11th Aug 2010 12:00
Press Release www.shire.com Half Yearly Report
August 11, 2010 - In order to meet its obligations under the Disclosure Rules and Transparency Rules of the United Kingdom Financial Services Authority, Shire plc ("Shire" or the "Group") is publishing today its Half Yearly Report for the six months ended June 30, 2010.
It should be noted that on August 4, 2010 Shire previously announced its results in respect of the same period.
For further information please contact:
Investor Relations Eric Rojas +1 781 482 0999 Media Jessica Mann (Rest of the World) +44 1256 894 280 Jessica Cotrone (North America) +1 781 482 9538 Matt Cabrey (North America) +1 484 595 8248 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 ("ADHD"),human genetic therapies ("HGT") and gastrointestinal ("GI") diseases as well asopportunities in other therapeutic areas to the extent they arise throughacquisitions. Shire's in-licensing, merger and acquisition efforts are focusedon products in specialist markets with strong intellectual property protectionand global rights. Shire believes that a carefully selected and balancedportfolio of products with strategically aligned and relatively small-scalesales forces will deliver strong results.
For further information on Shire or to view this Half Yearly Report, please visit Shire's website: www.shire.com
Shire plc Half Yearly Report 2010 Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PXContents Page The "safe harbor" statement under the Private Securities Litigation Reform Act 2 of 1995
Chief Executive Officer's review 3 Business overview for the six months to June 30, 2010 4 Results of operations for the six months to June 30, 2010 and 2009 10 Principal risks and uncertainties 18 Directors' responsibility statement 19
Unaudited consolidated balance sheets at June 30, 2010 and December 31, 2009
20 Unaudited consolidated statements of income for the six months to June 30, 2010 22 and June 30, 2009
Unaudited consolidated statement of changes in equity for the six months to
24 June 30, 2010 Unaudited consolidated statement of comprehensive income for the six months to 25 June 30, 2010 and June 30, 2009 Unaudited consolidated statement of cash flows for the six months to June 30, 26 2010 and June 30, 2009
Notes to the unaudited consolidated financial statements 28 Independent review report to Shire plc
49
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 Group'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 Group's SpecialtyPharmaceutical and Human Genetic Therapies products, as well as the ability tosecure new products for commercialization and/or development; governmentregulation of the Group's products; the Group's ability to manufacture itsproducts in sufficient quantities to meet demand; the impact of competitivetherapies on the Group's products; the Group's ability to register, maintainand enforce patents and other intellectual property rights relating to itsproducts; the Group's ability to obtain and maintain government and otherthird-party reimbursement for its products; and other risks and uncertaintiesdetailed from time to time in the Group's filings with the Securities andExchange Commission.
The following are trademarks either owned or licensed by Shire plc or its subsidiaries, which are the subject of trademark registrations in certain territories, or which are owned by third-parties as indicated and referred to in this Half Yearly Report:
ADDERALL XR® (mixed salts of a single entity amphetamine)
CALCICHEW® range (calcium carbonate with or without vitamin D3)
CARBATROL® (carbamazepine extended-release capsules)
DAYTRANA® (methylphenidate transdermal system)
ELAPRASE® (idursulfase)
EQUASYM® IR (methylphenidate hydrochloride)
EQUASYM® XL (methylphenidate hydrochloride)
FIRAZYR® (icatibant)
FOSRENOL® (lanthanum carbonate)
INTUNIVâ„¢ (guanfacine extended release)
JUVISTA®LIALDA® (mesalamine)MEZAVANT® (mesalazine)
PENTASA® (trademark of Ferring A/S Corp)
RAZADYNE® (trademark of Johnson & Johnson ("J&J"))
RAZADYNE® ER (trademark of J&J)
REMINYL® (galantamine hydrobromide) (United Kingdom ("UK") and Republic of Ireland) (trademark of J&J, excluding UK and Republic of Ireland)
REMINYL XLâ„¢ (galantamine hydrobromide) (UK and Republic of Ireland) (trademark of J&J, excluding UK and Republic of Ireland)
REPLAGAL® (agalsidase alfa)
RESOLOR® (trademark of Movetis NV ("Movetis"))
SEASONIQUE® (trademark of Barr Laboratories, Inc. ("Barr"))
VENVANSE (lisdexamfetamine dimesylate)
VYVANSE® (lisdexamfetamine dimesylate)
VPRIV® (velaglucerase alfa)
XAGRID® (anagrelide hydrochloride)
ZEFFIX® (trademark of GlaxoSmithKline ("GSK"))
3TC® (trademark of GSK)
Chief Executive Officer's review
We are pleased to enclose our financial results for the six-month period endedJune 30, 2010. This Half Yearly Report includes consolidated financialstatements prepared in accordance with generally accepted accounting principlesin the United States of America ("US GAAP").
This was an excellent half year with strong performance from core product sales, up 38%, driving increases in operating income and earnings per ADS. Shire is performing well on all fronts.
In ADHD, sales of VYVANSE are up 31% and clinical trial enrolment hasprogressed for the European program and for the new indication proof-of-conceptstudies. Marketing authorization was recently given for VYVANSE in Brazil, ourfirst approval for this product outside North America, and the launch is beingplanned for mid 2011. INTUNIV continues to build share with child andadolescent psychiatrists and we recently filed an sNDA for its adjunctive usewith long-acting oral stimulants for the treatment of ADHD. Sales of our Fabry treatment, REPLAGAL are up 77%, and we've seen very rapiduptake of VPRIV in the Gaucher market place with approximately 850 patients nowtreated globally. We received a positive opinion for VPRIV from the Committeefor Medicinal Products for Human Use and although we already have sales on apre approved basis, the anticipated European Commission decision later thisyear will enable the product's commercial roll out. LIALDA for ulcerative colitis is also performing well with sales up 28% and aUSmarket share approaching 19%. Phase 3 clinical trials investigating the useof the product for the treatment of diverticular disease are progressing.
With cash generation(1) of $694 million during the half year and excellent growth prospects ahead, we continue to invest in our marketed products, our pipeline and our international presence.
Angus RussellChief Executive Officer
(1) Cash generation is a Non GAAP measure, see page 48 for further details. Business overview for the six months to June 30, 2010
The following discussion should be read in conjunction with Shire plc's and itssubsidiaries (collectively "Shire" or "the Group") unaudited consolidatedfinancial statements and related notes appearing elsewhere in this Half YearlyReport. OverviewShire's mission is to be the most valuable specialty biopharmaceutical companyin the world, focused on enabling people with life altering conditions to leadbetter lives. Shire focuses its business on ADHD, HGT and gastrointestinalareas as well as opportunities in other therapeutic areas to the extent theyarise through acquisitions. Shire's in-licensing, merger and acquisitionefforts are focused on products in specialist markets with strong intellectualproperty protection and global rights. Shire believes that a carefully selectedand balanced portfolio of products with strategically aligned and relativelysmall-scale sales forces will deliver strong results.
Significant events in the six months to June 30, 2010 and recent developments
Products
VYVANSE - for the treatment of ADHD
On July 5, 2010 ANVISA, the Brazilian health authority, granted approval of the Marketing Authorization Application ("MAA") for the product under the trade name VENVANSE for the treatment of ADHD in children aged 6 to 12. This represents the first approval of lisdexamfetamine dimesylate in Latin America.
On May 4, 2010 the US Food and Drug Administration ("FDA") approved a change tothe prescribing information for the once-daily ADHD treatment VYVANSE, toinclude supplemental data demonstrating significant improvement in attention inadults with ADHD across all six assessments conducted at two, four, eight, 10,12 and 14 hours after administration as measured by average Permanent ProductMeasure of Performance total scores, as well as at each time point measured. VYVANSE is now the first and only oral ADHD long-acting stimulant treatment tohave efficacy data at 14 hours post-dose for adult patients included in itsproduct labeling. On March 4, 2010 the District Court upheld the FDA's decision that VYVANSE isentitled to five-year market exclusivity in the US. The five-year exclusivityperiod for VYVANSE expires on February 23, 2012, and precludes genericmanufacturers from submitting an Abbreviated New Drug Application ("ANDA") tothe FDA until that time, or until February 23, 2011 should a generic applicantchallenge the US patents covering VYVANSE, which remain in effect until June29, 2023. Actavis Elizabeth LLC ("Actavis")has appealed the District Court'sruling to the US Court of Appeals for the DC Circuit. A hearing is scheduledfor September 20, 2010. On February 1, 2010 Shire announced the Canadian availability of VYVANSE, thefirst and only prodrug therapyapproved for ADHD treatment in Canada. This isthe first launch of VYVANSE outside the US.
LIALDA/MEZAVANT - for the treatment of ulcerative colitis
On July 8, 2010 Shire announced that its subsidiaries Shire Development Inc.and Shire Pharmaceutical Development Inc. have filed a lawsuit in the USDistrict Court for the District of Delaware against Zydus Pharmaceuticals USA,Inc. ("Zydus") Cadila Healthcare Limited, doing business as Zydus Cadila forthe infringement of US Patent No. 6,773,720 (the "'720 patent"). The lawsuitwas filed as a result of an ANDA filed by Zydus seeking FDA approval to marketand sell generic versions of LIALDA prior to the expiration of the '720 patent.
DAYTRANA - for the treatment of ADHD
On July 6, 2010 Shire announced the FDA approval of DAYTRANA for the treatmentof ADHD in adolescents aged 13 to 17 years. DAYTRANA, the first and onlytransdermal ADHD patch, is already an FDA-approved ADHD treatment for childrenaged 6 to 12 years. On August 10, 2010 Shire announced the planned divestment of DAYTRANA to NovenPharmaceuticals Inc. ("Noven"). Noven developed and currently manufacturesDAYTRANA and licensed the product to Shire in 2003. Shire has been marketingand selling DAYTRANA since its approval and launch in 2006. The divestureagreement will be effective October 1, 2010 at which point the product willcontinue to be available for patients through Noven.
REPLAGAL - for the treatment of Fabry disease
REPLAGAL is experiencing significant demand globally and is now the marketleader in many key regions, due principally to a competitor's ongoing supplydisruption. Currently there are approximately 2,000 patients worldwide beingtreated with REPLAGAL and Shire has capacity to add 150-250 more patients in2010. Shire anticipates that it could add 250-350 more patients phasedthroughout 2011. Shire's continuing priority is to ensure the long term,uninterrupted supply to patients currently being treated with REPLAGAL and wewill continue to monitor demand and manage supply carefully. On August 3, 2010 Shire withdrew the Biologics License Application ("BLA") forREPLAGAL in order to consider updating the submission with additional clinicaldata. On April 14, 2010 Mt. Sinai School of Medicine of New York University sought toinitiate lawsuits in Sweden and Germany alleging that Shire's enzymereplacement therapy ("ERT") for Fabry disease, REPLAGAL, infringes Mt. Sinai'sEuropean Patent No. 1 942 189, granted April 14, 2010. Mt. Sinai is seeking aninjunction against the use of REPLAGAL in these jurisdictions until expirationof the patent on November 30, 2013. Shire will defend its right tocommercialize REPLAGAL in these countries and will vigorously oppose thevalidity of this patent.
VPRIV - for the treatment of Type 1 Gaucher disease
On June 25, 2010 Shire received a positive opinion from the Committee forMedicinal Products for Human Use ("CHMP") of the European Medicines Agency("EMA") on the marketing authorization for VPRIV, its ERT for the Treatment ofType 1 Gaucher Disease in the EU. The CHMP positive opinion will now beforwarded to the European Commission for ratification. In addition to the CHMPpositive opinion, VPRIV has received orphan drug designation from the Committeefor Orphan Medicinal Products. In many European countries patients have beenreceiving VPRIV on an early access basis, developed in partnership withnational and regional authorities. On February 26, 2010 the FDA granted marketing approval for VPRIV, a human cellline derived ERT for the long-term treatment of Type 1 Gaucher disease inpediatric and adult patients. The FDA designated VPRIV for Priority Review andgranted marketing approval in just six months. VPRIV offers patients and theirphysicians a new treatment option at a critical time, as the supply of apreviously approved ERT for Gaucher disease is uncertain and remains disrupted.
With the accelerated adoption of VPRIV worldwide, and the earlier than anticipated US approval and EU positive opinion, Shire expects continued high demand, and currently has about 850 patients on therapy with capacity to support approximately 1,000 patients in 2010. As a result, Shire is now implementing a program with physicians and patients to monitor demand and manage requests from new patients carefully in order to ensure long-term, uninterrupted treatment with VPRIV.
INTUNIV - for the treatment of ADHD
A supplemental New Drug Application ("sNDA") was submitted to the FDA on April28, 2010 to seek approval for INTUNIV as adjunctive treatment with long-actingoral stimulants for the treatment of ADHD in children and adolescents. In the six months to June 30, 2010 Shire was notified that three separate ANDAwere submitted under the Hatch-Waxman Act seeking permission to market genericversions of 1mg, 2mg, 3mg, and 4mg strengths of INTUNIV. The notices were fromTeva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd(collectively "Teva"), Actavis and Actavis Inc. (collectively "Activis") andAnchen Pharmaceuticals, Inc. and Anchen, Inc. (collectively "Anchen"). Withinthe requisite period of 45 days, Shire filed lawsuits in the US District Courtof the District of Delaware against each of Teva, Actavis and Anchen forinfringement of certain of Shire's INTUNIV patents. The filing of the lawsuitstriggered a stay of approval of these ANDAs for up to 30 months. No trial
datehas been set. Pipeline
HGT-1410 for Sanfilippo Syndrome (Mucopolysaccharidosis IIIA)
HGT-1410 is in development as an ERT for the treatment of Sanfilippo Syndrome,a lysosomal storage disorder. The product has been granted orphan drugdesignation in the US and in the EU. The Group initiated a Phase 1/2 clinicaltrial in August 2010.
