                                                     CER     US Rx  Quarterly
                                         Sales  Growth(2) Growth(1)   Market
    Product                 Sales $M  Growth(2)       (3)       (2)  Share(1)
    Specialty
    Pharmaceuticals
    VYVANSE                    129.0       34%       34%       57%       13%
    DAYTRANA                    17.4       -4%       -4%      -12%        1%
    EQUASYM                      9.2       n/a       n/a    n/a(5)    n/a(5)
    LIALDA / MEZAVANT           65.4       62%       63%       34%       17%
    PENTASA                     51.3        4%        4%       -3%       16%
    FOSRENOL                    47.7       11%       14%       -3%        8%
    XAGRID(R)                   21.5       11%       18%    n/a(5)    n/a(5)

    ADDERALL XR                 70.9      -74%      -74%      -59%        8%

    Human Genetic Therapies
    ELAPRASE                    90.9       16%       20%    n/a(4)    n/a(4)
    REPLAGAL                    48.3        8%       15%    n/a(5)    n/a(5)
    FIRAZYR                      1.8         -         -    n/a(5)    n/a(5)

    (1) Product specific prescription data is provided by IMS Health ("IMS")
        National Prescription Audit, a leading global provider of business
        intelligence for the pharmaceutical and healthcare industries. All
        other US market share data stated in the text below is also provided
        by IMS.
    (2) Compared to Q3 2008.
    (3) CER growth, which is a Non GAAP measure, is calculated after
        restating Q3 2009 results using Q3 2008 average foreign exchange
        rates.
    (4) IMS Data not available.
    (5) Not sold in the US.


    Specialty Pharmaceuticals
    US ADHD market share

Shire's share of the total US ADHD market for the three months to September 30, 2009 was 22%. Shire continues to have the leading portfolio of branded products in the US ADHD market.

VYVANSE - ADHD

Product sales of VYVANSE for the three months to September 30, 2009 increased by 34% to $129.0 million (2008: $96.0 million), with VYVANSE's average share of the US ADHD market for Q3 2009 increasing to 13% (2008: 9%). Product sales growth was driven by a 57% increase in US prescription demand in Q3 2009 over the same period in 2008, as a result of increased average market share and 10% growth in the US ADHD market. Product sales growth was less than prescription growth due to the stocking benefits from new dosage strengths of VYVANSE in Q3 2008.

ADDERALL XR - ADHD

Product sales of ADDERALL XR for the three months to September 30, 2009 were $70.9 million (2008: $268.7 million), a decrease of 74%, following the launch by Teva in April 2009 of its authorized generic version of ADDERALL XR. The launch of the authorized generic version led to a 59% decline in ADDERALL XR US prescription demand and higher US sales deductions in Q3 2009 than the same period last year.

Sales deductions represented 73% of branded ADDERALL XR gross sales in Q3 2009, compared to 26% in the same period in 2008 following higher Medicaid and Managed Care rebates subsequent to generic launch. These factors more than offset the positive impacts of price increases taken since Q3 2008, and the inclusion in product sales of shipments of authorized generic ADDERALL XR to Teva and Impax Laboratories, Inc. ("Impax") in Q3 2009.

US oral mesalamine market share

Shire's average market share of the US oral mesalamine market was 33% for the three months to September 30, 2009.

LIALDA/MEZAVANT - Ulcerative colitis

Product sales of LIALDA/MEZAVANT for the three months to September 30, 2009 increased by 62% to $65.4 million (2008: $40.4 million). US prescriptions increased by 34%, due to an increase in LIALDA's average share of the US oral mesalamine market to 17% (2008: 13%), underlying growth in the US oral mesalamine market and price increases.

By September 30, 2009 MEZAVANT was available in eight countries outside the US, and further launches are planned in other countries throughout 2009 and 2010, subject to the successful conclusion of pricing and reimbursement negotiations.

PENTASA - Ulcerative colitis

Product sales of PENTASA(R) for the three months to September 30, 2009 were $51.3 million, an increase of 4% compared to the same period in 2008 (2008: $49.2 million). Sales grew despite a 3% decrease in prescriptions primarily due to the impact of price increases.

