DUBLIN, August 5 /PRNewswire-FirstCall/ --
- 2009 Guidance Framework Reaffirmed
Shire plc the global specialty biopharmaceutical company, announces results for the three months to June 30, 2009.
(2) Sales growth at constant exchange rates (“CER”), which is a Non GAAP measure, is calculated after restating Q2 2009 results using Q2 2008 average foreign exchange rates.
Angus Russell, Chief Executive Officer, commented:
“In the second quarter we delivered strong core product sales, excluding ADDERALL XR, of $491 million, representing growth of 20% compared to the same quarter last year. The strategic steps we have taken over the last few years are now delivering clear commercial benefits, as we enter a new phase of Shire’s development.
We have diversified into a broader portfolio of young products with strong intellectual property and exciting growth prospects. We continue to increase the global reach of our business, and now have a presence in 26 countries worldwide compared to nine countries four years ago.
We have also developed a promising pipeline with encouraging recent news. With the receipt of a Complete Response Letter from the US Food and Drug Administration (“FDA”) for INTUNIV, we are confident that we will quickly come to agreement on the final wording of the product label and will launch in the fourth quarter of 2009 as planned. We are also initiating Phase 2 pilot clinical trials to assess the efficacy and safety of VYVANSE in non ADHD (“Attention Deficit Hyperactivity Disorder”) indications. Our HGT pipeline has been strengthened by positive results from our trial of velaglucerase in naA ve Gaucher patients. A treatment protocol for early access has been approved by the FDA and the agency has approved Fast Track designation for the product. Rolling review of the New Drug Application (“NDA”) has started.
Our core portfolio has made good progress in the quarter. We are pleased with the performance of VYVANSE as it has retained market share during the historically quieter summer vacation season in contrast to other branded ADHD treatments that have lost market share. We are anticipating the benefits of the back to school season for VYVANSE and are looking forward to increased sales momentum from our co-promote agreement with GSK for adult ADHD. We are also expecting further positive newsflow from our pipeline during the second half of this year.
Supported by pro-active cost management, our business is well placed to deliver on our unchanged guidance framework for 2009 and looking ahead we reiterate our aspiration of growing sales in the mid-teens range on average between 2009 and 2015.”
Note: Average exchange rates for Q2 2009 were $1.55:GBP1.00 and $1.36:EUR1.00, (Q2 2008: $1.97:GBP1.00 and $1.57: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 and 23.
Pipeline
INTUNIV(TM) - for the treatment of ADHD in children and adolescents in the US.
FIRAZYR(R) - for the treatment of hereditary angioedema (“HAE”)
- In June 2009, Shire initiated a Phase 3 study in patients with acute attacks of HAE, known as the FAST-3 trial, which is designed to support filing of a NDA for FIRAZYR in the US.
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 half of 2009 we have already achieved Non GAAP diluted earnings per ADS of $1.88.
We identified that each 10c movement in the EUR:$ 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:
(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:
DIVIDEND
In respect of the six months ended June 30, 2009, the Board resolved to pay an interim dividend of 2.147 US cents per ordinary share (2008: 2.147 US cents per share).
Dividend payments will be made in Pounds Sterling to Ordinary shareholders and in US Dollars to holders of American Depository Shares (“ADS”). A dividend of 1.302 pence per ordinary share (2008: 1.085 pence) and 6.441 US cents per ADS (2008: 6.441 US cents) will be paid on October 8, 2009 to persons whose names appear on the register of members of the Company at the close of business on September 11, 2009.
Dial in details for the live conference call for investors 14:00 BST/09:00 EDT on August 5, 2009:
Revenues from continuing operations for the three months to June 30, 2009 decreased by 19% to $629.7 million (2008: $775.6 million), primarily due to the decline in branded ADDERALL XR product sales in Q2 2009 following the launch of an authorized generic version by Teva in April 2009. Excluding ADDERALL XR, product sales increased by 20% to $491.0 million (2008: $409.3 million).
Non GAAP operating income for the three months to June 30, 2009 decreased by 53% to $115.5 million (2008: $246.5 million). The lower product sales of ADDERALL XR in Q2 2009 were partially offset by higher revenues from other products and lower operating expenses, as the Company benefits from its more diversified portfolio and continues to focus on cost management, with some additional benefits from foreign exchange compared to 2008.
US GAAP operating income from continuing operations for the three months to June 30, 2009 increased by $102.0 million to $34.7 million (2008: $67.3 million loss). US GAAP operating income from continuing operations in Q2 2009 includes a charge of $36.9 million following the amendment of an in-license agreement for INTUNIV. The US GAAP operating loss from continuing operations in Q2 2008 included in-process R&D charges on acquisition of METAZYM(R) from Zymenex A/S ($135.0 million) and costs associated with the cessation of commercialization of DYNEPO(TM) ($150.3 million). Excluding the above charges the fall in US GAAP operating income from continuing operations in Q2 2009 principally resulted from lower revenues following declines in branded ADDERALL XR product sales.
Net cash provided by operating activities decreased by 60% to $72.0 million for the three months to June 30, 2009 (2008: $180.4 million). The cash inflow from operating activities was lower in Q2 2009 than the same period in 2008 as lower sales receipts, higher cash tax payments and cash payments on forward exchange contracts in 2009 were only partially offset by lower operating expense payments during the quarter.
Cash, cash equivalents and restricted cash at June 30, 2009 totaled $299.1 million (December 31, 2008: $247.4 million), an increase of $51.7 million. Cash inflows from operating activities, cash received on the disposal of Shire’s minority investment in Virochem Pharma Inc. and Jerini’s Peptides business have been partially offset by cash outflows to acquire EQUASYM, investment in property, plant and equipment at the HGT campus in Lexington and the dividend payment.
2. Product sales
For the three months to June 30, 2009 product sales decreased by 21% to $558.4 million (2008: $705.7 million) and represented 89% of total revenues (2008: 91%). Excluding ADDERALL XR, product sales increased by 20% to $491.0 million (2008: $409.3 million).
(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 Q2 2008.
(3) CER growth is calculated after restating Q2 2009 results using Q2 2008 average foreign exchange rates.
Shire’s share of the total US ADHD market for the three months to June 30, 2009 declined by approximately 8 percentage points to 24.5% (2008: 32.3%), following the launch by Teva in April 2009 of an authorized generic version of ADDERALL XR. Shire continues to have the leading portfolio of branded products in the US ADHD market.
VYVANSE - ADHD
Sales of VYVANSE for the three months to June 30, 2009 increased by 75% to $114.2 million (2008: $65.2 million), with VYVANSE’s average share of the US ADHD market for Q2 2009 increasing to 12.1% (2008: 7.4%). Product sales growth was driven by an 80% increase in US prescription demand in Q2 2009 over the same period in 2008, as a result of increased US ADHD average market share and 10% growth in the US ADHD market.
ADDERALL XR - ADHD
Sales of ADDERALL XR for the three months to June 30, 2009 were $67.4 million, a decrease of 77% (2008: $296.4 million) resulting from the launch by Teva in April 2009 of its authorized generic version of ADDERALL XR. The launch of the generic version led to a 48% decline in ADDERALL XR US prescription demand, higher US sales deductions and significant de-stocking (equivalent to gross sales of $67 million) by wholesalers and retail pharmacies in Q2 2009 compared to the same period in 2008. These factors more than offset the positive impacts of price increases taken since Q2 2008, and the inclusion within product sales of shipments of authorized generic ADDERALL XR to Teva in Q2 2009.
Sales deductions represented 72% of branded ADDERALL XR gross sales in Q2 2009 (2008: 22%), the increase primarily resulting from higher sales deductions for Managed Care and Medicaid rebates as well as the impact of revising estimates made at the end of Q1 and used in the measurement of the rebate liability on the wholesale and retail pipeline. These revisions increased Q2 sales deduction expense by the equivalent of 11% of Q2 2009 ADDERALL XR gross sales.
The Managed Care rebate percentage increased due to higher rebates offered to Managed Care organizations (“MCO”) from April 1, 2009.
The Medicaid rebate percentage was higher in Q2 2009 than the same period last year due to a higher proportion of gross sales being made through Medicaid and an increased unit rebate amount (“URA”). The rise in URA is a direct result of price increases and the inclusion of shipments of authorized generic ADDERALL XR to Teva in the URA calculation.
DAYTRANA - ADHD
Product sales of DAYTRANA for the three months to June 30, 2009 decreased by 34% to $14.9 million (2008: $22.6 million). Product sales declined due to a 14% reduction in US prescription demand, following a decline in DAYTRANA’s average share of the US ADHD market to 1.4% (2008: 1.8%) together with the impact of de-stocking in Q2 2009. These declines were partially offset by price increases taken since Q2 2008.
EQUASYM - ADHD
Following the acquisition of EQUASYM from UCB on March 31, 2009 the Company has recorded product sales of EQUASYM for the three months to June 30, 2009 of $4.9 million (2008: $nil).
US oral mesalamine market share
Shire’s average market share of the US oral mesalamine market rose to 31.8% for the three months to June 30, 2009 (2008: 27.6%).
LIALDA/MEZAVANT - Ulcerative colitis
Product sales of LIALDA/MEZAVANT for the three months to June 30, 2009 increased by 71% to $54.6 million (2008: $32.0 million). US prescriptions increased by 53%, due to an increase in LIALDA’s average share of the US oral mesalamine market to 15.9% (2008: 10.8%) and underlying growth in the US oral mesalamine market of 4%.
By June 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
Sales of PENTASA(R) for the three months to June 30, 2009 were $54.0 million, an increase of 21% compared to the same period in 2008 (2008: $44.8 million). Sales grew despite a 2% decrease in prescriptions primarily due to the impact of price increases.
FOSRENOL - Hyperphosphatemia
Product sales of FOSRENOL(R) for the three months to June 30, 2009 were up 17% to $49.6 million (2008: $42.4 million). On a CER basis sales were up 26%. 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 Q2 2009 declined to 7.8% (2008: 8.2%) due to a 3% decrease in prescriptions. However, US product sales grew 15% as price increases offset the prescription decline.
XAGRID - Thrombocythemia
Sales of XAGRID(TM) for the three months to June 30, 2009 were $20.7 million (2008: $20.6 million). On a CER basis sales increased by 12% (XAGRID is primarily sold in Euros and Pounds Sterling).
Human Genetic Therapies
ELAPRASE - Hunter syndrome
Product sales for the three months to June 30, 2009 were $85.3 million, an increase of 6% (2008: $80.8 million). Expressed on a CER basis sales increased by 15% (ELAPRASE(R) 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 June 30, 2009 were $44.4 million, a decrease of 1% (2008: $44.7 million). Expressed on a CER basis sales increased by 14% (REPLAGAL(R) is primarily sold in Euros and Pounds Sterling). The sales growth was primarily driven by increased volumes in Europe and Asia Pacific.
FIRAZYR - HAE
Sales for the three months to June 30, 2009 were $1.5 million (2008: $nil). Sales of FIRAZYR in Q1 2009 were $0.5 million. With Q2 launches in France and Portugal, FIRAZYR is now launched in nine countries, including four of the five largest European countries. FIRAZYR also received final price publication in Italy during June, which will enable launch in Italy during Q3. 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 increased by 3% to $66.9 million for the three months to June 30, 2009 (2008: $64.8 million). The following table provides an analysis of Shire’s royalty income:
Shire receives royalties from GSK on worldwide sales of 3TC(R) sales. Royalties from sales of 3TC for the three months to June 30, 2009 were $29.2 million (2008: $35.6 million). Excluding unfavorable foreign exchange movements of 7%, royalties have decreased by 11% mainly due to competition from other HIV treatments.
ZEFFIX - Chronic hepatitis B infection
Shire receives royalties from GSK on worldwide ZEFFIX(R) sales. Royalties from sales of ZEFFIX for the three months to June 30, 2009 were $10.2 million, a decrease of 6% (2008: $10.8 million). The impact of foreign exchange movements has contributed 4% to the reported decrease, with the remainder of the decrease due to increased competition from other hepatitis B treatments.
ADDERALL XR - ADHD
Royalties from Teva’s sales of authorized generic ADDERALL XR for the three months to June 30, 2009 were $13.6 million (2008: $nil). Receipt of this royalty began with Teva’s sales of authorized generic ADDERALL XR in April 2009.
OTHER
Other royalties are primarily in respect of REMINYL(R) and REMINYL XL(TM) (known as RAZADYNE(R) and RAZADYNE(R) ER in the US), for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer’s type.
The range of REMINYL products is marketed worldwide (excluding the UK and the Republic of Ireland where Shire has exclusive marketing rights) by Janssen Pharmaceutical N.V., an affiliate of Johnson & Johnson (“J&J”). Sales of the REMINYL/RAZADYNE range continue to grow in most countries, however the entry of generic versions of RAZADYNE and RAZADYNE ER into the US market in Q3 2008 has significantly decreased sales in that region.