Guanfacine CarrierWave ("GCW"; SPD 547)for the treatment of ADHD
SPD 547 is in early stage development for the treatment of ADHD. A feasibilitystudy in humans using microdosing has been completed and results indicatecharacteristics suitable for entering formal Phase 1 trials. The Phase 1program is expected to be initiated in the third quarter of 2010 with resultsthroughout 2011. GCW could potentially improve on the current guanfacineprofile to minimize known food, GI and sedation effects.
Other developments
Proposed acquisition of Movetis NV
On August 3, 2010 Shire announced that it was launching a voluntary publictakeover offer for all the shares in Movetis, the Belgium-based Europeanspecialty GI company, for a fully diluted equity purchase price of €428million. Movetis' board unanimously supports the transaction and Institutionalshareholders holding 38.9% of Movetis' shares have unconditionally agreed toaccept the offer. It is anticipated that the takeover offer, which iscontingent upon the fulfilment of certain conditions, will open for acceptancein September. This proposed acquisition will significantly broaden Shire's global GIportfolio and adds growing revenues from RESOLOR (prucalopride), a new chemicalentity indicated for the symptomatic treatment of chronic constipation in womenin whom laxatives fail to provide adequate relief. Movetis has the rights toRESOLOR in the EU, Iceland, Lichtenstein, Norway and Switzerland and isentitled to royalties on sales of RESOLOR outside of Europe from Johnson &Johnson.
The acquisition also brings to Shire world-class research and development talent and a promising GI pipeline.
Purchase of Lexington Technology Park
On June 30, 2010 Shire purchased Lexington Technology Park in Lexington,Massachusetts for a cash purchase price of $165 million. The purchaseunderlines our investment in the growth of Shire's HGT business, and givesShire the ownership of an additional 570,000 square feet of expansion potentialavailable under the current permit, including 170,000 square feet already underconstruction. US Healthcare Reform
During the six months to June 30, 2010, US President Obama signed into law thePatient Protection and Affordable Care Act and the Health Care and EducationReconciliation Act (together "Healthcare Reform"), with the goal of expandinghealthcare access to millions of Americans currently without health insuranceand lowering the overall costs of healthcare. Healthcare Reform willaffect Shire in a number of ways, including a limited impact coming from thechanges to the calculation of Medicaid rebates effective during the first half,and from Shire's share of the industry wide excise tax starting in 2011. Shireis pleased with the expansion of healthcare coverage to previously uninsuredpatients and believes this should provide a positive benefitfor Shire. Furthermore, Shire is also pleased with Healthcare Reform providingcertainty regarding regulatory exclusivity for biologics. Healthcare Reform didnot materially impact Shire's results in the first half of 2010, and Shirebelieves that it is well placed to manage the changes Healthcare Reform willbring in future periods. Dividend
In respect of the six months ended June 30, 2010, the Board resolved to pay an interim dividend of 2.250 US cents per Ordinary Share (2009: 2.147 US cents per share).
Dividend payments will be made in Pounds Sterling to ordinary shareholders andin US Dollars to holders of American Depositary Shares ("ADS"). A dividend of1.410 pence per Ordinary Share (2009: 1.302 pence) and 6.750 US cents per ADS(2009: 6.441 US cents) will be paid on October 7, 2010 to persons whose namesappear on the register of members of Shire plc at the close of business on
September 10, 2010. Board changes
On March 15, 2010, Bill Burns was appointed to the Board as a Non Executive Director. Mr Burns has also been appointed a member of Shire's Remuneration Committee. On June 16, 2010 Dr David Ginsburg and Ms Anne Minto OBE were appointed to Shire's Board of Directors. Dr Ginsburg was also appointed to Shire's Science & Technology Committee. Ms Minto was appointed to Shire's Remuneration Committee and assumed the Chair of that Committee on the retirement of Ms Kate Nealon from the Shire Board at the end of Ms Nealon's term of office on July 26, 2010.
Research and development
Products in registration as at June 30, 2010
INTUNIV - for the treatment of ADHD
A sNDA was submitted to the FDA on April 28, 2010 to seek approval for INTUNIVas adjunctive treatment with long-acting oral stimulants for the treatment ofADHD in children and adolescents.
LIALDA for the maintenance of remission in ulcerative colitis in the US
On June 14, 2010 Shire submitted a sNDA and supplemental New Drug Submission("sNDS") to seek approval for LIALDA for the maintenance of remission ofulcerative colitis to the FDA and Health Canada. The product was indicated forthe maintenance of remission in patients who have ulcerative colitis onapproval in the EU.
FOSRENOL for the treatment of pre-dialysis chronic kidney disease ("CKD")
Shire is continuing to explore the regulatory pathway required to secure a label extension for FOSRENOL to treat hyperphosphataemia in pre-dialysis CKD in the US.
VPRIV - for the treatment of Type 1 Gaucher Disease in the EU
On November 24, 2009 Shire submitted a European MAA to the EMA. On June 25, 2010 Shire received a positive opinion from the CHMP of the EMA on the marketing authorization for VPRIV in the EU. The CHMP positive opinion will now be forwarded to the EC for ratification. In addition to the CHMP positive opinion, VPRIV has received orphan drug designation from the Committee for Orphan Medical Products.
VPRIV is available prior to commercial launch on a pre-approval basis in response to the ongoing shortage of a currently marketed treatment for Gaucher disease.
REPLAGAL - for the treatment of Fabry disease
Shire filed a BLA for REPLAGAL in December 2009, and in the first quarter of2010 the FDA requested additional pharmacokinetic comparability data. As aresult of this request, Shire withdrew its December BLA filing, and, at thesuggestion of the FDA, requested and received Fast Track designation. Shireinitiated a rolling submission of a REPLAGAL BLA. On August 3, Shire withdrewthe BLA for REPLAGAL in order to consider updating the submission withadditional clinical data. REPLAGAL is currently approved for the treatment of Fabry disease in 45countries and was made available to US patients free of charge starting inDecember 2009 under an FDA-approved treatment protocol filed at the request ofFDA. This protocol is now closed to enrolment. The Group is supporting a finitenumber of emergency Investigational New Drug requests in the US.
Products in clinical development as at June 30, 2010
Phase 3 VYVANSE for ADHD in EU
VYVANSE for the treatment of ADHD in children aged 6 to 17 in the EU is in Phase 3 development. Shire anticipates submission of the regulatory filing for VYVANSE in Europe in 2011.
LIALDA/MEZAVANT for the treatment of diverticulitis
LIALDA/MEZAVANT is being investigated as a treatment to prevent recurrentattacks of diverticulitis. Phase 3 worldwide clinical trials investigating theuse of the product for the treatment of diverticulitis were initiated in 2007and are ongoing. Enrollment in these trials has completed and data is estimatedto be available in 2012 following the completion of a 2 year dosing regimen.
FIRAZYR for Hereditaryangioedema ("HAE") in the US
Prior to its acquisition by Shire, Jerini AG received a not approvable letter for FIRAZYR from the FDA. Shire has agreed with the FDA that an additional clinical study would be required and that a response to the not approvable letter would be filed after completion of this study.
In June 2009 Shire initiated a Phase 3 study in patients with acute attacks ofHAE, known as the FAST-3 trial, which is designed to support filing of a NewDrug Application for FIRAZYR in the US in early 2011. This trial is ongoing. Phase 2
VYVANSE for the treatment of non ADHD indications in adults
Shire is conducting Phase 2 pilot clinical trials to assess the efficacy and safety of VYVANSE as adjunctive therapy in depression, for the treatment of negative symptoms and cognitive impairment in schizophrenia, and for the treatment of cognitive impairment in depression.
Phase 1
SPD 535 for the treatment of arteriovenous grafts in hemodialysis patients
SPD 535 is in development as a novel platelet lowering agent. The initial proof-of-concept program will target prevention of thrombotic complications associated with arteriovenous grafts in hemodialysis patients. Phase 1 development was initiated in the third quarter of 2009.
SPD 547 (Guanfacine CarrierWave, GCW) for the treatment of ADHD
SPD 547 is in early stage development for the treatment of ADHD. A feasibilitystudy in humans using microdosing has been completed and results indicatecharacteristics suitable for entering formal Phase 1 trials. The Phase 1program is expected to be initiated in the third quarter of 2010 with resultsthroughout 2011. GCW could potentially improve on the current guanfacineprofile to minimize known food, GI and sedation effects.
HGT-2310 for the treatment ofHunter syndrome with central nervous system ("CNS") symptoms, idursulfase-IT(intrathecal delivery)
HGT 2310 is in development as an ERT delivered intrathecally for Hunter syndrome patients with CNS symptoms. The Group initiated a Phase 1/2 clinical trial in the first quarter of 2010. This product has been granted orphan designation in the US.
HGT-1410 for Sanfilippo Syndrome (Mucopolysaccharidosis IIIA)
HGT-1410 is in development as an ERT for the treatment of Sanfilippo Syndrome (Mucopolysaccharidosis IIIA), a lysosomal storage disorder. The product has been granted orphan drug designation in the US and in the EU. The Group initiated a Phase 1/2 clinical trial in August 2010.
Products in pre-clinical development as at June 30, 2010
HGT-1110 - for the treatment of Metachromatic Leukodystrophy
Development of a formulation of HGT-1110, expressed from Shire's human cellplatform and suitable for direct delivery to the CNS, is ongoing, andpreclinical studies are planned for 2010. The Shire platform for directdelivery of proteins to the CNS was advanced in the first quarter of 2010 withthe initiation of intrathecal delivery of idursulfase in the Phase 1/2 study inHunter Syndrome.
HGT-2610 for the treatment of Globoid cell leukodystrophy ("GLD")
HGT 2610 is an ERT for the treatment of GLD, a lysosomal storage disorder. This program is in early development and preclinical studies.
Other pre-clinical development projects
A number of additional projects are underway in the early stages of pre-clinical development for the Specialty Pharmaceutical ("SP") area, including potential programs leveraging CarrierWave technology primarily focused in the areas of pain and ADHD. More data on these programs is expected in the second half of 2010 and throughout 2011.
Results of operations for the six months to June 30, 2010 and 2009
The financial information contained within the Half Yearly Report has been prepared under US GAAP, being the accounting policies under which Shire plc prepared or will prepare its annual financial statements for the years ended December 31, 2010 and 2009.
The Group's management analyzes product sales growth for certain products soldin markets outside of the US on a constant exchange rate ("CER") basis, so thatproduct sales growth can be considered excluding movements in foreign exchangerates. Product sales growth on a CER basis is a Non GAAP financial measure("Non GAAP CER"), computed by comparing 2010 product sales restated using 2009average foreign exchange rates to 2009 actual product sales. Average exchangerates for the six months to June 30, 2010 were $1.53:£1.00 and $1.33:€1.00(2009: $1.49:£1.00 and $1.33:€1.00).
Financial highlights for the six months to June 30, 2010 are as follows:
Product sales excluding ADDERALL XR ("Core Products") were up 38% to $1,310 million (2009: $951 million). On a Non GAAP CER basis, Core Products sales were up 37%.
The continued growth in Core Product sales was the result of strong performance across the portfolio:
VYVANSE (up 31% to $302 million, Non GAAP CER: up 31%);
ELAPRASE (up 19% to $201 million, Non GAAP CER: up 18%);
REPLAGAL (up 77% to $150 million, Non GAAP CER: up 77%);
LIALDA/MEZAVANT(up 28% to $133 million, Non GAAP CER: up 28%); and
Recently launched INTUNIV ($86 million) and VPRIV ($35 million).
The increase in total product sales, up 13% to $1,482 million (2009: $1,314 million), was less than the increase in Core Product sales as ADDERALL XR product sales were down 53% to $172 million (2009: $363 million), as the first quarter of 2009 represented the last quarter of exclusivity for ADDERALL XR.
Total revenues were up 15% (Non GAAPCER: up 15%) to $1,666 million (2009:$1,447 million), as a result of increased product sales and higher royalties(up 51% due to higher royalty income on sales of authorized generic ADDERALLXR).
Operating income increased by $181 million, or 70%, to $442 million (2009: $261million). Operating income in the half year 2009 included costs of $65 millionon termination of the Women's Health development agreement with Duramed and $37million on amendment of an INTUNIV license. Excluding these items, operatingincome increased by $79 million in 2010 due to higher total revenues andimproved total operating expense ratios compared to 2009, despite increasedinvestment in research and development ("R&D") programs and selling, generaland administrative ("SG&A") costs in support of recent growth.
Total revenues
The following table provides an analysis of the Group's total revenues bysource: 6 months to 6 months to June 30, June 30, 2010 2009 change $'M $'M % __________________ __________________ __________________ Product sales 1,482.4 1,314.3 +13 Royalties 178.0 117.5 +51 Other revenues 5.1 15.6 -67 __________________ __________________ __________________ Total 1,665.5 1,447.4 +15 __________________ __________________ __________________ Product sales
The following table provides an analysis of the Group's key product sales:
6 months to 6 months to Non Exit GAAP market June 30, June 30, Product sales CER USprescription Share 2010 2009 growth growth Growth(1) (1) $'M $'M % % % % Specialty Pharmaceuticals ADHD VYVANSE 302.4 230.7 +31 +31 +31 14 ADDERALL XR 172.2 363.3 -53 -53 -48 8 INTUNIV 85.7 - n/a n/a n/a 2 DAYTRANA 34.7 34.8
(1) Data provided by IMS Health National Prescription Audit ("IMS NPA"). Exit market share represents the US market share in the week ending June 25, 2010.
(2) IMS NPA Data not available.
(3) Not sold in the US in the first half of 2010.
