Press Release
2007 guidance upgraded as revenue growth accelerates
26 Jul 2007 - Basingstoke, UK and Philadelphia, US – July 26, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) the global specialty biopharmaceutical company announces results for the second quarter 2007.
Q2 2007 Financial Highlights
Product sales up 34% to 4 million;
Total revenues up 31% to 5 million;
Net cash provided by operating activities up 33% to 3 million; and
2007 revenue growth is now expected to be at least 25% (previous guidance: low 20% range).
Matthew Emmens, Chief Executive Officer, commented:
“We continue to execute our strategy effectively and this is reflected in the delivery of an excellent second quarter. Revenues were up 31%, led by ADDERALL XR and DAYTRANA in a growing ADHD market. ELAPRASE also made a significant contribution to overall growth as did our other new products FOSRENOL and LIALDA. For the half year, total revenues grew by 30%, with strong operating cash generation.
Importantly, we have just launched VYVANSE, our next generation ADHD product. We believe this product is best in class and early results are promising with positive feedback from both physicians and patients. In addition, we have received two FDA approvable letters in the ADHD category - for INTUNIV, a non-stimulant treatment for ADHD, and SPD465, a longer acting version of ADDERALL XR for the treatment of adult ADHD.
Our business continues to broaden into biopharmaceuticals. Our in-licensing of JUVISTA, a protein candidate for the prevention and reduction of scarring in connection with both therapeutic and cosmetic surgery, fits well within our model of focusing on the specialist physician. JUVISTA could become the first agent with such an indication and has the potential to create a substantial market.
With established positions in major pharmaceutical territories, we are now expanding into selected newer, faster growing markets in a measured way.
Shire has never been stronger and we now expect revenue growth in 2007 to be not less than 25%. We have impressive and well focused product franchises and we continue to bring in new projects, strengthening our pipeline.”
Business Highlights
JUVISTA® (Human TGFbeta3)
On June 19, 2007 Shire signed an agreement with Renovo Limited (“Renovo”) to develop and commercialize JUVISTA, Renovo’s novel drug candidate in late Phase 2 development. JUVISTA is being studied for the prevention and reduction of scarring in connection with both cosmetic and therapeutic surgery; areas often paid for “out of pocket” by patients choosing elective surgery. Under the terms of the agreement Shire has the exclusive right to commercialize JUVISTA worldwide, with the exception of EU member states. Phase 3 trials for JUVISTA are expected to commence in mid 2008.
Following the expiration of the Hart Scott-Rodino (“HSR”) waiting period of 30 days commencing July 11, 2007, Shire will pay Renovo million (expensed as R&D for US GAAP purposes) and will make an equity investment in Renovo Group plc of million (at a subscription price of £2 per share, which represents approximately 7% of Renovo’s share capital). In addition, Shire will pay Renovo million on filing of JUVISTA with the US Food and Drug Administration (“FDA”), up to 0 million on FDA approval, royalties on net sales of JUVISTA and up to 5 million on the achievement of very significant sales targets.
Issue of Convertible Bonds
In May 2007 Shire issued .1 billion principal amount of Convertible Bonds due 2014. The proceeds of the issue were used by Shire to repay borrowings under its bank facilities previously drawn to partially fund the acquisition of New River Pharmaceuticals Inc. (“New River”). The bonds are convertible into ordinary shares of Shire plc, have a semi-annual coupon of 2.75% per annum and an initial conversion price of US.5879 per ordinary share (equivalent to 0.7637 per American Depository Share (“ADS”)).
New River Acquisition
On April 19, 2007 Shire completed the acquisition of New River by way of a short-form merger for per share, or approximately .6 billion. The acquisition of New River allows Shire to capture the full economic value of VYVANSE™ and gain control of the future development and commercialization of this product.
Product Highlights
VYVANSE™ (lisdexamfetamine dimesylate) – Attention Deficit Hyperactivity Disorder (“ADHD”).