FOSRENOL - Hyperphosphatemia

Product sales of FOSRENOL for the three months to September 30, 2009 were up 11% to $47.7 million (2008: $43.0 million). On a CER basis sales were up 14%. In markets outside the US FOSRENOL sales increased as the product entered new countries, and continued to grow in countries entered in the last two years. In the US, FOSRENOL's average share of the phosphate binder market in Q3 2009 remained constant at 8% (2008: 8%).

Human Genetic Therapies

ELAPRASE - Hunter syndrome

Product sales for the three months to September 30, 2009 were $90.9 million, an increase of 16% (2008: $78.2 million). Expressed on a CER basis, sales increased by 20% (ELAPRASE is primarily sold in US dollars and Euros). The sales growth was driven by increased volumes across all regions where ELAPRASE is sold.

REPLAGAL - Fabry disease

Product sales for the three months to September 30, 2009 were $48.3 million, an increase of 8% (2008: $44.6 million). Expressed on a CER basis product sales increased by 15% (REPLAGAL is primarily sold in Euros and Pounds Sterling). The product sales growth was driven by increased volumes in Europe and Asia Pacific.

FIRAZYR - HAE

Product sales for the three months to September 30, 2009 were $1.8 million (2008: $0.2 million). With a Q3 launch in Italy, FIRAZYR is now marketed in the five largest European countries. FIRAZYR is the first new product for HAE in Europe in 30 years and has orphan exclusivity in the EU until 2018.

3. Royalties

Royalty revenue decreased by 1% to $60.3 million for the three months to September 30, 2009 (2008: $60.8 million). The following table provides an analysis of Shire's royalty revenue:

                             Royalties to Shire      Year on year
    Product                          $M               change(1)       CER(2)
    3TC(R) and ZEFFIX(R)            42.0                 -6%            0%
    ADDERALL XR                     2.2                  n/a           n/a
    Other                           16.1                 -1%           n/a
    Total                           60.3                 -1%            0%

    (1) Compared with Q3 2008

    (2) CER growth, which is a Non GAAP measure, is calculated after
        restating Q3 2009 results using Q3 2008 average foreign exchange
        rates.

Royalties from Teva's sales of authorized generic ADDERALL XR for the three months to September 30, 2009 were $2.2 million (2008: $nil). Receipt of this royalty began with Teva's sales of an authorized generic version of ADDERALL XR in April 2009 and ceased in September 2009. From Q4 2009, Shire will receive royalties on Impax's sales of its authorized generic version of ADDERALL XR.

    4. Financial details

    Cost of product sales
                                                      % of              % of
                                             2009  product     2008  product
                                               $M    sales       $M    sales

    Cost of product sales (US GAAP)         104.9      17%     84.2      12%

    Fair value adjustment for
    acquired inventories                     (0.6)                -
    Accelerated depreciation on transfer
    of manufacturing from Owings Mills       (4.5)                -
    Depreciation                             (0.8)             (3.2)
    Cost of product sales (Non GAAP)         99.0      16%     81.0      11%

Non GAAP cost of product sales as a percentage of product sales increased by 5 percentage points compared to 2008. This increase primarily results from changes to the product mix following the launch by Teva of an authorized generic version of ADDERALL XR in April 2009. Higher sales deductions on Shire's sales of branded ADDERALL XR, together with lower margin sales of the authorized generic version of ADDERALL XR to Teva and Impax have both depressed gross margin for that product.

    Research and development ("R&D")
                                                      % of              % of
                                             2009  product     2008  product
                                               $M    sales       $M    sales

    R&D (US GAAP)                           147.8      25%    120.2      17%
    Depreciation                             (3.6)             (3.4)
    R&D (Non GAAP)                          144.2      24%    116.8      16%

Non GAAP R&D increased 23% to $144.2 million (2008: $116.8 million) as the Company has continued to increase investment in R&D programs, including an up-front payment of $6.5 million to Santaris for technology access and R&D funding in August 2009. Non GAAP R&D as a percentage of product sales increased due to lower product sales in Q3 2009 following the genericization of ADDERALL XR.

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

                                                      % of              % of
                                             2009  product     2008  product
                                               $M    sales       $M    sales

    SG&A (US GAAP)                          320.6      53%    327.3      46%
    Intangible asset amortization           (34.8)            (29.7)

    New holding company costs                   -              (2.0)
    Depreciation                            (18.5)            (12.0)
    SG&A (Non GAAP)                         267.3      44%    283.6      40%

Non GAAP SG&A declined in absolute terms by 6% due to the Company's continued focus on cost management. Non GAAP SG&A increased as a percentage of product sales due to lower product sales following the genericization of ADDERALL XR.