Specialty Pharmaceuticals VYVANSE - ADHD
The increase in VYVANSE product sales was driven by higher US prescription demand, price increases taken since the first six months of 2009 and the launch of the product in Canada during 2010, partially offset by higher sales deductions principally due to US Healthcare Reform.
Litigation proceedings regarding Shire's VYVANSE patents are ongoing. Furtherinformation about this litigation can be found in Note 14 of this Half YearlyReport. ADDERALL XR - ADHD
ADDERALL XR product sales decreased in the six months to June 30, 2010 as aresult of lower US prescription demand, a corresponding reduction in ADDERALLXR's share of the US ADHD market (8% for the six months to June 30, 2010,compared to 16% in 2009) and higher sales deductions as a percentage of brandedADDERALL XR gross sales (69% in 2010 compared to 47% in 2009). These declinesresulted from the launch of authorized generic versions by Teva and ImpaxLaboratories Inc. ("Impax") in April and October 2009 respectively, (the firstquarter of 2009 represented the final quarter of exclusivity for ADDERALL XR).The above factors offset the positive effect of price increases taken since thefirst half of 2009 and stocking. Stocking was $11 million (gross salesequivalent) in the first half of 2010 compared to the significant destocking inthe first half of 2009 ($92 million gross sales equivalent) as a result of thelaunch of an authorized generic version in April 2009. There are potentially different interpretations as to how shipments ofauthorized generic ADDERALL XR to Teva and Impax should be included in theMedicaid rebate calculation pursuant to Medicaid rebate legislation, includingthe Deficit Reduction Act of 2005 (the "Medicaid rebate legislation"). As aresult, more than one unit rebate amount ("URA") is calculable for the purposesof determining the Group's Medicaid rebate liability to the States afterauthorized generic launch. In the six months to June 30, 2010, the Group hasrecorded its accrual for Medicaid rebates based on its best estimate of therebate payable. This best estimate is consistent with (i) the Group'sinterpretation of the Medicaid rebate legislation, (ii) the Group's repeatedand consistent submission of price reporting to the Center for Medicare andMedicaid Services, ("CMS") using the Group's interpretation of the Medicaidrebate legislation, (iii) CMS calculating the URA based on that interpretation,(iv) States submitting Medicaid rebate invoices using this URA, and (v) Shirepaying these invoices. Shire believes that its interpretation of the Medicaid rebate legislation isreasonable and correct. However, CMS could disagree with the Group'sinterpretation, and require Shire to apply an alternative interpretation of theMedicaid rebate legislation and pay up to $190 million above the recordedliability. For rebates in respect of 2009 prescriptions of ADDERALL XR ("2009rebates") this would represent a URA substantially in excess of the unit salesprice of ADDERALL XR and accordingly in excess of the approximate amount of thefull cost to the States of reimbursement for Medicaid prescriptions of ADDERALLXR. For rebates in respect of 2010 prescriptions, as a result of HealthcareReform, the URA would be limited to an amount approximating the unit salesprice of ADDERALL XR. Should CMS require Shire to apply an alternative interpretation of the Medicaidrebate legislation, Shire could seek to limit any additional payments for 2009Rebates to a level approximating the full, un-rebated cost to the States ofADDERALL XR, or $110 million above the recorded liability. Further, Shirebelieves it has a strong legal basis supporting its interpretation of theMedicaid rebate legislation, and that there would be a strong basis to initiatelitigation to recover any amount paid in excess of the recorded liability. Theresult of any such litigation cannot be predicted and could result inadditional rebate liability above Shire's current best estimate.
INTUNIV - ADHD
Product sales of INTUNIV include both revenue from initial stocking shipmentsin 2009, which were deferred in accordance with Shire's accounting policy, andshipments made in the six months to June 30, 2010. At June 30, 2010 all initialstocking shipments have been recognized as revenue and no deferred revenueremains. Litigation proceedings regarding Shire's INTUNIV patents are ongoing. Furtherinformation about this litigation can be found in Note 14 of this Half YearlyReport.
LIALDA/MEZAVANT - Ulcerative colitis
Product sales growth for LIALDA/MEZAVANT continued in the six months to June30, 2010, driven by increased US prescription demand and price increases,partially offset by higher sales deductions. The US oral mesalamine market
wasbroadly flat year on year. Litigation proceedings regarding Shire's LIALDA/MEZAVANT patents are ongoing.Further information about this litigation can be found in Note 14 of this HalfYearly Report. PENTASA - Ulcerative colitis
Product sales of PENTASA increased due to price increases taken since the first half of 2009, which more than offset lower US prescription demand.
FOSRENOL - Hyperphosphatemia
Product sales of FOSRENOL increased in the six months to June 30, 2010 due tothe growth in its share of existing markets outside the US, price increases andgrowth in non-retail demand. These factors were offset by mandatory pricereductions in the EU, and higher sales deductions and a decline in retailprescription demand in the US.
Litigation proceedings regarding Shire's FOSRENOL patents are ongoing. Furtherinformation about this litigation can be found in Note 14 of this Half Yearly Report.
Human Genetic Therapies ELAPRASE- Hunter syndrome
The growth in sales of ELAPRASE was driven by increased volumes across all regions where ELAPRASE is sold. On a Non GAAP CER basis sales grew by 18% (77% of ELAPRASE sales are made outside of the US).
REPLAGAL - Fabry disease
The growth in REPLAGAL product sales was driven by an increase in demand due toan acceleration of patients switching to REPLAGAL in the EU, principally due tothe disruption to supply of a competitor product. The growth was, in part,attributable to the sales of product that will be used in the treatment ofpatients in the second half of 2010. Sales increased 77% on a Non GAAP CERbasis (REPLAGAL is sold primarily in Euros and Pounds sterling). Litigation proceedings regarding Shire's REPLAGAL patents are ongoing. Furtherinformation about this litigation can be found in Note 14 of this Half YearlyReport. VPRIV - Gaucher disease
Product sales in the US were generated on an approved basis after February 26,2010 when approval was received from the FDA, and in the EU on a pre-approvalbasis via patient early access programs. On the June 25, 2010, the CHMP issueda positive opinion on VPRIV, which has been forwarded to the EuropeanCommission for ratification. FIRAZYR - HAE
The product sales growth was driven by increased volumes across markets in Europe. FIRAZYR is the first new product for HAE in Europe in 30 years and has orphan exclusivity for acute attacks of HAE in adults in the EU until 2018.
RoyaltiesRoyalty revenue increased by 51% to $178.0 million for the six months to June30, 2010 (2009: $117.5 million). The following table provides an analysis ofShire's royalty income: 6 months to 6 months to June 30, June 30, 2010 2009 Change $'M $'M % ____________ ____________ ___________ 3TC and ZEFFIX 74.7 78.3 -5 ADDERALL XR 68.3 13.6 +402 Others 35.0 25.6 +37 ____________ ____________ __________ Total 178.0 117.5 +51 ____________ ____________ __________
Royalty income increased by 51% due to higher royalties received on sales of authorized generic versions of ADDERALL XR (royalties in 2010 were received from Impax, and in 2009 were received from Teva) and higher other royalties principally on sales of FOSRENOL in Japan. Royalties received for 3TC and Zeffix from GSK were lower in 2010 compared to 2009 as 3TC royalties were adversely impacted by increased competition from other treatments.
Generic drug companies have filed ANDAs seeking approval for COMBIVIR in theUS. GSK has filed lawsuits against both Teva and Lupin Ltd ("Lupin"), each ofwhom have filed ANDAs and Paragraph IV certifications for generic versions ofCOMBIVIR. The lawsuit against Lupin has been stayed pending resolution of theTeva lawsuit. Neither Teva nor Lupin has challenged the patents licensed byShire to GSK. The thirty month stay of approval for Teva's ANDA expired inMarch 2010. No trial date has been set.
Cost of product sales
Cost of product sales increased to $221.0 million for the six months to June30, 2010 (15% of product sales), up from $180.0 million in the correspondingperiod in 2009 (2009: 14% of product sales). The increase in cost of goods as apercentage of product sales primarily resulted from lower gross margins onADDERALL XR in 2010 compared to 2009 following the launch by Teva and Impax oftheir authorized generic versions of ADDERALL XR in April and October 2009.This decline offset the changes to product mix within the Group's Core Productsportfolio towards higher margin products in 2010 compared to 2009. For the six months to June 30, 2010 cost of product sales included depreciationof $18.4 million (2009: $11.5 million). Depreciation charged in 2010 is higherthan 2009 due to accelerated depreciation of $12.1 million (2009: $3.0 million)following a change in the estimate of the useful lives of the property, plantand equipment at Shire's Owings Mills facility as a result of the anticipatedclosure of the facility in 2011.
R&D
R&D expenditure decreased to $278.0 million for the six months to June 30, 2010(19% of product sales), compared to $344.6 million in the corresponding periodin 2009 (26% of product sales). R&D costs in the six months to June 30, 2009included a charge of $36.9 million (3% of product sales) related to the paymentto amend an INTUNIV in-license agreement and $65.0 million (5% of productsales) following the agreement with Duramed Pharmaceuticals, Inc. ("Duramed")to terminate development of the Women's Health products. Excluding thesetermination and license costs, R&D increased by $35.3 million in the first halfof 2010 compared to the same period in 2009 as the Group has continued toincrease investment in R&D programs, principally VYVANSE international,INTUNIV, LIALDA and other early stage development programs. For the six monthsto June 30, 2010 R&D included depreciation of $7.2 million (2009: $7.8million). SG&ASG&A expenses increased to $714.3 million (48% of product sales) for the sixmonths to June 30, 2010 from $653.3 million (50% of product sales) in thecorresponding period in 2009, primarily due to increased selling and marketingcosts incurred to support recently launched products and growth into newmarkets. For the six months to June 30, 2010 SG&A included depreciation of$32.9 million (2009: $30.7 million) and amortization of $68.4 million (2009:$66.8 million).
Gain on sale of product rights
For the six months to June 30, 2010 Shire recorded a gain of $4.1 million (2009: $nil) on the sale of product rights. This gain had been deferred pending the transfer of the relevant consents following the disposal of the product concerned to Laboratorios Almirall S.A. in 2007.
Reorganization costs
For the six months to June 30, 2010 Shire recorded reorganization costs of $13.6 million (2009: $5.1 million) principally relating to the transfer of manufacturing from its Owings Mills facility of $6.7 million (2009: $5.1 million) and establishment of Swiss commercial hub of $6.9 million (2009: $nil).
Interest expense
For the six months to June 30, 2010 the Group incurred interest expense of $17.3 million (2009: $21.2 million). Interest expense principally relates to the coupon and amortization of issue costs on Shire's $1,100 million 2.75% convertible bonds due 2014.
Other (expense)/income, netFor the six months to June 30, 2010 the Group recognized income, net of $8.2million (2009: $54.9 million). In the six months to June 30, 2010 Shirerecognized a gain of $11.1 million (2009: $55.2 million) relating to thedisposal of its investment in Virochem Pharma Inc. ("Virochem") in March 2009.At that time, an element of the consideration was held in escrow for twelvemonths pending any warranty claims and breaches of representations made byVirochem and by all selling shareholders, including Shire. The considerationwas released from escrow in March 2010, resulting in gain of $11.1 millionbeing recognized in the six months to June 30, 2010.
This gain in the six months to June 30, 2010 was offset by a loss of $3.6 million related to the extinguishment of building finance obligations following the acquisition of Lexington Technology Park in June 2010.
Taxation
For interim reporting purposes, the Group calculates its tax expense byestimating its global annual effective tax rate and applies that rate inproviding for income taxes on a year-to-date basis. The Group has calculated anexpected annual effective tax rate, excluding significant, unusual orextraordinary items, and the tax effect of jurisdictions with losses for whicha tax benefit cannot be recognized. During the six months to June 30, 2010 theeffective tax rate was 25% (2009: 9%). The low effective tax rate for the six months to June 30, 2009 resulted fromthe favorable rate impact of two discrete items that arose during the secondquarter of 2009: (i) the recognition of tax attributes amounting to $27.0million following Massachusetts state tax law changes enacted during the secondquarter of 2009 which enabled the Group to reduce valuation allowances inrespect of State tax credits and loss carry-forwards, together with the effectof the change in the effective State tax rate on the net State deferred taxbalance, and (ii) recognition of a tax deduction of $13.0 million at a ratehigher than the Group's effective rate on the payment made during the secondquarter of 2009 to amend a license agreement for INTUNIV. Excluding both ofthese discrete items would have resulted in an effective tax rate of 20% in thesix months to June 30, 2009. The effective rate of tax in 2010 (25%) was higherthan this underlying rate in 2009 (20%) due to unfavorable changes in profitmix in 2010 compared to 2009.
Financial condition at June 30, 2010 and December 31, 2009
Cash and cash equivalents
Cash and cash equivalents have increased by $183.6 million to $682.5 million atJune 30, 2010 (December 31, 2009: $498.9 million). Cash generated by operatingactivities of $469.9 million in the six months to June 30, 2010 was partiallyoffset by the cost of acquiring Lexington Technology Park, other investments inProperty plant and equipment and the dividend payment.
Inventories
Inventories have increased by $43.0 million to $232.7 million at June 30, 2010 (December 31, 2009: $189.7 million), primarily due to increase in the production of the Group's HGT products in the anticipation of higher future demand.
Prepaid expenses and other current assets
Prepaid expenses and other currents assets have increased by $79.9 million to $195.1 million at June 30, 2010 (December 31, 2009: $115.2 million), principally due to the increase in income tax receivables.
Property, plant and equipment, net
Property, plant and equipment, net increased by $124.3 million to $801.1 million at June 30, 2010 (December 31, 2009: $676.8 million), principally due to the acquisition of and construction at the Lexington Technology Park.
