second quarter results to june 30, 2006 -...
TRANSCRIPT
Second Quarter resultsto June 30, 2006Shire plc
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THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
"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, Shire'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; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE (SPD476) (ulcerative colitis) and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to benefit from the acquisition of Transkaryotic Therapies Inc.; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2005.
The following are trademarks of Shire plc or its subsidiaries, which are the subject of trademark registrations in certain countries.
ADDERALL XR® (mixed salts of a single-entity amphetamine prroduct), AGRYLIN® (anagrelide hydrochloride), CALCICHEW® (range (calcium carbonate with or without vitamin D3 )), CARBATROL® (carbamazepine), EQUETROTM (carbamazepine), FOSRENOL® (lanthanum carbonate), XAGRID® (anagrelide hydrochloride), REPLAGALTM (agalsidase alfa), MESAVANCE™ (mesalamine)
The following are trademarks of third parties. 3TC® (trademark of GlaxoSmithKline (GSK)), PENTASA® (trademark of Ferring AS) ), DYNEPO® (trademark of Aventis Pharma Holdings GmbH), ZEFFIX® (GSK), REMINYL/RAZADYNE ® (trademark of Johnson & Johnson, excluding UK and Republic of Ireland), DAYTRANA™ (methylphenidate transdermal) (trademark of Noven Pharmaceuticals Inc. (Noven))
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Agenda
Introduction and summary of Q2 Matthew Emmens
Q2 Financial Review Angus Russell
Conclusion Matthew Emmens
Questions & Answers All
Matthew Emmens Chief Executive OfficerIntroduction and summary of Q2
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Financial Highlights
36.1c
EPS (diluted):
+12%
H1 Growth
+23%
Q1 Growth
+3%424.6439.1Total Revenues
65.9c- ADS
Q2 Growth
65.9c
Q2 05(1)
$m Q2 06
$m
43.9cNon GAAP EPS (diluted)(2) - ADS
(1) Adjusted to reflect retrospective adoption of SFAS 123R
(2) This is a non GAAP financial measure. It excludes items that management believe are not indicative of the ongoing business in 2006 & 2005.
Good results in line with expectations
Q2 revenues up 3%
Revenue growth in H1 of 12%
Dividend of 5.8038 cents per ADS
Re-affirming guidance
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Q2 Execution
Demonstrating our ability to execute
DAYTRANA launched
SPD465 filed
ELAPRASE US approval
FOSRENOL– continued roll-out internationally
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ADHD Progress
ADDERALL XR US market share leader : 26%
Citizen Petition – still under review by the FDA
No generic copies of ADDERALL XR drugs approved to date
Patent litigation and settlement discussions progressing with Barr
DAYTRANA
Launched in the US market
Very positive reaction from patients and physicians
NRP104 - US PDUFA October 6 2006
SPD465 – filed with the FDA on July 21 – PDUFA May 21 2007
SPD503 – filing scheduled for Q3 2006
*source IMS
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ADHD Portfolio Positioning
√√√√Stimulant / methylphenidate
First transdermal patchDAYTRANA
Non-stimulant / guanfacineSPD503
Stimulant / amphetamine
Long acting – 16 hoursSPD465
Pro drug / *amphetamine
Low abuse potentialNRP104
√√√√√√Stimulant / amphetamine
First in Class / 8-10 hoursADDERALL XR
EuropeUSAdultPediatricDifferentiating
features
Products
√√ = approved= approved = in development = in development -- not yet filednot yet filed
= filed not yet approved= filed not yet approved = future development planned= future development planned
*with potential to treat within the non-stimulant market
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Renal and GI
FOSRENOL (Hyperphosphatemia)
Product performing well in launched markets
US market share increase – 11.9% week ending 14 July 2006*
Major European countries to launch in Q4 2006
DYNEPO (anemia in cancer)
Results study inconclusive; Shire to review
MESAVANCE (Ulcerative Colitis)
US PDUFA October 21 2006
Expected responses from European and Canadian authorities Q1 2007
*source IMS
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HGT ELAPRASE (Hunter Syndrome)
US approval received
Potential for up to 500 patients in the US
European response expected before year-end
Pre-approval access received for France, Italy, Spain and Sweden
GA-GCB (Gaucher Disease)
Phase 3 enrolment commenced
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R&D Pipeline and new product launches
The above launch and filing dates are indicative and subject to the regulatory/government approvals process.
