Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth)....
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Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY
Growth). Revenue Guidance Upgrade.
BASINGSTOKE, England and PHILADELPHIA, July 31 /PRNewswire-FirstCall/ --
Shire Limited (LSE: SHP, NASDAQ: SHPGY) the global specialty
biopharmaceutical company announces results for the three months to June 30,
2008. Q2 2008 Financial Highlights
- Product sales up 40% to $706m
- Product sales excluding ADDERALL XR(R) up 64% to $409m
- New product sales(1) $243m, 34% of product sales (2007: 18%)
- Total revenues up 35% to $776m
- US GAAP earnings per ADS: loss $0.44 (2007: loss $9.93)
- Non GAAP earnings per ADS up 70% to $0.95 (2007: $0.56)
- Revenue guidance upgraded - 2008 revenue growth now expected to
be at least 20% (previous guidance: mid to high teens)
(1) New product sales comprise DAYTRANA, ELAPRASE, FOSRENOL, LIALDA /
MEZAVANT and VYVANSE
Angus Russell, Chief Executive Officer, commented:
"Shire continues to deliver strong growth and broaden its business in
specialty biopharmaceuticals. Our product sales for the quarter were up 40%
on Q2 2007 with sales of new products now comprising 34% of total product
sales. At $409m, product sales excluding ADDERALL XR were up 64% reflecting
the success of our strategy to build a pipeline and portfolio for Shire's
future growth.
"We are pleased with the performance of ELAPRASE, FOSRENOL, LIALDA,
REPLAGAL and VYVANSE and are looking forward to the continued growth of
VYVANSE in the US supplemented by the recent launch of the adult indication,
the additional dosage strengths and the back-to-school season.
"We have decided to commence a phased discontinuation of DYNEPO.
Resources supporting this product will be re-directed to faster growing,
profitable core global products.
"The proposed acquisition of Jerini AG in Germany, which we expect to
complete in Q3, is an excellent match for our business and we expect to
benefit from both its near term revenues and long term growth. The recent EU
approval of Jerini's orphan drug FIRAZYR(R) reinforces our confidence in this
product.
In addition to FIRAZYR, we have acquired seven new products since the
start of 2007 which supports delivery of our long term strategy. Shire is in
line to deliver another set of excellent results for 2008 and is upgrading
its full year guidance for total revenue growth from the mid to high teens to
at least 20%." Q2 2008 Unaudited Results
Q2 2008 Q2 2007
US Non US Non
GAAP Adjustments GAAP(1) GAAP Adjustments GAAP(1)
$M $M $M $M $M $M
Revenues 775.6 - 775.6 574.9 - 574.9
Operating (67.3) 313.8 246.5 (1,775.1) 1,915.8 140.7
(loss)/
income
Net (79.0) 267.1 188.1 (1,811.3) 1,916.6 105.3
(loss)/income
Diluted
(loss)/
earnings
per:
Ordinary (14.6c) 46.2c 31.6c (331.0c) 349.6c 18.6c
share
ADS (43.8c) 138.6c 94.8c (993.0c) 1,048.8c 55.8c
Note: Average exchange rates for Q2 2008 and Q2 2007 were $1.97: GBP1.00
and $1.98: GBP1.00, respectively.
(1) Non GAAP operating income, Non GAAP net income, Non GAAP diluted
earnings per ordinary share and Non GAAP diluted earnings per ADS
exclude intangible asset amortization charges and other items as
described on page 7. For an explanation of why Shire's management
believes that these Non GAAP financial measures are useful to
investors, see page 7. For a reconciliation of these Non GAAP
financial measures to the most directly comparable financial
measures prepared in accordance with US GAAP, see pages 25-28.
2008 Financial Outlook
Apart from the updates below, we reiterate the guidance given as part of
the first quarter 2008 results, including confirmation that we expect VYVANSE
sales to be at the lower end of a range of $350 to $400 million. In
combination, the updates constitute upgraded guidance following a strong
performance in the first half of 2008. This guidance excludes revenues and
costs associated with the proposed acquisition of Jerini AG ("Jerini"):
- Revenue growth to be at least 20% (previous guidance: mid to high
teens);
- Capital expenditure to be in the range $300 to $330 million (previous
guidance: $320 to $350 million);
- Depreciation to be approximately $75 million (previous guidance:
approximately $90 million); and
- R&D spend is being increased to approximately $500 million (previous
guidance: $465 to $490 million). This increase reflects Shire's strong
pipeline with the completion during Q2 of the acquisition of
METAZYM(TM) (arylsulfatase-A), and the acceleration of various core
projects including the Phase 3 trials for velaglucerase alfa.
The following items are excluded from net (loss)/income in calculating
Non GAAP earnings, all of which are excluded from our financial outlook:
- Intangible asset amortization charges;
- Gains and losses on the sale of non-core assets;
- Upfront payments and milestones in respect of in-licensed and acquired
products, including the payment to Zymenex A/S ("Zymenex") for METAZYM
of $135 million;
- Intangible asset impairment charges, inventory write-downs and exit
costs of $150 million associated with DYNEPO, which Shire has decided
to stop commercializing;
- Costs associated with the introduction of a new holding company,
expected to be approximately $15 million; and
- Taxes associated with these items.
In addition depreciation, which is included in cost of product sales, R&D
costs and selling, general and administrative costs in our GAAP results, has
been separately disclosed for the presentation of non GAAP earnings (see
pages 25 to 28).
Recent Developments
Proposed acquisition of Jerini
On July 3, 2008 Shire announced that it was launching a voluntary public
takeover offer for all shares in Jerini for an equity purchase price of
EUR328 million. Shire has also invested approximately EUR21 million in return
for the subscription of newly issued Jerini shares, equating to approximately
9% of the increased share capital. Jerini's Supervisory and Management Boards
unanimously support the transaction and will recommend acceptance of the
offer to its shareholders. Subject to completion of certain sale and purchase
agreements, Shire has rights to approximately 76% of Jerini's share capital
before the receipt of any takeover offer acceptances. Once the offer document
is posted, it is anticipated that the offer will be open for acceptance by
the remaining shareholders until the end of Q3 2008 and is contingent upon
the fulfilment of certain customary terms and conditions, including approval
by relevant merger control authorities.
The proposed acquisition will add Jerini's hereditary angioedema ("HAE")
product, FIRAZYR(R) (icatibant), (expected to be launched in the EU in H2
2008) to Shire's Human Genetic Therapies ("HGT") portfolio.
On July 15, 2008 Shire announced that the European Commission had granted
Jerini marketing authorization for FIRAZYR in the treatment of acute attacks
of HAE which allows Jerini to market FIRAZYR in the European Union's 27
member states, making it the first product to be approved in all EU countries
for the treatment of HAE.
On July 17, 2008 the German Federal Cartel Office issued confirmation of
merger clearance.
For further details see Shire's press releases of July 3 and July 15,
2008.
DYNEPO
The Company has today announced that it has decided to stop the
commercialization of DYNEPO. Changes in the external environment including
the launch of several bio-similars at lower prices have proved challenging
for DYNEPO, a gene-activated erythropoietin indicated for use in treating
anemia associated with kidney disease, making it an uneconomic product for
Shire. Product sales will wind down over the second half of 2008 as all
patients are transferred off DYNEPO by the end of the year.
Shire has recorded charges of $150.3 million in the quarter ended June
30, 2008 to cover intangible asset impairment, inventory write-down and other
exit costs. The cash effect of these exit costs is approximately $20 million.
Product Highlights
New Product Launches - subject to obtaining relevant
regulatory/governmental approvals, product launches planned over the next two
years include:
- MEZAVANT(R) (mesalazine) in certain EU countries during
2008;
- INTUNIV(TM) (guanfacine) for use in children and adolescents
in the US in 2009;
- FOSRENOL(R) (lanthanum carbonate) in the pre-dialysis
Chronic Kidney Disease ("CKD") market in the US in 2009;
- DAYTRANA(TM) (methylphenidate transdermal system) for use in
children in the EU in 2009 and adolescents in the US in 2010; and
- Velaglucerase alfa for the treatment of Gaucher disease in
the US and the EU in 2010.
VYVANSE(TM) (lisdexamfetamine dimesylate) - Attention Deficit and
Hyperactivity Disorder ("ADHD")
- On April 23, 2008 Shire announced that the Food and Drug Administration
("FDA") had approved the adult indication for VYVANSE, making it the
first and only once-daily prodrug stimulant approved to treat adults
with ADHD. Shire launched VYVANSE for adult ADHD in June 2008.
- On May 8, 2008 Shire announced the results of a Phase 3 pivotal study
in which VYVANSE demonstrated significant improvements in ADHD
symptoms in adults and met all safety and efficacy endpoints.
- By June 30, 2008 Shire had agreements with nine of its top eleven
managed care organizations for VYVANSE.