Other intangible assets, net
Other intangible assets, net have decreased by $137.6 million to $1,653.1million at June 30, 2010 (December 31, 2009: $1,790.7 million). The decrease isprincipally due to amortization charges ($69.3 million) and translationalforeign exchange losses ($71.0 million) on non-US dollar denominated intangibleassets.
Accounts payable and accrued expenses
Accounts payable and accrued expenses have increased by $102.8 million to$1,031.9 million (December 31, 2009: $929.1 million), primarily due to higheraccrued Medicaid rebates, partially offset by the decrease in deferred revenue on recognition into revenues of INTUNIV initial stocking shipments.
Other long term debt
Other long term debt has decreased by $36.8 million to $6.8 million at June 30,2010 (December 31, 2009: $43.6 million), due to the extinguishment of buildingfinance obligations following the acquisition of Lexington Technology Park.
Liquidity and capital resources
General
The Group's funding requirements depend on a number of factors, including thetiming and number of its development programs; corporate, business and productacquisitions; the level of resources required for the expansion ofmanufacturing and marketing capabilities as the product base expands; increasesin accounts receivable and inventory which may arise with any increase inproduct sales; competitive and technological developments; the timing and costof obtaining required regulatory approvals for new products; the timing andquantum of milestone payments on collaborative projects; the timing and quantumof tax and dividend payments; the timing and quantum of purchases by the ESOTof Shire shares in the market to satisfy option exercises; the timing andquantum of any amount that could be paid by the Group if CMS were to employ analternative interpretation of the URA in respect of ADDERALL XR Medicaidrebates; and the continuing cash generated from sales of Shire's products androyalty receipts.
An important part of Shire's business strategy is to protect its products and technologies through the use of patents, proprietary technologies and trademarks, to the extent available. The Group intends to defend its intellectual property and as a result may need cash for funding the cost of litigation.
The Group finances its activities through cash generated from operating activities; credit facilities; private and public offerings of equity and debt securities; and the proceeds of asset or investment disposals.
Shire's balance sheet includes $682.5 million of cash and cash equivalents atJune 30, 2010. Substantially all of Shire's debt relates to its $1,100 million2.75% convertible bond which matures in 2014, although these bonds include aput option which could require repayment of the bonds in 2012. In addition,Shire has a revolving credit facility until 2012 of $1,200 million, which iscurrently undrawn. FinancingShire anticipates that its operating cash flow together with available cash,cash equivalents and the revolving credit facility will be sufficient to meetits anticipated future operating expenses, capital expenditures, theacquisition of Movetis, interest payments and lease obligations as they becomedue over the next twelve months.
If the Group decides to acquire other businesses, it expects to fund these acquisitions from existing cash resources, the revolving credit facility and possibly through new borrowings and the issue of new equity if necessary.
Sources and uses of cash
The following table provides an analysis of the Group's gross and net debt (excluding restricted cash), as at June 30, 2010 and December 31, 2009:
June 30, December 31, 2010 2009 $'M $'M _________________ _________________ Cash and cash equivalents 682.5 498.9 _________________ _________________ Convertible debt 1,100.0 1,100.0 Building financing obligation 7.3 46.7 _________________ _________________ Total debt 1,107.3 1,146.7 _________________ _________________ Net debt (424.8) (647.8) _________________ _________________ Cash flow activityNet cash provided by operating activities for the six months to June 30, 2010increased by $213.9 million to $469.9 million (2009: $256.0 million), primarilydue to higher cash receipts from product sales and royalties, cash inflows fromforward foreign exchange contracts in 2010 compared to outflows in 2009,partially offset by higher cash tax payments in the first half of 2010 comparedto the same period in 2009.
Net cash used in investing activities was $202.7 million in the six months toJune 30, 2010. This included cash expenditure on property, plant and equipmentof $208.1 million. Capital expenditure on property, plant and equipmentincludes $121.8 million for the acquisition of new properties and propertiesoccupied under operating leases, and $46.9 million on construction work, atLexington Technology Park. Net cash used in investing activities was $163.4 million in the six months toJune 30, 2009. This included the cash cost of purchasing EQUASYM of $72.8million, acquiring additional interests in Jerini of $2.7 million andexpenditure on property, plant and equipment of $101.8 million. These cashoutflows were partially offset by receipts of $19.6 million from the sale ofnon-current investments and Property, plant and equipment. Capital expenditureon property, plant and equipment included $64.1 million on construction work atLexington Technology Park, $11.2 million on construction work at the UK officein Basingstoke, Hampshire, $8.3 million on other leasehold improvements and$14.7 million on infrastructure and capital management projects in the US.
Net cash used in financing activities was $89.7 million for the six months to June 30, 2010, including the dividend payment of $49.8 million and $43.1 million to extinguish building finance obligations.
Net cash used in financing activities was $46.0 million for the six months to June 30, 2009 of which $43.0 million related to the dividend payment.
Obligations and commitments
During the six months to June 30, 2010 other than the acquisition of LexingtonTechnology Park and the extinguishment of related operating leases and buildingfinance obligations, there have been no material changes outside the ordinarycourse of the Group's business to the contractual obligations previouslydisclosed in the Liquidity and capital resources section of the Financialreview in the Group's Annual Report and Accounts for the year ended December31, 2009.
Principal risks and uncertainties
The Group has adopted a risk management strategy designed to identify, assessand manage the significant risks it faces. Whilst the Group aims to identifyand manage such risks, no risk management strategy can provide absoluteassurance against loss.
A summary of the principal risks and uncertainties facing the Group for the remaining six months of 2010 are outlined below. The Group's process for managing these risks is consistent with those processes as outlined in the Annual Report and Accounts of Shire plc for the year ended December 31, 2009. Some of these risks are specific to the Group and others are more generally applicable to the pharmaceutical industry in which the Group operates. The Annual Report and Accounts are available on the Group's website, www.shire.com.
In summary, these risks and uncertainties were as follows:
The Group's key products may not be a commercial success
Unanticipated decreases in revenues from ADDERALL XR could significantly reduce the Group's revenues and earnings
Any decrease in royalties derived from the sales of 3TC and ZEFFIX could significantly reduce earnings
The failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for the Group's products may impact future revenues and earnings
A disruption to the product supply chain may result in the Group being unableto continue marketing or developing a product or may result in the Group beingunable to do so on a commercially viable basisThere is no assurance that suppliers will continue to supply on commerciallyviable terms, or be able to supply components that meet regulatoryrequirements. The Group is also subject to the risk that suppliers will not beable to make the quantities needed to meet market requirements
The actions of certain customers can affect the Group's ability to sell or market products profitably, as well as impact net sales and growth comparisons
Investigations or enforcement action by regulatory authorities or lawenforcement agencies relating to the Group's activities in the highly regulatedmarkets in which it operates may result in the distraction of seniormanagement, significant legal costs and the payment of substantial compensationor fines
The out-sourcing of services can create a significant dependency on third-parties, the failure of whom can affect the ability to operate the Group's business and to develop and market products
The actions of governments, industry regulators and the economic environments in which the Group operates may adversely affect its ability to develop and market its products profitably
The introduction of new products by competitors may impact future revenues
The successful development of pharmaceutical products is highly uncertain and requires significant expenditures and time
The failure of a strategic partner to develop and commercialize products could result in delays in approval or loss of revenue
The failure to secure new products or compounds for development, either through in-licensing, acquisition or internal research and development efforts, may have an adverse impact on the Group's future results
The Group may fail to obtain, maintain, enforce or defend the intellectual property rights required to conduct its business
If a marketed product fails to work effectively or causes adverse side effects,this could result in damage to the Group's reputation, the withdrawal of theproduct and legal action against the Group
Loss of highly qualified management and scientific personnel could cause the Group subsequent financial loss
There has been no significant change in the principal risks and uncertaintiessince these risks were set out in the Annual Report and Accounts (pages 26-29)for the year ended December 31, 2009.
Directors' responsibility statement
The Directors confirm that this condensed set of financial statements has beenprepared in accordance with US GAAP and that the Half Yearly Report hereinincludes a fair review of the information required by DTR 4.2.7 R and DTR 4.2.8R.
The Directors of Shire plc are listed in Shire's Annual Report and Accounts for the year ended December 31, 2009, with the exception of the following changes:
Bill Burns was appointed to the Board on March 15, 2010;
Dr David Ginsburg and Ms Anne Minto OBE were appointed to the Board on June 16, 2010; and
Ms Kate Nealon retired from the Board on July 26, 2010.
Details of all current Directors are available on Shire's website atwww.shire.com. On behalf of the Board: Angus Russell Graham Hetherington Chief Executive Officer Chief Financial Officer August 11, 2010 August 11, 2010
Unaudited consolidated balance sheets
June 30, December 31, 2010 2009 Notes $'M $'M _________ _______________ _______________ ASSETS Current assets: Cash and cash equivalents 682.5 498.9 Restricted cash 27.1 33.1 Accounts receivable, net 4 612.5 597.5 Inventories 5 232.7 189.7 Deferred tax asset 140.0 135.8
Prepaid expenses and other current assets 6 195.1
115.2 _______________ _______________ Total current assets 1,889.9 1,570.2 Non-current assets: Investments 7 84.0 105.7
Property, plant and equipment, net 8 801.1
676.8 Goodwill 355.7 384.7
Other intangible assets, net 9 1,653.1
1,790.7 Deferred tax asset 76.4 79.0 Other non-current assets 8.7 10.4 _______________ _______________ Total assets 4,868.9 4,617.5 _______________ _______________ LIABILITIES AND EQUITY Current liabilities:
Accounts payable and accrued expenses 10 1,031.9
929.1 Deferred tax liability 2.9 2.9 Other current liabilities 11 41.1 88.0 _______________ _______________ Total current liabilities 1,075.9 1,020.0 Non-current liabilities Convertible bonds 1,100.0 1,100.0 Other long-term debt 12 6.8 43.6 Deferred tax liability 341.8 294.3
Other non-current liabilities 13 226.0
247.1 _______________ _______________ Total liabilities 2,750.5 2,705.0 _______________ _______________
Commitments and contingencies 14
Unaudited consolidated balance sheets (continued)
June 30, December 31, 2010 2009 Notes $'M $'M ___________ _____________ _____________ Equity:
Common stock of 5p par value; 1,000 million shares authorized; and 562.1 million shares issued and outstanding (2009: 1,000 million shares authorized; and 561.5 million shares
issued and outstanding) 55.7 55.6 Additional paid-in capital 2,711.8 2,677.6
Treasury stock: 15.4 million shares (2009:
17.8 million shares) (308.9) (347.4)
Accumulated other comprehensive income 45.8
149.1 Accumulated deficit (386.0) (622.4) ________________ ________________ Total equity 2,118.4 1,912.5 ________________ ________________
Total liabilities and equity 4,868.9
4,617.5 ________________ ________________
The accompanying notes are an integral part of these unaudited consolidated financial statements.
Unaudited consolidated statements of income
6 months to 6 months to June 30, 2010 June 30, 2009 Notes $'M $'M _______ _______________ _______________ Revenues: Product sales 1,482.4 1,314.3 Royalties 178.0 117.5 Other revenues 5.1 15.6 _______________ _______________ Total revenues 1,665.5 1,447.4 _______________ _______________ Costs and expenses: Cost of product sales(1) 221.0 180.0 Research and development 278.0 344.6 Selling, general and administrative (1) 714.3 653.3 Gain on sale of product rights (4.1) - Reorganization costs 3 13.6 5.1
Integration and acquisition costs 0.6
3.8 _______________ _______________ Total operating expenses 1,223.4 1,186.8 _______________ _______________ Operating income 442.1 260.6 Interest income 0.8 1.3 Interest expense (17.3) (21.2) Other (expenses)/income, net 8.2 54.9 _______________ _______________ Total other (expenses)/income, net (8.3) 35.0 _______________ _______________
Income from continuing operations before income taxes and equity in earnings of equity method investees 433.8 295.6 Income taxes (108.1) (26.1)
Equity in earnings of equity method
investees, net of taxes 0.5 0.4 _______________ _______________
Income from continuing operations, net
of taxes 326.2 269.9
Loss from discontinued operations (net of income tax expense of $nil in all
periods) - (12.4) _______________ _______________ Net income 326.2 257.5
Add: Net loss attributable to the noncontrolling interest in subsidiaries -
0.2 _______________ _______________ Net income attributable to Shire plc 326.2 257.7 _______________ _______________ Cost of product sales includes amortization of intangible assets relating tofavorable manufacturing contracts of $0.9 million for the six months to June30, 2010 (2009: $0.9 million). Selling, general and administrative costsincludes amortization of intangible assets relating to intellectual propertyrights acquired of $68.4 million for the six months to June 30, 2010 (2009:
$66.8 million).
Unaudited consolidated statements of income (continued)
6 months to 6 months to Notes June 30, 2010 June 30, 2009 _________ _______________ _______________
Earning per ordinary share - basic
Earnings from continuing operations
attributable to Shire plc shareholders 59.8c 50.0c
Loss from discontinued operations
attributable to Shire plc shareholders - (2.3c) _______________ _______________
Earnings per ordinary share
attributable to Shire plc shareholders - basic 59.8c 47.7c _______________ _______________
Earnings per ordinary share - diluted
Earnings from continuing operations
attributable to Shire plc shareholders 58.2c 49.6c
Loss from discontinued operations
attributable to Shire plc shareholders - (2.3c) _______________ _______________ Earnings per ordinary share attributable to Shire plc shareholders - diluted 58.2c 47.3c _______________ _______________
Weighted average number of shares
(millions): Basic 17 545.7 539.7 Diluted 17 589.1 545.0 _______________ _______________ 6 months to 6 months to June 30, 2010 June 30, 2009 $'M $'M _______________ _______________
Amounts attributable to Shire plc
Income from continuing operations, net of taxes 326.2 270.1
Loss from discontinued operations, net of taxes - (12.4) _______________ _______________ Net income attributable to Shire plc 326.2 257.7 _______________ _______________
The accompanying notes are an integral part of these unaudited consolidated financial statements.
