30th Apr 2009 12:00
Shire begins the year with a strong performance
April 30, 2009 - Shire plc the global specialtybiopharmaceutical company, announces results for the three months to March 31,2009.Financial Highlights Q1 2009 (1) Product sales $756 +20% million Product sales (excluding ADDERALL XR) $460 +24% million Product sales growth (excluding ADDERALL XR) at constant +32%exchange rates (2) Non GAAP operating income $327 +70% million US GAAP operating income $226 +39% million Non GAAP diluted earnings per ADS $1.28
+73%
US GAAP diluted earnings per ADS $1.16
+70%
Cash provided by operating activities $184 +180% million (1) Figures compare Q1 2009 results with the same period in 2008.
(2) Sales growth at constant exchange rates ("CER") is calculated after restating Q1 2009 results using Q1 2008 average foreign exchange rates.
Angus Russell, Chief Executive Officer, commented:
"This has been a solid first quarter with the delivery of strong earningsgrowth, reflecting the continuing development of our business and effectivecost control. We have built strong, competitive products that provide cuttingedge therapies for our patients, which together with our late stage pipeline,will act as the principal drivers of Shire's future growth.We are putting the right level of resources behind our products as evidenced bythe recently announced co-promotion agreement for VYVANSE in the US. We arecontinuing to progress our R&D pipeline and in the second half of the year weare anticipating the launch of INTUNIV and the completion of several Phase 2and Phase 3 studies. We are committed to expanding our international businessfor both our Human Genetic Therapies and Specialty Pharmaceuticals products andhave made progress during the quarter with the opening of a representativeoffice in Japan and the acquisition of product rights for EQUASYM, providing aEuropean entry point for our Attention Deficit Hyperactivity Disorderportfolio. We also have the flexibility to take advantage of opportunities forfurther expansion of our business.
We remain confident that our business is well positioned to deliver on our previously stated and unchanged 2009 guidance framework and looking ahead, we also reiterate our aspiration of growing sales in the mid teens range on average between 2009 and 2015."
First Quarter 2009 Unaudited Results
Q1 2009 Q1 2008 Non GAAP Non GAAP USGAAP Adjustments (1) USGAAP Adjustments (1) $M $M $M $M $M $M _______ _________ __________ _______ __________ __________ Revenues 818 - 818 702 - 702 Operating income 226 101 327 163 29 192 Net income 214 23 237 129 11 140 Diluted earnings 116c 12c 128c 68c 6c 74cper ADS
Note: Average exchange rates for Q1 2009 were: $1.44:£1.00 and $1.31:€1.00, (Q1 2008: $1.98:£1.00 and $1.49:€1.00)
(1) The Non GAAP financial measures included above are explained on pages 23and 24, together with an explanation of why Shire's management believes thatthese measures are useful to investors. For a reconciliation of these Non GAAPfinancial measures to the most directly comparable financial measures preparedin accordance with US GAAP, see pages 21 and 22.
Financial Summary - First Quarter 2009 (see page 6 for Full Financial Results)
* Product sales were up 20% (up 24% at CER) to $756 million, driven by strong
growth in:
VYVANSE (up 114% to $117 million);
LIALDA/MEZAVANT (up 82% to $49 million); and
ELAPRASE (up 16% to $83 million).
* Non GAAP operating income increased by 70% to $327 million (up 39% to $226
million on a US GAAP basis) with higher revenues supported by lower costs
driving improved margins. The lower costs are a result of our increased
focus on cost management and the benefit of foreign exchange movements on
both R&D and selling, general and administrative costs. Non GAAP operating
expenses decreased to 65% of product sales (81% of product sales in Q1 2008) and decreased to 78% of product sales on a US GAAP basis (85% of product sales in Q1 2008). * Strong earnings growth with Non GAAP diluted earnings per ADS up 73% to $1.28 and US GAAP diluted earnings per ADS up 70% to $1.16.
* Cash generated by operating activities increased by 180% to $184 million,
supporting our robust balance sheet. Cash and cash equivalents at March 31,
2009 totalled $291 million. Shire has no debt maturing within the next two
years, and has a committed facility of $1.2 billion which is currently undrawn. FIRST QUARTER HIGHLIGHTS Products VYVANSE
* On March 31, 2009 Shire announced a co-promotion agreement with
GlaxoSmithKline plc ("GSK") for VYVANSE® (lisdexatetamine dimesylate) with
the aim of improving recognition and treatment of Attention Deficit
Hyperactivity Disorder ("ADHD") in adults. The three year agreement, which
commences in May 2009, covers the US and will more than double the reach
and frequency of the current sales effort for VYVANSE. * By April 17, 2009 VYVANSE had achieved a US ADHD market share of 11.9% based on weekly prescription volumes.
Acquisition of EQUASYM IR and XL
* On March 31, 2009 the Company completed the acquisition from UCB S.A
("UCB") of the worldwide rights (excluding the US, Canada and Barbados) to
the currently marketed products EQUASYM® IR and XL (methylphenidate
hydrochloride) used for the treatment of ADHD. The Company made a payment
of €55 million on completion of the acquisition and small milestone
payments may become due in 2009 and 2010 if certain targets are met. This
acquisition will broaden the scope of Shire's ADHD portfolio and will facilitate immediate access to the European ADHD market as well as providing a platform to enter additional world markets. Launch of FOSRENOL in Japan
* On March 11, 2009 FOSRENOL® (lanthanum carbonate) was launched in Japan
through Shire's partner Bayer Yakuhin Limited ("Bayer"). Shire will receive
a double digit royalty on Bayer's net sales of FOSRENOL, which will be recorded by Shire as royalty income within revenues.
License agreement for LIALDA in Japan
* On January 16, 2009 Shire announced that it had entered into a license
agreement with Mochida Pharmaceutical Co., Ltd to develop and sell LIALDA®
(mesalamine) in Japan.
Termination of LIALDA co-promotion agreement
* As of March 31, 2009, Shire terminated the agreement with Takeda Pharmaceuticals North America, Inc., successor to TAP Pharmaceutical Products Inc., for the co-promotion of LIALDA in the US. Pipeline
DAYTRANA - for the treatment of ADHD in children in the EU
* During March 2009 Shire withdrew the European marketing authorization
application ("MAA") for DAYTRANA® (methylphenidate transdermal system) for
the treatment of ADHD. The decision to withdraw the MAA does not impact
Shire's commitment to DAYTRANA in the US where the product has been used as
a pediatric treatment for ADHD since 2006.