- On July 2, 2008 Shire shipped to wholesalers stocks of three additional
dosage strengths (20mg, 40mg and 60mg) for VYVANSE representing product
sales of approximately $24 million. These product sales will be
recognized into revenue in Q3 2008.
LIALDA(R)/MEZAVANT - Ulcerative Colitis
- On April 1, 2008 the product was launched in Ireland as MEZAVANT XL
and, following approval in Luxembourg on June 26, 2008, is now approved
in 15 countries. Further launches are planned in certain other EU
countries during 2008, subject to the successful conclusion of pricing
and reimbursement negotiations.
- During April 2008, TAP Pharmaceutical Products Inc. ("TAP") commenced
co-promotion of LIALDA in the US in accordance with the co-promotion
agreement entered into on March 26, 2008. This agreement adds more than
500 additional sales representatives from TAP which will increase the
reach and frequency of sales calls covering an additional 22,000
doctors.
FOSRENOL - Hyperphosphatemia
- Following the launch of the product in Slovenia and Switzerland during
the second quarter of 2008 and in Malta and Malaysia in July 2008,
FOSRENOL is now available in 29 countries.
ELAPRASE(R) - Hunter syndrome
- During the three months to June 30, 2008 ELAPRASE was approved for
commercial sale in Brazil. ELAPRASE is now approved in 40 countries
worldwide.
Pipeline Highlights
INTUNIV(TM) - ADHD
- On May 8, 2008 Shire announced pivotal trial results for INTUNIV which
is in registration in the US. The data demonstrated that INTUNIV has
significant efficacy in reducing ADHD symptoms for patients taking the
medication when compared to patients taking a placebo at all measured
time points up to 24 hours after dosing.
JUVISTA(R) - Improvement of scar appearance
- Nine Phase 2 efficacy trials for JUVISTA have now been reported of
which seven demonstrated statistically significant efficacy. Further
Phase 2 clinical trials in other surgery types are ongoing and are
expected to report during 2008 and 2009. Renovo Limited ("Renovo") is
also intending to initiate a Phase 3 trial in the second half of 2008
in support of Renovo's filing of a European regulatory dossier and has
recently announced that the European Medicines Agency ("EMEA") has
given clearance to commence Phase 3 trials. Shire is considering the
EMEA advice to Renovo and Renovo's EU Phase 3 plans and will give
guidance on the US development plan in due course.
Velaglucerase alfa - Gaucher disease
- Shire has completed enrolment in a worldwide Phase 3 clinical program
for velaglucerase alfa, an enzyme replacement therapy being developed
for the treatment of Gaucher disease. This comprehensive development
program includes the evaluation of velaglucerase alfa in naive patients
and patients previously treated with imiglucerase across three clinical
studies. It is anticipated that this development program will support
global filings in the second half of 2009.
METAZYM (HGT-1111) - Metachromatic Leukodystrophy ("MLD")
- METAZYM is being investigated for the treatment of MLD and has
completed a Phase 1b clinical trial in twelve patients in Europe and an
extension to this study is ongoing. The product has been granted orphan
drug designation in the US and in the EU. The current plan is to
initiate a Phase 2/3 clinical trial by the end of 2008. This product
will now be referred to as HGT-1111.
PLICERA(TM) (HGT-3410) - Gaucher disease
- In March 2008 Amicus Therapeutics Inc. ("Amicus") announced positive
data from its Phase 2 clinical trial for PLICERA. Results from this
Phase 2 trial support the previously reported interim findings that
PLICERA was generally safe and well tolerated at all doses and
increased target enzyme activity levels in a majority of patients.
Shire has rights to PLICERA in markets outside the US.
HGT-3510 - Pompe disease
- In June 2008 Amicus initiated Phase 2 clinical trials of HGT-3510, an
orally administered, small molecule pharmacological chaperone being
jointly developed for the treatment of Pompe disease by Shire and
Amicus. Shire has rights to HGT-3510 in markets outside the US.
HGT-1410 - Sanfilippo syndrome (Mucopolysaccharidosis IIIA)
- On May 22, 2008 orphan drug designation was granted by the FDA for
HGT-1410, an enzyme replacement therapy being developed for the
treatment of Sanfilippo syndrome, a lysosomal storage disorder.
Pre-clinical development for this product is continuing.
Business Highlights
A new listed holding company for the Shire group
- On May 23, 2008 Shire Limited, a public company with its primary
listing on the London Stock Exchange (secondary listing on NASDAQ),
incorporated in Jersey and tax resident in the Republic of Ireland,
became the holding company of the Shire group, pursuant to a scheme of
arrangement under Sections 895 to 899 of the United Kingdom Companies
Act 2006 (the "Scheme"). The Scheme was approved by the High Court of
England and Wales and the shareholders of Shire plc, the former holding
company of the Shire group. The introduction of a new holding company
tax resident in Ireland, is designed to help protect Shire's tax
position.
- Immediately prior to the Scheme becoming effective, Shire Limited was
substituted for Shire plc as principal obligor under Shire's $1.1
billion 2.75 per cent convertible bond due 2014 originally issued by
Shire plc (and the terms and conditions of such bonds were accordingly
amended).
- Shire incurred costs associated with the introduction of the new
holding company of $12.2 million in the six months to June 30, 2008.
Completion of acquisition of METAZYM
- On June 4, 2008 Shire completed the acquisition of the global rights to
the clinical candidate arylsulfatase-A, currently known as METAZYM,
from Zymenex for $135 million in cash (see Pipeline Highlights above).
This acquisition is expected to bring forward Shire's entry into the
MLD market.
Sale of non-core assets
- Following the transfer of the relevant marketing consents
Shire recognised previously deferred gains of $9.1 million arising from
product divestments in 2007, including $8.6 million from the sale of
non-core products to Laboratorios Almirall S.A ("Almirall") in 2007.
HGT analyst day
- Shire is planning an analyst day for November 18, 2008 in
Lexington, Massachusetts - specific details will be issued nearer the
date.
Share purchases
- In the three months to June 30, 2008 1.4 million American
Depositary Shares ("ADSs") were acquired by the Employee Share
Ownership Trust ("ESOT") for a cash consideration of $71.0 million
(2007: $55.5 million) at an average ADS price of $50.12.
Board changes
- On June 18, 2008 Shire's former Chief Financial Officer,
Angus Russell, became Chief Executive Officer and Shire's former Chief
Executive Officer Matthew Emmens became Chairman and Non-Executive
Director. Shire's former Chairman, Dr James Cavanaugh, retired from the
Shire Board and David Kappler became Deputy Chairman.
- On July 1, 2008 Graham Hetherington joined Shire as Chief
Financial Officer and Executive Board Director. Graham Hetherington has
a broad range of experience in senior financial roles having most
recently held positions as Chief Financial Officer of Bacardi (2007)
and Allied Domecq plc (1999-2005).
- On April 24, 2008 Shire announced that Michael Rosenblatt
M.D. joined the Shire Board as a Non-Executive Director.
- On July 29, 2008 Robin Buchanan, due to his other
commitments, stepped down from the Shire Board on the completion of his
term of office.
Dividend
In respect of the six months ended June 30, 2008, the Board resolved to
pay an interim dividend of 2.147 US cents per ordinary share (2007: 2.147 US
cents per share).
Dividend payments will be made in Pounds Sterling to Ordinary
shareholders and in US Dollars to holders of American Depository Shares
("ADSs"). A dividend of 1.085 pence per ordinary share (2007: 1.048 pence)
and 6.441 US cents per ADS (2007: 6.441 US cents) will be paid on October 9,
2008 to persons whose names appear on the register of members of the Company
at the close of business on September 12, 2008.
As previously disclosed Shire intends to put in place Income Access Share
arrangements enabling shareholders to choose whether they receive their
dividends from a company resident for tax purposes in the Republic of Ireland
or from a company resident for tax purposes in the United Kingdom. The
arrangements will be in place for the interim dividend. In accordance with
the Shire ADS Deposit Agreement, the ADS Depositary will make an election on
behalf of all holders of ADSs to receive UK sourced dividends. Details of the
Income Access Share arrangements can be found in the Scheme Circular issued
on April 16, 2008, which is available on the Company's website
http://www.shire.com.
Dial in details for the live conference call for investors 14:30
BST/09:30 EDT on July 31, 2008:
UK and International dial in: +44(0)2030234496
US dial in: 1-8669665335
Password/Conf ID: Shire
Webcast:
http://www.shire.com/shire/InvestorRelations/showevent.jsp?event=73&tn=2&m1=3
3
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this hyperlink into your Internet browser's URL address field. Remove the
space if one exists.)