On May 3, 2007 the US Drug Enforcement Administration (“DEA”) classified VYVANSE as a Schedule II controlled substance, consistent with the earlier recommendation of the FDA. VYVANSE is indicated for the treatment of ADHD in children aged six to twelve years old. The VYVANSE launch meeting took place in the week commencing June 25, 2007. Shire’s ADHD sales force is now actively promoting this product.
LIALDA™ (mesalamine) - Ulcerative colitis
On March 19, 2007 LIALDA was launched in the US. By July 13, 2007 LIALDA had achieved a US market share of 4.2%. Preparations are underway for the launch of the product, known as MEZAVANT™ in the EU, in the second half of this year.
DYNEPO® (epoetin delta) – Anemia associated with chronic kidney disease
Following the launch of DYNEPO in Germany in Q1 2007, this quarter saw the launch of DYNEPO in the UK.
FOSRENOL® (lanthanum carbonate) – Hyperphosphatemia
FOSRENOL was launched in Italy and Canada in Q2 2007. FOSRENOL has now been launched in 21 countries. FOSRENOL’s European sales for the three months to June 30, 2007 were .0 million (2006:
Press Release
2007 guidance upgraded as revenue growth accelerates
26 Jul 2007 - Basingstoke, UK and Philadelphia, US – July 26, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) the global specialty biopharmaceutical company announces results for the second quarter 2007.
Q2 2007 Financial Highlights
Product sales up 34% to $504 million;
Total revenues up 31% to $575 million;
Net cash provided by operating activities up 33% to $183 million; and
2007 revenue growth is now expected to be at least 25% (previous guidance: low 20% range).
Matthew Emmens, Chief Executive Officer, commented:
“We continue to execute our strategy effectively and this is reflected in the delivery of an excellent second quarter. Revenues were up 31%, led by ADDERALL XR and DAYTRANA in a growing ADHD market. ELAPRASE also made a significant contribution to overall growth as did our other new products FOSRENOL and LIALDA. For the half year, total revenues grew by 30%, with strong operating cash generation.
Importantly, we have just launched VYVANSE, our next generation ADHD product. We believe this product is best in class and early results are promising with positive feedback from both physicians and patients. In addition, we have received two FDA approvable letters in the ADHD category - for INTUNIV, a non-stimulant treatment for ADHD, and SPD465, a longer acting version of ADDERALL XR for the treatment of adult ADHD.
Our business continues to broaden into biopharmaceuticals. Our in-licensing of JUVISTA, a protein candidate for the prevention and reduction of scarring in connection with both therapeutic and cosmetic surgery, fits well within our model of focusing on the specialist physician. JUVISTA could become the first agent with such an indication and has the potential to create a substantial market.
With established positions in major pharmaceutical territories, we are now expanding into selected newer, faster growing markets in a measured way.
Shire has never been stronger and we now expect revenue growth in 2007 to be not less than 25%. We have impressive and well focused product franchises and we continue to bring in new projects, strengthening our pipeline.”
Business Highlights
JUVISTA® (Human TGFbeta3)
On June 19, 2007 Shire signed an agreement with Renovo Limited (“Renovo”) to develop and commercialize JUVISTA, Renovo’s novel drug candidate in late Phase 2 development. JUVISTA is being studied for the prevention and reduction of scarring in connection with both cosmetic and therapeutic surgery; areas often paid for “out of pocket” by patients choosing elective surgery. Under the terms of the agreement Shire has the exclusive right to commercialize JUVISTA worldwide, with the exception of EU member states. Phase 3 trials for JUVISTA are expected to commence in mid 2008.
Following the expiration of the Hart Scott-Rodino (“HSR”) waiting period of 30 days commencing July 11, 2007, Shire will pay Renovo $75 million (expensed as R&D for US GAAP purposes) and will make an equity investment in Renovo Group plc of $50 million (at a subscription price of £2 per share, which represents approximately 7% of Renovo’s share capital). In addition, Shire will pay Renovo $25 million on filing of JUVISTA with the US Food and Drug Administration (“FDA”), up to $150 million on FDA approval, royalties on net sales of JUVISTA and up to $525 million on the achievement of very significant sales targets.