Gain on sale of product rights

For the three months to September 30, 2009 Shire recorded gains of $6.3 million (2008: $4.0 million) from the sale of non-core products to Laboratorios Almirall S.A. in 2007. These gains had been deferred since 2007 pending transfer of the relevant consents.

Reorganization costs

For the three months to September 30, 2009 Shire recorded reorganization costs of $2.0 million (2008: $nil) relating to the transfer of manufacturing from its Owings Mills facility.

Integration and acquisition costs

For the three months to September 30, 2009 Shire recorded integration and acquisition costs of $6.2 million (2008: $7.5 million), primarily relating to the integration of Jerini.

Interest income

For the three months to September 30, 2009 Shire received interest income of $0.2 million (2008: $3.8 million), primarily earned on cash and cash equivalents. Interest income for the three months to September 30, 2009 is lower than the same period in 2008 due to significantly lower interest rates in 2009 compared to 2008, and lower average cash and cash equivalent balances.

    Interest expense
                                                              2009     2008
                                                                $M       $M

    Interest expense (US GAAP)                                 9.4     92.9
    Additional interest on settlement of appraisal rights
    litigation                                                   -    (73.0)
    Interest expense (Non GAAP)                                9.4     19.9

For the three months to September 30, 2009 the Company incurred interest expense of $9.4 million (2008: $92.9 million). Interest expense in 2008 was higher than 2009 due to accrued interest expense of $77.0 million recorded in respect of the Transkaryotic Therapies, Inc. ("TKT") appraisal rights litigation; of the $77.0 million, $73.0 million was additional interest arising from the settlement of the litigation in November 2008.

    Other income/(expense), net
                                                               2009     2008
                                                                 $M       $M

    Other income/(expense), net (US GAAP)                       7.0    (52.0)
    Other than temporary impairment of available for sale         -     54.1
    securities
    Other income, net (Non GAAP)                                7.0      2.1

Non GAAP other income, net in 2009 was higher than the same period in 2008 due to a gain recognized following the substantial modification of a property lease.

Taxation

The effective rate of tax for the three months to September 30, 2009 was 34% (2008: -103%), and the effective tax rate on Non GAAP income is 33% (2008: 19%).

The Non GAAP effective tax rate was higher in Q3 2009 compared to the same period in 2008 principally as a result of the recognition of valuation allowances against certain EU deferred tax assets and increases to accrued interest on tax contingencies in the third quarter of 2009. The adverse rate impact of these items was partially offset by foreign exchange gains on the retranslation of certain deferred tax assets, together with the benefit of tax return to provision adjustments following the submission of various tax returns in Q3 2009.

Equity in earnings of equity method investees

Equity in earnings of equity method investees of $0.6 million were recorded for the three months to September 30, 2009 (2008: $1.6 million). This comprised earnings of $1.4 million from the 50% share of the anti-viral commercialization partnership with GSK in Canada (2008: $1.6 million earnings) and losses of $0.8 million, being the Company's share of losses in the GeneChem, AgeChem and EGS Funds (2008: $nil).

    Unaudited US GAAP results for the three months and nine months to
    September 30, 2009 Consolidated Balance Sheets

                                                  September 30,  December 31,
                                                          2009          2008
                                                            $M            $M
    ASSETS
    Current assets:
    Cash and cash equivalents                            332.7         218.2
    Restricted cash                                       39.3          29.2
    Accounts receivable, net                             539.2         395.0
    Inventories                                          173.3         154.5
    Assets held for sale                                   1.7          16.6
    Deferred tax asset                                    99.8          89.5
    Prepaid expenses and other current assets            149.2         141.4

    Total current assets                               1,335.2       1,044.4

    Non-current assets:
    Investments                                           95.2          42.9
    Property, plant and equipment, net                   630.0         534.2
    Goodwill                                             385.9         350.8
    Other intangible assets, net                       1,832.9       1,824.9
    Deferred tax asset                                   136.7         118.1
    Other non-current assets                              11.6          18.4

    Total assets                                       4,427.5       3,933.7

    LIABILITIES AND EQUITY
    Current liabilities:
    Accounts payable and accrued expenses                938.9         708.6
    Deferred tax liability                                10.9          10.9
    Other current liabilities                            124.6         104.3