Notes to editors
Shire Limited
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit and hyperactivity
disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)
diseases as well as opportunities in other therapeutic areas to the extent
they arise through acquisitions. Shire's in-licensing, merger and acquisition
efforts are focused on products in specialist markets with strong
intellectual property protection and global rights. Shire believes that a
carefully selected and balanced portfolio of products with strategically
aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website:
http://www.shire.com
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995
Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve a number
of risks and uncertainties and are subject to change at any time. In the
event such risks or uncertainties materialize, the Company's results could be
materially affected. The risks and uncertainties include, but are not limited
to, risks associated with: the inherent uncertainty of pharmaceutical
research, product development, manufacturing and commercialization including,
but not limited to, the establishment in the market of VYVANSE(TM)
(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder
("ADHD")); the impact of competitive products, including, but not limited to,
the impact of those on the Company's ADHD franchise; patents, including but
not limited to, legal challenges relating to the Company's ADHD franchise;
government regulation and approval, including but not limited to the expected
product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD);
the Company's ability to secure new products for commercialization and/or
development; the Company's proposed offer for Jerini AG, including but not
limited to, the Company's ability to successfully complete the offer and
integrate Jerini AG, as well as realize the anticipated benefits of the
acquisition; and other risks and uncertainties detailed from time to time in
the Company's filings with the Securities and Exchange Commission, including
the Company's Annual Report on Form 10-K for the year ended December 31, 2007.
Non GAAP Measures
This press release contains financial measures not prepared in accordance
with US GAAP. These measures are referred to as "non GAAP" measures and
include Non GAAP operating income, Non GAAP net income, Non GAAP diluted
earnings per ordinary share, Non GAAP diluted earnings per ADS and effective
tax rate on Non GAAP income. These non GAAP measures exclude the effect of
certain cash and non-cash items, both recurring and non-recurring, that
Shire's management believes are not related to the core performance of
Shire's business.
These non GAAP financial measures are used by Shire's management to make
operating decisions because they facilitate internal comparisons of the
Company's performance to historical results and to competitors' results.
These measures are also considered by Shire's Remuneration Committee in
assessing the performance and compensation of employees, including its
executive directors.
The non GAAP measures are presented in this press release as the
Company's management believe that they will provide investors with a means of
evaluating, and an understanding of how Shire's management evaluates, the
Company's performance and results on a comparable basis that is not otherwise
apparent on a US GAAP basis, since many one-time, infrequent or non-cash
items that the Company's management believe are not indicative of the core
performance of the business may not be excluded when preparing financial
measures under US GAAP.
These non GAAP measures should not be considered in isolation from, as
substitutes for, or superior to financial measures prepared in accordance
with US GAAP.
The following are trademarks either owned or licensed by Shire Limited or
companies within the Shire group which are the subject of trademark
registrations in certain territories, or which are owned by third parties as
indicated and referred to in this press release:
Shire Product Active ingredient
ADDERALL(R) XR (mixed salts of a single-entity amphetamine)
AMIGAL(TM) (migalastat hydrochloride) (trademark of
Amicus Therapeutics ("Amicus"))
CALCICHEW(R) range (calcium carbonate with or without Vitamin D3)
CARBATROL (carbamazepine - extended-release capsules)
COMBIVIR (R) (lamivudine) (trademark of GlaxoSmithKline
("GSK"))
DAYTRANA(TM) (methylphenidate transdermal system)
DYNEPO(R) (epoetin delta) (trademark of Sanofi-Aventis)
ELAPRASE(R) (idursulfase)
EPIVIR (R) (lamivudine) (trademark of GSK)
EPZICOM(R)/KIVEXA (lamivudine) (trademark of GSK)
(EPZICOM)
FIRAZYR(R) (icatibant) (trademark of Jerini)
FOSRENOL(R) (lanthanum carbonate)
INTUNIV(TM) (guanfacine - extended release)
JUVISTA(R) (human TGFIsquared3) (trademark of Renovo)
LIALDA(R) (mesalamine)
METAZYM(TM) (arylsulfatase-A)
MEZAVANT(R) (mesalazine)
PENTASA(R) (mesalamine) (trademark of Ferring)
PLICERA(TM) (isofagomine tartrate) (trademark of Amicus)
RAZADYNE(R) (galantamine) (trademark of Johnson & Johnson
("J&J"))
RAZADYNE(R) ER (galantamine) (trademark of J&J)
REMINYL(R) (galantamine hydrobromide) (UK and Republic of
Ireland)
REMINYL (galantamine) (trademark of J&J, excluding UK
and Republic of Ireland)
REMINYL XL(TM) (galantamine hydrobromide) (UK and Republic of
Ireland)
REMINYL XL (galantamine) (trademark of J&J, excluding UK
and Republic of Ireland)
REPLAGAL(R) (agalsidase alfa)
VYVANSE(TM) (lisdexamfetamine dimesylate)
XAGRID(TM) (anagrelide hydrochloride)
ZEFFIX (lamivudine) (trademark of GSK)
3TC (lamivudine) (trademark of GSK)
OVERVIEW OF US GAAP FINANCIAL RESULTS
1. Introduction
Summary of Q2 2008
Revenues from operations for the three months to June 30, 2008 increased
by 35% to $775.6 million (2007: $574.9 million).
The operating loss for the three months to June 30, 2008 was $67.3
million (2007 loss: $1,775.1 million). The loss in the second quarter of 2008
was due to the $135.0 million write-off of in-process research and
development in respect of the acquisition of METAZYM, and the intangible
asset impairment charge, inventory write-down and exit costs ($150.3 million)
in respect of DYNEPO, which Shire has decided to stop commercialising. The
operating loss in the second quarter of 2007 was due to the $1,896.0 million
write-off of in-process research and development acquired as part of the $2.6
billion acquisition of New River Pharmaceuticals Inc. ("New River").
Cash inflow from operating activities for the three months to June 30,
2008 decreased by 1% to $180.4 million (2007: $183.0 million), as a result of
the payment of $135.0 million in respect of the acquisition of METAZYM offset
by strong cash generation from underlying operations.
Cash, cash equivalents and restricted cash at June 30, 2008 totaled
$835.5 million (December 31, 2007: $802.0 million). The increase of $33.5
million was less than the cash inflow from operating activities primarily due
to the purchase of property, plant and equipment, payments to acquire shares
by the ESOT and the dividend payment.
2. Product sales
For the three months to June 30, 2008 product sales increased by 40% to
$705.7 million (2007: $504.2 million) and represented 91% of total revenues
(2007: 88%).
Product Highlights
US Rx US Average
Sales Sales Growth Quarterly
Product $M Growth(2) (1) (2) Market Share(1)
Specialty
Pharmaceuticals
ADDERALL XR 296.4 16% -6% 23.1%
VYVANSE 65.2 n/a n/a 7.4%
DAYTRANA 22.6 14% -11% 1.8%
LIALDA / MEZAVANT 32.0 n/a n/a 10.8%
PENTASA 44.8 11% -2% 16.8%
FOSRENOL 42.4 73% -4% 8.2%
XAGRID 20.6 20% n/a n/a
Human Genetic Therapies
ELAPRASE 80.8 89% n/a n/a
REPLAGAL 44.7 40% n/a n/a
(1) Product specific prescription data is provided by IMS Health
("IMS"), a leading global provider of business intelligence for the
pharmaceutical and healthcare industries. All other US market share
data stated in the text below is also provided by IMS.
(2) Compared to Q2 2007.
Specialty Pharmaceuticals
US ADHD market share
Shire's average quarterly market share of the US ADHD market rose to
32.3% in the three months to June 30, 2008 (2007: 28.6%), driven by the
introduction of VYVANSE in July 2007. The overall US ADHD market grew by 7%
in the same period. Shire has the leading portfolio of products in the US
ADHD market.
ADDERALL XR - ADHD
As a result of the launch of VYVANSE in July 2007, ADDERALL XR's average
quarterly market share of the US ADHD market for Q2 2008 fell to 23.1% (2007:
26.3%), a decrease of 12% compared to Q2 07. US prescriptions for ADDERALL XR
for the period to June 30, 2008 decreased by 6% compared to the same period
in 2007 due to the 12% decrease in average market share offset by 7% growth
in the US ADHD market.
Sales of ADDERALL XR for the three months to June 30, 2008 were $296.4
million, an increase of 16% compared to the same period in 2007 (2007: $255.1
million). Product sales grew despite the decline in US prescriptions
primarily due to price increases in October 2007 and April 2008.
Litigation proceedings concerning Shire's ADDERALL XR patents are
ongoing. Further information on this litigation can be found in our filings
with the US Securities and Exchange Commission ("SEC"), including our Annual
Report on Form 10-K for the year to December 31, 2007.
VYVANSE - ADHD
VYVANSE was launched in the US market in July 2007. Product sales for the
three months to June 30, 2008 were $65.2 million (2007: $nil) representing a
20% increase compared to sales of $54.4 million in Q1 2008.
