DUBLIN, Oct. 30, 2009 (PRNewswire-FirstCall) -- Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.
Q3 2009 Financial Highlights
Q3 2009(1)
Product sales $603 million -15%
Product sales from core products(2) $532 million +20%
Product sales growth from core products at
constant exchange rates(2)(3) +23%
Total revenues $667 million -14%
Non GAAP operating income $134 million -52%
US GAAP operating income $92 million -25%
Non GAAP diluted earnings per ADS $0.49 -58%
US GAAP diluted earnings per ADS $0.33 +$0.52
(1) Figures compare Q3 2009 results with the same period in 2008.
(2) Core products represent Shire's products excluding ADDERALL XR.
(3) Sales growth at constant exchange rates ("CER"), which is a Non GAAP
measure, is calculated after restating Q3 2009 results using Q3 2008
average foreign exchange rates.
Angus Russell, Chief Executive Officer, commented:
"Shire continues to deliver excellent growth from its core products, which were up 20% over an exceptionally strong Q3 2008. This performance reflects our transformation in the past few years into a global biopharmaceutical company with a proven differentiated strategy and a balanced portfolio of new products which is protected by strong exclusivity and patent protection.
The growth of our core products and continued pro-active cost management are positioning us well to deliver on our unchanged guidance framework for 2009 and our aspiration of growing sales in the mid-teens range on average between 2009 and 2015.
Following US approval of INTUNIV, our new ADHD treatment, we are preparing for the US launch next week. INTUNIV adds a new choice of treatment for physicians and patients within our market-leading branded portfolio of ADHD products. We have also continued to grow VYVANSE's market share which is now 13.4%, benefiting from both the 'back to school' season and strong 10% ADHD market growth. These results reinforce our confidence that VYVANSE will grow to become a leading product in this market.
Our HGT business continues to deliver; a New Drug Application for velaglucerase alfa, for Gaucher disease, was filed with the FDA at the end of August. Velaglucerase alfa is available ahead of its commercial launch in the US via a treatment protocol and elsewhere on a pre-approval access basis. We are supporting the Fabry disease community with a stronger uptake of REPLAGAL in Europe. In the US a treatment protocol has been approved, enabling immediate access to the drug. In addition we plan to file a Biologics License Application with the FDA for REPLAGAL by the end of the year.
We continue to invest in our R&D pipeline. This quarter we announced a research collaboration with Santaris Pharma A/S, a leading player in RNA-based therapeutics, to develop its proprietary Locked Nucleic Acid technology in a range of rare diseases, thereby enabling us to build on our already strong competitive position in this area."
Third Quarter 2009 Unaudited Results
Q3 2009 Q3 2008
US Adjust- Non Adjust- Non
GAAP ments GAAP(1) US GAAP ments GAAP(1)
$M $M $M $M $M $M
Revenues 667 - 667 779 - 779
Operating income 92 42 134 123 156 279
Net income/(loss) 60 29 89 (35) 251 216
Diluted earnings
/(loss) per ADS 33c 16c 49c (20c) 137c 117c
Note: Average exchange rates for Q3 2009 were $1.64:GBP1.00 and
$1.43:EUR1.00, (Q3 2008: $1.89:GBP1.00 and $1.52:EUR1.00).
(1) The Non GAAP financial measures included above are explained on pages
26 and 27, together with an explanation of why Shire's management
believes that these measures are useful to investors. For a
reconciliation of these Non GAAP financial measures to the most
directly comparable financial measures prepared in accordance with
US GAAP, see pages 22 to 25.
FINANCIAL SUMMARY
Third Quarter 2009 (see page 7 for full Financial Results)
- Product sales from core products were up 20% (up 23% at CER) to $532
million, driven by continued strong growth from:
- VYVANSE(R) (up 34% to $129 million);
- LIALDA(R)/MEZAVANT(R) (up 62% to $65 million);
- ELAPRASE(R) (up 16% to $91 million, up 20% at CER); and
- REPLAGAL(R) (up 8% to $48 million, up 15% at CER).