INTUNIV- for the treatment of ADHD in children and adolescents in the US
On January 27, 2009 Shire made a resubmission to the US Food and DrugAdministration ("FDA") of the New Drug Application to support registration ofINTUNIVTM (guanfacine extended release) for the treatment of ADHD in children.The Prescription Drug User Fee Act date for INTUNIV is July 26, 2009 and thelaunch of INTUNIV in the US is anticipated for the fourth quarter of 2009.
SPD550 - for the treatment of celiac disease
In study 006, a Phase 2 study of larazotide acetate for treatment of celiacdisease, the primary endpoint was not met. An exploratory, predefined analysisof secondary endpoints showed differences of nominal significance favoringlarazotide acetate over placebo for anti-TTG antibodies at all three dosestested and for gastrointestinal symptom scales at the 1 mg dose only. The drugwas well tolerated. Alba Therapeutics Corporation has a further Phase 2 studyongoing.
HGT-3510 - for the treatment of Pompe Disease
* In February 2009, the Phase 2 clinical trial for HGT-3510 initiated by
Amicus Therapeutics Inc. ("Amicus") was placed on clinical hold in response
to reports of two serious adverse events that were probably related to
treatment with HGT-3510. HGT-3510 is being jointly developed by Shire and
Amicus, and Shire has rights to HGT-3510 in markets outside the US.
Agreement to terminate development of Women's Health products
* As previously disclosed in Shire's Annual Report on Form 10-K for the year
ended December 31, 2008, on February 24, 2009 Shire and Duramed
Pharmaceuticals ("Duramed"), a subsidiary of Teva Pharmaceutical Industries
Ltd ("Teva"), amended the license and development agreement for the Women's
Health products, following which Shire returned its rights under the
agreement effective February 24, 2009 and the agreement will terminate on
December 31, 2009. Shire has recorded a charge of $65 million in Q1 2009 to
reflect the cash payment made in Q1 2009 and other termination related costs. At December 31, 2008 Shire's maximum future reimbursement for Duramed incurred development expenses was $96 million. Business
Disposal of investment in Virochem Pharma Inc. ("Virochem")
* On March 12, 2009 the Company completed the disposal of its minority equity
investment in Virochem to Vertex Pharmaceuticals Inc., ("Vertex") in a cash
and stock transaction. Shire received total consideration of $19 million in
cash and two million Vertex shares from the disposal, recognizing a gain of
$55 million in Q1 2009. A further gain of up to $8 million may be recognized in 2010 pending the release from escrow of cash and stock consideration held as collateral for warranties made on disposal. Owings Mills
* After a comprehensive evaluation of its operations and strategic focus,
Shire has decided to phase out operations at its Specialty Pharmaceuticals
manufacturing facility at Owings Mills, Maryland. Over the next three
years, all products currently manufactured by Shire at this site will
transition to DSM Pharmaceutical Products, and operations and employee
numbers at the site will wind down over this period. The cash costs that
will be incurred as part of this re-organization are estimated to be $30
million, of which up to $15 million will be accounted for in 2009.
2009 Outlook On April 2, 2009 Teva announced that it had commenced commercial shipment ofits generic version of ADDERALL XR®(mixed salts of single amphetamine). Asanticipated and reflected in our 2009 guidance framework, sales of ADDERALL XRwill decrease significantly due to generic competition. We are reiterating our previously announced guidance framework for Non GAAPdiluted earnings per ADS for 2009, which remains unchanged from that providedin our third quarter 2008 earnings release. At that time, and in our fourthquarter 2008 earnings release, we provided details of the effect of changes inforeign exchange rates on the earnings guidance. Specifically, our plans for2009, 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 (€1:$1.52,£1:$1.95) for the ten months to October 2008. We identified that each 10c movement in the €:$ and £:$ exchange rates impactsShire'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, theimpact on our base guidance would be: Euro fx £ fx Non GAAP diluted earnings per rate rate ADS range (1) Base guidance $1.52 $1.95 $3.00 to $3.40 At average January 2009 $1.33 $1.45 $2.76 to $3.16exchange rates At average March 2009 $1.30 $1.42 $2.73 to $3.13exchange rates (1)Our guidance framework for Non GAAP diluted earnings per ADS is not preparedin accordance with US GAAP. Non GAAP diluted earnings per ADS excludes theeffect 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 23-24. New Product Launches
Subject to obtaining the relevant regulatory/governmental approvals, product launches planned over the next two years include:
MEZAVANT®(mesalamine) for the treatment of ulcerative colitis in certain EU countries during 2009;
FIRAZYR®(icatibant) for the symptomatic treatment of acute attacks of herediatary angioedema ("HAE") in certain European and Latin American countries during 2009;
INTUNIV for the treatment of ADHD in children and adolescents in the US in the fourth quarter of 2009;
DAYTRANA for the treatment of ADHD in adolescents in the US in 2010;
Velaglucerase Alfa for the treatment of Gaucher disease in the US and the EU in 2010; and
VYVANSE for the treatment of ADHD, in ex-US and ex-EU regions starting in 2010, and in the EU in 2011.
Additional Information
The following additional information is included in this press release:
Page Overview of Financial Results 6 Financial Information 12 Notes to Editors 23 Safe Harbor Statement 23 Explanation of Non GAAP Measures 23 Trademarks 24
For further information please contact:
Investor Relations Cl©a Rosenfeld (Rest of the World) +44 1256 894 160 Eric Rojas (North America) +1 617 551 9715 Media Jessica Mann (Rest of the World) +44 1256 894 280 Matthew Cabrey (North America) +1 484 595 8248
Dial in details for the live conference call for investors 14:30 BST/09:30 EDT on April 30, 2009:
UK dial in: 0808 100 5150
US dial in: 1 866 804 8688 or 1 718 354 1175
International dial in: +44 (0) 1296 480 100
Password/Conf ID: 228 831
Webcast: http://www.shire.com/shire/InvestorRelations/index.jsp?tn=2
OVERVIEW OF US GAAP FINANCIAL RESULTS
1. Introduction Summaryof Q1 2009
Revenues from continuing operations for the three months to March 31, 2009 increased by 16% to $817.8 million (2008: $702.2 million).