Product sales growth was driven by a 15% increase in prescription demand
compared to Q1 2008 together with a price increase in May 2008. For the three
months to June 30, 2008 VYVANSE's average quarterly market share was 7.4% (Q1
08: 6.1%) of the US ADHD market.
By July 18, 2008 VYVANSE had achieved a US ADHD average weekly market
share of 8.2% based on weekly prescription volumes.
DAYTRANA - ADHD
Product sales for the three months to June 30, 2008 were $22.6 million
(2007: $19.9 million). Prescriptions declined by 11% from the same period
last year due to a reduction in DAYTRANA's average quarterly market share of
the US ADHD market to 1.8% (2007: 2.2%).
Despite the decrease in prescriptions compared to 2007, sales of DAYTRANA
grew 14% due to higher market growth, lower sales deductions and a price
increase in January 2008.
On June 9, 2008 Shire announced a voluntary recall of a limited portion
of DAYTRANA patches because certain patches did not meet their release liner
removal specifications which may have resulted in some patients and
caregivers having difficulties removing the liners. The voluntary recall was
not due to safety issues. Shire and Noven Pharmaceuticals Inc. (the
manufacturer of DAYTRANA) continue to pursue enhancements to the product and
to work closely with the FDA to implement changes that may improve the
usability of DAYTRANA. No interruption in the production of DAYTRANA is
anticipated.
US oral mesalamine market share
Shire's average quarterly market share of the US oral mesalamine market
rose to 27.6% in the three months to June 30, 2008 (2007: 19.9%), driven by
the introduction of LIALDA in March 2007. The overall US oral mesalamine
market grew by 1% in the same period.
LIALDA/MEZAVANT - Ulcerative colitis
Shire launched LIALDA in the US oral mesalamine market in March 2007, and
during the three months to June 30, 2008 LIALDA had reached an average
quarterly market share of 10.8%. LIALDA's product sales in the US for the
three months to June 30, 2008 were $30.9 million (2007: $5.0 million). This
compares to sales of $26.7 million and an average quarterly market share of
9.1% in Q1 2008.
Sales of MEZAVANT outside the US for the three months ended June 30, 2008
were $1.1 million (2007: $nil). The product was launched as MEZAVANT XL in
the UK in November 2007 and as MEZAVANT in Canada and Germany in January and
February 2008 respectively. Shire launched MEZAVANT XL in Ireland in April
2008 and further launches are planned in certain other EU countries during
2008, subject to the successful conclusion of pricing and reimbursement
negotiations.
PENTASA - Ulcerative colitis
Sales of PENTASA for the three months to June 30, 2008 were $44.8
million, an increase of 11% compared to the same period in 2007 (2007: $40.2
million). Sales grew despite a decrease in prescriptions due to the impact of
price increases in August 2007 and April 2008.
US prescriptions for the three months to June 30, 2008 were down 2%
compared to the same period in 2007 primarily due to a 3% decrease in
PENTASA's US average quarterly market share from 17.3% in 2007 to 16.8% in
2008, offset by a 1% increase in the US oral mesalamine market.
FOSRENOL - Hyperphosphatemia
FOSRENOL has been launched in 29 countries and global sales totaled $42.4
million for the three months to June 30, 2008 (2007: $24.5 million). Sales of
FOSRENOL outside the US for the three months ended June 30, 2008 were $19.3
million (2007: $9.0 million).
US sales of FOSRENOL for the three months to June 30, 2008 were up 49% to
$23.1 million compared to the same period in 2007 (2007: $15.5 million).
FOSRENOL's average quarterly prescription share of the US phosphate
binder retail market decreased to 8.2% for the three months to June 30, 2008
(2007: 8.5%). Contributing to product sales increase were price increases in
October 2007 and February 2008. As a consequence of focusing on specialist
physicians, clinics and dialysis centers, FOSRENOL's dollar share of the
non-retail market has increased to 17.2% in June 2008 compared to 12.3% in
June 2007.
Effective April 16, 2008 Shire and Abbott Laboratories Inc. mutually
agreed to terminate their Co-Promotion Agreement for FOSRENOL in the United
States. Shire will continue to promote FOSRENOL on its own in the United
States and throughout Europe.
XAGRID - Thrombocythemia
Sales for the three months to June 30, 2008 were $20.6 million, an
increase of 20% compared to the same period in 2007 (2007: $17.1 million).
Expressed in transaction currencies (XAGRID is primarily sold in Euros and
Pounds Sterling), sales increased by 10% due to growth in many of Shire's
existing markets, with exchange rate movements against the US dollar
accounting for the remaining 10% increase.
Human Genetic Therapies
ELAPRASE - Hunter syndrome
Sales for the three months to June 30, 2008 were $80.8 million, an
increase of 89% compared to the same period in 2007 (2007: $42.7 million).
The sales growth was primarily driven by increased unit sales in North
America, EU, Latin America, and Asia Pacific. The product is now approved for
marketing and commercial distribution in 40 countries. Exchange rate
movements against the US dollar contributed 12% to the growth compared to the
prior year.
REPLAGAL - Fabry disease
Sales for the three months to June 30, 2008 were $44.7 million, an
increase of 40% compared to the same period in 2007 (2007: $31.9 million).
The sales growth was primarily driven by increased unit sales in the EU and
Latin America. The product is now approved for marketing and commercial
distribution in 42 countries. Exchange rate movements against the US dollar
contributed 11% to the growth compared to the prior year.
3. Royalties
Royalty revenue increased by 1% to $64.8 million for the three months to
June 30, 2008 (2007: $64.0 million). The following table provides an analysis
of Shire's royalty income:
Royalty Highlights
Royalties Royalty
to Shire Growth(1)
Product $M %
3TC 35.6 -9%
ZEFFIX 10.8 4%
Other 18.4 26%
Total 64.8 1%
(1) Compared with Q2 2007.
3TC - HIV infection and AIDS
Shire receives royalties from GSK on worldwide 3TC sales. Royalties from
sales of 3TC for the three months to June 30, 2008 were $35.6 million, (2007:
$39.0 million). Excluding favorable foreign exchange movements of 7%, there
has been a decline of 16% compared to the same period in 2007. While the
nucleoside analogue market for HIV has continued to grow, competitive
pressures from new products and entrants to the market have increased,
leading to a decline in 3TC sales.
ZEFFIX - Chronic hepatitis B infection
Shire receives royalties from GSK on worldwide ZEFFIX sales. Royalties
from sales of ZEFFIX for the three months to June 30, 2008 were $10.8
million, an increase of 4% (2007: $10.4 million). The impact of foreign
exchange movements has contributed 13% to the reported growth; excluding
favorable foreign exchange movements there has been a decrease of 9% compared
to the same period in 2007.
OTHER
Other royalties are primarily in respect of REMINYL and REMINYL XL (known
as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide
(excluding the UK and the Republic of Ireland) by Janssen Pharmaceutical N.V.
("Janssen"), an affiliate of Johnson & Johnson. Shire has exclusive marketing
rights in the UK and the Republic of Ireland.
Sales of the REMINYL/RAZADYNE range, for the symptomatic treatment of
mild to moderately severe dementia of the Alzheimer's type, continue to grow.
Litigation proceedings relating to 3TC, COMBIVIR, EPIVIR, EPZICOM,
RAZADYNE, RAZADYNE ER, REMINYL, REMINYL XL and ZEFFIX are ongoing. Further
information on these litigations can be found in our filings with the SEC,
including our Annual Report on Form 10-K for the year to December 31, 2007.
4. Financial details
Cost of product sales
% of % of
product product
2008 sales 2007 sales
$m $m
_________ _________ _________ _________
Cost of product sales (US 142.9 20% 74.0 15%
GAAP)
Write-down of inventory and
exit costs of DYNEPO
(53.4) -
Depreciation (3.0) (2.9)
_________ _________
Cost of product sales (Non 86.5 12% 71.1 14%
GAAP)
_________ _________
The cost of product sales increased to $142.9 million for the three
months to June 30, 2008 (20% of product sales), up from $74.0 million in the
corresponding period in 2007 (2007: 15% of product sales).
For the three months to June 30, 2008 cost of product sales included
charges of $53.4 million (8% of product sales) (2007: $nil) relating to the
write-down of inventory and other exit costs for DYNEPO, which the Company
has decided to stop commercialising, and $3.0 million of depreciation (2007:
$2.9 million). Excluding these charges, cost of product sales decreased as a
percentage of product sales to 12% (2007: 14% of product sales). Research
and development ("R&D")
% of % of
product product
2008 sales 2007 sales
$m $m
_________ _________ _________ _________
R&D (US GAAP) 145.3 21% 103.1 20%
Payments in respect of
in-licensed products
- (5.9)
R&D commitments in respect
of DYNEPO
(6.5) -
Depreciation (3.1) (3.1)
_________ _________
R&D (Non GAAP) 135.7 19% 94.1 19%
_________ _________
R&D expenditure increased to $145.3 million for the three months to June
30, 2008 (21% of product sales), up from $103.1 million in the corresponding
period in 2007 (20% of product sales).