Unaudited consolidated statement of changes in equity
Shire plc shareholders' equity Common stock Accumulated Number Additional other Common of paid-in Treasury comprehensive Accumulated Total stock shares capital stock income deficit equity $'M M's $'M $'M $'M $'M $'M As at January 1, 2010 55.6 561.5 2,677.6 (347.4) 149.1 (622.4) 1,912.5 Net income - - - - - 326.2 326.2 Foreign currency translation - - - - (82.2) - (82.2) Options exercised 0.1 0.6 1.5 - - - 1.6 Share-based compensation - - 28.3 - - - 28.3 Excess tax benefit associated with exercise of stock options - - 4.4 - - - 4.4 1 Shares purchased by the Employee Share Ownership Trust ("ESOT") - - - (1.7) - - (1.7) Shares released by ESOT to satisfy exercise of stock options - - - 40.2 - (40.0) 0.2 Unrealized holding loss on available-for-sale securities, net of taxes - - - - (22.6) - (22.6) Other than temporary impairment of available-for-sale securities, net of taxes - - - - 1.5 - 1.5 Dividends - - - - - (49.8) (49.8) As at June 30, 2010 55.7 562.1 2,711.8 (308.9) 45.8 (386.0) 2,118.4
The accompanying notes are an integral part of these unaudited consolidated financial statements.
Dividends per shareDuring the six months to June 30, 2010 Shire plc declared and paid dividends of9.250 US cents per ordinary share (equivalent to 27.750 US cents per AmericanDepositary Share) totalling $49.8 million.
Unaudited consolidated statements of comprehensive income
6 months to 6 months to June 30, June 30, 2010 2009 $'M $'M _______________ _______________ Net income 326.2 257.5 Other comprehensive income: Foreign currency translation adjustments (82.2) 11.4 Unrealized holding (loss)/gain on available-for-sale securities (net of taxes of $2.6 million and $nil) (22.6) 11.3 Other than temporary impairment of available-for-sale securities (net of taxes of $nil and $nil) 1.5 - _______________ _______________ Comprehensive income 222.9 280.2 Add: net loss attributable to the noncontrolling interest in subsidiaries - 0.2 _______________ _______________
Comprehensive income attributable to Shire plc 222.9
280.4 _______________ _______________
The components of accumulated other comprehensive income as at June 30, 2010 and December 31, 2009 are as follows:
June 30, December 31, 2010 2009 $'M $'M _______________ _______________
Foreign currency translation adjustments 54.5
136.7
Unrealized holding (loss)/gain on available-for-sale
securities, net of taxes (8.7) 12.4 ________________ _______________
Accumulated other comprehensive income 45.8
149.1 ________________ _______________
The accompanying notes are an integral part of these unaudited consolidated financial statements.
Unaudited consolidated statements of cash flows
6 months to 6 months to June 30, June 30, 2010 2009 $'M $'M _____________ _____________
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income 326.2 257.5
Adjustments to reconcile net income to net cash provided by operating activities: Loss from discontinued operations - 12.4 Depreciation and amortization 129.1 117.7 Share based compensation 26.7 33.2 Gain on sale of non-current investments
(11.1) (55.2)
Gain on sale of product rights (4.1) - Other 11.0 6.3 Movement in deferred taxes 58.8 (45.7) Equity in earnings of equity method investees (0.5) (0.4)
Changes in operating assets and liabilities: Increase in accounts receivable
(43.9) (42.9)
Increase in sales deduction accrual 154.3 117.5 Increase in inventory (50.1) (12.8) Increase in prepayments and other current assets
(82.5) (33.8)
(Increase)/decrease in other assets (0.8) 4.4 Decrease in accounts and notes payable and other (43.2) (101.2) liabilities
Returns on investment from joint venture - 4.9 Cash flows used in discontinued operations -
(5.9)
______________ ______________
Net cash provided by operating activities(A) 469.9
256.0
______________ ______________
CASH FLOWS FROM INVESTING ACTIVITIES
Movements in restricted cash 6.0 (6.6)
Purchases of subsidiary undertakings and businesses, net of -
(75.5)cash acquired Purchases of property, plant and equipment
(208.1) (101.8)
Purchases of intangible assets
(2.7) (6.0)
Proceeds from disposal of non-current investments and 2.1
19.6 property plant and equipment
Proceeds from disposal of subsidiary undertakings - 6.7 Returns from equity investments -
0.2 _____________ _____________ Net cash used in investing activities(B) (202.7) (163.4) _____________ _____________
Unaudited consolidated statements of cash flows (continued)
6 months to 6 months to June 30, June 30, 2010 2009 $'M $'M ____________ __________
CASH FLOWS FROM FINANCING ACTIVITIES: Payment under building financing obligation (1.3)
(3.0)
Extinguishment of building finance obligation (43.1) - Tax benefit of stock based compensation 4.4 - Proceeds from exercise of options 1.8 1.0
Payment of dividend (49.8) (43.0) Payments to acquire shares by ESOT (1.7) (1.0) _____________ ___________ Net cash used in financing activities(C) (89.7) (46.0) _____________ ___________
Effect of foreign exchange rate changes on cash
and cash equivalents(D) 6.1 (1.5) _____________ ___________
Net increase in cash and cash equivalents(A+B+C+D) 183.6 45.1 Cash and cash equivalents at beginning of period 498.9 218.2
_____________ ___________
Cash and cash equivalents at end of period 682.5 263.3
_____________ ___________
Supplemental information associated with continuing
operations: 6 months to 6 months to June 30, June 30, 2010 2009 $'M $'M _____________ _____________ Interest paid (13.0) (17.6) Income taxes paid (205.0) (119.2)
Non cash investing and financing activities: Equity in Vertex Pharmaceuticals, Inc. ("Vertex") received as part consideration for disposal of
non-current investment 9.1 50.8
Building financing obligation -
7.1 _____________ _____________
The accompanying notes are an integral part of these unaudited consolidated financial statements.
Notes to the unaudited consolidated financial statements
1. Summary of Significant Accounting Policies
(a) Basis of preparation
These interim financial statements of Shire and other financial information included in this Half Yearly Report are unaudited. They have been prepared in accordance with US GAAP and US Securities and Exchange Commission ("SEC") regulations for interim reporting.
The balance sheet as of December 31, 2009 was derived from audited financialstatements but does not include all disclosures required by US GAAP. However,the Group believes that the disclosures are adequate to make the informationpresented not misleading.
These interim financial statements should be read in conjunction with the consolidated financial statements and accompanying notes included in Shire's Annual Report and Accounts for the year to December 31, 2009.
Certain information and footnote disclosures normally included in financialstatements prepared in accordance with US GAAP have been condensed or omittedfrom these interim financial statements. However, these interim financialstatements include all adjustments, which are, in the opinion of management,necessary to fairly state the results of the interim period. Interim resultsare not necessarily indicative of results to be expected for the full year.
The directors continue to adopt the going concern basis of accounting in preparing this Half Yearly Report.
(b) Use of estimates in interim financial statements
The preparation of interim financial statements, in conformity with US GAAP andSEC regulations, requires management to make estimates and assumptions thataffect the reported amounts of assets and liabilities, disclosure of contingentassets and liabilities at the date of the consolidated financial statements andreported amounts of revenues and expenses during the reporting period. Actualresults could differ from those estimates. Estimates and assumptions areprimarily made in relation to the valuation of intangible assets, the valuationof equity investments, sales deductions, income taxes and provisions forlitigation and legal proceedings.
(c) New accounting pronouncements
Adopted during the period
Amendments to the Accounting and Disclosure Requirements for the Consolidation of Variable Interest Entities
On January 1, 2010 the Group adopted new guidance issued by the FinancialAccounting Standard Board ("FASB") on the consolidation of variable interestentities. This guidance changes how a reporting entity determines when anentity that is insufficiently capitalized or is not controlled through voting(or similar rights) should be consolidated. The determination of whether areporting entity is required to consolidate another entity is based on, amongother things, the other entity's purpose and design and the reporting entity'sability to direct the activities of the other entity that most significantlyimpact the other entity's economic performance. The guidance also requires areporting entity to provide additional disclosures about its involvement withvariable interest entities and any significant changes in risk exposure due tosuch involvement. The adoption of the guidance did not impact the Group'sconsolidated financial position, results of operations or cash flows.
The effective date of these amendments has been deferred for a reporting entity's interest in an entity (1) that has all the attributes of an investment company or (2) for which it is industry practice to apply measurement principles for financial reporting purposes that are consistent with those followed by investment companies.
Accounting for Transfers of Financial Assets
On January 1, 2010 the Group adopted new guidance issued by the FASB on theaccounting for transfers of financial assets. This guidance requires moreinformation about transfers of financial assets, including securitizationtransactions, and where entities have continuing exposure to the risks relatedto transferred financial assets. It eliminates the concept of a "qualifyingspecial-purpose entity," changes the requirements for derecognizing financialassets, and requires additional disclosures. The adoption of the guidance didnot impact the Group's consolidated financial position, results of operationsor cash flows.
Improving Disclosures about Fair Value Measurements
On January 1, 2010 the Group adopted new guidance issued by the FASB requiringnew disclosures for amounts transferred in and out of Levels 1 and 2 and foractivity in Level 3 of the hierarchy for fair value measurements. The guidancealso clarifies existing fair value measurement disclosures in respect of thelevel of disaggregation and disclosures about inputs and valuation techniques. This guidance is effective for Shire from January 1, 2010, except for theadditional disclosures about activity in Level 3 of the hierarchy for fairvalue measurements, which is effective from January 1, 2011 and for interimperiods within that year. The adoption of the guidance did not impact theGroup's disclosure on fair value measurement.
To be adopted in future periods
Revenue Recognition in Multiple Deliverable Revenue Arrangements
In September 2009, the FASB issued guidance on revenue recognition in multipledeliverable revenue arrangements. This amends the existing guidance onallocating consideration received between the elements in amultiple-deliverable arrangement and establishes a selling price hierarchy fordetermining the selling price of a deliverable. The selling price used for eachdeliverable will be based on vendor specific objective evidence ("VSOE") ifavailable, third-party evidence if VSOE is not available, or estimated sellingprice if neither VSOE or third-party evidence is available. It replaces theterm fair value in the revenue allocation with selling price to clarify thatthe allocation of revenue is based on entity specific assumptions rather thenthe assumptions of a market place participant. The guidance eliminates theresidual method of allocation and requires that arrangement consideration beallocated using the relative selling price method. The guidance alsosignificantly expands the disclosures related to a vendor'smultiple-deliverable revenue arrangements. It will be effective prospectivelyfor revenue arrangements entered into or materially modified for fiscal yearsbeginning on or after June 15, 2010. The Group is currently evaluating theimpact of adopting this guidance.
Effect of Denominating the Exercise Price of a Share-Based Payment Award in the Currency of the Market in Which the Underlying Equity Security Trades
In April 2010, the FASB issued guidance on the effect of denominating theexercise price of a share-based payment award in the currency of the market inwhich the underlying equity security trades. This guidance clarifies that anemployee share-based payment award with an exercise price denominated in thecurrency of a market in which a substantial portion of the entity's equitysecurities trades should not be considered to contain a condition that is not amarket, performance, or service condition. Therefore, an entity would notclassify such an award as a liability if it otherwise qualifies as equity. Theguidance will be effective for fiscal years beginning on or after December 15,2010. The Group does not currently expect the guidance to impact itsconsolidated financial position, results of operations or cash flows.
Milestone Method of Revenue Recognition
In April 2010, the FASB issued guidance on defining a milestone and determiningwhen it may be appropriate to apply the milestone method of revenue recognitionfor research or development transactions. This guidance clarifies that:consideration that is contingent on achievement of a milestone in its entiretymay be recognized as revenue in the period in which the milestone is achievedonly if the milestone is judged to meet certain criteria to be consideredsubstantive; milestones should be considered substantive in their entirety andmay not be bifurcated; an arrangement may contain both substantive and nonsubstantive milestones; and each milestone should be evaluated individually todetermine if it is substantive. The guidance is effective on a prospectivebasis for milestones achieved in fiscal years, and interim periods within thoseyears, beginning on or after June 15, 2010. Early adoption is permitted. TheGroup is currently evaluating the impact of adopting this guidance. 2. Business combinationsEQUASYM IR and XLOn March 31, 2009 the Group acquired the worldwide rights (excluding the US,Canada and Barbados) to EQUASYM IR and XL for the treatment of attentiondeficit and hyperactivity disorder ("ADHD") from UCB Pharma Limited ("UCB") forcash consideration of $72.8 million. Included within the recognized purchaseprice for the acquisition is further consideration of $18.2 million, of which $12.0 million was paid to UCB in the six months to June 30, 2010 and theremaining $6.2 million may become payable in 2011 if certain sales targets aremet. This acquisition broadened the scope of Shire's ADHD portfolio andfacilitated immediate access to the European ADHD market as well as providingShire the opportunity to enter additional markets around the world.
The acquisition of EQUASYM IR and XL was accounted for as a business combination. The purchase price was allocated to the currently marketed products acquired ($73.0 million), in process research and development ("IPR& D") ($5.5 million), other liabilities ($0.7 million) and goodwill ($13.2 million).