    Total current liabilities                          1,074.4         823.8

    Non-current liabilities:
    Convertible bonds                                  1,100.0       1,100.0
    Other long-term debt                                  43.7          43.1
    Deferred tax liability                               315.5         377.0
    Other non-current liabilities                        219.5         291.3

    Total liabilities                                  2,753.1       2,635.2

    Shareholders' equity:
    Common stock of 5p par value; 1,000 million
    shares authorized; and 561.0 million shares
    issued and outstanding (2008: 1,000 million
    shares authorized; and 560.2 million shares
    issued and outstanding)                               55.6          55.5
    Additional paid-in capital                         2,645.0       2,594.6
    Treasury stock: 19.2 million shares (2008:
    20.7 million)                                       (375.5)       (397.2)
    Accumulated other comprehensive income               146.6          97.0
    Accumulated deficit                                 (797.7)     (1,051.7)

    Total Shire plc shareholders' equity               1,674.0       1,298.2
    Noncontrolling interest in subsidiaries                0.4           0.3

    Total equity                                       1,674.4       1,298.5

    Total liabilities and equity                       4,427.5       3,933.7


    Unaudited US GAAP results for the three months and nine months to
    September 30, 2009 Consolidated Statements of Operations

                       3 months to   3 months to   9 months to   9 months to
                         September     September     September     September
                          30, 2009      30, 2008      30, 2009      30, 2008
                                $M            $M            $M            $M
    Revenues:
    Product sales            602.5         712.5       1,916.8       2,049.9
    Royalties                 60.3          60.8         177.8         190.7
    Other revenues             4.2           5.3          19.8          15.8
    Total revenues           667.0         778.6       2,114.4       2,256.4

    Costs and expenses:
    Cost of product
    sales(1)                 104.9          84.2         284.9         317.4
    Research and
    development(2)           147.8         120.2         492.5         368.4
    Selling, general and
    administrative(1)(2)     320.6         327.3         973.8       1,109.7
    Gain on sale of product
    rights                    (6.3)         (4.0)         (6.3)        (20.7)
    In-process R&D charge        -         120.5             -         255.5
    Reorganization costs       2.0             -           7.1             -
    Integration and
    acquisition costs          6.2           7.5          10.0           7.5
    Total operating
    expenses                 575.2         655.7       1,762.0       2,037.8

    Operating income          91.8         122.9         352.4         218.6

    Interest income            0.2           3.8           1.5          23.0
    Interest expense          (9.4)        (92.9)        (30.6)       (127.0)
    Other
    income/(expenses), net     7.0         (52.0)         61.9         (38.6)
    Total other
    (expense)/income, net     (2.2)       (141.1)         32.8        (142.6)

    Income/(loss) from
    continuing operations
    before income taxes and
    equity in earnings of
    equity method investees   89.6         (18.2)        385.2          76.0
    Income taxes             (30.6)        (18.7)        (56.7)        (63.0)
    Equity in earnings of
    equity method
    investees, net of taxes    0.6           1.6           1.0           1.3
    Income/(loss) from
    continuing operations,
    net of tax                59.6         (35.3)        329.5          14.3

    Loss from discontinued
    operations (net of
    income tax expense of
    $nil in all periods)         -          (0.9)        (12.4)         (0.9)
    Net income/(loss)         59.6         (36.2)        317.1          13.4

    Add: Net loss
    attributable to
    noncontrolling interest
    in subsidiaries              -           1.3           0.2           1.3
    Net income/(loss)
    attributable to Shire
    plc                       59.6         (34.9)        317.3          14.7

    (1) Cost of product sales includes amortization of intangible assets
        relating to favorable manufacturing contracts of $0.4 million for
        the three months to September 30, 2009 (2008: $0.4 million) and
        $1.3 million for the nine months to September 30, 2009 (2008:
        $1.3 million). Selling, general and administrative costs include
        amortization and impairment charges of intangible assets relating to
        intellectual property rights acquired of $34.8 million for the three
        months to September 30, 2009 (2008: $29.7 million) and $101.6 million
        for the nine months to September 30, 2009 (2008: $181.9 million).

    (2) Promotional costs totaling $6.9 million and $26.0 million have been
        reclassified from Research and development to Selling, general and
        administrative costs for the three and nine months to September 30,
        2008 respectively.