Excluding costs relating to the exiting of post-approval marketing
commitments for DYNEPO, which the Company has decided to stop commercialising
, and depreciation (see reconciliation table above), R&D expenditure
increased by $41.6 million over the same period in 2007, remaining consistent
as a percentage of product sales at 19% (2007: 19% of product sales).
Contributing to the increased R&D expenditure in the second quarter of 2008
over 2007 were costs associated with projects in-licensed and acquired since
the second half of 2007 including PLICERA, SPD550, AMIGAL, JUVISTA and
METAZYM together with Phase 3(b) and Phase 4 studies to support new product
launches. Selling, general and administrative ("SG&A")
% of % of
product product
2008 sales 2007 sales
$m $m
_________ _________ _________ _________
SG&A (US GAAP) 428.8 61% 280.6 56%
Costs associated with the
introduction of a new
holding company
(6.6) -
Amortization (31.0) (17.6)
Impairment of intangible (90.4) -
assets
Depreciation (11.2) (9.9)
_________ _________
SG&A (Non GAAP) 289.6 41% 253.1 50%
_________ _________
SG&A expenses increased to $428.8 million for the three months to June
30, 2008 from $280.6 million in the corresponding period in 2007. Excluding
an intangible asset impairment charge of $90.4 million in respect of DYNEPO,
amortization of intangible assets (increased due to VYVANSE, launched July
2007), costs associated with the introduction of the new holding company and
depreciation costs (see reconciliation table above), SG&A expenditure
increased by $36.5 million to $289.6 million.
Excluding these items, SG&A decreased as a percentage of product sales to
41% (2007: 50%) reflecting the sales impact in the three months to June 30,
2008 of the successful launches of VYVANSE, LIALDA/MEZAVANT and ELAPRASE.
Other increases in SG&A expenses mainly relate to the increase in
advertising, promotional and marketing spend to support VYVANSE and
LIALDA/MEZAVANT.
Gain on sale of product rights
For the three months to June 30, 2008 Shire recognized gains of $9.1
million (2007: $5.0 million) arising from product divestments in 2007,
including $8.6 million from the sale of non-core products to Almirall.
These gains were deferred at December 31, 2007 pending the transfer of
the relevant consents.
In process R&D charge
During the three months to June 30, 2008 the Company recorded an
in-process R&D charge of $135.0 million in respect of the acquisition of the
global rights to the clinical candidate arylsulfatase-A currently known as
METAZYM (HGT-1111), from Zymenex.
During the three months to June 30, 2007 Shire expensed the portion of
the New River purchase price allocated to in-process R&D totaling $1,896.0
million. This amount represented the value of those acquired development
projects which, at the acquisition date, had not been approved by the FDA or
other regulatory authorities, including the adult indication of VYVANSE.
Interest income
For the three months to June 30, 2008 Shire received interest income of
$6.5 million (2007: $14.9 million). Interest income primarily relates to
interest received on cash and cash equivalents. Interest income for the three
months to June 30, 2008 is lower than the same period in 2007 due to lower
average cash and cash equivalent balances and lower average US Dollar
interest rates.
Interest expense
For the three months to June 30, 2008 the Company incurred interest
expense of $16.8 million (2007: $28.0 million). In the three months to June
30, 2007 interest expense included a $7.9 million write-off of deferred
financing charges on repayment of term loans used to fund the acquisition of
New River following the issue of the $1.1 billion convertible bonds in May
2007.
In both three month periods to June 30, 2008 and 2007 interest expense
includes a provision for interest, which may be awarded by the Court in
respect of amounts due to those ex-Transkaryotic Therapies, Inc. ("TKT")
shareholders who have requested appraisal of the acquisition consideration
payable for their TKT shares. A trial date of December 10, 2008 has been set.
Further information on this litigation can be found in our filings with the
SEC, including our Annual Report on Form 10-K for the year to December 31,
2007.
Taxation
The effective rate of tax for the three months to June 30, 2008 was -0.3%
(2007: -1%). Excluding the tax effect of items excluded from non GAAP income
as outlined on pages 25-26, the effective rate of tax on non GAAP income is
20% (2007: 24%). The effective rate of tax on non GAAP income in the three
months to June 30, 2008 was 4% lower than the corresponding period in 2007
principally due to a permanent tax benefit arising on the debtor substitution
of the Company's convertible bond on the Scheme of Arrangement in May 2008.
Equity in earnings of equity method investees
Net losses of equity method investees of $1.9 million were recorded for
the three months to June 30, 2008 (2007: earnings $0.7 million). This
comprised earnings of $1.5 million from the 50% share of the anti-viral
commercialization partnership with GSK in Canada (2007: $3.1 million) offset
by losses of $3.4 million being the Company's share of losses in the
GeneChem, AgeChem and EGS Funds (2007: loss $2.4 million). FINANCIAL
INFORMATION
Unaudited US GAAP results for the three months to June 30, 2008
Consolidated Balance Sheets
June 30, December 31,
2008 2007
$M $M
_________ _________
ASSETS
Current assets:
Cash and cash equivalents 801.2 762.5
Restricted cash 34.3 39.5
Accounts receivable, net 463.5 441.5
Inventories, net 151.6 174.1
Assets held for sale 4.7 10.6
Deferred tax asset 135.0 143.3
Prepaid expenses and other current assets 100.3 125.3
_________ _________
Total current assets 1,690.6 1,696.8
Non current assets:
Investments 66.7 110.2
Property, plant and equipment, net 434.2 368.6
Goodwill 221.8 219.4
Other intangible assets, net 1,620.5 1,764.5
Deferred tax asset 142.2 143.7
Other non-current assets 26.8 26.9
_________ _________
Total assets 4,202.8 4,330.1
_________ _________
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses 677.2 674.2
Deferred tax liability 10.6 11.3
Liability to dissenting shareholders 490.5 480.2
Other current liabilities 40.3 96.5
_________ _________
Total current liabilities 1,218.6 1,262.2
Non-current liabilities:
Convertible bonds 1,100.0 1,100.0
Other long term debt 31.9 32.9
Deferred tax liability 338.1 332.4
Other non-current liabilities 388.0 375.6
_________ _________
Total non-current liabilities 1,858.0 1,840.9
_________ _________
Total liabilities 3,076.6 3,103.1
_________ _________
Unaudited US GAAP results for the three months to June 30, 2008
Consolidated Balance Sheets (continued)
June 30, December 31,
2008 2007
$M $M
_________ _________
Shareholders' equity:
Common stock of 5p par value; 1,000 million
shares authorized; and 559.9 million shares
issued and outstanding (2007: 750 million
shares authorized; and 553.2 million shares
issued and outstanding) 55.5 55.2
Exchangeable shares: nil shares issued and
outstanding (2007: 0.7 million) - 33.6
Treasury stock (19.6 million shares (380.5) (280.8)
(2007: 10.3 million shares))
Additional paid-in capital 2,563.9 2,503.4
Accumulated other comprehensive income 14.2 55.7
Accumulated deficit (1,126.9) (1,140.1)
_________ _________
Total shareholders' equity 1,126.2 1,227.0
_________ _________
Total liabilities and shareholders' equity 4,202.8 4,330.1
_________ _________
Unaudited US GAAP results for the three and six months to June
30, 2008 Consolidated Statements of Operations
3 months 3 months 6 months 6 months
to June to June to June to June
30, 30, 30, 30,
2008 2007(1) 2008 2007(1)
$M $M $M $M
________ ________ ________ ________
Revenues:
Product sales 705.7 504.2 1,337.4 965.7
Royalties 64.8 64.0 129.9 123.5
Other revenues 5.1 6.7 10.5 13.9
________ _______ ________ ________
Total revenues 775.6 574.9 1,477.8 1,103.1
________ _______ ________ ________
Costs and expenses:
Cost of product sales(1) (2) (3) 142.9 74.0 233.2 141.3
Research and development(1) (3) 145.3 103.1 267.3 184.2
Selling, general and
administrative(1) (2) 428.8 280.6 763.3 519.2
Integration costs - 1.3 - 1.3
Gain on sale of product rights (9.1) (5.0) (16.7) (5.0)
In-process R&D charge 135.0 1,896.0 135.0 1,896.0
________ _______ ________ ________
Total operating expenses 842.9 2,350.0 1,382.1 2,737.0
________ _______ ________ ________
Operating (loss)/income (67.3) (1,775.1) 95.7 (1,633.9)
Interest income 6.5 14.9 19.2 34.7
Interest expense (16.8) (28.0) (34.1) (35.8)
Other income/(expenses), net 0.7 1.8 13.4 2.3
________ _______ ________ ________
Total other (expenses)/income, net (9.6) (11.3) (1.5) 1.2
________ _______ ________ ________
(Loss)/income before income taxes
and equity in (losses)/earnings of
equity method investees (76.9) (1,786.4) 94.2 (1,632.7)
Income taxes (0.2) (25.6) (44.3) (67.1)
Equity in (losses)/earnings of
equity method investees (1.9) 0.7 (0.3) 1.2
________ _______ ________ ________
Net (loss)/income (79.0) (1,811.3) 49.6 (1,698.6)
________ _______ ________ ________
(1) For the three months to June 30, 2007 $4.7 million of depreciation
was reclassified from Selling, general and administrative (SG&A)
costs to Cost of product sales ($1.9 million) and Research and
Development costs ($2.8 million). For the six months to June 30, 2007
$8.7 million of depreciation was reclassified from SG&A costs to Cost
of product sales ($3.9 million) and Research and development ($4.8
million).