3. Reorganization costs
Establishment of Swiss Commercial Hub
In March 2010 the Group initiated plans to relocate certain commercial and R&Doperations to Switzerland to support its HGT and SP businesses outside the US.In the six months to June 30, 2010, the Group incurred reorganization coststotaling $6.9 million relating to employee involuntary termination benefits andother re-organization costs. The transition to the Swiss commercial hub will beeffected over 2010 and 2011. Owings MillsIn March 2009 the Group initiated plans to phase out operations and close itsSP manufacturing facility at Owings Mills, Maryland. Between 2009 and 2011, allproducts manufactured by Shire at this site will transition to DSMPharmaceutical Products, and operations and employee numbers at the site willwind down over this period. During the six months to June 30, 2010 the Groupincurred reorganization costs of $6.7 million which relate to employeeinvoluntary termination benefits and other costs. The total reorganizationcosts incurred since March 2009 are $19.4 million. As a result of the decision to transfer manufacturing from the Owings Millssite the Group revised the useful life of property, plant and equipment in thefacility and in the six months to June 30, 2010 incurred accelerateddepreciation of $12.1 million, which has been charged to Cost of product sales.Consequently, the Group estimates an accelerated depreciation charge, over thelevel which would have been charged absent the wind down of operations, of $11.5 million in the second half of 2010. The reorganization costs andaccelerated depreciation have been recorded within the SP reportable segment. Jerini non-core operationsIn the second quarter of 2009 the operations of Jerini Ophthalmic, Inc., andcertain other non-core pre-clinical operations acquired through the acquisitionof Jerini AG ("Jerini") were closed down, and the Group recorded a closurecosts liability of $9.1 million, relating to employee involuntary terminationbenefits, contract termination costs and other closure costs. The Group haspaid all remaining closure costs during the six months to June 30, 2010 and noliability for these closure costs remains at June 30, 2010.
The liability for reorganization costs arising on the establishment of the Swiss commercial hub, transfer of manufacturing from Owings Mills and the closure of Jerini non-core operations at June 30, 2010 is as follows:
Amount Opening liability at charged to Closing liability January 1, re- at June 30, Paid/ 2010 organization Utilized 2010 $'M $'M $'M $'M ___________ ____________ ___________ ___________ Involuntary 4.1 6.2 (2.4) 7.9 termination benefits Contract termination 2.8 - (2.8) - costs Other termination - 7.4 (2.6) 4.8 costs ___________ ___________ ___________ ___________ 6.9 13.6 (7.8) 12.7 ___________ ___________ ___________ ___________
At June 30, 2010 the closing reorganization cost liability was recorded within accounts payable and accrued expenses ($8.7 million) and other non-current liabilities ($4.0 million).
4. Accounts receivable, net
Accounts receivable at June 30, 2010 of $612.5 million (December 31, 2009: $597.5 million), are stated net of a provision for discounts and doubtful accounts of $22.8 million (December 31, 2009: $20.8 million).
Provision for discounts and doubtful accounts:
2010 2009 $'M $'M _____________ _____________ As at January 1, 20.8 20.2
Provision charged to operations 85.2
54.1 Provision utilization (83.2) (61.4) _____________ _____________ As at June 30, 22.8 12.9 _____________ _____________
At June 30, 2010 accounts receivable included $80.3 million (December 31, 2009: $92.4 million) of receivables related to royalty income.
5. Inventories
Inventories are stated at the lower of cost or market value and comprise:
June 30, December 31, 2010 2009 $'M $'M ____________ ____________ Finished goods 66.6 50.9 Work-in-progress 118.4 102.1 Raw materials 47.7 36.7 ____________ ____________ 232.7 189.7 ____________ ____________ At June 30, 2010 inventories included $nil (December 31, 2009: $18.8 million)for products which have not yet received regulatory approval. Pre-approvalinventories at December 31, 2009 related to VPRIV, which was granted marketingapproval by the FDA on February 26, 2010.
6. Prepaid expenses and other current assets
June 30, December 31, 2010 2009 $'M $'M ______________ ____________ Prepaid expenses 37.8 44.9 Income tax receivable 112.1 - Value added taxes receivable 15.4 37.3 Other current assets 29.8 33.0 ______________ ____________ 195.1 115.2 ______________ ____________ The income tax receivable of $112.1 million (December 31, 2009: $nil) includestaxes on inter-company sales (which are recorded as prepaid assets until therelated inventory has been sold to a third-party customer) and interim taxpayments on account made during the six months to June 30, 2010. 7. InvestmentsOn March 12, 2009 the Group completed the disposal of its investment inVirochem Pharma Inc. ("Virochem") to Vertex in a cash and stock transaction.The disposal was part of a transaction entered into by all the shareholders ofVirochem with Vertex. The carrying amount of the Group's investment in Virochemon March 12, 2009 was $14.8 million. In 2009 Shire received consideration of$19.2 million in cash and 2 million Vertex shares (valued at $50.8 million)from the disposal, recognizing a gain of $55.2 million in Other (expense)/income, net in the six months to June 30, 2009. In the six months to June 30, 2010 the Group received further consideration of$2.0 million in cash and 0.2 million Vertex shares (valued at $9.1 million)which had been held in escrow until certain substantive conditions expired inMarch 2010. The Group recognized an additional gain on disposal of $11.1million in Other (expense)/income, net in the six months to June 30, 2010.
The Vertex stock received has been accounted for as an available-for-sale investment.
8. Property, plant and equipment, net
June 30, December 31, 2010 2009 $'M $'M ____________ ____________ Land and buildings 519.2 398.7
Office furniture, fittings and equipment 289.9 280.5 Warehouse, laboratory and manufacturing equipment 111.7 114.5
Assets under construction 242.5 193.2 ____________ ____________ 1,163.3 986.9
Less: Accumulated depreciation (362.2) (310.1)
____________ ____________ 801.1 676.8 ____________ ____________
Depreciation expense for the six months to June 30, 2010 was $63.5 million (sixmonths to June 30, 2009: $52.7 million). The expense included impairment lossesof $5.0 million (six months to June 30, 2009: $2.6 million) in the six monthsto June 30, 2010.
Purchase of the Lexington Technology Park campus in Lexington, Massachusetts
On June 30, 2010 Shire completed the purchase of certain properties on theLexington Technology Park campus in Lexington, Massachusetts, some of which theGroup had previously leased, for a cash purchase price of $165.0 million paidduring the six months to June 30, 2010. The purchase price of $165.0 millionhas been allocated to the acquired properties using a relative fair valueapproach: $121.9 million has been recorded as Property, plant and equipment,being land ($72.1 million) and buildings ($49.8 million). The remaining $43.1million relates to the extinguishment of existing building finance obligations,and has been applied against the relevant financing obligations, (see note
12).
9. Other intangible assets, net
June 30, December 31, 2010 2009 $'M $'M ________________ ________________
Intellectual property rights acquired:
- Currently marketed products 2,272.6 2,351.6 - IPR&D 6.1 6.1
Favorable manufacturing contracts 8.7 8.7
________________ ________________ 2,287.4 2,366.4
Less: Accumulated amortization (634.3) (575.7)
________________ ________________ 1,653.1 1,790.7 ________________ ________________ At June 30, 2010 the net book value of intangible assets allocated to the SPsegment was $1,160.5 million (December 31, 2009: $1,238.0 million) and in theHGT segment was $492.6 million (December 31, 2009: $552.7 million).
The change in the net book value of other intangible assets for the six months to June 30, 2010 is shown in the table below:
Other intangible assets $'M As at January 1, 2010 1,790.7 Acquisitions 2.7 Amortization charged (69.3) Foreign currency translation (71.0) ________________ As at June 30, 2010 1,653.1 ________________
The weighted average amortization period for acquired currently marketed products is 10 years.
The Group reviews its intangible assets for impairment whenever events orcircumstances suggest that they may not be recoverable. In the six months toJune 30, 2010, the Group reviewed the recoverability of its DAYTRANA intangibleasset, (carrying value $92 million), and based on estimates and intentions atJune 30, 2010 the Group determined that its DAYTRANA intangible asset remainedrecoverable. However, it is reasonably possible that changes to circumstances,estimates or intentions existing at June 30, 2010 could result in impairment ofthe DAYTRANA intangible asset in future periods. On August 10, 2010 the Group announced the divestment of DAYTRANA to Noven.Consequently in the third quarter of 2010 the held for sale criteria have beenmet, and the Group will re-measure the DAYTRANA intangible asset to the lowerof its carrying amount or fair value less costs to sell. The divestment ofDAYTRANA to Noven is effective from October 1, 2010. Management estimates that the annual amortization charge in respect ofintangible assets held at June 30, 2010 will be approximately $140 million foreach of the five years to June 30, 2015. Estimated amortization expense can beaffected by various factors including future acquisitions, disposals of productrights, regulatory approval and subsequent amortization of the acquired IPR&Dprojects, foreign exchange movements and the technological advancement andregulatory approval of competitor products.
10. Accounts payable and accrued expenses
June 30, December 31, 2010 2009 $'M $'M ________________ ________________ Trade accounts payable and accrued purchases 164.7 170.6 Accrued rebates - Medicaid 334.2 188.2 Accrued rebates - Managed care 156.7 153.4 Sales return reserve 67.7 62.7 Accrued bonuses 51.6 66.8
Accrued employee compensation and benefits
payable 49.3 42.6 Research and development accruals 49.7 53.1 Marketing accruals 27.3 31.5 Deferred revenue 16.3 52.2 Other accrued expenses 114.4 108.0 ________________ ________________ 1,031.9 929.1 ________________ ________________
Accrued Medicaid rebates have increased by $146.0 million to $334.2 million at June 30, 2010 (December 31, 2009: $188.2 million) due to higher Medicaid rebates on higher product sales in 2010 and timing of the payment of first quarter Medicaid rebates.
Deferred revenue has reduced by $35.9 million to $16.3 million (December 31,2009: $52.2 million) due to the recognition into revenue in the six months toJune 30, 2010 of INTUNIV launch stocking shipments which had initially beendeferred. 11. Other current liabilities June 30, December 31, 2010 2009 $'M $'M _____________ _____________ Income taxes payable - 46.7 Value added taxes 11.9 10.3 Other accrued liabilities 29.2 31.0 _____________ _____________ 41.1 88.0 _____________ _____________ 12. Other long-term debtDuring 2007 and 2009 Shire entered into certain multi-year leases for its HGTbusiness unit at North Reading and Lexington, Massachusetts. For some of theseleases Shire was considered, the in substance owner of these properties overtheir construction period and as a result Shire recorded assets (being the fairvalue of the building element at inception of the relevant lease) withinProperty, plant and equipment and the corresponding building financingobligations were recorded within other long term debt. The land element ofthese leases was accounted for as an operating lease. On June 30, 2010, as outlined in note 8, Shire completed the purchase ofcertain properties on the Lexington Technology Park campus, includingproperties held under building finance obligations. Accordingly Shire applied $43.1 million of the purchase price for the Lexington campus to extinguish theexisting building finance obligations, recognizing a loss of $3.6 millionwithin Other (expense)/income, net in the six months to June 30, 2010.
13. Other non-current liabilities
June 30, December 31, 2010 2009 $'M $'M ____________ ____________ Income taxes payable 166.8 170.4 Deferred revenue 15.7 20.0 Deferred rent 13.7 14.5 Insurance provisions 19.7 18.3 Other accrued liabilities 10.1 23.9 ____________ ____________ 226.0 247.1 ____________ ____________
14. Commitments and contingencies
(a) Leases
Future minimum lease payments under operating leases at June 30, 2010 arepresented below: Operating leases $'M _____________ 2010 16.6 2011 30.1 2012 16.8 2013 14.4 2014 13.9 2015 11.7 Thereafter 1 17.9 _____________ 121.4 _____________ The Group leases land, facilities, motor vehicles and certain equipment underoperating leases expiring through 2019. Lease and rental expense amounted to$16.6 million for the six months to June 30, 2010 (six months to June 30, 2009:$16.4 million), which is predominately included in Selling, general andadministrative expenses in the consolidated statements of income.
(b) Letters of credit and guarantees
At June 30, 2010 the Group had irrevocable standby letters of credit andguarantees with various banks totaling $10.4 million, providing security forthe Group's performance of various obligations. These obligations are primarilyin respect of the recoverability of insurance claims, lease obligations andsupply commitments. The Group has restricted cash of $9.2 million, as requiredby these letters of credit.
(c) Collaborative arrangements
Details of significant collaborative arrangements are included below:
In-licensing arrangements
(i) 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 researchcollaboration with Santaris, to develop its proprietary LNA technology in arange of rare diseases. LNA technology has the benefit of shortened targetvalidation and proof-of-concept, potentially increasing the speed and loweringthe cost of development. As part of the joint research project Santaris willdesign, develop and deliver pre-clinical LNA oligonucleotides forShire-selected orphan disease targets, and Shire will have the exclusive rightto further develop and commercialize these candidate compounds on a worldwidebasis. Shire has remaining obligations to pay Santaris $13.5 million subject tocertain success criteria, and development and sales milestones up to a maximumof $72 million for each indication. Shire will also pay single or double digittiered royalties on net sales of the product.
Shire and Santaris have formed a joint research committee to monitor R&D activities through preclinical lead candidate selection at which point all development and commercialization costs will be the responsibility of Shire.
(ii) JUVISTAOn June 19, 2007 Shire signed an agreement with Renovo Limited ("Renovo") todevelop and commercialize JUVISTA, Renovo's novel drug candidate beinginvestigated for the reduction of scarring in connection with surgery, outsideof the EU. On March 1, 2010 the license agreement was revised. In the revised license agreement, the rights to sell JUVISTA in all territoriesoutside the US, Mexico and Canada were returned to Renovo. Milestone androyalty obligations remain unchanged from the original agreement except thatShire will pay Renovo an additional $5 million milestone if Shire elects tocommence a clinical trial following Shire's review of the clinical trial reportfrom Renovo's first EU Phase 3 clinical trial. Shire has remaining obligationsto pay Renovo $25 million on the filing of JUVISTA with the FDA; up to $150million on FDA approval; royalties on net sales of JUVISTA; and up to $525million on the achievement of very significant sales targets. Under the revised agreement, each party is responsible for its own developmentcosts but future development costs can be shared by agreement. Each party hasfree-of-charge access to the other party's data to support regulatory filingsin their respective territories. In the six months to June 30, 2010 Shire madea payment to Renovo of $3.2 million (2009: $0.5 million), being the finalpayment under the terms of the original license agreement. Out-licensing arrangements Shire has entered into various collaborative arrangements under which the Grouphas out-licensed certain product or intellectual property rights forconsideration such as up-front payments, development milestones, salesmilestones and/or royalty payments. In certain of these arrangements Shire andthe licensee are both actively involved in the development andcommercialization of the licensed product and have exposure to risks andrewards dependent on its commercial success. In the six months to June 30, 2010Shire received milestone payments totaling $nil (2009: $4.0 million). In thesix months to June 30, 2010 Shire recognized milestone income of $4.3 million(2009: $3.1 million) within Other revenues and $22.8 million (2009: $12.3million) within Product sales for shipment of product to the relevant licensee.
Co-promotion agreements - VYVANSE
On March 31, 2009 Shire announced a three-year co-promotion agreement with GSKfor VYVANSE in the US with the aim of improving recognition and treatment ofADHD in adults. The agreement is based on profit sharing above an agreed uponbaseline and these profit share payments will be included within Selling,general and administrative costs. (d) Commitments(i) Clinical testingAt June 30, 2010 the Group had committed to pay approximately $166.6 million(December 31, 2009: $183.9 million) to contract vendors for administering andexecuting clinical trials. The Group expects to pay $104.1 million of thesecommitments in the remainder of 2010 (December 31, 2009: $104.1 million in2010), however the timing of these payments is dependent upon actual servicesperformed by the organizations as determined by patient enrolment levels andrelated activities. (ii) Contract manufacturingAt June 30, 2010 the Group had committed to pay approximately $133.5 million(December 31, 2009: $152.3 million) in respect of contract manufacturing. TheGroup expects to pay all of these commitments in the remainder of 2010(December 31, 2009: $77.3 million in 2010).
(iii) Other purchasing commitments
At June 30, 2010 the Group had committed to pay approximately $37.8 million(December 31, 2009: $22.9 million) for future purchases of goods and services,predominantly relating to active pharmaceutical ingredients sourcing and IToutsourcing. The Group expects to pay $31.0 million of these commitments in theremainder of 2010 (December 31, 2009: $21.0 million in 2010).
(iv) Investment commitments
At June 30, 2010 the Group had outstanding commitments to subscribe for interests in companies and partnerships for amounts totaling $5.5 million (December 31, 2009: $5.4 million) which may all be payable in the remainder of 2010, depending on the timing of capital calls.
(v) Capital commitments
At June 30, 2010 the Group had committed to spend $64.0 million (December 31,2009: $41.4 million) on capital projects. This includes commitments for theexpansion and modification of its offices and manufacturing facilities at theHGT campus in Lexington, Massachusetts.
(e) Legal and other proceedings
General
The Group recognizes loss contingency provisions for probable losses whenmanagement is able to reasonably estimate the loss. Where the estimated losslies within a range and no particular amount within that range is a betterestimate than any other amount, the minimum amount is recorded. In other casesmanagement's best estimate of the loss is recorded. These estimates aredeveloped substantially before the ultimate loss is known and the estimates arerefined in each accounting period in light of additional information becomingknown. In instances where the Group is unable to develop a reasonable estimateof loss, no litigation loss is recorded at that time. As information becomesknown a loss provision is set up when a reasonable estimate can be made. Theestimates are reviewed quarterly and are changed when expectations are revised.Any outcome upon settlement that deviates from the Group's estimate may resultin an additional expense in a future accounting period. At June 30, 2010provisions for litigation losses, insurance claims and other disputes totaled$20.7 million (December 31, 2009: $20.1 million). Specific VYVANSEOn February 24, 2009 Actavis Elizabeth LLC brought a lawsuit in the US DistrictCourt for the District of Columbia (the "District Court") against the FDAseeking to overturn the FDA's decision granting new chemical entity exclusivityto VYVANSE. Shire has intervened in the lawsuit. On October 23, 2009, followinga period for public comment, the FDA issued a letter setting forth its analysisof the legal and regulatory issues and reaffirming its decision that VYVANSE isentitled to new chemical entity exclusivity. A hearing on cross-motions forsummary judgment was held on February 17, 2010. On March 4, 2010 the DistrictCourt upheld the FDA's decision that VYVANSE is entitled to 5-year marketexclusivity and confirmed that the FDA's actions complied with federaladministrative law standards as a reasonable exercise of the agency'sscientific expertise. Actavis Elizabeth LLC has appealed the District Court'sruling to the US Court of Appeals for the District of Columbia Circuit. Ahearing is scheduled for September 20, 2010. FOSRENOLIn February 2009 Shire was notified that three separate Abbreviated New DrugApplications ("ANDAs") were submitted under the Hatch-Waxman Act seekingpermission to market generic versions of 500mg, 750mg and 1,000mg strengths ofFOSRENOL. The notices were received from Barr; Mylan, Inc., MylanPharmaceuticals, Inc. and Matrix Laboratories, Inc. (collectively "Mylan"); andNatco Pharma Limited ("Natco"). Within the requisite 45 day period, Shire filedlawsuits in the US District Court of the Southern District of New York againsteach of Barr, Mylan and Natco for infringement of certain of Shire's FOSRENOLpatents. The filing of the lawsuits triggered a stay of approval of these ANDAsfor up to 30 months. The lawsuits have been consolidated into a single case. AMarkman hearing was held on June 17, 2010. No trial date has been set.
INTUNIV
In March and April, 2010 Shire was notified that three separate ANDAs weresubmitted under the Hatch-Waxman Act seeking permission to market genericversions of 1mg, 2mg, 3mg, and 4mg strengths of INTUNIV. The notices were fromTeva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd(collectively "Teva"); Actavis Elizabeth LLC and Actavis Inc. (collectively"Actavis"); and Anchen Pharmaceuticals, Inc. and Anchen, Inc. (collectively"Anchen"). Within the requisite 45 days period, Shire filed lawsuits in the USDistrict Court of the District of Delaware against each of Teva, Actavis andAnchen for infringement of certain of Shire's INTUNIV patents. The filing ofthe lawsuits triggered a stay of approval of these ANDAs for up to 30 months.No trial date has been set.
REPLAGAL
Mt. Sinai School of Medicine of New York University ("Mt. Sinai") initiatedlawsuits against Shire in Sweden on April 14, 2010 and in Germany on April 20,2010 alleging that Shire's enzyme replacement therapy for Fabry disease,REPLAGAL, infringes Mt. Sinai's European Patent No. 1 942 189, granted April14, 2010. Mt. Sinai is seeking an injunction against the use of REPLAGAL inthese jurisdictions until expiration of the patent on November 30, 2013. Shirewill defend its right to commercialize REPLAGAL in these countries and willvigorously oppose the validity of this patent.
LIALDA/MEZAVANT
In May 2010 Shire was notified that an ANDA was submitted under theHatch-Waxman Act seeking permission to market a generic version of LIALDA. Thenotice was received from Zydus Pharmaceuticals USA, Inc. ("Zydus"). Within therequisite 45 days period, Shire filed a lawsuit in the US District Court of theDistrict of Delaware against Zydus and Cadila Healthcare Limited, doingbusiness as Zydus Cadila. The filing of the lawsuits triggered a stay ofapproval of the ANDA for up to 30 months. No trial date has been set.
Subpoena related to ADDERALL XR, DAYTRANA and VYVANSE
On September 23, 2009 the Group received a subpoena from the US Department ofHealth and Human Services Office of Inspector General in coordination with theUS Attorney for the Eastern District of Pennsylvania seeking production ofdocuments related to the sales and marketing of ADDERALL XR, DAYTRANA andVYVANSE. The Group is cooperating with this investigation. 15. Derivative instruments
Treasury policies and organization
The Group's principal treasury operations are coordinated by its corporatetreasury function. All treasury operations are conducted within a framework ofpolicies and procedures approved annually by the Board of Directors. As amatter of policy, the Group does not undertake speculative transactions thatwould increase its currency or interest rate exposure.
Interest rate risk
The Group is exposed to interest rate risk on restricted cash, cash and cashequivalents and on foreign exchange contracts on which interest is at floatingrates. This exposure is primarily to US dollar, Euro and Canadian dollarinterest rates. As the Group maintains all of its cash and liquid investmentsand foreign exchange contracts on a short term basis for liquidity purposes,this risk is not actively managed. In the six months to June 30, 2010 theaverage interest rate received on cash and liquid investments was less than 1%per annum. The largest proportion of these cash and liquid investments was inmoney market and liquidity funds. The Group incurs interest at a fixed rate of 2.75% on Shire's $1,100 million inprincipal amount convertible bonds due 2014. The building financing obligationof $7.3 million is also subject to a fixed interest rate over the lease term onthe amount outstanding.
During the six months to June 30, 2010 the Group did not enter into any derivative instruments to manage interest rate exposure. The Group continues to review its interest rate risk and the policies in place to manage the risk.
Market risk of investments
As at June 30, 2010 the Group has $84.0 million of investments comprisingavailable-for-sale investments in publicly quoted companies ($70.6 million),equity method investments ($9.5 million) and cost method investments in privatecompanies ($3.9 million). The investments in publicly quoted companies andequity method investments, for certain investment funds which contain a mixedportfolio of public and private investments, are exposed to market risk. Nofinancial instruments or derivatives have been employed to hedge this risk.
Credit risk
Financial instruments that potentially expose Shire to concentrations of creditrisk consist primarily of short-term cash investments, trade accountsreceivable (from product sales and royalty receipts) and derivative contracts.Cash is invested in short-term money market instruments, including money marketand liquidity funds and bank term deposits. The money market and liquidityfunds in which Shire invests are all triple A rated by both Standard & Poor'sand by Moody's credit rating agencies. The Group is exposed to the credit risk of the counterparties with which itenters into derivative contracts. The Group aims to limit this exposure througha system of internal credit limits which require counterparties to have a longterm credit rating of A / A2 or better from the major rating agencies. Theinternal credit limits are approved by the Board of Directors and exposureagainst these limits is monitored by the corporate treasury function. Thecounterparties to the derivative contracts are major international financialinstitutions. The Group has entered into many agreements with third-parties for the provisionof services to enable it to operate its business. If the third-party can nolonger provide the service on the agreed basis, the Group may not be able tocontinue the development or commercialization of its products as planned or ona commercial basis. Additionally, it may not be able to establish or maintaingood relationships with suppliers. Foreign exchange risk
The Group trades in numerous countries and as a consequence has transactional and translational foreign exchange exposure.
Transactional exposure arises where transactions occur in currencies differentto the functional currency of the relevant subsidiary. The main tradingcurrencies of the Group are the US dollar, the Canadian dollar, Pounds Sterlingand the Euro. It is the Group's policy that these exposures are minimized tothe extent practicable by denominating transactions in the subsidiary'sfunctional currency. Where significant exposures remain, the Group uses foreign exchange contracts(being spot, forward and swap contracts) to manage the exposure in respect ofbalance sheet assets and liabilities that are denominated in currenciesdifferent to the functional currency of the relevant subsidiary. These assetsand liabilities relate predominantly to inter-company financing and accrualsfor royalty receipts. The Group utilizes these derivative instruments to managecurrency risk on balance sheet foreign exchange exposures but the foreignexchange contracts have not been designated as hedging instruments.
Translational foreign exchange exposure arises on the translation into US dollars of the financial statements of non-US dollar functional subsidiaries.
At June 30, 2010 the Group had 19 swap and forward foreign exchange contractsoutstanding to manage currency risk. The swaps and forward contracts maturewithin 90 days. The Group did not have credit risk related contingent featuresor collateral linked to the derivatives. These foreign exchange contracts wereclassified in the consolidated balance sheet as follows: Fair value Fair value June 30, December 31, 2010 2009 $'M $'M _____________ _____________ Assets Prepaid expenses and other current assets 2.3 5.4 Liabilities Other current liabilities 5.8
1.2 _____________ _____________
Net gains and losses (both realized and unrealized) arising on foreign exchange contracts have been classified in the consolidated statements of income as follows:
Location of net gain/(loss) Amount of net
gain/(loss)
recognized in income recognized in income __________________________________ ____________
____________ Six months to June 30, June 30, 2010 2009 $'M $'M _____________ _____________ Foreign exchange contracts Other (expense)/income, net 38.5 (14.2) _____________ _____________ These net foreign exchange gains/(losses) are offset within Other (expense)/income, net by net foreign exchange (losses)/gains arising on the balance sheetitems that these contracts were put in place to manage.16. Fair value measurement
Assets and liabilities that are measured at fair value on a recurring basis
The following financial assets and liabilities are measured at fair value on a recurring basis using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3).
Carrying Fair value value Total Level 1 Level 2 Level 3 $'M $'M $'M $'M $'M ____________ ____________ ___________ ___________ ___________ Financial assets: Available-for-sale securities(1) 70.6 70.6 70.6 - - Foreign exchange contracts 2.3 2.3 - 2.3 - Financial liabilities: Foreign exchange contracts 5.8 5.8 - 5.8 - ____________ ____________ ___________ ___________ ___________
(1) Available-for-sale securities are included within Investments in the consolidated balance sheet.
Certain estimates and judgments were required to develop the fair valueamounts. The fair value amounts shown above are not necessarily indicative ofthe amounts that the Group would realize upon disposition, nor do they indicatethe Group's intent or ability to dispose of the financial instrument.
The following methods and assumptions were used to estimate the fair value of each material class of financial instrument:
Available-for-sale securities - the fair values of available-for-sale securities are estimated based on quoted market prices for those investments.
Foreign exchange contracts - the fair values of the swap and forward foreign exchange contracts have been determined using an income approach based on current market expectations about the future cash flows.
Financial assets and liabilities that are not measured at fair value on a recurring basis
The carrying amounts and estimated fair values as at June 30, 2010 and December31, 2009 of the Group's financial assets and liabilities which are not measuredat fair value on a recurring basis are as follows: June 30, 2010 December 31, 2009 Carrying Carrying amount Fair value amount Fair value $'M $'M $'M $'M ____________ ____________ ____________ ___________ Financial liabilities: Convertible bonds 1,100.0 1,067.6 1,100.0 1,067.0 Building financing 7.3 8.4 46.7 47.3 obligation ____________ ____________ ____________ ___________ Certain estimates and judgments were required to develop the fair valueamounts. The fair value amounts shown above are not necessarily indicative ofthe amounts that the Group would realize upon disposition, nor do they indicatethe Group's intent or ability to dispose of the financial instrument.
The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate to fair value because of the short-term maturity of these amounts.
The following methods and assumptions were used to estimate the fair value of each material class of financial instrument:
convertible bonds - the fair value of Shire's $1,100 million 2.75% convertiblebonds due 2014 is estimated by reference to the market price of the instrumentas the convertible bonds are publicly traded; and building financing obligations - the fair value of building financingobligations are estimated based on the present value of future cash flows, andan estimate of the residual value of the underlying property at the end of thelease term, associated with these obligations. 17. Earnings per share
The following table reconciles net income attributable to Shire plc and the weighted average Ordinary Shares outstanding for basic and diluted earnings per share for the periods presented:
6 months to 6 months to June 30, June 30, 2010 2009
Amounts attributable to Shire plc shareholders $'M
$'M _________________ _________________
Numerator for basic earnings per share 326.2
257.7
Interest on convertible bonds, net of tax(1) 16.8
- _________________ _________________
Numerator for diluted earnings per share 343.0
257.7 _________________ _________________
Weighted average number of shares:
Millions Millions _________________ _________________ Basic(2) 545.7 539.7 Effect of dilutive shares:
Stock based awards to employees(3) 10.2
5.3
Convertible bonds 2.75% due 2014(4) 33.2
- _________________ _________________ Diluted 589.1 545.0 _________________ _________________
(1) For the six month period ended June 30, 2009 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 Group 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:
6 months to 6 months to June 30, June 30, 2010(1) 2009(1)(2) No. of shares No. of shares Millions Millions _________________ _________________
Share options out of the money 8.1
18.9
Convertible bonds 2.75% due 2014 -
32.7 _________________ _________________
(1) In the six months to June 30, 2010 and 2009 certain stock options have beenexcluded from the calculation of the diluted weighted average number of sharesbecause their exercise prices exceeded Shire plc's average share price duringthe calculation period.
(2) In the six months to 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.
18. Segmental reporting
Shire's internal financial reporting is in line with its business unit and management reporting structure and includes two segments: SP and HGT. The SP and HGT reportable segments represent the Group's revenues and costs for currently promoted and sold products, together with the costs of developing projects for future commercialization. 'All Other' has been included in the table below in order to reconcile the two operating segments to the total consolidated figures.
The Group evaluates performance based on revenue and operating income. The Group does not have inter-segment transactions. Assets that are directly attributable or allocable to the segments have been separately disclosed.
SP HGT All Other Total 6 months to June 30, 2010 $'M $'M $'M $'M _____________ ____________ ___________ ___________ Product sales 1,092.6 389.8 - 1,482.4 Royalties 102.8 - 75.2 178.0 Other revenues 1.2 1.3 2.6 5.1 _____________ ____________ ___________ ___________ Total revenues 1,196.6 391.1 77.8 1,665.5 _____________ ____________ ___________ ___________ Cost of product sales(1) 165.0 56.0 - 221.0 Research and development(1) 158.7 119.3 - 278.0 Selling, general and administrative(1) 486.1 124.7 103.5 714.3 Gain on sale of product rights (4.1) - - (4.1) Reorganization costs 6.7 - 6.9 13.6 Integration and acquisition costs 0.6 - - 0.6 _____________ ____________ ___________ ___________ Total operating expenses 813.0 300.0 110.4 1,223.4 _____________ ____________ ___________ ___________ Operating income/(loss) 383.6 91.1 (32.6) 442.1 _____________ ____________ ___________ ___________ Total assets 2,081.5 1,574.3 1,213.1 4,868.9 Long-lived assets(2) 169.5 587.4 48.8 805.7 Capital expenditure on long-lived assets(2) 5.0 187.4 4.0 196.4 _____________ ___________ ___________ ___________
(1) Depreciation from manufacturing plants ($18.4 million) and amortization offavorable manufacturing contracts ($0.9 million) is included in Cost of productsales; depreciation of research and development assets ($7.2 million) isincluded in Research and development; and all other depreciation andamortization ($101.3 million) is included in Selling, general andadministrative.
(2) Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred tax assets, investments, income tax receivable and financial instruments).
SP HGT All Other Total 6 months to June 30, 2009 $'M $'M $'M $'M _____________ ____________ ___________ ___________ Product sales 1,059.7 254.6 - 1,314.3 Royalties 16.9 - 100.6 117.5 Other revenues 8.1 1.8 5.7 15.6 _____________ ____________ ___________ ___________ Total revenues 1,084.7 256.4 106.3 1,447.4 _____________ ____________ ___________ ___________ Cost of product sales(1) 131.3 41.7 7.0 180.0 Research and development(1) 221.7 117.6 5.3 344.6 Selling, general and administrative(1) 465.8 93.9 93.6 653.3 Reorganization costs 5.1 - - 5.1
Integration and acquisition costs 1.5 2.3 -
3.8 _____________ ____________ ___________ ___________ Total operating expenses 825.4 255.5 105.9 1,186.8 _____________ ____________ ___________ ___________ Operating income 259.3 0.9 0.4 260.6 _____________ ____________ ___________ ___________ Total assets 2,169.5 1,278.3 773.5 4,221.3 Long-lived assets(2) 211.0 331.0 60.1 602.1
Capital expenditure on long-lived
assets(2) 21.0 82.7 6.7 110.4 _____________ ___________ ___________ ___________
(1) Depreciation from manufacturing plants ($11.5 million) and amortization offavorable manufacturing contracts ($0.9 million) is included in Cost of productsales; depreciation of research and development assets ($7.8 million) isincluded in Research and development; and all other depreciation andamortization ($97.5 million) is included in Selling, general andadministrative.
(2) Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred tax assets, investments, income tax receivable and financial instruments).
19. Share-based compensation plans
The Group grants stock-settled share appreciation rights ("SARs") andperformance share awards ("PSAs") over ordinary shares and ADSs under the ShirePortfolio Share Plan (Parts A and B) to Executive Directors and employees. Inthe six months to June 30, 2010 the Group amended the rules of the ShirePortfolio Share Plan effective on a prospective basis for newly granted awards.After this amendment SARs and PSAs granted under the Shire Portfolio Share Plan(Part A & B) to Executive Directors are exercisable subject to performance andservice criteria, and awards made to employees below the level of ExecutiveDirector are exercisable subject only to service criteria. The amendments had the following principal effect on the terms and conditionsof SARs and PSAs: i) the contractual life of SARs has been extended from fiveto seven years, ii) the vesting period of SARs and PSAs granted to employeesbelow the level of Executive Vice President allows for graded vesting ratherthan mandatory cliff vesting, and iii) awards granted to Executive Directorscontain performance rather than market conditions. In the six months to June30, 2010 the Group has not recorded any significant incremental compensationcosts as a result of the above amendments to the Shire Portfolio Share Plan. 20. Subsequent Events
On August 3, 2010 Shire announced that it was launching a voluntary publictakeover offer for all the shares in Movetis, the Belgium-based Europeanspecialty GI company, for a fully diluted equity purchase price of €428 million(or €19 per share) in cash. Movetis' board unanimously supports the transactionand institutional shareholders holding 38.9% of Movetis' shares haveunconditionally agreed to accept the offer. It is anticipated that the takeoveroffer, which is contingent upon the fulfilment of certain conditions, will openfor acceptance in September. The proposed acquisition will be funded out of Shire's current cash resources.In August 2010, Shire deposited €428 million in a blocked account to be usedexclusively for the purpose of paying the purchase price for the proposedacquisition. Whilst deposited in the blocked account, the deposited funds willbe presented as restricted cash on the Group's balance sheet. This proposed acquisition will significantly broaden Shire's global GIportfolio and adds growing revenues from RESOLOR® (prucalopride), a newchemical entity indicated for the symptomatic treatment of chronic constipationin women in whom laxatives fail to provide adequate relief. Movetis has therights to RESOLOR in the EU, Iceland, Lichtenstein, Norway and Switzerland andis entitled to royalties on sales of RESOLOR outside of Europe from J&J. Theproposed acquisition also brings to Shire world-class research and developmenttalent and a promising GI pipeline. Non GAAP MeasuresThis Half Yearly Report contains financial measures not prepared in accordancewith US GAAP. These measures are referred to as "Non GAAP" measures andinclude: Non GAAP diluted earnings per ADS; and Non GAAP cash generation. TheseNon GAAP measures exclude the effect of certain cash and non-cash items, bothrecurring and non-recurring, that Shire's management believes are not relatedto the core performance of Shire's business.
These Non GAAP financial measures are used by Shire's management to make operating decisions because they facilitate internal comparisons of Shire's performance to historical results and to competitors' results. Shire's Remuneration Committee uses certain key Non GAAP measures when assessing the performance and compensation of employees, including Shire's Executive Directors.
The Non GAAP measures are presented in this Half Yearly Report as Shire'smanagement believe that they will provide investors with a means of evaluating,and an understanding of how Shire's management evaluates, Shire's performanceand results on a comparable basis that is not otherwise apparent on a US GAAPbasis, since many one-time, infrequent or non-cash items that Shire'smanagement believe are not indicative of the core performance of the businessmay 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 Non GAAP earnings:
Amortization and asset impairments:
Intangible asset amortization and impairment charges; and
Other than temporary impairment of investments.
Acquisitions and integration activities:
Upfront payments and milestones in respect of in-licensed and acquired products;
Costs associated with acquisitions, including transaction costs, and fair value adjustments on contingent consideration and acquired inventory; and
Costs associated with the integration of companies.
Divestments, re-organizations and discontinued operations
Gains and losses on the sale of non-core assets;
Costs associated with restructuring and re-organization activities;
Termination costs; and
Income / (losses) from discontinued operations.
The following table reconciles US GAAP net cash provided by operating activities to Non GAAP cash generation:
6 months to June 30, 2010 2009 $M $M
Net cash provided by operating activities 469.9
256.0
Tax and interest payments, net 217.7
135.0
Payments for acquired and in-licensed products -
36.9 Foreign exchange on cash 6.1 (1.5) Non GAAP cash generation 693.7 426.4
Independent review report to Shire plc
We have been engaged by Shire plc to review the consolidated condensed set offinancial statements in the Half Yearly Report for the six months ended June,30 2010 which comprises the consolidated balance sheet, consolidated statementsof income, consolidated statement of changes in equity, consolidated statementsof comprehensive income, the consolidated statements of cash flows and relatednotes 1 to 20. We have read the other information contained in the Half YearlyReport and considered whether it contains any apparent misstatements ormaterial inconsistencies with the information in the consolidated condensed
setof financial statements.
This report is made solely to Shire plc in accordance with International Standard on Review Engagements (UK and Ireland) 2410 "Review of Interim Financial Information performed by the Independent Auditor of the Entity"
issued by the Auditing Practices Board. Our work has been undertaken so thatwe might state to Shire plc those matters we are required to state to them inan independent review report and for no other purpose. To the fullest extentpermitted by law, we do not accept or assume responsibility to anyone otherthan Shire plc, for our review work, for this report, or for the conclusions wehave formed. Directors' responsibilities
The Half Yearly Report is the responsibility of, and has been approved by, theDirectors. The Directors are responsible for preparing the Half Yearly Reportin accordance with the Disclosure Rules and Transparency Rules of the UnitedKingdom's Financial Services Authority. As disclosed in note 1(a), the annual financial statements of the Group areprepared in accordance with accounting policies generally accepted in theUnited States of America ("US GAAP"). The consolidated condensed set offinancial statements included in this Half Yearly Report have been prepared inaccordance with the accounting policies the Group intends to use in preparingits next annual financial statements.
Our responsibility
Our responsibility is to express to Shire plc a conclusion on the consolidatedcondensed set of financial statements in the Half Yearly Report based on ourreview. Scope of Review
We conducted our review in accordance with International Standard on ReviewEngagements (UK and Ireland) 2410, "Review of Interim Financial InformationPerformed by the Independent Auditor of the Entity" issued by the AuditingPractices Board for use in the United Kingdom. A review of interim financialinformation consists of making inquiries, primarily of persons responsible forfinancial and accounting matters, and applying analytical and other reviewprocedures. A review is substantially less in scope than an audit conducted inaccordance with International Standards on Auditing (UK and Ireland) andconsequently does not enable us to obtain assurance that we would become awareof all significant matters that might be identified in an audit. Accordingly,we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us tobelieve that the consolidated condensed set of financial statements in the HalfYearly Report for the six months ended June 30, 2010 is not prepared, in allmaterial respects, in accordance with US GAAP and with the Disclosure andTransparency Rules of the United Kingdom's Financial Services Authority. Deloitte LLPChartered AccountantsLondon, United KingdomAugust 11, 2010
vendorRelated Shares:
Shire