H1 06 H2 06 H1 07
MESAVANCEEU / Canada
Launch
ELAPRASEUS Launch
SPD465FDA filed
FOSRENOLContinue the roll-out in Europe
MESAVANCEFiled in Canada
and EU
SPD503FDA filing
DAYTRANALaunched in US
MESAVANCEUS Launch
NRP104US Launch
ELAPRASEEU Launch
DYNEPOEU Launch
GA-GCBEnrolment Phase 3
Angus Russell Chief Financial OfficerQ2 Financial Review
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Total Revenues
____
+12%
0%
- 59%
+16%
H1 Growth
+5%
-33%
-4%
-74%
62.6
10.4
60.4
2.7
Royalties
Other Revenue
____
+23%
+28%
Q1 Growth
____
+3%
____
424.6
____
439.1Total Revenues
+7%
Q2 Growth
351.6
Q2 05$m
Q2 06$m
376.0Product Sales
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* Source: IMS Data** Pre-acquisition sales
Major Product Sales
+23%-38%9.96.2FOSRENOL
n/a+25%**22.628.3REPLAGAL
-10%-25%21.816.2CARBATROL
-4%+11%31.034.5PENTASA
-88%-88%17.22.0North America
n/a+14%12.414.1ROW
n/a+16%10.111.7CALCICHEW
220.7
Q2 06$m
205.4
Q2 05$m
+7%
Sales Growth
AGRYLIN/XAGRID
+8%ADDERALL XR
US Rx Growth *
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* Foreign exchange movements have contributed +1% to reported growth** Foreign exchange movements have contributed +2% to reported growth*** Includes REMINYL/RAZADYNE and the impact of RAZADYNE ER US launch stocking during Q2 05
Royalties
60.4
13.7
8.4
38.3
Q2 06$m
62.6
14.4
7.7
40.5
Q2 05$m
-4%
-5%
+9%**
-5%*
Growth
Other ***
Total
ZEFFIX
3TC
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Net Income/EPS
Non GAAP EPS (diluted)(2)
65.9c
69.1c
43.9c
46.8c
- ADS
Non GAAP EPS (diluted)(2)
- ADS (excluding FAS123R)
65.9c36.1c- ADS
EPS (diluted):
$m
109.9
-
109.9
Q2 05(1)Q2 06
$m
61.3
13.2
74.5
Net income
- GAAP
- Adjustments
- Non GAAP(2)
(1) Adjusted to reflect retrospective adoption of SFAS 123R
(2) This is a non GAAP financial measure. It excludes items that management believe are not indicative of the ongoing business in 2006 & 2005.
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EPS Reconciliation
69.1c116.246.8c81.9Net income for non GAAP diluted EPS (ADS) (Ex FAS 123R)
3.2c6.32.9c7.4FAS 123R effect (net of tax)
--(3.1c)(5.1)Taxes on above adjustments
--0.9c1.6Integration costs
--10.0c16.7Cost of product sales fair value adjustment
65.9c109.936.1c61.3Net income for diluted EPS (ADS)
43.9c
Q2 06cents/ADS
109.9
Q2 05 (1)
$m
65.9c74.5Net income for non GAAP diluted EPS (ADS)
Q2 05 (1)
cents/ADSQ2 06
$m
(1) Adjusted to reflect retrospective adoption of SFAS 123RThis slide contains non GAAP financial measures. Management believes that the presentation of these non GAAP financial measures provide useful information to investors regarding Shire’s performance as the excluded items are not indicative of the ongoing business in 2006 & 2005.