(2 ) Cost of product sales includes amortization of intangible assets
relating to favorable manufacturing contracts of $0.4 million for
the three months to June 30, 2008 (2007: $nil) and $0.9 million for
the six months to June 30, 2008 (2007: $nil). Selling, general and
administrative costs includes amortization and impairment charges of
intangible assets relating to intellectual property rights acquired
of $121.4 million for the three months to June 30, 2008 (2007: $17.6
million) and $152.3 million for the six months to June 30, 2008
(2007: $32.9 million).
(3) Costs, predominantly relating to manufacturing set-up costs for new
products, of $1.8 million and $3.6 million for the three months and
six months to June 30, 2007, have been reclassified from Research and
development to Cost of product sales.
Unaudited US GAAP results for the three months and six months to June 30,
2008
Consolidated Statements of Operations (continued)
3 months 3 months 6 months 6 months
to June to June to June to June
30, 30, 30, 30,
2008 2007 2008 2007
$M $M $M $M
________ ________ ________ ________
(Loss)/earnings per ordinary share -
basic (14.6c) (331.0c) 9.1c (317.5c)
________ ________ ________ ________
(Loss)/earnings per ordinary share - (14.6c) (331.0c) 8.2c (317.5c)
diluted
________ ________ ________ ________
(Loss)/earnings per ADS - diluted (43.8c) (993.0c) 24.6c (952.5c)
________ ________ ________ ________
Weighted average number of shares:
Basic 542.5 547.3 579.6 535.0
Diluted 542.5 547.3 579.6 535.0
________ ________ ________ ________
Unaudited US GAAP results for the three months and six months to June 30,
2008
Consolidated Statements of Cash Flows
3 months 3 months 6 months 6 months
to June to June to June to June
30, 30, 30, 30,
2008 2007 2008 2007
$M $M $M $M
________ ________ ________ ________
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net (loss)/income (79.0) (1,811.3) 49.6 (1,698.6)
Adjustments to reconcile net
(loss)/income to net cash provided
by operating activities:
Depreciation and amortization 48.9 33.5 96.3 63.7
Amortization of deferred financing
charges 1.2 9.2 2.5 9.2
Interest on building financing
obligation 0.7 - 1.9 -
Share based compensation 19.4 11.8 35.7 22.4
In-process R&D charge on New River
acquisition - 1,896.0 - 1,896.0
Impairment of intangible assets 90.4 - 90.4 -
Gain on sale of long-term assets (0.4) - (9.8) -
Gain on sale of product rights (9.1) (5.0) (16.7) (4.9)
Movement in deferred taxes (16.4) 0.1 17.4 13.8
Equity in losses/(earnings) of
equity method investees 1.9 (0.7) 0.3 (1.2)
Changes in operating assets and
liabilities, net of acquisitions:
Decrease/(increase) in accounts
receivable 22.0 (25.2) (28.4) (103.0)
Increase/(decrease) in sales
deduction accrual 27.6 (10.8) 35.5 18.9
Decrease/(increase) in inventory 19.5 (26.6) 10.4 (40.0)
Decrease in prepayments and other
current assets
3.8 25.1 24.3 11.3
(Increase)/decrease in other assets (2.7) 9.8 (2.4) 0.7
Increase/(decrease) in accounts and
notes payable and other liabilities
50.7 25.1 (66.4) 7.6
Increase in deferred revenue 1.9 52.0 5.5 88.5
________ ________ ________ ________
Net cash provided by operating 180.4 183.0 246.1 284.4
activities(A)
________ ________ ________ ________
Unaudited US GAAP results for the three months and six months to
June 30, 2008
Consolidated Statements of Cash Flows
3 months 3 months 6 months 6 months
to June to June to June to June
30, 30, 30, 30,
2008 2007 2008 2007
$M $M $M $M
________ ________ ________ ________
CASH FLOWS FROM INVESTING
ACTIVITIES:
Movements in short-term investments - 55.8 - 55.8
Movements in restricted cash 0.2 (9.2) 5.2 (9.6)
Purchases of subsidiary
undertakings, net of cash acquired
- (2,458.6) - (2,458.6)
Expenses related to the New River
acquisition - (57.3) - (60.4)
Purchases of long-term investments (0.1) (3.7) (1.1) (5.8)
Purchases of property, plant and
equipment (61.6) (15.7) (89.4) (33.6)
Purchases of intangible assets - (3.6) - (31.8)
Proceeds from disposal of long-term
assets - - 10.3 -
Proceeds/deposits received for sale
of product rights - 9.8 5.0 16.8
Proceeds from disposal of property,
plant and equipment
0.8 - 0.9 -
Returns from equity investments 0.4 1.0 0.4 2.2
________ ________ ________ ________
Net cash used in investing (60.3) (2,481.5) (68.7) (2,525.0)
activities(B)
________ ________ ________ ________
CASH FLOWS FROM FINANCING
ACTIVITIES:
Proceeds from drawings under bank
facility - 1,300.0 - 1,300.0
Repayment of drawings under bank
facility - (1,300.0) - (1,300.0)
Proceeds from issue of 2.75%
convertible bonds due 2014 - 1,100.0 - 1,100.0
Redemption of New River convertible
notes - (279.4) - (279.4)
Proceeds from exercise of New River
purchased call option - 141.8 - 141.8
Payment of debt arrangement and
issuance costs - (29.8) - (32.7)
Payment under building financing
obligation (0.2) - (0.4) -
Proceeds from exercise of options 0.7 1.7 1.0 24.1
(Costs)/proceeds from issue of
common stock, net (2.9) (1.0) (2.9) 877.3
Proceeds from exercise of warrants - - - 7.0
Payment of dividend (36.4) (29.4) (36.4) (29.4)
Payments to acquire shares by
employee share ownership trust
("ESOT") (71.0) (55.5) (104.1) (99.9)
________ ________ ________ ________
Net cash (used in)/provided by
financing activities(C) (109.8) 848.4 (142.8) 1,708.8
________ ________ ________ ________
Effect of foreign exchange rate 0.3 2.4 4.1 3.4
changes on cash and cash equivalents
(D)
________ ________ ________ ________
Net increase/(decrease) in cash and
cash equivalents(A) +(B) +(C) +(D)
10.6 (1,447.7) 38.7 (528.4)
Cash and cash equivalents at
beginning of period
790.6 2,046.2 762.5 1,126.9
________ ________ ________ ________
Cash and cash equivalents at end of
period 801.2 598.5 801.2 598.5
________ ________ ________ ________
Unaudited US GAAP results for the three and six months to June 30, 2008
Selected Notes to the US GAAP Financial Statements
(1) Earnings per share
3 months 3 months 6 months 6 months
to June to June to June to June
30, 30, 30, 30,
2008 2007 2008 2007
$M $M $M $M
________ ________ ________ ________
Net (loss)/income (79.0) (1,811.3) 49.6 (1,698.6)
________ ________ ________ ________
Numerator for basic EPS (79.0) (1,811.3) 49.6 (1,698.6)
Impact of convertible bonds, net
of tax(1) - - (2.2) -
________ ________ ________ ________
Numerator for diluted EPS (79.0) (1,811.3) 47.4 (1,698.6)
________ ________ ________ ________
No. of No. of No. of No. of
shares shares shares shares
Weighted average number of shares: Millions Millions Millions Millions
Basic (2) 542.5 547.3 543.7 535.0
Effect of dilutive shares:
Stock options(3) - - 3.2 -
Convertible bonds 2.75% due
2014(4) - - 32.7 -
________ ________ ________ ________
Diluted 542.5 547.3 579.6 535.0
________ ________ ________ ________
(1) Includes the after tax interest charge in respect of the convertible
bonds ($9.3 million), and the tax benefit recognized on substitution
of the convertible bonds from Shire plc to Shire Limited on the
Scheme of Arrangement ($11.5 million).