- Product sales including ADDERALL(R) XR, were down 15% to $603 million,
as ADDERALL XR product sales declined by 74%, or $198 million to
$71 million.
- Non GAAP operating income decreased by 52%, or $145 million, to $134
million due to the lower ADDERALL XR revenues in Q3 2009 and increased
investment in research and development, which were partially offset
by higher revenues from core products and lower selling, general and
administrative costs. On a US GAAP basis operating income in Q3 2009
was $92 million, compared to $123 million in 2008 (2008 included the
impact of a $121 million in-process R&D charge relating to the
acquisition of Jerini AG ("Jerini")).
- Non GAAP diluted earnings per ADS were down 58% to $0.49 (Q3 2008:
$1.17), and on a US GAAP basis diluted earnings per ADS were $0.33
(Q3 2008: $(0.20)).
- During the first three quarters of 2009 Shire has generated Non GAAP
diluted earnings per ADS of $2.38 ($1.74 on a US GAAP basis).
THIRD QUARTER HIGHLIGHTS AND RECENT DEVELOPMENTS
Products
VYVANSE - for the treatment of Attention Deficit and Hyperactivity
Disorder ("ADHD")
- Following a review of governing statutory and regulatory
standards and public comments, the US Food and Drug Administration
("FDA") has affirmed its prior decision to grant five-year New Chemical
Entity ("NCE") exclusivity to lisdexamfetamine dimesylate. The
five-year exclusivity period for VYVANSE expires on February 23, 2012.
As a consequence of this decision, the FDA appropriately refused to
file the Abbreviated New Drug Application submitted by Actavis
Elizabeth, LLC ("Actavis") for generic lisdexamfetamine dimesylate in
January 2009. VYVANSE is covered by US patents which remain in effect
until June 29, 2023.
INTUNIV(TM) - for the treatment of ADHD in children and adolescents in
the US
- On September 3, 2009 Shire announced that it received approval from
the FDA for INTUNIV Extended Release Tablets for the treatment of ADHD
in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily
non-scheduled formulation of guanfacine, is the first selective
alpha-2A adrenergic receptor agonist approved for the treatment of
ADHD.
- Once-daily INTUNIV is expected to be widely available in US pharmacies
in November 2009 and will come in four dosage strengths (1 mg, 2 mg,
3 mg, and 4 mg). INTUNIV will be marketed in the US by the existing
Shire ADHD sales team of nearly 600 representatives.
FOSRENOL(R) - for the treatment of pre-dialysis chronic kidney disease
("CKD") in the EU
- Shire has received approval through the European Mutual Recognition
Procedure for an extension to the current indication for FOSRENOL as a
treatment to control hyperphosphataemia in CKD patients who are not on
dialysis and with a serum phosphorus level greater than or equal to
1.78mmol/L (5.5mg/dL).
Pipeline
Velaglucerase alfa - for the treatment of Gaucher disease
- On July 30, 2009 Shire began the rolling submission with the FDA under
Fast Track designation of a New Drug Application ("NDA") for
velaglucerase alfa, its enzyme replacement therapy in development for
the treatment of Type 1 Gaucher disease. On September 1, 2009 Shire
reported that it had completed its NDA submission. Velaglucerase alfa
is available ahead of its commercial launch, in the US via a treatment
protocol and elsewhere on a pre-approval basis, to 300-600 patients in
2009 and will be available to several hundred more in 2010.
REPLAGAL - for the treatment of Fabry disease
- On October 21, 2009 Shire announced plans to file a Biologics License
Application with the FDA for REPLAGAL (agalsidase alfa), its enzyme
replacement therapy for Fabry disease, by the end of the year. The
Company also announced that a treatment protocol for REPLAGAL, filed at
the request of the FDA, has been approved, and that Shire will support
emergency Investigational New Drug requests, in view of the announced
supply restriction of the only currently marketed treatment for Fabry
disease in the US.
FIRAZYR(R) - for the treatment of hereditary angioedema ("HAE")
- In September 2009 Shire initiated a clinical trial to investigate the
safety of self-administration of FIRAZYR.
Amicus collaboration for the development of pharmacological chaperones
- On November 7, 2007 Shire licensed from Amicus Therapeutics Inc.