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Financial Ratios
23%
52%
17%
88%
12%
Q2 06
32%Operating margin
45%
16%
88%
12%
Q2 05(1)
R&D : Revenues
SG&A (excl. D&A) : Product sales
Gross margin
COGS : Product sales
(on a non-GAAP basis)
(1) Adjusted to reflect retrospective adoption of SFAS 123RThis slide contains non GAAP financial measures. Management believes that the presentation of these non GAAP financial measuresprovide useful information to investors regarding Shire’s performance as the excluded items are not indicative of the ongoing business in 2006 & 2005.
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Cash generation
Cash Flow – Q2 2006
Cash surplus for Q2 : +41
+ 133
Tax / interest
Equity financing
- 32
Millions of USD
Net long-term asset purchases
+ 8
947*Total Liquidity at 30.06.06
500Add Revolving facility
447“Free Cash”
(30)Restricted cash
(439)Provision for amounts due for appraisal rights
916Net Cash at 30.06.06
41Cash Surplus
875Net Cash at 31.3.06
- 50 Daytrana
* Excludes $300m revolving facility
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Outlook - 2006
Shire’s business continues to perform strongly - 2006 revenue growth expected to be in the low double digit range.low double digit range.
Earnings for 2006 impacted by costs associated with the continued development and launch of 5 new products in 2006 and H1 2007 in addition to the roll-out of FOSRENOL across Europe and new higher strengths of FOSRENOL in the US.
These launches will require additional A&P spend and in some cases additional sales reps. In addition, Shire is seeking to maximize the level of ADDERALL XR market share. Consequently, SG&A costs are expected to rise during the year to between $770 – 800 million;
The level of quarterly SG&A spend is expected to increase over Q2 2006 as we reflect a full quarter’s cost for the new US sales forces for GI (to launch MESAVANCE) and HGT (to launch ELAPRASE);
The planned regulatory filings, phase 3(b)/4 studies to support new product launches, the transfer of 2 HGT projects into pre-clinical development and the commencement of phase 3 trials on GA-GCB, are expected to result in R&D spend in the range of $310 – 330 million;
The level of quarterly R&D spend is expected to increase over Q2 2006 as we commence new phase 3(b)/4 studies to support new product launches (including DAYTRANA, FOSRENOL and MESAVANCE);
D&A - approximately 50% higher than 2005 charge reflecting the acquisition of TKT and the amortization of anticipated capitalized BD milestone payments;
Estimated tax rate - approximately 28%.
The following statements are based on the assumption that there will be no generic launch of ADDERALL XR during 2006 and that prescription growth in the US ADHD market will be 5%.
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Outlook - 2006The financial outlook for the full year stated above excludes the accounting impact of the following items:
The milestone payment of $50m paid to New River in February 2006 following the FDA’sacceptance of the filing of NRP104. This has increased R&D expense in Q1 2006;
A US GAAP adjustment of approximately $50m (recorded within cost of goods sold) to reflect the difference between the accounting fair value and book value of acquired REPLAGAL inventory of which $40.3m was charged in H1 2006 ;
HGT integration costs estimated at $7m in 2006 of which $3.9m was incurred in H1 2006;
The adoption from January 1, 2006 of US GAAP accountancy standard SFAS 123R for share based compensation; $45m expected for 2006 of which $16.7m charged in H1 2006 (H1 2005: $13.0m charge adopted retrospectively)
Note: Any launch of a generic version of ADDERALL XR during 2006 would have a material impact on the Company’s performance and would be expected to put the Company’s expected revenue growth at significant risk.
Matthew Emmens Chief Executive OfficerConcluding remarks
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Concluding Remarks
Good results - in line with expectations
Guidance re-affirmed – 2006 revenue growth expected to be in the low double digit range
Demonstrating our ability to execute
DAYTRANA - launched
SPD465 - filed
ELAPRASE - approved
FOSRENOL – continued roll-out internationally
Launches and filing before mid-2007 - on track
NRP104
MESAVANCE
DYNEPO
SPD503
Planned launches before mid - 2007
Filing planned for Q3 2006
Questions and answers
All