(2) Excludes shares purchased by the ESOT and presented by the Company as
treasury stock.
(3) Calculated using the treasury stock method.
(4) Calculated using the "if-converted" method.
The share equivalents not included in the above calculation of the
diluted weighted average number of shares are shown below:
3 months to 3 months to 6 months to 6 months to
June 30, June 30, June 30, June 30,
2008 2007 2008 2007
No. of No. of No. of No. of
shares shares shares shares
Millions(2) Millions(2) Millions(1) Millions(2)
___________ ___________ ___________ __________
Stock options out of 17.9 1.1 17.4 1.4
the money
Stock options in the 1.3 6.4 - 7.1
money
Warrants - 0.4 - 0.6
Convertible bonds 32.7 21.2 - 10.7
2.75% due 2014
_________ _________ _________ _________
(1) For the six months ended June 30, 2008, certain stock options have
been excluded from the calculation of diluted EPS because their
exercise prices exceeded Shire Limited's average share price during
the calculation period.
(2) For the three months ended June 30, 2008 and the three and six months
ended June 30, 2007 no share options, warrants or ordinary shares
underlying the convertible bonds have been included in the
calculation of the diluted weighted average number of shares, because
the Company made a net loss during the calculation period and the
inclusion of these items would be anti-dilutive.
Unaudited US GAAP results for the three months to June 30, 2008
Selected Notes to the US GAAP Financial Statements (continued)
(2) Analysis of revenues
three months to June 30, 2008 2007 2008 2008
% % of total
$M $M change revenue
Net product sales:
Specialty Pharmaceuticals ("Specialty")
ADHD
ADDERALL XR 296.4 255.1 16% 38%
VYVANSE 65.2 - - 8%
DAYTRANA 22.6 19.9 14% 3%
384.2 275.0 40% 49%
GI
PENTASA 44.8 40.2 11% 6%
LIALDA / MEZAVANT 32.0 5.0 - 4%
76.8 45.2 70% 10%
General products
FOSRENOL* 42.4 24.5 73% 6%
DYNEPO* 7.0 1.9 - 1%
CALCICHEW 13.9 13.5 3% 2%
CARBATROL 16.2 17.9 -9% 2%
REMINYL/REMINYL XL 8.7 7.6 14% 1%
XAGRID 20.6 17.1 20% 3%
108.8 82.5 32% 15%
Other product sales 10.4 26.9 -61% 1%
Total Specialty product 580.2 429.6 35% 75%
sales
Human Genetic Therapies
("HGT")
ELAPRASE 80.8 42.7 89% 10%
REPLAGAL 44.7 31.9 40% 6%
Total HGT product sales 125.5 74.6 68% 16%
Total product sales 705.7 504.2 40% 91%
Royalty income:
3TC 35.6 39.0 -9% 5%
ZEFFIX 10.8 10.4 4% 1%
Other 18.4 14.6 26% 2%
Total 64.8 64.0 1% 8%
Other income 5.1 6.7 -24% 1%
Total Revenue 775.6 574.9 35% 100%
* Reclassified to General products following Shire's decision to
stop the commercialization of DYNEPO.
Unaudited US GAAP results for the six months to June 30, 2008
Selected Notes to the US GAAP Financial Statements (continued)
(2) Analysis of revenues
six months to June 30, 2008 2007 2008 2008
% % of total
$M $M change revenue
Net product sales:
Specialty Pharmaceuticals ("Specialty")
ADHD
ADDERALL XR 557.9 504.2 11% 38%
VYVANSE 119.6 - - 8%
DAYTRANA 42.9 31.8 35% 3%
720.4 536.0 34% 49%
GI
PENTASA 89.0 84.0 6% 6%
LIALDA / MEZAVANT 59.2 5.0 - 4%
148.2 89.0 67% 10%
General products
FOSRENOL* 78.6 47.3 66% 5%
DYNEPO* 13.7 1.9 - 1%
CALCICHEW 27.5 25.6 7% 2%
CARBATROL 34.1 33.4 2% 2%
REMINYL/REMINYL XL 17.0 14.6 16% 1%
XAGRID 39.3 31.6 24% 3%
210.2 154.4 36% 14%
Other product sales 19.1 52.6 -64% 1%
Total Specialty product 1,097.9 832.0 32% 74%
sales
Human Genetic Therapies
("HGT")
ELAPRASE 152.3 69.3 120% 10%
REPLAGAL 87.2 64.4 35% 6%
Total HGT product sales 239.5 133.7 79% 16%
Total product sales 1,337.4 965.7 38% 90%
Royalty income:
3TC 72.9 74.5 -2% 5%
ZEFFIX 21.2 19.4 9% 1%
Other 35.8 29.6 21% 3%
Total 129.9 123.5 5% 9%
Other income 10.5 13.9 -24% 1%
Total Revenue 1,477.8 1,103.1 34% 100%
* Reclassified to General products following Shire's decision
stop the commercialization of DYNEPO.
Unaudited results for the three months to June 30, 2008
Non GAAP reconciliation
US GAAP Non GAAP
3 months to 3 months to
June 30, Reclassify June 30,
2008 Adjustments depreciation 2008
$M $M $M $M
Total revenues 775.6 - - 775.6
Costs and expenses:
Cost of product sales 142.9 (53.4) (a) (3.0) (g) 86.5
Research and development 145.3 (6.5) (b) (3.1) (g) 135.7
Selling, general and 428.8 (128.0) (c) (11.2) (g) 289.6
administrative
Gain on sale of product (9.1) 9.1 (d) - -
rights
In-process R&D charge 135.0 (135.0) (e) - -
Depreciation - - 17.3 (g) 17.3
Total operating expenses 842.9 (313.8) - 529.1
Operating (loss)/income (67.3) 313.8 - 246.5
Interest income 6.5 - - 6.5
Interest expense (16.8) - - (16.8)
Other income, net 0.7 - - 0.7
Total other (expenses) (9.6) - - (9.6)
/income, net
(Loss)/income before
income taxes and equity
in losses of equity method
investees (76.9) 313.8 - 236.9
Income taxes (0.2) (46.7) (f) - (46.9)
Equity in losses of
equity method -
investees, net of tax (1.9) - (1.9)
Net (loss)/income (79.0) 267.1 - 188.1
Impact of convertible
debt, net of tax - (5.8) (1) - (5.8)
Numerator for diluted (79.0) 261.3 - 182.3
EPS from ongoing
operations
Weighted average number of
shares (millions) - 542.5 34.0 (1) 576.5
diluted
Diluted earnings per (14.6c) 46.2c 31.6c
ordinary share
Diluted earnings per ADS (43.8c) 138.6c 94.8c
(1) After the above adjustments, the Company made non GAAP net income
during the calculation period. As a result, (i) the after tax impact
of the convertible bond has been deducted from the numerator and
(ii) in-the-money share options and convertible bonds are now
included in the calculation of the diluted weighted average number of
shares as they have a dilutive effect.
The following adjustments and reclassifications are included above:
a) Write down of inventory and other exit costs in respect of DYNEPO
($53.4 million);
b) R&D commitment in respect of DYNEPO ($6.5 million);
c) Amortization of intangible assets relating to intellectual property
rights acquired ($31.0 million), impairment charge in respect of
DYNEPO intangible asset ($90.4 million) and costs associated with the
introduction of the new holding company ($6.6 million);
d) Gains on the disposal of non-core product rights ($9.1 million);
e) In-process R&D in respect of METAZYM acquired from Zymenex ($135.0
million);
f) Tax effect of adjustments outlined in (a) to (e); and
g) Depreciation of $17.3 million included in cost of product sales, R&D
costs and SG&A costs for US GAAP now separately disclosed for the
presentation of non GAAP earnings.