("Amicus") the rights to three pharmacological chaperone compounds in
markets outside of the US: AMIGAL (HGT-3310) for Fabry disease,
PLICERA (HGT-3410) for Gaucher Disease and HGT-3510 (formerly referred
to as AT2220) for Pompe disease which were in clinical development.
The parties have mutually agreed to terminate the collaboration and to
return all rights for the three products to Amicus.
Alba collaboration for the development of SPD 550
- On October 16, 2009 and following review of Phase 2 data, Shire
informed Alba Therapeutics Corporation ("Alba") of its intent to
terminate the collaboration. Effective November 15, 2009 Shire will
return to Alba all rights to SPD 550 (larazotide cetate for celiac
disease), also known as AT-1001. In December 2007 Shire had acquired
rights to SPD550 in markets outside of the US and Japan.
Business
Research Collaboration with Santaris Pharma A/S ("Santaris") on Locked
Nucleic Acid ("LNA") Drug Platform
- On August 24, 2009 Shire announced that it had entered into a research
collaboration with Santaris, to develop its proprietary LNA technology
in a range of rare diseases. LNA technology has the benefit of
shortened target validation and proof of concept, potentially
increasing the speed and lowering the cost of development. As part of
the joint research project Santaris will design, develop and deliver
pre-clinical LNA oligonucleotides for Shire-selected orphan disease
targets, and Shire will have the exclusive right to further develop
and commercialize these candidate compounds on a worldwide basis.
Legal proceedings
- On September 23, 2009 the Company received a subpoena from the US
Department of Health and Human Services Office of Inspector General in
coordination with the US Attorney for the Eastern District of
Pennsylvania, seeking production of documents related to the sales and
marketing of ADDERALL XR, DAYTRANA(R) and VYVANSE. Shire is cooperating
and responding to this subpoena.
- On October 19, 2009 Teva Pharmaceuticals USA, Inc. ("Teva") filed suit
against Shire claiming that Shire is in breach of its supply contract
for the authorized generic version of ADDERALL XR. Shire has been
supplying Teva with authorized generic ADDERALL XR since April 1,
2009. Shire's ability to supply this product, however, is limited by
quota restrictions that the US Drug Enforcement Administration places
on amphetamine, which is the product's active ingredient.
2009 OUTLOOK
We are reiterating our previously announced guidance framework for Non GAAP diluted earnings per ADS for 2009, which remains unchanged from that provided in our Q3 2008 earnings release. At that time, and in subsequent earnings releases, we provided details of the effect of changes in foreign exchange rates on the earnings guidance. Specifically, our plans for 2009, supporting Non GAAP diluted earnings per ADS for 2009 in the range of $3.00 to $3.40, were based on average actual foreign exchange rates (EUR1:$1.52, GBP1:$1.95) for the ten months to October 2008. During the first three quarters of 2009 we have already achieved Non GAAP diluted earnings per ADS of $2.38.
We identified that each 10c movement in the EUR:$ and GBP:$ exchange rates impacts Shire's Non GAAP diluted earnings per ADS by $0.10 and $0.01 respectively. Based on the following exchange rate scenarios, which are not forecasts, the impact on our base guidance would be:
Euro fx GBP fx Non GAAP diluted
rate rate earnings per ADS
range(1)
Base guidance $1.52 $1.95 $3.00 to $3.40
As advised at Q2 2009 $1.37 $1.56 $2.80 to $3.20
At average rate for nine months
to September 2009 & September
average rate for Q4 2009 $1.39 $1.56 $2.83 to $3.23
(1) Our guidance framework for Non GAAP diluted earnings per ADS is not
prepared in accordance with US GAAP. Non GAAP diluted earnings per
ADS excludes the effect of certain cash and non-cash items, both
recurring and non-recurring, that Shire's management believes are
not related to the core performance of Shire's business. A list of
these items can be found on pages 26-27.
PRODUCT LAUNCHES
Subject to obtaining the relevant regulatory/governmental approvals,
product launches planned over the next two years include:
- INTUNIV for the treatment of ADHD in children and
adolescents in the US in November 2009 (already approved);
- Velaglucerase alfa for the treatment of Gaucher disease in
the US and the EU in 2010;
- REPLAGAL for the treatment of Fabry disease in the US in 2010;
- MEZAVANT for the treatment of ulcerative colitis; launches
will continue in certain EU and RoW countries in 2009 and 2010;
- FIRAZYR for the symptomatic treatment of acute attacks of HAE; launches
will continue in certain European and Latin American countries during
2009 and 2010;
- DAYTRANA for the treatment of ADHD in adolescents in the US in 2010;
- EQUASYM(R) for the treatment of ADHD; launches will continue in certain
EU countries during 2009 and 2010; and
- VYVANSE for the treatment of ADHD, in ex-US and ex-EU regions starting
in 2010, and in the EU in 2011.
BOARD CHANGES
The Shire Board announces that Mr David Stout will be joining the Board as a non executive director with effect from October 31, 2009. Mr Stout brings significant pharmaceutical industry experience to the Shire Board, having spent many years at both GSK and prior to that Schering-Plough. Most recently, he was President of Pharmaceutical Operations at GSK. In this role he had responsibility for GSK's pharmaceutical operations in the United States, Europe, Japan and all other International Markets. Mr Stout was also responsible for global manufacturing and global Biologics (vaccines) at GSK.
The Shire Board also announces that Mr David Mott will be stepping down from the Shire Board on the expiry of his term of office on October 30, 2009.
Matt Emmens, Chairman of Shire commented;
"We are delighted to welcome David Stout to the Shire Board. He brings with him extensive international experience in the pharmaceutical industry, which we believe will be of great value to Shire as it continues its growth trajectory and becomes a more global company.
We would also like to thank David Mott for his valuable contribution to the Shire Board over the last few years."
Dial in details for the live conference call for investors 14:00 GMT/ 10:00 ET on October 30, 2009:
UK dial in: 0800-077-8492 or 0-1296-311-600
US dial in: 1-866-804-8688 or 1-718-354-1175
International dial in: +44(0)1296-311-600
Password/Conf ID: 891 799#
Live Webcast: http://www.shire.com/shire/InvestorRelations/index.jsp?tn=2
OVERVIEW OF FINANCIAL RESULTS
1. Introduction
Summary of Q3 2009
Revenues from continuing operations for the three months to September 30, 2009 decreased by 14% to $667.0 million (2008: $778.6 million), due to the decline in branded ADDERALL XR product sales in Q3 2009 following the launch of an authorized generic version by Teva in April 2009. However, core product sales increased by 20% to $531.6 million (2008: $443.8 million).
Non GAAP operating income for the three months to September 30, 2009 decreased by 52% to $133.6 million (2008: $278.6 million). Increased revenues from core products, combined with lower selling, general and administrative expenses achieved through the Company's continued focus on cost management partially offset the impact of lower revenues from ADDERALL XR and increased investment in research and development, in part reflecting the Santaris collaboration up-front costs and the acceleration of the velaglucerase program.
US GAAP operating income from continuing operations for the three months to September 30, 2009 decreased by 25% to $91.8 million (2008: $122.9 million). US GAAP operating income in Q3 2008 included an in-process R&D ("IPR&D") charge of $120.5 million on the acquisition of Jerini in 2008. Excluding this charge the decline in US GAAP operating income in the third quarter of 2009 principally resulted from lower ADDERALL XR revenues following genericization in the second quarter of 2009.
Net cash provided by operating activities decreased by 52% to $134.0 million for the three months to September 30, 2009 (2008: $279.4 million). The cash provided by operating activities was lower in Q3 2009 than the same period in 2008 due to lower sales receipts following the genericization of ADDERALL XR and cash inflows from forward exchange contracts in Q3 2008, which more than offset lower payments on operating costs.
Cash, cash equivalents and restricted cash at September 30, 2009 totaled $372.0 million (December 31, 2008: $247.4 million), an increase of $124.6 million. Cash provided by operating activities of $390.0 million in the nine months to September 30, 2009 have been partially offset by investments in property, plant and equipment at the HGT campus in Lexington, the acquisition of EQUASYM from UCB S.A. and the dividend payment.
2. Product sales
For the three months to September 30, 2009 product sales decreased by 15% to $602.5 million (2008: $712.5 million) and represented 91% of total revenues (2008: 92%). Excluding ADDERALL XR, product sales from core products increased by 20% to $531.6 million (2008: $443.8 million).
Product Highlights
US
Average
CER US Rx Quarterly
Sales Growth(2) Growth(1) Market
Product Sales $M Growth(2) (3) (2) Share(1)
Specialty
Pharmaceuticals
VYVANSE 129.0 34% 34% 57% 13%
DAYTRANA 17.4 -4% -4% -12% 1%
EQUASYM 9.2 n/a n/a n/a(5) n/a(5)
LIALDA / MEZAVANT 65.4 62% 63% 34% 17%
PENTASA 51.3 4% 4% -3% 16%
FOSRENOL 47.7 11% 14% -3% 8%
XAGRID(R) 21.5 11% 18% n/a(5) n/a(5)
ADDERALL XR 70.9 -74% -74% -59% 8%
Human Genetic Therapies
ELAPRASE 90.9 16% 20% n/a(4) n/a(4)
REPLAGAL 48.3 8% 15% n/a(5) n/a(5)
FIRAZYR 1.8 - - n/a(5) n/a(5)
(1) Product specific prescription data is provided by IMS Health ("IMS")
National Prescription Audit, a leading global provider of business
intelligence for the pharmaceutical and healthcare industries. All
other US market share data stated in the text below is also provided
by IMS.
(2) Compared to Q3 2008.
(3) CER growth, which is a Non GAAP measure, is calculated after
restating Q3 2009 results using Q3 2008 average foreign exchange
rates.
(4) IMS Data not available.
(5) Not sold in the US.
Specialty Pharmaceuticals
US ADHD market share
Shire's share of the total US ADHD market for the three months to September 30, 2009 was 22%. Shire continues to have the leading portfolio of branded products in the US ADHD market.
VYVANSE - ADHD
Product sales of VYVANSE for the three months to September 30, 2009 increased by 34% to $129.0 million (2008: $96.0 million), with VYVANSE's average share of the US ADHD market for Q3 2009 increasing to 13% (2008: 9%). Product sales growth was driven by a 57% increase in US prescription demand in Q3 2009 over the same period in 2008, as a result of increased average market share and 10% growth in the US ADHD market. Product sales growth was less than prescription growth due to the stocking benefits from new dosage strengths of VYVANSE in Q3 2008.
ADDERALL XR - ADHD
Product sales of ADDERALL XR for the three months to September 30, 2009 were $70.9 million (2008: $268.7 million), a decrease of 74%, following the launch by Teva in April 2009 of its authorized generic version of ADDERALL XR. The launch of the authorized generic version led to a 59% decline in ADDERALL XR US prescription demand and higher US sales deductions in Q3 2009 than the same period last year.
Sales deductions represented 73% of branded ADDERALL XR gross sales in Q3 2009, compared to 26% in the same period in 2008 following higher Medicaid and Managed Care rebates subsequent to generic launch. These factors more than offset the positive impacts of price increases taken since Q3 2008, and the inclusion in product sales of shipments of authorized generic ADDERALL XR to Teva and Impax Laboratories, Inc. ("Impax") in Q3 2009.
US oral mesalamine market share
Shire's average market share of the US oral mesalamine market was 33% for the three months to September 30, 2009.
LIALDA/MEZAVANT - Ulcerative colitis
Product sales of LIALDA/MEZAVANT for the three months to September 30, 2009 increased by 62% to $65.4 million (2008: $40.4 million). US prescriptions increased by 34%, due to an increase in LIALDA's average share of the US oral mesalamine market to 17% (2008: 13%), underlying growth in the US oral mesalamine market and price increases.
By September 30, 2009 MEZAVANT was available in eight countries outside the US, and further launches are planned in other countries throughout 2009 and 2010, subject to the successful conclusion of pricing and reimbursement negotiations.