After the exclusion of those charges outlined above, Non GAAP cost of product sales as a percentage of product sales increased by 4 percentage points (from 12% to 16%) 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 have both depressed gross margin for that product.
Non GAAP R&D decreased 7% to $118.0 million (2008: $126.8 million). The continued investment in core R&D programs has been offset by the benefit of foreign exchange rates in Q2 2009 over the same period in 2008 and the cessation of certain non-core programs since Q2 2008. As a percentage of product sales, Non GAAP R&D increased to 21% (2008: 18%) due to the lower product sales in Q2 2009.
Non GAAP SG&A declined by 5% to $284.5 million (2008: $298.5 million) as a result of the increased focus on cost management and favorable foreign exchange rates in 2009 over 2008. Non GAAP SG&A increased as a percentage of product sales to 51% (2008: 42%) as cost ratios were adversely affected by lower product sales following the genericization of ADDERALL XR.
Reorganization costs
For the three months to June 30, 2009 Shire recorded reorganization costs of $2.9 million (2008: $nil) relating to the transfer of manufacturing from its Owing Mills facility.
Integration and acquisition costs
For the three months to June 30, 2009 Shire recorded integration and acquisition costs of $2.3 million (2008: $nil) relating to the integration of Jerini AG and charges associated with the acquisition of EQUASYM.
Interest income
For the three months to June 30, 2009 Shire received interest income of $0.6 million (2008: $6.5 million), primarily received on cash and cash equivalents. Interest income for the three months to June 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
For the three months to June 30, 2009 the Company incurred interest expense of $10.1 million (2008: $16.8 million). The higher expense in 2008 was primarily due to the accrual of interest in respect of the Transkaryotic Therapies, Inc. (“TKT”) appraisal rights litigation. This litigation was settled in November 2008.
Taxation
The effective rate of tax for the three months to June 30, 2009 was -78% (2008: -0.3%). The effective tax rate on Non GAAP income is 2% (2008: 20%). The Non GAAP effective tax rate in the three months to June 30, 2009 was 18 percentage points lower than the corresponding period in 2008 principally due to the decrease in valuation allowances held in respect of US State tax credits and losses. Following the interpretation and analysis of the implications of new Massachusetts State tax regulations issued in Q2 2009, Shire determined during the second quarter that it was now more likely than not that these State tax credits and losses were realizable.
Equity in earnings/(losses) of equity method investees
Net earnings of equity method investees of $0.5 million were recorded for the three months to June 30, 2009 (2008: $1.9 million loss). This comprised earnings of $1.2 million from the 50% share of the anti-viral commercialization partnership with GSK in Canada (2008: $1.5 million earnings) and losses of $0.7 million, being the Company’s share of losses in the GeneChem, AgeChem and EGS Funds (2008: $3.4 million loss).
Discontinued operations
The loss from discontinued operations for the three months to June 30, 2009 was $9.8 million (2008: $nil), relating to net losses on discontinued Jerini businesses which were either divested or closed during the second quarter of 2009, the loss on divestment of Jerini’s Peptides business and the write-off of the fair value less costs to sell of assets previously classified as held for sale.
Unaudited US GAAP results for the three months and six months to June 30, 2009 Consolidated Balance Sheets
Unaudited US GAAP results for the three months and six months to June 30, 2009 Consolidated Statements of Income
(1) Cost of product sales includes amortization of intangible assets relating to favorable manufacturing contracts of $0.4 million for the three months to June 30, 2009 (2008: $0.4 million) and $0.9 million for the six months to June 30, 2009 (2008: $0.9 million). Selling, general and administrative costs include amortization and impairment charges of intangible assets relating to intellectual property rights acquired of $34.3 million for the three months to June 30, 2009 (2008: $121.4 million) and $66.8 million for the six months to June 30, 2009 (2008: $152.3 million).
(2) Promotional costs totaling $8.9 million and $19.1 million have been reclassified from Research and development to Selling, general and administrative costs for the three and six months to June 30, 2008 respectively.
Unaudited US GAAP results for the three months and six months to June 30, 2009 Consolidated Statements of Income (continued)
Unaudited US GAAP results for the three months and six months to June 30, 2009 Consolidated Statements of Cash Flows
Unaudited US GAAP results for the three months and six months to June 30, 2009 Consolidated Statements of Cash Flows (continued)
Unaudited US GAAP results for the three months and six months to June 30, 2009
(1) For the three and six month periods ended June 30, 2009 and the three month period ended June 30, 2008 interest on the convertible bonds has not been added back as the effect would be anti-dilutive.