    Unaudited US GAAP results for the three months and nine months to
    September 30, 2009 Consolidated Statements of Operations (continued)

                       3 months to   3 months to   9 months to   9 months to
                         September     September     September     September
                          30, 2009      30, 2008      30, 2009      30, 2008

    Earnings/(loss) per
    ordinary share - basic
    Earnings/(loss) from
    continuing operations    11.0c         (6.3c)        61.1c          2.9c
    Loss from discontinued
    operations                   -         (0.2c)        (2.3c)        (0.2c)
    Earnings/(loss) per
    ordinary share - basic   11.0c         (6.5c)        58.8c          2.7c

    Earnings/(loss) per ADS
    - basic                  33.0c        (19.5c)       176.4c          8.1c

    Earnings/(loss) per
    ordinary share -
    diluted
    Earnings/(loss) from
    continuing operations    10.9c         (6.3c)        60.3c          2.9c
    Loss from discontinued
    operations                   -         (0.2c)        (2.3c)        (0.2c)
    Earnings/(loss) per
    ordinary share -
    diluted                  10.9c         (6.5c)        58.0c          2.7c

    Earnings/(loss) per ADS
    - diluted                32.7c        (19.5c)       174.0c          8.1c

    Weighted average number
    of shares (millions):

    Basic                    540.6         540.3         540.0         542.6
    Diluted                  548.3         540.3         547.1         545.3


    Unaudited US GAAP results for the three months and nine months to
    September 30, 2009 Consolidated Statements of Cash Flows


                                   3 months   3 months   9 months   9 months
                                         to         to         to         to
                                  September  September  September  September
                                         30,        30,        30,        30,
                                       2009       2008       2009       2008
                                         $M         $M         $M         $M
    CASH FLOWS FROM OPERATING
    ACTIVITIES:
    Net income/(loss)                  59.6      (36.2)     317.1       13.4
    Adjustments to reconcile net
    income/(loss) to net cash
    provided by operating
    activities:
            Loss from discontinued
            operations                    -        0.9       12.4        0.9
            Depreciation and
            amortization               59.7       49.1      177.4      145.4
            Share based
            compensation               16.9       16.2       50.1       52.0
            In-process R&D charge         -      120.5          -      120.5
            Impairment of
            intangible assets             -          -          -       90.4
            Impairment of available
            for sale securities         0.8       54.1        0.8       54.1
            Loss/(gain) on sale of
            non-current investments       -        0.4      (55.2)      (9.4)
            Gain on sale of product
            rights                     (6.3)      (4.0)      (6.3)     (20.7)
            Other                       4.4        2.0       10.7        6.4
    Movement in deferred taxes        (41.9)      (3.7)     (87.5)      13.9
    Equity in earnings of equity
    method investees                   (0.6)      (1.6)      (1.0)      (1.3)

    Changes in operating assets
    and liabilities:
            Increase in accounts
            receivable               (113.4)     (12.3)    (156.4)     (40.7)
            Increase in sales
            deduction accrual          94.7        1.4      212.2       36.9
            (Increase)/decrease in
            inventory                 (11.3)      29.2      (24.2)      39.6
            Decrease/(increase) in
            prepayments and other
            current assets             25.7      (24.5)      (8.1)      (0.2)
            Decrease/(increase) in
            other assets                0.9      (51.1)       5.3      (53.5)
            Increase/(decrease) in
            accounts and notes
            payable and other
            liabilities                44.8      131.9      (56.3)      70.7
    Returns on investment from
    joint venture                         -        7.1        4.9        7.1
    Cash flows used in
    discontinued operations               -          -       (5.9)         -
    Net cash provided by operating
    activities(A)                     134.0      279.4      390.0      525.5


    Unaudited US GAAP results for the three months and nine months to
    September 30, 2009 Consolidated Statements of Cash Flows (continued)

                       3 months to   3 months to   9 months to   9 months to
                         September     September     September     September
                          30, 2009      30, 2008      30, 2009      30, 2008

    CASH FLOWS FROM
    INVESTING ACTIVITIES:
    Movements in restricted
    cash                      (3.4)          2.5         (10.1)          7.7
    Purchases of subsidiary
    undertakings and
    businesses, net of cash
    acquired                     -        (462.5)        (75.5)       (462.5)
    Purchases of
    non-current investments      -          (0.2)            -          (1.3)
    Purchases of property,
    plant and equipment      (67.5)        (77.1)       (169.4)       (166.5)
    Purchases of intangible
    assets                    (1.0)        (25.0)         (7.0)        (25.0)
    Proceeds from disposal
    of non-current investments   -             -          19.2          10.3
    Proceeds from disposal
    of property, plant and
    equipment                    -           1.0           0.5           1.8
    Proceeds/deposits
    received on sales of
    product rights               -             -             -           5.0
    Proceeds from disposal
    of subsidiary undertakings   -             -           6.7             -
    Returns from equity
    investments                  -             -           0.2           0.4
    Net cash used in
    investing activities(B)  (71.9)       (561.3)       (235.4)       (630.1)

    CASH FLOWS FROM
    FINANCING ACTIVITIES:
    Payment under building
    financing obligation      (0.9)         (0.9)         (3.9)         (1.3)
    Costs of issue of
    common stock                 -          (0.1)            -          (2.9)
    Proceeds from exercise
    of options                 1.8           0.7           2.8           1.7
    Payment of dividend          -             -         (43.0)        (36.4)
    Payments to acquire
    shares by Employee
    Share Ownership Trust
    ("ESOT")                     -         (36.2)         (1.0)       (140.2)
    Net cash provided
    by/(used in) financing
    activities(C)              0.9         (36.5)        (45.1)       (179.1)

    Effect of foreign
    exchange rate changes
    on cash and cash
    equivalents (D)            6.4          (9.5)          5.0          (5.5)

    Net increase/(decrease)
    in cash and cash
    equivalents
    (A)+(B)+(C)+(D)           69.4        (327.9)        114.5        (289.2)
    Cash and cash
    equivalents at
    beginning of period      263.3         801.2         218.2         762.5
    Cash and cash
    equivalents at end of
    period                   332.7         473.3         332.7         473.3


    Unaudited US GAAP results for the three months and nine months to
    September 30, 2009

    Selected Notes to the Financial Statements

    (1) Earnings per share

                                   3 months   3 months   9 months   9 months
                                         to         to         to         to
                                  September  September  September  September
                                         30,        30,        30,        30,
                                       2009       2008       2009       2008
                                         $M         $M         $M         $M

    Income/(loss) from continuing
    operations                         59.6      (35.3)     329.5       14.3
    Loss from discontinued
    operations                            -       (0.9)     (12.4)      (0.9)
    Noncontrolling interest in
    subsidiaries                          -        1.3        0.2        1.3

    Numerator for basic and
    diluted EPS(1)                     59.6      (34.9)     317.3       14.7

    Weighted average number of
    shares:
                                   Millions   Millions   Millions   Millions
    Basic(2)                          540.6      540.3      540.0      542.6
    Effect of dilutive shares:
    Stock options(3)                    7.7          -        7.1        2.7

    Diluted                           548.3      540.3      547.1      545.3

    (1) For the three and nine month periods ended September 30, 2009 and
        2008 interest on the convertible bonds has not been added back as
       the effect would be anti-dilutive for all periods presented.
    (2) Excludes shares purchased by the ESOT and presented by the Company 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  3 months to  9 months to  9 months to
                            September    September    September    September
                                   30,          30,          30,          30,
                                 2009         2008         2009         2008
                             Millions     Millions     Millions     Millions
                               (1)(2)          (3)       (1)(2)       (1)(2)
    Stock options in the
    money                           -          1.2            -            -
    Stock options out of
    the money                    16.8         17.0         18.0         17.0
    Convertible bonds 2.75%
    due 2014                     33.2         32.7         33.1         32.7

    (1) For the three and nine month periods ended September 30, 2009 and
        the nine month period ended September 30, 2008, 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.

    (2) For the three and nine month periods ended September 30, 2009 and the
        nine month period ended September 30, 2008 the ordinary shares
        underlying the convertible bonds have not been included in the
        calculation of the diluted weighted average number of shares,
        because the effect of their inclusion would be anti-dilutive.

    (3) For the three month period ended September 30, 2008 no share options
        or ordinary shares underlying the convertible bonds have been
        included in the calculation of the diluted weighted average number
        of shares because the Company made a net loss during the calculation
        period and the inclusion of these items would be anti-dilutive.