Non GAAP operating income for the three months to March 31, 2009 increased by70% to $326.9 million (2008: $191.8 million), with the increase of $135.1million resulting from higher product sales and improved operating cost ratiosin 2009 over the same period in 2008. Non GAAP operating expenses reduced by 16percentage points to 65% of product sales during Q1 2009 (2008: 81% of productsales), due to the increased focus on cost management, and the benefit offoreign exchange movements on both R&D and SG&A costs. US GAAP operating income from continuing operations for the three months toMarch 31, 2009 increased by 39% to $225.8 million (2008: $163.0 million). USGAAP operating income from continuing operations for Q1 2009 includes a chargeof $65.0 million on reaching agreement with Duramed to terminate development ofthe Women's Health products. US GAAP operating expenses reduced by sevenpercentage points to 78% of product sales in Q1 2009 (85% of product sales inQ1 2008) due to the increased focus on cost management and the benefit offoreign exchange movements. Cash inflow from operating activities for the three months to March 31, 2009increased by 180% to $184.1 million (2008: $65.7million) an increase of $118.4million. The higher operating cash flow in 2009 compared to 2008 is due toincreased revenues and the cash flow benefit of the focus on cost management inQ1 2009.
Cash, cash equivalents and restricted cash at March 31, 2009 totaled $327.2million (December 31, 2008: $247.4 million), an increase of $79.8 million.Strong cash inflows from operating activities and cash received on the disposalof Shire's minority interest in Virochem have been partially offset by cashoutflows from the acquisition of EQUASYM from UCB ($72.8 million) andinvestment in property, plant and equipment at the new HGT campus at Lexington,Massachusetts. 2. Product sales For the three months to March 31, 2009 product sales increased by 20% to $756.0million (2008: $631.7 million) and represented 92% of total revenues (2008:90%). Product Highlights CER Sales US Rx Sales Growth Growth Growth US Average Market Product $M (2) (3) (1) Share(1) Specialty Pharmaceuticals ADDERALL XR 295.8 13% 14% -5% 20.9% VYVANSE 116.6 114% 114% 102% 11.5% DAYTRANA 19.9 -2% -2% -13% 1.6% LIALDA / MEZAVANT 49.4 82% 84% 66% 14.8% PENTASA 51.2 16% 16% -2% 16.3% FOSRENOL 39.8 10% 20% -2% 7.8% XAGRID 20.1 7% 32% n/a n/a Human Genetic Therapies ELAPRASE 82.8 16% 26% n/a (4) n/a (4) REPLAGAL 40.2 -5% 6% n/a (5) n/a (5) FIRAZYR 0.5 - - 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 intelligencefor the pharmaceutical and healthcare industries. All other US market sharedata stated in the text below is also provided by IMS.
(2) Compared to Q1 2008.
(3) CER growth is calculated after restating Q1 2009 results using Q1 2008 average foreign exchange rates.
(4) IMS Data not available.(5) Not sold in US. Specialty Pharmaceuticals USADHD market share The continued growth in market share of VYVANSE helped Shire grow its averageshare of the US ADHD market for the three months to March 31, 2009 to 34.0%compared to 31.8% in the same period in 2008. Shire has the leading portfolioof products in the US ADHD market. ADDERALL XR - ADHD Sales of ADDERALL XR for the three months to March 31, 2009 were $295.8million, an increase of 13% compared to the same period in 2008 (2008: $261.5million). Product sales grew due to price increases, which offset the negativeimpact of significantly higher sales deductions in Q1 2009, declining USprescriptions (down 5% compared to Q1 2008), and wholesaler de-stocking. The increase in sales deductions in Q1 2009 to 37% of gross sales (2008: 24%)results from two factors: (i) a higher Medicaid rebate reserve on wholesale andretail pipeline inventory, as a consequence of shipment of authorized genericADDERALL XR to Teva in April 2009 and the impact of including these shipmentsin the Medicaid rebate calculation pursuant to the Deficit Reduction Act of2005; and (ii) a reserve on pipeline inventory for larger rebates offered tomanaged care organizations from April 1, 2009. On April 2, 2009 Teva announced that it had commenced commercial shipment ofits generic version of ADDERALL XR. As anticipated and reflected in our 2009guidance framework, sales of ADDERALL XR will decrease significantly due to
generic competition. VYVANSE - ADHD
Sales of VYVANSEfor the three months to March 31,2009 increased by 114% to$116.6 million (2008: $54.4 million), with VYVANSE's average share of the USADHD market for Q1 2009 increasing to 11.5% (2008: 6.1%). US prescriptions ofVYVANSE increasedby 102% in Q1 2009 over the same period in 2008, due to theincrease in average share and 8% growth in the US ADHD market. On February 24, 2009 Actavis Elizabeth LLC ("Actavis") brought a lawsuitagainst the FDA seeking to overturn the FDA's decision granting new chemicalentity exclusivity to VYVANSE. Shire believes the FDA's decision was correct.VYVANSE has new chemical entity exclusivity through February 23, 2012 andpatents listed in the Orange Book which expire on June 29, 2023. The suitbrought by Actavis has been stayed and the FDA has opened a public docket toenable the public to register comments on the legal and regulatory issuesraised by Actavis. DAYTRANA - ADHD
Product sales of DAYTRANA for the three months to March 31, 2009 decreased by2% to $19.9 million (2008: $20.3 million). Prescriptions reduced by 13%compared to 2008 due to a reduction in DAYTRANA's average share of the US ADHDmarket from 2.0% in Q1 2008 to 1.6% in Q1 2009. This decline in average sharewas partially offset by an 8% growth in the US ADHD market. Despite a 13%decrease in prescriptions sales of DAYTRANA only declined by 2% primarily dueto price increases.
USoral mesalamine market share
Driven by the growth of LIALDA since its launch in March 2007, Shire's average market share of the US oral mesalamine market rose to 31.1% for the three months to March 31, 2009 (2008: 26.1%).