Unaudited results for the three months to June 30, 2007
Non GAAP reconciliation
US GAAP Non GAAP(1)
3 months to 3 months to
June 30, Reclassify June 30,
2007 Adjustments depreciation 2007
$M $M $M $M
Total revenues 574.9 - - 574.9
Costs and expenses:
Cost of product sales 74.0 - (2.9) (h) 71.1
Research and development 103.1 (5.9) (a) (3.1) (h) 94.1
Selling, general and 280.6 (17.6) (b) (9.9) (h) 253.1
administrative
Integration costs 1.3 (1.3) ( c) - -
Gain on sale of product
rights (5.0) 5.0 (d) - -
In-process R&D charge 1,896.0 (1,896.0) (e) - -
Depreciation - - 15.9 (h) 15.9
Total operating expenses 2,350.0 (1,915.8) - 434.2
Operating (loss)/income (1,775.1) 1,915.8 - 140.7
Interest income 14.9 - - 14.9
Interest expense (28.0) 7.9 (f) - (20.1)
Other income, net 1.8 - - 1.8
Total other (expenses)/
income, net (11.3) 7.9 - (3.4)
(Loss)/income before
income taxes
and equity in earnings
of equity
method investees (1,786.4) 1,923.7 - 137.3
Income taxes (25.6) (7.1) (g) - (32.7)
Equity in earnings of
equity
method investees,
net of tax 0.7 - - 0.7
Net (loss)/income (1,811.3) 1,916.6 - 105.3
Impact of convertible
debt, net of tax - 1.7 (2) - 1.7
Numerator for diluted (1,811.3) 1,918.3 - 107.0
EPS from ongoing
operations
Weighted average number
of shares
(millions) - diluted 547.3 28.0 (2) 575.3
Diluted (loss)/earnings (331.0c) 349.6c 18.6c
per ordinary share
Diluted (loss)/earnings
per ADS (993.0c) 1,048.8c 55.8c
(1) Non GAAP earnings for 2007 have been recalculated to include the
impact of the share based compensation charge which had previously
been excluded. The impact, net of tax, is a decrease in non GAAP net
income of $8.9 million.
(2) After the above adjustments, the Company made non GAAP net income
during the calculation period. As a result (i) the after tax impact
of the convertible bond has been added to the numerator and (ii) in
the-money share options, warrants and convertible bonds are now
included in the calculation of the diluted weighted average number of
shares as they have a dilutive effect.
The following adjustments and reclassifications are included above:
a) Upfront and milestone payments in respect of in-licensing technology
from Noven ($5.9 million);
b) Amortisation of intangible assets relating to intellectual property
rights acquired ($17.6 million);
c) Integration costs in respect of the acquisition of New River ($1.3
million);
d) Gain on disposal of non-core product rights ($5.0 million);
e) Write-off of in-process research and development acquired as part of
the acquisition of New River ($1,896.0 million);
f) Write-off of deferred financing costs on repayment of term loans drawn
down to partly fund the New River acquisition;
g) Tax effect of adjustments outlined in (a) to (f); and
h) Depreciation of $15.9 million included in cost of product sales, R&D
costs and SG&A costs for US GAAP now separately disclosed for the
presentation of non GAAP earnings.
Unaudited results for the six months to June 30, 2008
Non GAAP reconciliation
US GAAP Non GAAP
6 months to 6 months to
June 30, Reclassify June 30,
2008 Adjustments depreciation 2008
$M $M $M $M
Total revenues 1,477.8 - - 1,477.8
Costs and expenses:
Cost of product sales 233.2 (53.4) (a) (5.6) (h) 174.2
Research and development 267.3 (6.5) (b) (6.0) (h) 254.8
Selling, general and
administrative 763.3 (164.5) (c) (22.0) (h) 576.8
Gain on sale of product
rights (16.7) 16.7 (d) - -
In-process R&D charge 135.0 (135.0) (e) - -
Depreciation - - 33.6 (h) 33.6
Total operating expenses 1,382.1 (342.7) - 1,039.4
Operating income 95.7 342.7 - 438.4
Interest income 19.2 - - 19.2
Interest expense (34.1) - - (34.1)
Other income, net 13.4 (9.4) (f) - 4.0
Total other (expenses)/
income, net (1.5) (9.4) - (10.9)
Income before income taxes
and equity in losses of
equity method investees 94.2 333.3 - 427.5
Income taxes (44.3) (55.1) (g) - (99.4)
Equity in losses of
equity method
investees, net of tax (0.3) - - (0.3)
Net income 49.6 278.2 - 327.8
Impact of convertible debt, (2.2) - - (2.2)
net of tax
Numerator for diluted EPS 47.4 278.2 - 325.6
from ongoing operations
Weighted average number
of shares (millions)
diluted 579.6 - - 579.6
Diluted earnings per
ordinary share 8.2c 48.0c 56.2c
Diluted earnings per ADS 24.6c 144.0c 168.6c
The following adjustments and reclassifications are included above:
a) Write down of inventory and exit costs in respect of DYNEPO ($53.4
million);
b) R&D commitment in respect of DYNEPO ($6.5 million);
c) Amortization of intangible assets relating to intellectual property
rights acquired ($61.9 million), impairment charge in respect of
DYNEPO intangible asset ($90.4 million) and costs associated with the
new holding company ($12.2 million);
d) Gains on the disposal of non-core product rights ($16.7 million);
e) In-process R&D in respect of METAZYM acquired from Zymenex ($135.0
million);
f) Gain on the disposal of a minority equity investment ($9.4 million);
g) Tax effect of adjustments outlined in (a) to (f); and
h) Depreciation of $33.6 million included in cost of product sales, R&D
costs and SG&A costs for US GAAP now separately disclosed for the
presentation of non GAAP earnings.
Unaudited results for the six months to June 30, 2007
Non GAAP reconciliation
US GAAP Non GAAP(1)
6 months to 6 months to
June 30, Reclassify June 30,
2007 Adjustments depreciation 2007
$M $M $M $M
Total revenues 1,103.1 - - 1,103.1
Costs and expenses:
Cost of product sales 141.3 - (5.9) (h) 135.4
Research and development 184.2 (5.9) (a) (5.5) (h) 172.8
Selling, general and 519.2 (32.9) (b) (19.4) (h) 466.9
administrative
Integration costs 1.3 (1.3) (c) - -
Gain on sale of product
rights (5.0) 5.0 (d) - -
In-process R&D charge 1,896.0 (1,896.0) (e) - -
Depreciation - - 30.8 (h) 30.8
Total operating expenses 2,737.0 (1,931.1) - 805.9
Operating (loss)/income (1,633.9) 1,931.1 - 297.2
Interest income 34.7 - - 34.7
Interest expense (35.8) 7.9 (f) - (27.9)
Other income, net 2.3 - - 2.3
Total other income, net 1.2 7.9 - 9.1
(Loss)/income before
income taxes and equity
in earnings
of equity method
investees (1,632.7) 1,939.0 - 306.3
Income taxes (67.1) (11.2) (g) - (78.3)
Equity in earnings
of equity
method investees,
net of tax 1.2 - - 1.2
Net (loss)/income (1,698.6) 1,927.8 - 229.2
Impact of convertible - 1.7 (2) - 1.7
debt, net of tax
Numerator for diluted
EPS from ongoing
operations (1,698.6) 1,929.5 - 230.9
Weighted average
number of shares
(millions) - diluted 535.0 18.4 (2) 553.4
Diluted (loss)/ (317.5c) 359.2c 41.7c
earnings per
ordinary share
Diluted (loss)/ (952.5c) 1,077.6c 125.1c
earnings per ADS
(1) Non GAAP earnings for 2007 have been recalculated to include the
impact of the share based compensation charge which had previously
been excluded. The impact, net of tax, is a decrease in non GAAP net
income of $16.6 million.
(2) After the above adjustments the Company made non GAAP net income
during the calculation period. As a result (i) the after tax impact
of the convertible bond has been added to the numerator and (ii) in-
the-money share options, warrants and convertible bonds are now
included in the calculation of the diluted weighted average number of
shares as they have a dilutive effect.
The following adjustments and reclassifications are included above:
a) Upfront and milestone payments in respect of in-licensing technology
from Noven ($5.9 million);
b) Amortisation of intangible assets relating to intellectual property
rights acquired ($32.9 million);
c) Integration costs in respect of the acquisition of New River ($1.3
million);
d) Gain on the disposal of non-core product rights ($5.0 million);
e) Write-off of in-process research and development acquired as part of
the acquisition of New River ($1,896.0 million);
f) Write-off of deferred financing costs on repayment of term loans drawn
down to partly fund the New River acquisition;
g) Tax effect of adjustments outlined in (a) to (f); and
h) Depreciation of $30.8 million included in cost of product sales, R&D
costs and SG&A costs for US GAAP now separately disclosed for the
presentation of non GAAP earnings.
UK Headquarters
Hampshire International Business Park
Chineham Basingstoke
Hampshire RG24 8EP
United Kingdom
Tel +44(0)1256-894000
Fax +44(0)1256-894708
http://www.shire.com
For further information please contact:
Investor Relations: Clea Rosenfeld (Rest of the World) +44-1256-894-160
Eric Rojas (North America) +1-484-595-8252
Media: Jessica Mann (Rest of the World) +44-1256-894-280
Matthew Cabrey (North America) +1-484-595-8248
SOURCE Shire Ltd
For further information please contact: Investor Relations: Clea Rosenfeld
(Rest of the World), +44-1256-894-160; Eric Rojas (North America),
+1-484-595-8252; Media: Jessica Mann (Rest of the World), +44-1256-894-280;
Matthew Cabrey (North America), +1-484-595-8248
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