Issue of Convertible Bonds
In May 2007 Shire issued $1.1 billion principal amount of Convertible Bonds due 2014. The proceeds of the issue were used by Shire to repay borrowings under its bank facilities previously drawn to partially fund the acquisition of New River Pharmaceuticals Inc. (“New River”). The bonds are convertible into ordinary shares of Shire plc, have a semi-annual coupon of 2.75% per annum and an initial conversion price of US$33.5879 per ordinary share (equivalent to $100.7637 per American Depository Share (“ADS”)).
New River Acquisition
On April 19, 2007 Shire completed the acquisition of New River by way of a short-form merger for $64 per share, or approximately $2.6 billion. The acquisition of New River allows Shire to capture the full economic value of VYVANSE™ and gain control of the future development and commercialization of this product.
Product Highlights
VYVANSE™ (lisdexamfetamine dimesylate) – Attention Deficit Hyperactivity Disorder (“ADHD”).
On May 3, 2007 the US Drug Enforcement Administration (“DEA”) classified VYVANSE as a Schedule II controlled substance, consistent with the earlier recommendation of the FDA. VYVANSE is indicated for the treatment of ADHD in children aged six to twelve years old. The VYVANSE launch meeting took place in the week commencing June 25, 2007. Shire’s ADHD sales force is now actively promoting this product.
LIALDA™ (mesalamine) - Ulcerative colitis
On March 19, 2007 LIALDA was launched in the US. By July 13, 2007 LIALDA had achieved a US market share of 4.2%. Preparations are underway for the launch of the product, known as MEZAVANT™ in the EU, in the second half of this year.
DYNEPO® (epoetin delta) – Anemia associated with chronic kidney disease
Following the launch of DYNEPO in Germany in Q1 2007, this quarter saw the launch of DYNEPO in the UK.
FOSRENOL® (lanthanum carbonate) – Hyperphosphatemia
FOSRENOL was launched in Italy and Canada in Q2 2007. FOSRENOL has now been launched in 21 countries. FOSRENOL’s European sales for the three months to June 30, 2007 were $9.0 million (2006: $0.3 million). In addition sales of FOSRENOL in the US have increased from $5.9 million in Q2 2006 to $15.5 million in Q2 2007.
ELAPRASE™ (idursulfase) – Hunter syndrome
On June 14, 2007 Health Canada (under priority review) approved ELAPRASE for sale and marketing in Canada. ELAPRASE had been made available on a limited basis to Canadian patients since January 2007 through Health Canada’s Special Access Program and reimbursement discussions across Canada are now underway to enable widespread access. In less than eleven months since its first approval in the US, ELAPRASE is now available in 25 countries and sales for the three months to June 30, 2007 were $42.7 million.
Pipeline Highlights
VYVANSE – ADHD (adult)
On June 29, 2007 Shire submitted a supplemental New Drug Application to the FDA for VYVANSE for the treatment of ADHD in adults. This application is subject to a ten month FDA review period. Shire expects to release results from the Phase 3 clinical trials in Q4 2007.
INTUNIV™ (guanfacine) extended release (previously known as SPD503) - ADHD
On June 21, 2007 Shire received an approvable letter from the FDA for INTUNIV, a non-stimulant selective alpha-2A-receptor agonist. Shire is seeking approval of INTUNIV as monotherapy for the treatment of ADHD symptoms throughout the day in children aged six to 17 years. Shire is working with the FDA to provide a full and timely response to the agency’s request.
Amphetamine transdermal system (“ATS”) - ADHD
In June 2007 following completion by Noven Pharmaceuticals Inc. (“Noven”) of Phase 1 studies for ATS, Shire paid $5.9 million to Noven to acquire exclusive development rights to ATS.
SPD465 – ADHD
On May 19, 2007 Shire received an approvable letter from the FDA for SPD465, an investigational oral stimulant intended to provide symptom control of ADHD in adults for up to 16 hours with one daily dose. Shire is evaluating its response to the approvable letter.