LIALDA/MEZAVANT - Ulcerative colitis
Product sales of LIALDA/MEZAVANT for the three months to March 31, 2009increased by 82% to $49.4 million (2008: $27.2 million). US prescriptionsincreased by 66%, due to an increase in LIALDA's average share of the US oralmesalamine market to 14.8% (2008: 9.1%) and underlying growth in the US oralmesalamine market of 2%. By March 31, 2009 MEZAVANT was available in six countries outside the US, andfurther launches are planned in other countries throughout 2009, subject to thesuccessful conclusion of pricing and reimbursement negotiations. PENTASA - Ulcerative colitis
Sales of PENTASA for the three months to March 31, 2009 were $51.2 million, anincrease of 16% compared to the same period in 2008 (2008: $44.2 million).Sales grew despite a 2% decrease in prescriptions primarily due to the impactof price increases.
FOSRENOL - Hyperphosphatemia
Product sales of FOSRENOL for the three months to March 31, 2009 were up 10% to$39.8 million (2008: $36.2 million). On a CERbasis sales were up 20%. Inmarkets outside the US FOSRENOL sales increased as the product entered newcountries, and continued to grow in countries entered in the last two years.FOSRENOL's average share of the US phosphate binder market decreased to 7.8%(2008: 8.2%) and despite a 2% decrease in prescriptions product salesincreased, primarily due to price increases. During March and April, 2009 Shire filed lawsuits in the US District Court ofthe Southern District of New York against Barr Laboratories, Inc. (“Barrâ€), Mylan Inc., MylanPharmaceuticals Inc. and Matrix Laboratories Inc. (collectively "Mylan") andNatco Pharma Limited ("Natco") for infringement of certain of Shire's FOSRENOLpatents. The lawsuits were filed in response to Abbreviated New DrugApplications filed by Barr, Mylan and Natco seeking FDA approval to market andsell generic versions of Shire's 500 mg, 750 mg, and 1 g FOSRENOL products.
XAGRID - Thrombocythemia Sales for the three months to March 31, 2009 were $20.1 million, an increase of7% compared to the same period in 2008 (2008: $18.7 million). On a CER basissales increased by 32% (XAGRIDTM (anagrelide hydrochloride) is primarily soldin Euros and Pounds Sterling). Human Genetic Therapies ELAPRASE- Hunter syndrome Sales for the three months to March 31, 2009 were $82.8 million, an increase of16% compared to the same period in 2008 (2008: $71.5 million). Expressed on aCER basis sales increased by 26% (ELAPRASE® (idursulfase) is primarily sold inUS dollars and Euros). The sales growth was driven by increased unit sales inEurope, North America, and Latin America. REPLAGAL - Fabry disease
Product sales for the three months to March 31, 2009 were $40.2 million, adecrease of 5%compared to the same period in 2008 (2008: $42.5 million).Expressed on a CER basis sales increased by 6% (REPLAGAL®(agalsidase alfa)isprimarily sold in Euros and Pounds Sterling). The sales growth on a CER basiswas primarily driven by increased unit sales in Europe and Asia. FIRAZYR - HAE Sales for the three months to March 31, 2009 were $0.5 million (2008: $ nil).The launch of FIRAZYR in Europe continued with Q1 launches in Spain, Greece,and Denmark and will continue across Europe through 2009, as reimbursement andformulary listings (often required at local hospital level) are concluded ineach country. Feedback from physicians and patients has been very positive.
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 22% to $50.6 million for the three months to March31, 2009 (2008: $65.1 million). The following table provides an analysis ofShire's royalty income: Royalty Highlights Royalties Year on year to Shire change(1) Product $M % 3TC 29.8 -20% ZEFFIX 9.0 -13% Other 11.8 -32% Total 50.6 -22% (1) Compared with Q1 2008. 3TC - HIV infection and AIDS Royalties from sales of 3TC for the three months to March 31, 2009 were $29.8million, a decrease of 20% compared to the same period in 2008 (2008: $37.3million). Shire receives royalties from GSK on worldwide 3TC sales, and GSK'ssales of 3TC inclusive products declined by 7% on a CER basis mainly due tocompetition from other HIV treatments. The balance of the decline in Shire'sroyalty revenue is predominantly due to unfavourable exchange rate movements.
ZEFFIX - Chronic hepatitis B infection
Royalties from sales of ZEFFIX for the three months to March 31, 2009 were $9.0million, a decrease of 13% compared to the same period in 2008 (2008: $10.4million). Shire receives royalties from GSK on worldwide ZEFFIX sales, andGSK's sales of Zeffix declined 13% on a CER basis, due to increased competitionfrom other hepatitis B treatments. OTHER Other royalties were primarily received for REMINYL and REMINYL XL (known asRAZADYNE and RAZADYNE ER in the US), for the symptomatic treatment of mild tomoderately severe dementia of the Alzheimer's type. The range of products ismarketed worldwide (excluding the UK and the Republic of Ireland where Shirehas exclusive marketing rights) by Janssen Pharmaceutical N.V., an affiliate ofJohnson & Johnson ("J&J"). Sales of the REMINYL/RAZADYNE range continue to grow in most countries, howeverthe entry of generic versions of RAZADYNE and RAZADYNE ER into the US market inQ3 2008 has significantly decreased sales in that region. Information on the RAZADYNE and RAZADYNE ER patent litigation (which isongoing) can be found in our filings with the Securities and ExchangeCommission ("SEC") in our Annual Report on Form 10-K for the year to December31, 2008. 4. Financial detailsCost of product sales 2009 2008 % of product % of product $m sales $m sales _________ _________ _________ _________ Cost of product sales (US 83.6 11% 90.3 14%GAAP) Depreciation (3.6) (2.6) _________ _________ Cost of product sales (Non 80.0 11% 87.7 14%GAAP) _________ _________
Cost of product sales as a percentage of product sales has decreased by 3 percentage points (from 14% to 11%) compared to 2008 due to favorable product mix and the impact of price increases on Shire's product sales.
Research and development ("R&D")
2009 % of product 2008 % of product sales sales $m $m _________ _________ _________ _________ R&D (US GAAP) 185.9 25% 111.8 18% Women's Health exit (65.0) - costs Depreciation (4.0) (2.9) _________ _________ R&D (Non GAAP) 116.9 15% 108.9 17% _________ _________
R&D costs in the three months to March 31, 2009 included a charge of $65.0million (9% of product sales) following the agreement with Duramed to terminatedevelopment of Women's Health products. Non GAAP R&D as a percentage of productsales decreased by two percentage points in 2009 compared to 2008 (from 17% to15%) with increased investment in R&D programs compared to last year offset bythe benefits of foreign exchange movements.
Selling, general and administrative ("SG&A")
2009 % of product 2008 % of product sales sales $m $m _________ _________ _________ _________ SG&A (US GAAP) 318.9 42% 344.7 55% Intangible asset (32.5) (30.8) amortization Depreciation (14.8) (10.7) New holding company costs - (5.6) _________ ________ SG&A (Non GAAP) 271.6 36% 297.6 47% _________ ________
SG&A decreased in absolute terms and as a percentage of product sales withincreased focus on cost management, favorable foreign exchange rates and higherproduct sales in 2009 over 2008 all benefitting SG&A ratios on both a US GAAPand Non GAAP basis. Reorganization Costs
For the three months to March 31, 2009 Shire recorded reorganization costs of$2.2 million (2008: $nil) related to the impairment of property, plant andequipment following the decision to phase out manufacturing at Shire's OwingsMills facility.
Integration and acquisition costs
For the three months to March 31, 2009 Shire recorded integration and acquisition costs of $1.4 million relating to the integration of Jerini and professional fees incurred on the acquisition of EQUASYM (2008: $nil).
Interest income For the three months to March 31, 2009 Shire received interest income of $0.6million (2008: $12.7 million). Interest income primarily relates to interestreceived on cash and cash equivalents. Interest income for the three months toMarch 31, 2009 is lower than the same period in 2008 due to lower average cashand cash equivalent balances and significantly lower interest ratesin 2009
compared to 2008. Interest expense For the three months to March 31, 2009 the Company incurred interest expense of$11.0 million (2008: $17.3 million). The higher expense in 2008 was primarilydue to the accrual of interest in respect of the Transkaryotic Therapies, Inc.("TKT") appraisal rights litigation. This litigation was settled in November in2008. Other income, net 2009 2008 $m $m _________ ________ Other income, net (US GAAP) 50.3 12.7 Gains on sale of investments (55.2) (9.4) _________ ________ Other (expense)/ income, net (Non GAAP) (4.9) 3.3 _________ ________
For the three months to March 31, 2009 other income, net includes a gain of$55.2 million arising on the disposal of Shire's cost investment in Virochem.In the three months to March 31, 2008 other income, net included a $9.4 milliongain on the sale of a minority equity investment in Questor Pharmaceuticals,Inc. Taxation The effective rate of tax for the three months to March 31, 2009 was 19% (2008:26%). Excluding the tax effect of items excluded from Non GAAP income asoutlined on pages 21-22, the effective tax rate on Non GAAP incomeis 24% (2008:28%). The Non GAAP effective tax rate for the three months to March 31, 2009 is lowerthan the same period in 2008 due to favourable changes in profit mix, theinclusion of the US R&D tax credit that was extended on October 3, 2008 and areduction in valuation allowances in relation to loss carry forward amounts.
Equity in (losses)/ earnings of equity method investees
Net losses of equity method investees of $0.1 million were recorded for thethree months to March 31, 2009 (2008: $1.6 million profit). This comprisedearnings of $1.0 million from the 50% share of the anti-viral commercializationpartnership with GSK in Canada (2008: $1.3 million) and losses of $1.1 million,being the Company's share of losses in the GeneChem, AgeChem and EGS Funds
(2008: $0.3 million). Discontinued Operations The loss from discontinued operations for the three months to March 31, 2009 of$2.6 million (2008: $nil) relate to those Jerini businesses that met thecriteria for held-for-sale and discontinued operations, which Jerini announcedin October 2008 that it intended to divest. FINANCIAL INFORMATION TABLE OF CONTENTS Page
Unaudited US GAAP Consolidated Balance Sheets 13 Unaudited US GAAP Consolidated Statements of Income 15 Unaudited US GAAP Consolidated Statements of Cash Flows 17 Selected Notes to the Unaudited US GAAP Financial Statements 19
(1) Earnings per share 19 (2) Analysis of revenues 20 Non GAAP reconciliation 21
Unaudited US GAAP results for the three months to March 31, 2009Consolidated Balance Sheets March 31, 2009 December 31, $M 2008 $M _______ _______ ASSETS Current assets: Cash and cash equivalents 291.1 218.2 Restricted cash 36.1 29.2 Accounts receivable, net 551.8 395.0 Inventories, net 164.9 154.5 Assets held-for-sale 15.9 16.6 Deferred tax asset 86.9 89.5
Prepaid expenses and other current assets 153.8
141.4 _______ _______ Total current assets 1,300.5 1,044.4 Non-current assets: Investments 73.8 42.9
Property, plant and equipment, net 559.4
534.2 Goodwill 355.7 350.8 Other intangible assets, net 1,852.5 1,824.9 Deferred tax asset 131.5 118.1 Other non-current assets 14.2 18.4 _______ _______ Total assets 4,287.6 3,933.7 _______ _______ LIABILITIES AND EQUITY Current liabilities:
Accounts payable and accrued expenses 829.7
708.6 Deferred tax liability 57.6 10.9 Other current liabilities 70.7 104.3 _______ _______ Total current liabilities 958.0 823.8 Non-current liabilities: Convertible bonds 1,100.0 1,100.0 Other long term debt 51.4 43.1 Deferred tax liability 371.9 377.0
Other non-current liabilities 263.8
291.3 _______ _______ Total liabilities 2,745.1 2,635.2 _______ _______
Unaudited US GAAP results for the three months to March 31, 2009 Consolidated Balance Sheets (continued)
March 31, December 2009 31, 2008 $M $M _________ _________ Shareholders' equity:
Common stock of 5p par value; 1,000 million shares authorized; and 560.3 million shares issued and outstanding (2008: 1,000 million shares authorized; and 560.2 million shares issued and outstanding)
55.5 55.5
Treasury stock : 20.6 million shares (2008: 20.7
million) (396.4) (397.2) Additional paid-in capital 2,610.5 2,594.6 Accumulated other comprehensive income 111.4 97.0 Accumulated deficit (838.9) (1,051.7) _________ _________ Total Shire plc shareholders' equity 1,542.1
1,298.2
Noncontrolling interest in subsidiaries 0.4 0.3 _________ _________ Total equity 1,542.5 1,298.5 _________ _________ Total liabilities and equity 4,287.6 3,933.7 _________ __________
Unaudited US GAAP results for the three months to March 31, 2009 Consolidated Statements of Income
3 months to March 31, 2009 2008 $M $M
_______________ _______________
Revenues: Product sales 756.0 631.7 Royalties 50.6 65.1 Other revenues 11.2 5.4
_______________ _______________
Total revenues 817.8 702.2
_______________ _______________
Costs and expenses: Cost of product sales(1) 83.6 90.3 Research and development(2) 185.9 111.8
Selling, general and administrative(1) (2) 318.9 344.7 Gain on sale of product rights
- (7.6) Reorganization costs 2.2 -
Integration and acquisition costs
1.4 -
_______________ _______________
Total operating expenses 592.0 539.2
_______________ _______________
Operating income 225.8 163.0 Interest income 0.6 12.7 Interest expense (11.0) (17.3) Other income, net 50.3 12.7
_______________ _______________
39.9 8.1Total other income, net
_______________ _______________
Income from continuing operations before income taxes and equity in (losses)/earnings of equity method investees
265.7 171.1 (49.5) (44.1)Income taxes
Equity in (losses)/earnings of equity method investees, net of taxes (0.1) 1.6
_______________ _______________
Income from continuing operations, net of tax
216.1 128.6
Loss from discontinued operations (net of income tax expense of $nil
(2.6) -and $nil respectively)
_______________ _______________
213.5 128.6Net income 0.1 -
Add: Net loss attributable to noncontrolling interest in subsidiaries
_______________ _______________
213.6 128.6 Net income attributable to Shire plc
_______________ _______________
(1)Cost of product sales includes amortization of intangible assets relating tofavorable manufacturing contracts of $0.4 million for the three months to March31, 2009 (2008 $0.4 million). Selling, general and administrative costs includeamortization of intangible assets relating to intellectual property rightsacquired of $32.5 million for the three months to March 31, 2009 (2008: $30.8million).
(2) Depreciation of $2.9 million has been reclassified from Selling, general and administrative to Research and development costs, and $10.2 million of promotional costs have been reclassified from Research and development to Selling, general and administrative costs for the three months to March 31, 2008.
Unaudited US GAAP results for the three months to March 31, 2009
Consolidated Statements of Income (continued)
3 months to March 31, 2009 2008 ________ ________ Earnings per ordinary share - basic
Earnings from continuing operations 40.1c 23.6c
Loss from discontinued operations (0.5c) -
________ ________
Earnings per ordinary share - basic 39.6c 23.6c
________ ________ Earnings per ADS - basic 118.8c 70.8c ________ ________ Earnings per ordinary share - diluted
Earnings from continuing operations 38.9c 22.7c
Loss from discontinued operations (0.4c) -
________ ________
Earnings per ordinary share - diluted 38.5c 22.7c
________ ________ Earnings per ADS - diluted 115.5c 68.1c ________ ________ Weighted average number of shares: Basic 539.2 545.1 Diluted 577.2 581.5 ________ ________
Unaudited USGAAP results for the three months to March 31, 2009 Consolidated Statements of Cash Flows
3 months to 3 months to March 31, March 31, 2009 2008 $'M $'M _____________ _____________
CASH FLOWS FROM OPERATING ACTIVITIES: Net income attributable to Shire plc 213.6
128.6
Adjustments to reconcile net income attributable to Shire plc to net cash provided by operating
activities:
Loss from discontinued operations 2.6
- Depreciation and amortization 55.3 47.4
Amortization of deferred financing charges 1.3
1.3
Interest on building financing obligation 0.5
1.2 Share-based compensation 15.8 16.3
Impairment of property, plant and equipment 2.2
-
Gain on sale of long-term assets (0.7)
-
Gain on sale of long-term investments (55.2)
(9.4)
Gain on sale of product rights -
(7.6) Movement in deferred taxes 33.7 33.8
Equity in losses/(earnings) of equity method investees 0.1
(1.6)
Noncontrolling interest in subsidiaries (0.1)
-
Change in operating assets and liabilities
Increase in accounts receivable (151.0) (50.4) Increase in sales deduction accrual 121.9 7.9 Increase in inventory (9.5) (9.1) (Increase)/decrease in prepayments and other (12.3) 20.5current assets Decrease in other assets 3.4 0.3 Decrease in accounts and notes payable and other (37.6) (117.1)liabilities (Decrease)/increase in deferred revenue (2.2) 3.6
Returns on investment from joint venture 4.9
-
Cash flow used in discontinued operations (2.6)
- ________ ________
Net cash provided by operating activities (A) 184.1
65.7 ________ ________
CASH FLOWS FROM INVESTING ACTIVITIES
Movement in restricted cash (6.9) 5.0
Purchases of subsidiary undertakings and businesses,
net of cash acquired (74.1) -
Purchase of long-term investments -
(1.0)
Purchase of property, plant and equipment (42.0)
(27.8) Purchase of intangible assets (6.0) -
Proceeds from sale of long-term investments 19.2
10.3
Proceeds from disposal of property, plant and 0.4
equipment 0.1
Proceeds/deposits received from sale of product rights -
5.0 Returns of equity investments 0.2 - ______________ _____________
Net cash used in investing activities (B) (109.2)
(8.4) ______________ _____________
Unaudited USGAAP results for the three months to March 31, 2009 Consolidated Statements of Cash Flows (continued)
3 months to 3 months to March 31, March 31, 2009 2008 $'M $'M ____________ __________
CASH FLOWS FROM FINANCING ACTIVITIES: Payment under building financing obligations (0.7)
(0.2)
Proceeds from exercise of options 0.1
0.3
Payments to acquire shares by Employee Share
Ownership Trust ("ESOT") - (33.1) ____________ __________
Net cash used in financing activities (C) (0.6)
(33.0) _____________ ___________
Effect of foreign exchange rate changes on cash
and cash equivalents (D) (1.4) 3.8 ____________ __________
Net increase in cash and cash equivalents (A+B+C+D) 72.9 28.1 Cash and cash equivalents at beginning of period 218.2
762.5 ____________ __________
Cash and cash equivalents at end of period 291.1
790.6 ____________ __________
Unaudited USGAAP results for the three months to March 31, 2009
Selected Notes to the US GAAP Financial Statements
Earnings per share 2009 2008 3 months to March 31, $M $M ________ ________
Income from continuing operations 216.1 128.6 Loss from discontinued operations (2.6) - Noncontrolling interest in subsidiaries 0.1 - ________ ________ Numerator for basic EPS 213.6 128.6
Interest on convertible bonds, net of tax(1) 8.4 3.4
________ ________ Numerator for diluted EPS 222.0 132.0 ________ ________ Weighted average number of shares: Millions Millions Basic (2) 539.2 545.1 Effect of dilutive shares: Stock options(3) 5.3 3.7
Convertible bonds 2.75% due 2014(4) 32.7 32.7
_______ _______ Diluted 577.2 581.5 ________ ________ (1) Following substitution of the convertible bond to Shire plc in 2008, theCompany no longer receives a tax deduction on its convertible bond interest,and the interest add back for 2009 represents gross interest expense. TheCompany expects the full year add back to be approximately $34 million.
(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 above calculation of the diluted weighted average number of shares are shown below:
3 months to March 31, 2009 2008 No. of shares No. of shares Millions(1) Millions(1) Stock options out of the 16.6 12.4money
(1)For the three month periods ended March 31, 2009 and 2008, certain stockoptions have been excluded from the calculation of diluted EPS because theirexercise prices exceeded Shire plc's average share price during the calculationperiod.
Unaudited US GAAP results for the three months to March 31, 2009 Selected Notes to the US GAAP Financial Statements (continued)
(2) Analysis of revenues 3 months to March 31, 2009 2008 2009 2009 % % of total $M $M Change Revenue Net product sales:
Specialty Pharmaceuticals ("Specialty")
ADHD ADDERALL XR 295.8 261.5 13% 36% VYVANSE 116.6 54.4 114% 14% DAYTRANA 19.9 20.3 -2% 2% 432.3 336.2 29% 52% GI PENTASA 51.2 44.2 16% 6% LIALDA / MEZAVANT 49.4 27.2 82% 6% 100.6 71.4 41% 12% General products FOSRENOL 39.8 36.2 10% 5% CALCICHEW 9.6 13.6 -29% 1% CARBATROL 18.1 17.9 1% 2% REMINYL/REMINYL XL 7.4 8.3 -11% 1% XAGRID 20.1 18.7 7% 2% 95.0 94.7 - 11% Other product sales 4.6 15.4 -70% 2% Total Specialty product sales 632.5 517.7 22% 77%
Human Genetic Therapies ("HGT")
ELAPRASE 82.8 71.5 16% 10% REPLAGAL 40.2 42.5 -5% 5% FIRAZYR 0.5 - - - Total HGT product sales 123.5 114.0 8% 15% Total product sales 756.0 631.7 20% 92% Royalty income: 3TC 29.8 37.3 -20% 4% ZEFFIX 9.0 10.4 -13% 1% Other 11.8 17.4 -32% 2% Total 50.6 65.1 -22% 7% Other income 11.2 5.4 107% 1% Total Revenue 817.8 702.2 16% 100%
Unaudited results for the three months to March 31, 2009
Non GAAP reconciliation 3 months to, USGAAP Adjustments Non GAAP Acquisitions Divestments, Amortization & re-organizations March 31, & asset integration & discontinued Reclassify March 31 2009 impairments activities operations depreciation , 2009 (a) (b) (c) (d) $M $M $M $M $M $M Total revenues 817.8 - - - - 817.8 Costs and expenses: Cost of product sales 83.6 - - - (3.6) 80.0
Research and development 185.9 - - (65.0) (4.0) 116.9 Selling, general and administrative 318.9 (32.5) -
- (14.8) 271.6 Reorganization costs 2.2 - - (2.2) - -
Integration and acquisition costs 1.4 - (1.4) - - - Depreciation - - - - 22.4 22.4 Total operating expenses 592.0 (32.5) (1.4) (67.2) - 490.9 Operating income 225.8 32.5 1.4 67.2 - 326.9 Interest income 0.6 - - - - 0.6 Interest expense (11.0) - - - - (11.0)
Other income /(expenses), net 50.3 - -
(55.2) - (4.9)
Total other income/(expenses), net 39.9 - -
(55.2) - (15.3)
Income from continuing operations before income taxes and equity in losses of equity method investees 265.7 32.5 1.4
12.0 - 311.6 Income taxes (49.5) (9.9) (0.2) (15.2) - (74.8)
Equity in losses of equity method
investees, net of tax (0.1) - - - - (0.1) - Income from continuing 216.1 22.6 1.2 (3.2) - 236.7operations, net of tax
Loss from discontinued operations (2.6) - -
2.6 - - Net income 213.5 22.6 1.2 (0.6) - 236.7
Net loss attributable to noncontrolling 0.1 - -
- - 0.1interest in subsidiaries
Net income attributable to Shire 213.6 22.6 1.2
(0.6) - 236.8plc Impact of convertible debt 8.4 - - - - 8.4 Numerator for diluted EPS 222.0 22.6 1.2 (0.6) - 245.2
Weighted average number of shares
(millions) - diluted 577.2 - - - 577.2 Diluted earnings per ADS 115.5c 11.7c 0.6c (0.3c) 127.5c
The following items are included in Adjustments:
Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($32.5 million) and tax effect of adjustment;
Acquisitions and Integration activitiesCosts associated with the integrationand acquisition of Jerini AG and EQUASYM from UCB ($1.4 million) and tax effectof adjustments;Divestments, Re-organizations and Discontinued Operations:Costs associated withagreement to terminate development of Women's Health products with Duramed($65.0 million); reorganization costs for the transition of manufacturing fromOwings Mills ($2.2 million); gain on disposal of the investment in Virochem($55.2 million);discontinued operations in respect of Jerini businesses heldfor sale ($2.6 million);and tax effect of adjustments; andDepreciation:Depreciation of $22.4 million included in Cost of Product Sales, R&D costs and SG&A costs for US GAAP separately disclosed for the presentationof Non GAAP earnings.
Unaudited results for the three months to March 31, 2008
Non GAAP reconciliation 3 months to, USGAAP Adjustments Non GAAP Divestments, Amortization re-organizations March 31, & asset & discontinued Reclassify March 31 2008 impairments operations depreciation , 2008 (a) (b) (c) $M $M $M $M $M Total revenues 702.2 - - - 702.2 Costs and expenses: Cost of product sales 90.3 - - (2.6) 87.7 Research and development (1) 111.8 - - (2.9) 108.9 Selling, general and 344.7 (30.8) (5.6) (10.7) 297.6administrative(1)
Gain on sale of product rights (7.6) - 7.6
- - Depreciation - - - 16.2 16.2 Total operating expenses 539.2 (30.8) 2.0 - 510.4 Operating income 163.0 30.8 (2.0) - 191.8 Interest income 12.7 - - - 12.7 Interest expense (17.3) - - - (17.3)
Other income /(expenses), net 12.7 - (9.4)
- 3.3
Total other income/(expenses), net 8.1 - (9.4)
- (1.3)
Income from continuing operations before income taxes, and equity in
earnings of equity method investees 171.1 30.8 (11.4) - 190.5 Income taxes (44.1) (10.7) 2.3 - (52.5) Equity in earnings of equity method investees, net of tax 1.6 - - - 1.6 Net income 128.6 20.1 (9.1) - 139.6
Impact of convertible debt, net of 3.4 - -
- 3.4tax Numerator for diluted EPS 132.0 20.1 (9.1) - 143.0
Weighted average number of shares
(millions) - diluted 581.5 - - 581.5 Diluted earnings per ADS 68.1c 10.5c (4.8c) 73.8c
Depreciation of $2.9 million has been reclassified from Selling, general and administrative to Research and development costs, and $10.2 million of promotional costs has been reclassified from Research and development to Selling, general and administrative costs for the three months to March 31, 2008.
The following items are included in Adjustments:
Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($30.8 million) and tax effect of adjustment;
Divestments, Re-organizations and Discontinued Operations:Costs associated withthe introduction of a new holding company ($5.6 million), gains on the disposalof non-core product rights ($7.6 million), gain on the disposal of a minorityequity investment ($9.4 million) and tax effect of adjustments;
Depreciation: Depreciation of $16.2 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 biopharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on attention deficit and hyperactivity disorder, humangenetic therapies and gastrointestinal diseases as well as opportunities inother therapeutic areas to the extent they arise through acquisitions. Shire'sin-licensing, merger and acquisition efforts are focused on products inspecialist markets with strong intellectual property protection and globalrights. Shire believes that a carefully selected and balanced portfolio ofproducts with strategically aligned and relatively small-scale sales forceswill deliver strong results.
For further information on Shire, please visit the Company's website: 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-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, the Company's results could be materially adverselyaffected. The risks and uncertainties include, but are not limited to, risksassociated with: the inherent uncertainty of research, development, approval,reimbursement, manufacturing and commercialization of the Company's SpecialtyPharmaceutical and Human Genetic Therapies products, as well as the ability tosecure and integrate new products for commercialization and/or development;government regulation of the Company's products; the Company's ability tomanufacture its products in sufficient quantities to meet demand; the impact ofcompetitive therapies on the Company's products; the Company's ability toregister, maintain and enforce patents and other intellectual property rightsrelating to its products; the Company's ability to obtain and maintaingovernment and other third-party reimbursement for its products; and otherrisks and uncertainties detailed from time to time in the Company's filingswith the Securities and Exchange Commission.
Non GAAP Measures
This press release contains financial measures not prepared in accordance withUS GAAP. These measures are referred to as "Non GAAP" measures and include: NonGAAP operating income; Non GAAP net income; Non GAAP diluted earnings per ADS;effective tax rate on Non GAAP income from continuing operations before incometaxes and equity method investees ("Effective tax rate on Non GAAP income");Non GAAP Cost of product sales; Non GAAP Research and development; Non GAAPSelling, general and administrative; Non GAAP operating expenses; and Non GAAPother income. These Non GAAP measures exclude the effect of certain cash andnon-cash items, both recurring and non-recurring, that Shire's managementbelieves are not related to the core performance of Shire's business.These Non GAAP financial measures are used by Shire's management to makeoperating decisions because they facilitate internal comparisons of theCompany's performance to historical results and to competitors' results. Thesemeasures are also considered by Shire's Remuneration Committee in assessing theperformance and compensation of employees, including its executive directors.The Non GAAP measures are presented in this press release as the Company'smanagement believe that they will provide investors with a means of evaluating,and an understanding of how Shire's management evaluates, the Company'sperformance and results on a comparable basis that is not otherwise apparent ona US GAAP basis, since many one-time, infrequent or non-cash items that theCompany's management believe are not indicative of the core performance of thebusiness may not be excluded when preparing financial measures under US GAAP.
These Non GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with US GAAP.
The following items, including their tax effect, have been excluded from both 2008 and 2009 Non GAAP earnings, and from our 2009 guidance for Non GAAP diluted earnings per ADS:
Amortization and asset impairments:
Intangible asset amortization and impairment charges; and
Other than temporary impairment of investments.
Acquisitions and integration activities:
Upfront payments and milestones in respect of in-licensed and acquired products;
Costs associated with acquisitions, including transaction costs, and fair value adjustments on contingent consideration and acquired inventory;
Costs associated with the integration of companies; and
Incremental interest charges arising on the settlement of litigation with the former dissenting shareholders of TKT.
Divestments, re-organizations and discontinued operations
Gains and losses on the sale of non-core assets;
Costs associated with restructuring and re-organization activities;
Termination costs;
Costs associated with the introduction of the new holding company; and
Income / (losses) from discontinued operations.
Depreciation, which is included in Cost of product sales, Research anddevelopment costs and Selling, general and administrative costs in our US GAAPresults, has been separately disclosed for the presentation of 2008 and 2009Non GAAP earnings (see pages 21-22). TRADEMARKS
All trademarks defined as ® and â„¢ used in this press release are trademarks of Shire plc or companies within the Shire group except for:
PENTASA® which is a trademark of Ferring Pharmaceuticals Ltd, RAZADYNE® whichis a trademark of J&J, RAZADYNE® ER which is a trademark of J&J, REMINYL XLâ„¢which is a trademark of J&J, excluding UK and Republic of Ireland 1, EQUASYM®XL and IR which are trademarks of UCB and ZEFFIX® and 3TC® which are trademarksof GSK .
1 REMINYL XLâ„¢ is a trademark of Shire in the UK and Republic of Ireland.
vendorRelated Shares:
Shire