PENTASA - Ulcerative colitis
Product sales of PENTASA(R) for the three months to September 30, 2009 were $51.3 million, an increase of 4% compared to the same period in 2008 (2008: $49.2 million). Sales grew despite a 3% decrease in prescriptions primarily due to the impact of price increases.
FOSRENOL - Hyperphosphatemia
Product sales of FOSRENOL for the three months to September 30, 2009 were up 11% to $47.7 million (2008: $43.0 million). On a CER basis sales were up 14%. In markets outside the US FOSRENOL sales increased as the product entered new countries, and continued to grow in countries entered in the last two years. In the US, FOSRENOL's average share of the phosphate binder market in Q3 2009 remained constant at 8% (2008: 8%).
Human Genetic Therapies
ELAPRASE - Hunter syndrome
Product sales for the three months to September 30, 2009 were $90.9 million, an increase of 16% (2008: $78.2 million). Expressed on a CER basis, sales increased by 20% (ELAPRASE is primarily sold in US dollars and Euros). The sales growth was driven by increased volumes across all regions where ELAPRASE is sold.
REPLAGAL - Fabry disease
Product sales for the three months to September 30, 2009 were $48.3 million, an increase of 8% (2008: $44.6 million). Expressed on a CER basis product sales increased by 15% (REPLAGAL is primarily sold in Euros and Pounds Sterling). The product sales growth was driven by increased volumes in Europe and Asia Pacific.
FIRAZYR - HAE
Product sales for the three months to September 30, 2009 were $1.8 million (2008: $0.2 million). With a Q3 launch in Italy, FIRAZYR is now marketed in the five largest European countries. FIRAZYR is the first new product for HAE in Europe in 30 years and has orphan exclusivity in the EU until 2018.
3. Royalties
Royalty revenue decreased by 1% to $60.3 million for the three months to September 30, 2009 (2008: $60.8 million). The following table provides an analysis of Shire's royalty revenue:
Royalties to Shire Year on year
Product $M change(1) CER(2)
3TC(R) and ZEFFIX(R) 42.0 -6% 0%
ADDERALL XR 2.2 n/a n/a
Other 16.1 -1% n/a
Total 60.3 -1% 0%
(1) Compared with Q3 2008
(2) CER growth, which is a Non GAAP measure, is calculated after
restating Q3 2009 results using Q3 2008 average foreign exchange
rates.
Royalties from Teva's sales of authorized generic ADDERALL XR for the three months to September 30, 2009 were $2.2 million (2008: $nil). Receipt of this royalty began with Teva's sales of an authorized generic version of ADDERALL XR in April 2009 and ceased in September 2009. From Q4 2009, Shire will receive royalties on Impax's sales of its authorized generic version of ADDERALL XR.
4. Financial details
Cost of product sales
% of % of
2009 product 2008 product
$M sales $M sales
Cost of product sales (US GAAP) 104.9 17% 84.2 12%
Fair value adjustment for
acquired inventories (0.6) -
Accelerated depreciation on transfer
of manufacturing from Owings Mills (4.5) -
Depreciation (0.8) (3.2)
Cost of product sales (Non GAAP) 99.0 16% 81.0 11%
Non GAAP cost of product sales as a percentage of product sales increased by 5 percentage points compared to 2008. This increase primarily results from changes to the product mix following the launch by Teva of an authorized generic version of ADDERALL XR in April 2009. Higher sales deductions on Shire's sales of branded ADDERALL XR, together with lower margin sales of the authorized generic version of ADDERALL XR to Teva and Impax have both depressed gross margin for that product.
Research and development ("R&D")
% of % of
2009 product 2008 product
$M sales $M sales
R&D (US GAAP) 147.8 25% 120.2 17%
Depreciation (3.6) (3.4)
R&D (Non GAAP) 144.2 24% 116.8 16%
Non GAAP R&D increased 23% to $144.2 million (2008: $116.8 million) as the Company has continued to increase investment in R&D programs, including an up-front payment of $6.5 million to Santaris for technology access and R&D funding in August 2009.