(2) Excludes shares purchased by the ESOT and presented by the Company as treasury stock.
(3) Calculated using the treasury stock method.
(4) Calculated using the “if-converted” method.
The share equivalents not included in the calculation of the diluted weighted average number of shares are shown below:
(1) For the three month period ended June 30, 2009 and the six month periods ended June 30, 2009 and 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 six month periods ended June 30, 2009 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 June 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.
(1) For the three months to June 30, 2009 interest expense on the convertible bonds has not been added back as the effect would be anti-dilutive.
The following items are included in Adjustments:
(a) Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($34.3 million) and tax effect of adjustment;
(b) Acquisitions and Integration activities Inventory fair value adjustment related to the acquisition of Jerini ($1.4 million); payment on amendment of INTUNIV in-licence agreement ($36.9 million), costs associated with the integration and acquisition of Jerini AG and EQUASYM from UCB ($2.3 million), and tax effect of adjustments;
(c) Divestments, Reorganizations and Discontinued Operations: Accelerated depreciation ($3.0 million) and reorganization costs ($2.9 million) for the transition of manufacturing from Owings Mills, discontinued operations in respect of non-core Jerini operations ($9.8 million), and tax effect of adjustments; and
(d) Depreciation: Depreciation of $24.6 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.
(1) $8.9m of promotional costs have been reclassified from Research and development to Selling, general and administrative costs for the three months to June 30, 2008.
(2) After the above adjustments, the Company made non GAAP net income during the calculation period. As a result (i) the after tax impact of the convertible bonds has been deducted from the numerator and (ii) in the money share options and convertible bonds are now included in the calculation of the diluted weighted average number of shares as they have a dilutive effect.
The following items are included in Adjustments:
(a) Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($31.0 million), impairment charge in respect of DYNEPO intangible asset ($90.4 million) and tax effect of adjustments;
(b) Acquisitions & integration activities: In-process R&D in respect of METAZYM acquired from Zymenex A/S ($135.0 million);
(c) Divestments, Re-organizations and Discontinued Operations: Costs associated with inventory write down and other exit costs in respect of DYNEPO ($53.4 million), R&D commitment in respect of DYNEPO ($6.5 million), costs associated with the introduction of a new holding company ($6.6 million), gains on the disposal of non core product rights ($9.1 million), and tax effect of adjustments; and
(d) Depreciation: Depreciation of $17.3 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.
(1) The impact of convertible debt, net of tax has a dilutive effect on a Non GAAP basis.
The following items are included in Adjustments:
(a) Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($66.8 million) and tax effect of adjustment;
(b) Acquisitions and Integration activities Inventory fair value adjustment related to the acquisition of Jerini AG ($1.4 million); payment on amendment of INTUNIV in-licence agreement ($36.9 million); costs associated with the integration and acquisition of Jerini AG and EQUASYM from UCB ($3.8 million); and tax effect of adjustments;
(c) Divestments, Reorganizations and Discontinued Operations: Accelerated depreciation ($3.0 million) and reorganization costs ($5.1 million) for the transition of manufacturing from Owings Mills, costs associated with agreement to terminate Women’s Health products with Duramed ($65.0 million), gain on disposal of the investment in Virochem ($55.2 million); discontinued operations in respect of non core Jerini operations ($12.4 million), and tax effect of adjustments; and
(d) Depreciation: Depreciation of $47.0 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.
(1) Promotional costs totaling $19.1 million have been reclassified from Research and development to Selling, general and administrative costs for the six months to June 30, 2008.
The following items are included in Adjustments:
(a) Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($61.9 million), impairment charge in respect of DYNEPO intangible asset ($90.4 million) and tax effect of adjustments;
(b) Acquisitions & integration activities: In-process R&D in respect of METAZYM acquired from Zymenex A/S ($135.0 million);
(c) Divestments, Re-organizations and Discontinued Operations: Costs associated with inventory write down and other exit costs in respect of DYNEPO ($53.4 million), R&D commitment in respect of DYNEPO ($6.5 million), and costs associated with the introduction of a new holding company ($12.2 million), gains on the disposal of non core assets ($16.7 million), gain on disposal of minority equity investment ($9.4 million) and tax effect of adjustments; and
(d) Depreciation: Depreciation of $33.6 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.
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.
For further information on Shire, please visit the Company’s website: http://www.shire.com
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, the Company’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 the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the im