    Unaudited US GAAP results for the three months to September 30, 2009
    Selected Notes to the Financial Statements

    (2) Analysis of revenues


    3 months to September 30,            2009      2008      2009        2009
                                                                %  % of total
                                           $M        $M    change     revenue
    Net product sales:
    Specialty Pharmaceuticals ("Specialty")
    ADHD
    ADDERALL XR                          70.9     268.7      -74%         11%
    VYVANSE                             129.0      96.0       34%         19%
    DAYTRANA                             17.4      18.1       -4%          3%
    EQUASYM                               9.2         -       n/a          1%
                                        226.5     382.8      -41%         34%
    GI
    PENTASA                              51.3      49.2        4%          8%
    LIALDA / MEZAVANT                    65.4      40.4       62%         10%
                                        116.7      89.6       30%         18%
    General products
    FOSRENOL                             47.7      43.0       11%          7%
    CALCICHEW(R)                         12.4      13.3       -7%          2%
    CARBATROL(R)                         20.8      21.6       -4%          3%
    REMINYL(R)/REMINYL XL(TM)            10.5       9.6        9%          2%
    XAGRID                               21.5      19.4       11%          3%
                                        112.9     106.9        6%         17%

    Other product sales                   5.4      10.2      -47%          1%
    Total Specialty product sales       461.5     589.5      -22%         70%

    Human Genetic Therapies ("HGT")
    ELAPRASE                             90.9      78.2       16%         14%
    REPLAGAL                             48.3      44.6        8%          7%
    FIRAZYR                               1.8       0.2       n/a          0%
    Total HGT product sales             141.0     123.0       15%         21%

    Total product sales                 602.5     712.5      -15%         91%

    Royalties:
    3TC and ZEFFIX                       42.0      44.5       -6%          6%
    ADDERALL XR                           2.2         -       n/a          0%
    Other                                16.1      16.3       -1%          2%
    Total royalties                      60.3      60.8       -1%          8%

    Other revenues                        4.2       5.3      -21%          1%

    Total Revenues                      667.0     778.6      -14%        100%


    Unaudited US GAAP results for the nine months to September 30, 2009
    Selected Notes to the Financial Statements

    (2) Analysis of revenues


    9 months to September 30,            2009      2008      2009        2009
                                                                %  % of total
                                           $M        $M    change     revenue
    Net product sales:
    Specialty Pharmaceuticals ("Specialty")
    ADHD
    ADDERALL XR                         434.2     826.6      -47%         21%
    VYVANSE                             359.7     215.6       67%         17%
    DAYTRANA                             52.2      61.0      -14%          2%
    EQUASYM                              14.1         -       n/a          1%
                                        860.2   1,103.2      -22%         41%
    GI
    PENTASA                             156.5     138.2       13%          7%
    LIALDA / MEZAVANT                   169.4      99.6       70%          8%
                                        325.9     237.8       37%         15%
    General products
    FOSRENOL                            137.2     121.6       13%          6%
    CALCICHEW                            32.8      40.8      -20%          2%
    CARBATROL                            59.7      55.7        7%          3%
    REMINYL/REMINYL XL                   28.8      26.6        8%          1%
    XAGRID                               62.3      58.7        6%          3%
                                        320.8     303.4        6%         15%

    Other product sales                  14.3      43.0      -67%          1%
    Total Specialty product
    sales                             1,521.2   1,687.4      -10%         72%

    Human Genetic Therapies ("HGT")
    ELAPRASE                            258.9     230.5       12%         12%
    REPLAGAL                            132.9     131.8        1%          6%
    FIRAZYR                               3.8       0.2       n/a          1%
    Total HGT product sales             395.6     362.5        9%         19%

    Total product sales               1,916.8   2,049.9       -6%         91%

    Royalties:
    3TC and ZEFFIX                      120.3     138.6      -13%          5%
    ADDERALL XR                          15.8         -       n/a          1%
    Other                                41.7      52.1      -20%          2%
    Total royalties                     177.8     190.7       -7%          8%

    Other revenues                       19.8      15.8       25%          1%

    Total Revenues                    2,114.4   2,256.4       -6%        100%


    Unaudited results for the three months to September 30, 2009
    Non GAAP reconciliation

                           US GAAP               Adjustments

                                                Acquisitions    Divestments,
                                   Amortization            & reorganizations
                         September      & asset  integration  & discontinued
    3 months to,          30, 2009  impairments   activities      operations
                                             (a)          (b)             (c)
                                $M           $M           $M              $M
    Total revenues           667.0            -            -               -

    Costs and expenses:
    Cost of product sales    104.9            -         (0.6)           (4.5)
    Research and
    development              147.8            -            -               -
    Selling, general and
    administrative           320.6        (34.8)           -               -
    Gain on sale of
    product rights            (6.3)           -            -             6.3
    Reorganization costs       2.0            -            -            (2.0)
    Integration and
    acquisition costs          6.2            -         (6.2)              -
    Depreciation                 -            -            -               -
    Total operating
    expenses                 575.2        (34.8)        (6.8)           (0.2)

    Operating income          91.8         34.8          6.8             0.2

    Interest income            0.2            -            -               -
    Interest expense          (9.4)           -            -               -
    Other income, net          7.0            -            -               -
    Total other expense,
    net                       (2.2)           -            -               -
    Income from continuing
    operations before
    income taxes and
    equity in earnings of
    equity method
    investees                 89.6         34.8          6.8             0.2
    Income taxes             (30.6)        (9.9)        (1.8)           (0.5)
    Equity in earnings of
    equity method
    investees, net of tax      0.6            -            -               -
    Net income
    attributable to Shire
    plc                       59.6         24.9          5.0            (0.3)
    Numerator for diluted
    EPS                       59.6         24.9          5.0            (0.3)
    Weighted average
    number of shares
    (millions) - diluted     548.3            -            -               -
    Diluted earnings per
    ADS                      32.7c        13.5c         2.7c               -


                                       Non GAAP

                        Reclassify    September
    3 months to,      depreciation     30, 2009
                                (d)
                                $M           $M
    Total revenues               -        667.0

    Costs and expenses:
    Cost of product sales     (0.8)        99.0
    Research and
    development               (3.6)       144.2
    Selling, general and
    administrative           (18.5)       267.3
    Gain on sale of product
    rights                       -            -
    Reorganization costs         -            -
    Integration and
    acquisition costs            -            -
    Depreciation              22.9         22.9
    Total operating
    expenses                     -        533.4

    Operating income             -        133.6

    Interest income              -          0.2
    Interest expense             -         (9.4)
    Other income, net            -          7.0
    Total other expense,
    net                          -         (2.2)
    Income from continuing
    operations before
    income taxes and equity
    in earnings of equity
    method investees             -        131.4
    Income taxes                 -        (42.8)
    Equity in earnings of
    equity method
    investees, net of tax        -          0.6
    Net income attributable
    to Shire plc                 -         89.2
    Numerator for diluted
    EPS                          -         89.2
    Weighted average number
    of shares (millions) -
    diluted                      -        548.3
    Diluted earnings per
    ADS                          -        48.9c

    The following items are included in Adjustments:

    (a) Amortization and asset impairments: Amortization of intangible assets
        relating to intellectual property rights acquired ($34.8 million)
        and tax effect of adjustment;
    (b) Acquisitions and integration activities Inventory fair value
        adjustment related to the acquisition of Jerini ($0.6 million); costs
        associated with the integration and acquisition of Jerini and
        EQUASYM from UCB ($6.2 million) and tax effect of adjustments;
    (c) Divestments, reorganizations and discontinued operations: Accelerated
        depreciation ($4.5 million) and reorganization costs ($2.0 million)
        for the transition of manufacturing from Owings Mills, gains on the
        disposal of non-core product rights ($6.3 million) and tax effect of
        adjustments; and
    (d) Depreciation: Depreciation of $22.9 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 September 30, 2008
    Non GAAP reconciliation

                         US GAAP                 Adjustments

                                                Acquisitions     Divestments,
                       September  Amortization             & reorganizations
                              30,      & asset   integration  & discontinued
    3 months to,            2008   impairments    activities      operations
                                           (a)           (b)             (c)
                              $M           $M            $M              $M
    Total revenues         778.6            -             -               -

    Costs and
    expenses:
    Cost of product
    sales                   84.2            -             -               -
    Research and
    development(1)         120.2            -             -               -
    Selling, general
    and
    administrative(1)      327.3        (29.7)            -            (2.0)
    In-process R&D
    charge                 120.5            -        (120.5)              -
    Integration and
    acquisition costs        7.5            - 
'/>"/>
SOURCE Shire Plc
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