ELAPRASE (idursulfase) - Hunter Central Nervous System (“Hunter CNS”)
In June 2007 Shire HGT had a pre-Investigational New Drug meeting with the FDA to finalize plans for the Phase 1 clinical trial program for Hunter CNS. The program remains on track for initiation of clinical trials in 2008.
Latest Press Releases
- Shire delivers strong quarter driven by $243m of new product sales
- Jerini receives european commission approval for FIRAZYR® (Icatibant) in HAE treatment
- Shire to add new orphan drug to its HGT portfolio - EU launch imminnent
- Graham Hetherington appointed Chief Financial Officer and Board Director at Shire
- First and Only Treatment for Hunter Syndrome Now Approved in 40 Countries Worldwide
- Results of Court Meeting and Extraordinary General Meeting - Shareholders Approve Scheme of Arrangement and New Share Plans
- Shire welcomes the Court of Appeal's decision that NICE review of Alzheimer's drugs was procedurally unfair
- Publication of Supplementary Prospectus
- Shire enhances its orphan drug pipeline with the acquisition of a new clinical candidate for Metachromatic Leukodystrophy
- FDA Approves VYVANSE (TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
ELAPRASE™ (idursulfase) – Hunter syndrome
On June 14, 2007 Health Canada (under priority review) approved ELAPRASE for sale and marketing in Canada. ELAPRASE had been made available on a limited basis to Canadian patients since January 2007 through Health Canada’s Special Access Program and reimbursement discussions across Canada are now underway to enable widespread access. In less than eleven months since its first approval in the US, ELAPRASE is now available in 25 countries and sales for the three months to June 30, 2007 were .7 million.
Pipeline Highlights
VYVANSE – ADHD (adult)
On June 29, 2007 Shire submitted a supplemental New Drug Application to the FDA for VYVANSE for the treatment of ADHD in adults. This application is subject to a ten month FDA review period. Shire expects to release results from the Phase 3 clinical trials in Q4 2007.
INTUNIV™ (guanfacine) extended release (previously known as SPD503) - ADHD
On June 21, 2007 Shire received an approvable letter from the FDA for INTUNIV, a non-stimulant selective alpha-2A-receptor agonist. Shire is seeking approval of INTUNIV as monotherapy for the treatment of ADHD symptoms throughout the day in children aged six to 17 years. Shire is working with the FDA to provide a full and timely response to the agency’s request.
Amphetamine transdermal system (“ATS”) - ADHD
In June 2007 following completion by Noven Pharmaceuticals Inc. (“Noven”) of Phase 1 studies for ATS, Shire paid .9 million to Noven to acquire exclusive development rights to ATS.
SPD465 – ADHD
On May 19, 2007 Shire received an approvable letter from the FDA for SPD465, an investigational oral stimulant intended to provide symptom control of ADHD in adults for up to 16 hours with one daily dose. Shire is evaluating its response to the approvable letter.
ELAPRASE (idursulfase) - Hunter Central Nervous System (“Hunter CNS”)
In June 2007 Shire HGT had a pre-Investigational New Drug meeting with the FDA to finalize plans for the Phase 1 clinical trial program for Hunter CNS. The program remains on track for initiation of clinical trials in 2008.
Latest Press Releases
- Shire delivers strong quarter driven by 3m of new product sales
- Jerini receives european commission approval for FIRAZYR® (Icatibant) in HAE treatment
- Shire to add new orphan drug to its HGT portfolio - EU launch imminnent
- Graham Hetherington appointed Chief Financial Officer and Board Director at Shire
- First and Only Treatment for Hunter Syndrome Now Approved in 40 Countries Worldwide
- Results of Court Meeting and Extraordinary General Meeting - Shareholders Approve Scheme of Arrangement and New Share Plans
- Shire welcomes the Court of Appeal's decision that NICE review of Alzheimer's drugs was procedurally unfair
- Publication of Supplementary Prospectus
- Shire enhances its orphan drug pipeline with the acquisition of a new clinical candidate for Metachromatic Leukodystrophy
- FDA Approves VYVANSE (TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults

