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CSL Ltd. — Interim / Quarterly Report 2010
Feb 16, 2010
17854_rns_2010-02-16_4aaf5291-60e9-4cf1-8858-f49e757b9bc3.pdf
Interim / Quarterly Report
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For immediate release 17 February 2010
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Interim Result Profit $617 million up 23% (up 32% at constant currency[1] ) Cash Flow from Operations $491 million up 10%
CSL Limited today announced a profit after tax of $617 million for the six months ended 31 December 2009, up 23% when compared to the six months ended 31 December 2008. This result included an unfavourable foreign exchange impact of $46 million. Adjusting for this item, net profit after tax grew 32%.
KEY ITEMS
Financial
-
Total sales revenue of $2.3 billion, up 5% when compared to the six months ended 31 December 2008, up 12% at constant currency
-
Reported net profit after tax up 23% to $617 million, up 32% at constant currency
-
Research and Development expenditure of $147 million
-
Cash flow from operations of $491 million, up 10%
-
On market share buyback 86% complete, ~$1.5 billion spent
-
Earnings per share of 106.3 cents, up 24%
-
Interim dividend up 17% to 35 cents per share, unfranked, payable on 9 April 2010
Operational
-
Australian fractionation agreement renewed to 31 December 2017
-
Berinert[®] (C1-Esterase Inhibitor)
-
US FDA grants marketing approval
-
European mutual recognition program completed
-
TGA approval, Notice of Compliance received from Health Canada;
-
Hizentra™ (Subcutaneous IG 20% Liquid)
-
License application submitted to the US FDA
-
Afluria[®] (Influenza Virus Vaccine)
-
Agreement with Merck & Co., Inc for US distribution
-
US FDA approves for use in paediatric population
-
Panvax[®] (Pandemic Influenza Vaccine)
-
Successful development and registration
-
GARDASIL[® ] (Human Papillomavirus Vaccine)
-
Merck & Co., Inc., submitted data to the US FDA for females aged 27 – 45
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1 Constant currency removes the impact of exchange rate movements to facilitate comparability
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17 February 2010
Dr McNamee, CSL’s Managing Director, said “This is a pleasing result in what has been a competitive trading environment.
Despite a currency headwind and the continuing impact of market dynamics, the underlying business remains sound. Demand for CSL’s plasma derived therapies has continued with product development underpinning an improvement in product sales.
Sales of Novel A (H1N1) Influenza or ‘Swine Flu’ Vaccine provided a significant contribution and I’m proud to report that following the outbreak in April 2009 CSL rapidly conducted clinical trials that were first published in September 2009 in the New England Journal of Medicine. The data played an important role in assisting Governments around the world in determining their vaccine immunisation policy. In a time-critical event such as a pandemic this is a notable achievement,” Dr McNamee said.
OUTLOOK (at 08/09 exchange rates)
Commenting on CSL’s outlook, Dr McNamee said “Demand growth for plasma derived therapies is expected to continue. CSL is well positioned with a broad portfolio of plasma derived proteins and an increasing demand for Vivaglobin[®] (subcutaneous delivery of liquid immunoglobulin) is expected.
“We continue to forecast a result, in line with previous guidance, for a net profit after tax of between $1,160 million and $1,260 million, at financial year 08/09 exchange rates. This represents 14 - 24% growth on the underlying operational profit. Furthermore, we now anticipate the result to be towards the upper end of this range. Using current exchange rates, net profit after tax is expected to be between $970 million and $1,070 million, recognising that there are a number of items that fall unevenly between the first half and second half of the financial year.
“In compiling our financial forecasts for the year ending 30 June 2010 we have determined a number of key variables which may have a significant impact on guidance, in particular, material price and volume movements on core plasma products, competitor activity, changes in healthcare regulations and reimbursement policies, royalties arising from the sale of Human Papillomavirus vaccine, successful implementation of the company’s influenza expansion strategy and plasma therapy life
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17 February 2010
cycle management strategies, enforcement of key intellectual property, the risk of regulatory action or litigation, the effective tax rate and foreign exchange movements.
“To assist investors in determining the impact of movement in key currency pairs, we have provided with our results materials a foreign currency sensitivity analysis,” Dr McNamee said.
BUSINESS REVIEW
Results overview
CSL Behring total sales of $1.8 billion grew 10% on a constant currency basis when compared to the six months ended 31 December 2008. Sales contribution from across the product portfolio has underpinned this growth.
Immunoglobulins grew 9% in constant currency terms, largely driven by product demand growth together with a shift in product mix. Sales of Vivaglobin[®] and Privigen[®] have been encouraging. Vivaglobin[® ] (Subcutaneous Immunoglobulin), a product which provides the convenience of immunoglobulin self administration, attracted significant patient growth. Immunoglobulin pricing has generally remained stable.
The Critical Care segment grew 8% in constant currency terms underpinned by volume growth of albumin, particularly in the US and emerging markets. Specialty products, primarily Haemocomplettan[® ] P and Berinert[® ] P, also made a significant contribution.
Haemophilia sales grew 10% in constant currency terms, mainly driven by product demand growth. Pricing has been steady, albeit the total average price was affected by growth in lower priced emerging and tender markets.
Sale of plasma raw material declined consistent with the new supply contract with Talecris Biotherapeutics.
CSL Biotherapies sales grew 31% to $528 million.
Sales of Novel A (H1N1) Influenza (Swine Flu) Vaccine contributed $160 million to sales. This was partially offset by the decline in GARDASIL[®] sales to $18 million for the first half of the financial year, down $66 million when compared to the prior comparable period. This decline is consistent with immunisation ‘catch-up’ programs in Australia
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17 February 2010
drawing to a close. Seasonal influenza vaccine sales totalled $91 million for the period, up 22% compared to the prior comparable period, arising from growth in the US and German markets. Strong contributions from Intragam[®] P (Liquid Immunoglobulin) in Australia and albumin in China also contributed to growth.
Business development
Australian fractionation agreement
On 23 December 2009, CSL signed an agreement with the Australian National Blood Authority to supply the Australian community with plasma-derived therapeutic products. The new Agreement, as previously announced, commenced on 1 January 2010 and will run for a total of eight years until 31 December 2017.
Russia – Plasma therapy agreement with GSK
During October 2009, CSL reached an agreement with GlaxoSmithKline (GSK) to initiate a strategic alliance in the territories of the Russian Federation. Under the terms of the agreement, GSK will distribute and promote in Russia, and the Commonwealth of Independent States, certain CSL Behring products. The first therapies to have received regulatory approval in Russia are Beriate[®] and Mononine[®] , coagulation factors VIII and IX respectively.
Berinert[®]
-
On 12 October 2009, the US Food and Drug Administration (FDA) granted marketing approval for Berinert[®] , (C1-Esterase Inhibitor, Human) for the treatment of acute abdominal or facial attacks of hereditary angioedema, a rare and serious genetic disorder, in adult and adolescent patients. Berinert[®] is the first and only therapy approved for this indication in the US.
-
In December 2009, CSL completed a mutual recognition program in Europe, where Berinert[®] is now approved in 23 countries.
-
In January 2010, CSL received Notice of Compliance from Health Canada for Berinert[®] for the treatment of acute episodes of hereditary angioedema.
-
In January 2010, Berinert[®] was approved by the Australian Therapeutic Goods Administration (TGA) for treatment of acute attacks in patients with hereditary angioedema.
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17 February 2010
Subcutaneous immunoglobulin
On 1 May 2009, CSL Behring announced that it had submitted a biologics license application to the US FDA requesting approval to market its 20% liquid formulation, subcutaneous immunoglobulin, for weekly replacement therapy in patients with primary immunodeficiencies. Subcutaneous immunoglobulin replacement therapy provides patients with the convenience of self infusion in the comfort of their own home. This new formulation will further add to patient convenience by reducing infusion time. CSL’s current subcutaneous immunoglobulin, Vivaglobin[®] , was launched into the US markets in March 2006 and has received strong patient take up.
Human Papillomavirus Vaccine
Before the end of calendar 2009, Merck & Co., Inc., submitted end of study data to the US FDA seeking to expand the GARDASIL[®] vaccine label claim to include adult women aged 27 - 45.
Royalties on global sales of Human Papillomavirus Vaccine totalled $58m for the half.
Influenza
On 11 November 2009, the US FDA approved Afluria[®] , influenza virus vaccine, for use in the paediatric population 6 months and older.
On 1 October 2009, CSL announced an agreement reached with Merck & Co., Inc., on rights to market and distribute Afluria[®] in the United States under an exclusive, six-year agreement effective 3 September 2009.
Share Buyback
On 9 June 2009, CSL announced its intention to conduct an on-market share buyback of up to 54,863,000 shares[2] . This represents approximately 9% of CSL’s current shares on issue. To-date CSL has repurchased 46,952,545 shares for approximately $1,497 million, representing 85.6% of the intended maximum number of shares to be repurchased.
CSL’s balance sheet remains very sound. Cash and cash equivalents totalled $956 million as at 31 December 2009, with interest bearing liabilities totalling $459 million.
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2 CSL reserves the right to suspend or terminate the buyback at any time
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17 February 2010
Additional details about CSL’s results are included in the company’s 4D statement, Investor Presentation slides and webcast, all of which can be found on the company’s website www.csl.com.au
For further information, please contact:
Media:
Tim Duncan / Jo Lynch Hintons Telephone: +613 9600 1979 Email: [email protected] [email protected]
Investors:
Mark Dehring Head of Investor Relations CSL Limited Telephone: +613 9389 2818 Email: [email protected]
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17 February 2010
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Page 7
Group Results
| Half year ended December | December 2009 December 2008 Change $m $m % |
|---|---|
| Sales Other Revenue / Income Total Revenue / Income |
2,317.4 2,206.7 5% 97.6 158.2 2,415.0 2,364.9 2% |
| Earnings before Interest, Tax, Depreciation & Amortisation Depreciation/Amortisation Earnings before Interest and Tax Net Interest Expense / (Income) Tax Expense Net Profit after Tax Interim Dividend (cents) Basic EPS (cents) |
874.4 701.5 25% 78.3 75.3 796.1 626.2 28% (15.2) (13.7) 193.9 138.0 |
| 617.4 501.9 23% |
|
| 35.00 30.00 106.34 85.44 |
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CSL Limited
ABN: 99 051 588 348
ASX Half-year Information 31 December 2009
Lodged with the ASX under Listing Rule 4.2A. This information should be read in conjunction with the 30 June 2009 Annual Report.
Contents
Page
Results for Announcement to the Market
Half-year Report
1 2
CSL Limited
ABN: 99 051 588 348
Appendix 4D Half-year ended 31 December 2009
(Previous corresponding period: Half-year ended 31 December 2008)
Results for Announcement to the Market
-
Revenues from continuing operations up 2.1% to $2.41 billion.
-
Profit from continuing operations after tax and net profit for the period attributable to members up 23% to $617.39m.
Dividends
| Dividends | ||
|---|---|---|
| Amount per | Franked amount per | |
| security | security | |
| Interim dividend (declared subsequent to balance date) | 35.00¢ | Unfranked* |
| Interim dividend from the previous corresponding period | 30.00¢ | Unfranked |
| Final dividend (prior year) | 40.00¢ | Unfranked |
| Record datefordetermining entitlements to the dividend: | 15March 2010 |
* Non-resident withholding tax is not payable on this dividend as it will be declared to be wholly conduit foreign income.
The Company's Dividend Reinvestment Plan remains suspended and does not apply to the interim dividend.
Explanation of results
For further explanation of the results please refer to the accompanying press release and “Review of Operations” in the Directors’ Report that is within the Half-year Report.
Other information required by Listing Rule 4.3A
The remainder of the information requiring disclosure to comply with Listing Rule 4.3A is contained in the attached Half-year Report (which includes the Directors’ Report) and Media Release.
1
CSL Limited Half-year Report – 31 December 2009
| Contents | Page |
|---|---|
| Directors’ Report | 3 |
| Auditor’s Independence Declaration | 5 |
| Statement of Comprehensive Income | 6 |
| Statement of Financial Position | 7 |
| Statement of Changes in Equity | 8 |
| Statement of Cash Flows | 9 |
| Notes to the Financial Statements | 10 |
| Directors’ Declaration | 18 |
| Independent Review Report to the Members of CSL Limited | 19 |
This Interim Financial Report does not include all the notes of the type normally included in an Annual Financial Report. Accordingly, this report is to be read in conjunction with the Annual Report for the year ended 30 June 2009 and any public announcements made by CSL Limited during the interim reporting period in accordance with the continuous disclosure requirements of the Corporations Act 2001 .
2
CSL Limited Directors’ Report
The Board of Directors of CSL Limited has pleasure in presenting their report on the consolidated entity for the half-year ended 31 December 2009.
Directors
The following persons were Directors of CSL Limited during the whole of the half-year and up to the date of this report:
Miss E A Alexander, AM (Chairman) Dr B A McNamee, AO (Managing Director) Mr J H Akehurst Mr D W Anstice Mr A M Cipa Mr I A Renard Mr M A Renshaw Professor J Shine, AO Mr D J Simpson
In addition, Mr P J Turner was appointed Director on 8 December 2009 and continues in office at the date of this report.
Review of Operations
In the half year ended 31 December 2009, total sales revenue of the Group was $2.32b, up 5% compared to the same period last year. Net profit after tax increased 23% to $617m. This result included an unfavourable foreign exchange impact of $46m. Adjusting for this item, net profit after tax grew 32%. Net operating cash flow was up 10% to $491m.
The Group’s operating results for the period reflected continuing demand for plasma therapies with CSL Behring’s total sales of $1.8b growing 10% on a constant currency basis. Sales contribution from across the product portfolio has underpinned this growth.
Sales of immunoglobulins grew 9% in constant currency terms, largely driven by product demand growth together with a shift in product mix. Sales of Vivaglobin® and Privigen® have been encouraging. Vivaglobin® (subcutaneous immunoglobulin), a product which provides the convenience of immunoglobulin self administration, attracted significant patient growth. Immunoglobulin pricing has generally remained stable.
The Critical Care segment grew 8% in constant currency terms underpinned by volume growth of albumin, particularly in the US and emerging markets. Specialty products, primarily Haemocomplettan® P and Berinert® P, also made a significant contribution.
Haemophilia sales grew 10% in constant currency terms, mainly driven by product demand growth. Pricing has been steady, albeit the total average price was affected by growth in lower priced emerging and tender markets.
CSL Biotherapies sales grew by 31% to $528m. Sales of Novel A (H1N1) Influenza (Swine Flu) Vaccine contributed $160m to sales. This was partially offset by the decline in GARDASIL® sales to $18m for the first half of the financial year, down $66m when compared to the prior comparable period. This decline is consistent with immunisation ‘catch-up’ programs in Australia drawing to a close.
Seasonal influenza vaccine sales totalled $91m for the period, up 22% compared to the prior comparable period, arising from growth in the US and German markets. Strong contributions from Intragam® P (liquid immunoglobulin) in Australia and albumin in China also contributed to growth.
3
CSL Limited Directors’ Report (continued)
Review of Operations (continued)
Royalties on global sales of Human Papillomavirus Vaccine totalled $58m for the half.
The Group’s balance sheet remains very sound. Cash and cash equivalents totalled $956m as at 31 December 2009, with interest bearing liabilities totalling $459m.
On 23 December, CSL signed an agreement with the Australian National Blood Authority to supply the Australian community with plasma-derived therapeutic products. The new Agreement commenced on 1 January 2010 and will run for a total of eight years until 31 December 2017.
On 9 June 2009, CSL announced its intention to conduct an on-market share buyback of up to 54,863,000 shares[1.] This represents approximately 9% of the company’s current shares on issue. Todate CSL has repurchased 46,952,545 shares for approximately $1,497 million, representing 85.6% of the intended maximum number of shares to be repurchased.
A final dividend of 40 cents per ordinary share (unfranked) was paid out of retained profits for the year ended 30 June 2009 on 9 October 2009. The Directors have declared an interim dividend of 35 cents per ordinary share (unfranked) payable on 9 April 2010.
Auditor’s independence declaration
A copy of the auditor’s independence declaration as required under section 307C of the Corporations Act 2001 is set out on page 5.
Rounding of Amounts
The amounts contained in this report and in the financial report have been rounded to the nearest $1,000 (where rounding is applicable) unless specifically stated otherwise under the relief available to the Company under ASIC Class Order 98/0100. The Company is an entity to which the Class Order applies.
This report has been made in accordance with a resolution of the directors.
Elizabeth A Alexander CHAIRMAN
Brian A McNamee MANAGING DIRECTOR
16 February 2010
1 CSL reserves the right to suspend or terminate the buyback at any time.
4
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Auditor’s Independence Declaration to the Directors of CSL Limited
In relation to our review of the financial report of CSL Limited for the half-year ended 31 December 2009, to the best of my knowledge and belief, there have been no contraventions of the auditor independence requirements of the Corporations Act 2001 or any applicable code of professional conduct.
Ernst & Young
Denis Thorn Partner 16 February 2010
Liability limited by a scheme approved under Professional Standards Legislation
5
CSL Limited and its controlled entities Statement of Comprehensive Income For the half-year ended 31 December 2009
| Consolidated Entity | Consolidated Entity | ||
|---|---|---|---|
| December | December | ||
| 2009 | 2008 | ||
| Notes | $000 | $000 | |
| Sales revenue | 2,317,392 | 2,206,655 | |
| Cost of sales | (1,097,529) | (1,192,431) | |
| Gross profit | 1,219,863 | 1,014,224 | |
| Other revenue | 4(a) | 97,581 | 158,216 |
| Research and development expenses | (146,924) | (153,034) |
|
| Selling and marketing expenses | (226,171) | (227,478) |
|
| General and administration expenses | 4(c) | (123,159) | (121,862) |
| Finance costs | 4(b) | (9,846) | (30,220) |
| Profit before income tax expense | 811,344 | 639,846 | |
| Income tax expense | 5 | (193,950) | (137,989) |
| Net profit for the period | **617,394 ** | **501,857 ** | |
| Other comprehensive income | |||
| Exchange differences on translation of foreign operations, net of | |||
| hedges on net foreign investments | 11 | (194,546) | 1,006,045 |
| Actuarial gains/(losses) on defined benefit plans, net of tax | 8,627 | (54,234) | |
| Total of other comprehensive income/(expense) | (185,919) | 951,811 | |
| Total comprehensive income for theperiod | 431,475 | 1,453,668 | |
| Earnings per share(based on netprofit for theperiod) | Cents |
Cents |
|
| Basic earnings per share | 6 | 106.34 | 85.44 |
| Diluted earnings per share | 6 | 106.00 | 85.05 |
6
CSL Limited and its controlled entities Statement of Financial Position As at 31 December 2009
| Statement of Financial Position As at 31 December 2009 |
|||
|---|---|---|---|
| Consolidated | Entity | ||
| December | June | ||
| 2009 | 2009 | ||
| Notes | $000 | $000 | |
| CURRENT ASSETS | |||
| Cash and cash equivalents | 7 | 955,804 | 2,528,097 |
| Trade and other receivables | 955,664 | 885,884 | |
| Current tax assets | - | 12,174 | |
| Inventories | 1,492,956 | 1,522,039 | |
| Other financial assets | 118 | 854 | |
| Total Current Assets | 3,404,542 | 4,949,048 | |
| NON-CURRENT ASSETS | |||
| Trade and other receivables | 10,321 | 10,225 | |
| Other financial assets | 6,243 | 8,397 | |
| Property, plant and equipment | 8 | 1,201,532 | 1,197,502 |
| Deferred tax assets | 211,932 | 227,096 | |
| Intangible assets | 915,024 | 974,547 | |
| Retirement benefit assets | 1,336 | - | |
| Total Non-Current Assets | 2,346,388 | 2,417,767 | |
| TOTAL ASSETS | 5,750,930 | 7,366,815 | |
| CURRENT LIABILITIES | |||
| Trade and other payables | 416,754 | 663,818 | |
| Interest-bearing liabilities | 9 | 133,595 | 332,358 |
| Current tax liabilities | 187,795 | 101,173 | |
| Provisions | 89,028 | 126,959 | |
| Deferred government grants | 995 | 469 | |
| Derivative financial instruments | 3,163 | 873 | |
| Total Current Liabilities | **831,330 ** | 1,225,650 | |
| NON-CURRENT LIABILITIES | |||
| Interest bearing liabilities | 9 | 325,420 | 385,420 |
| Deferred tax liabilities | 106,759 | 108,062 | |
| Provisions | 35,231 | 38,811 | |
| Deferred government grants | 11,103 | 12,083 | |
| Retirement benefit liabilities | 119,790 | 133,894 | |
| Total Non-Current Liabilities | 598,303 | 678,270 | |
| TOTAL LIABILITIES | 1,429,633 | 1,903,920 | |
| NET ASSETS | 4,321,297 | 5,462,895 | |
| EQUITY | |||
| Contributed equity | 10 | 1,413,256 | 2,760,207 |
| Reserves | 11 | (169,805) | 15,198 |
| Retained earnings | 3,077,846 | 2,687,490 | |
| TOTAL EQUITY | 4,321,297 | 5,462,895 |
7
CSL Limited and its controlled entities Statement of Changes in Equity For the half year ended 31 December 2009
| Ordinary | Foreign | Share | Retained | Total | ||
|---|---|---|---|---|---|---|
| shares | currency | based | earnings | |||
| translation | payment | |||||
| reserve | reserve | |||||
| $000 | $000 | $000 | $000 |
$000 | ||
| At 1 July 2009 | 2,760,207 | (50,541) | 65,739 | 2,687,490 |
5,462,895 | |
| Profit for the period | - | - | - | 617,394 |
617,394 | |
| Othercomprehensiveincome | - | (194,546) | - | 8,627 |
(185,919) | |
| Total comprehensive income for | ||||||
| the half year | - | (194,546) | - | 626,021 |
431,475 | |
| Transactions with owners in | ||||||
| their capacity as owners | ||||||
| Share based payments | 11 | - | - | 9,543 | - |
9,543 |
| Dividends | 12 | - | - | - | (235,665) |
(235,665) |
| Share buy back | 10 | (1,362,064) | - | - | - |
(1,362,064) |
| Capital raising tax benefit | 10 | 9,341 | - | - | - |
9,341 |
| Share issues | ||||||
| - Employee share scheme | 10 | 5,772 | - | - | - |
5,772 |
| Balance as at 31 December 2009 | 1,413,256 | (245,087) | 75,282 | 3,077,846 |
4,321,297 | |
| At 1 July 2008 | 1,034,337 | (171,552) | 37,253 | 1,906,087 |
2,806,125 | |
| Profit for the period | - | - | - | 501,857 |
501,857 | |
| Othercomprehensiveincome | - | 1,006,045 | - | (54,234) |
951,811 | |
| Total comprehensive income for | ||||||
| the half year | - | 1,006,045 | - | 447,623 |
1,453,668 | |
| Transactions with owners in | ||||||
| their capacity as owners | ||||||
| Share based payments | 11 | - | - | 19,508 | - |
19,508 |
| Dividends | 12 | - | - | - | (138,510) |
(138,510) |
| Share issues | ||||||
| - Employee share scheme | 5,308 | - | - | - |
5,308 | |
| - Institutional offer | 1,745,625 | - | - | - |
1,745,625 | |
| - Retail Offer | 145,471 | - | - | - |
145,471 | |
| - Capital raising costs | (39,840) | - | - | - |
(39,840) | |
| Transfertoreserves | - | 183 | - | (183) |
- | |
| Balance as at 31 December 2008 | 2,890,901 | 834,676 | 56,761 | 2,215,017 |
5,997,355 |
8
CSL Limited and its controlled entities Cash Flow Statement For the half-year ended 31 December 2009
| CSL Limited and its controlled entities Cash Flow Statement For the half-year ended 31 December 2009 |
|||
|---|---|---|---|
| Consolidated Entity | |||
| December | December | ||
| 2009 | 2008 | ||
| Notes | $000 | $000 | |
| Cash flows from Operating Activities | |||
| Receipts from customers (inclusive of goods and services tax) | 2,320,256 | 2,301,071 | |
| Payments to suppliers and employees (inclusive of goods and | |||
| services tax) | (1,772,726) | (1,712,289) | |
| 547,530 | 588,782 | ||
| Interest received | 25,214 | 28,884 | |
| Income taxes paid | (69,725) | (128,215) | |
| Borrowingcosts | (11,848) | (44,403) | |
| Net cash inflow from operatingactivities | 491,171 | 445,048 | |
| Cash flows from Investing Activities | |||
| Proceeds from sale of property, plant and equipment | 162 | 317 | |
| Payments for property, plant and equipment | 8 | (119,520) | (133,187) |
| Payments for intangible assets | (28,769) | (46,574) | |
| Payments for other financial assets | 1,654 | - | |
| Net cash outflow from investingactivities | (146,473) | (179,444) | |
| Cash flows from Financing Activities | |||
| Proceeds from issue of shares | 5,772 | 1,854,704 | |
| Payment for shares bought back | (1,442,732) | - | |
| Dividends paid | (235,665) | (138,510) | |
| Receipts (payments) on closure of foreign exchange hedges | 104 | (110,539) | |
| Repayment of borrowings | 9 | (213,562) | (395,364) |
| Net cash inflow(outflow)from financingactivities | (1,886,083) | 1,210,291 | |
| Net increase (decrease) in cash and cash equivalents | (1,541,385) | 1,475,895 | |
| Cash and cash equivalents at the beginning of the period | 2,522,192 | 695,596 | |
| Exchange rate variations on foreign cash and cash equivalent | |||
| balances | (25,025) | 560,635 | |
| Cash and cash equivalents at the end of theperiod | 955,782 | 2,732,126 | |
| Reconciliation of cash and cash equivalents | |||
| Cash and cash equivalents at the end of the period as shown in the | |||
| statement of cash flows is reconciled as follows: | |||
| Cash and cash equivalents | 7 | 955,804 | 2,732,394 |
| Bank overdrafts | (22) | (268) | |
| 955,782 | 2,732,126 |
9
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2009
1 Corporate Information
The financial report of CSL Limited (the Company) for the half-year ended 31 December 2009 was authorised for issue in accordance with a resolution of the directors on 16 February 2010. CSL Limited is a company incorporated in Australia and limited by shares, which are publicly traded on the Australian Stock Exchange.
The nature of the operations and principal activities of the Group are described in the Directors’ Report.
2 Summary of Significant Accounting Policies
(a) Basis of Accounting
The half-year financial report does not include all notes of the type normally included within the annual financial report and therefore cannot be expected to provide as full an understanding of the financial performance, financial position and financing and investing activities of the consolidated entity as the full financial report. The half-year financial report should be read in conjunction with the annual financial report of CSL Limited as at 30 June 2009.
It is also recommended that the half-year financial report be considered together with any public announcements made by CSL Limited and its controlled entities during the half-year ended 31 December 2009 in accordance with the continuous disclosure obligations arising under ASX listing rules.
(b) Basis of Preparation
The half-year consolidated financial report is a general-purpose financial report, which has been prepared in accordance with the requirements of the Corporations Act 2001, applicable Accounting Standards, including AASB 134 Interim Financial Reporting and other mandatory professional reporting requirements. The half-year financial report has been prepared on a historical cost basis, as modified by the revaluation of available-for-sale financial assets, financial assets and liabilities (including derivative instruments) at fair value through profit or loss, and land and buildings.
For the purpose of preparing the half-year financial report, the half-year has been treated as a discrete reporting period.
(c) Significant Accounting Policies
The half-year consolidated financial statements have been prepared using the same accounting policies as used in the annual financial statements for the year ended 30 June 2009.
(d)
Basis of Consolidation
The half-year consolidated financial statements comprise the financial statements of CSL Limited and its subsidiaries as at 31 December 2009 ('the Group').
10
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2009
3 Segment Information
| Intellectual | Other |
||||
|---|---|---|---|---|---|
| Property | Human |
Intersegment |
Consolidated | ||
| CSL Behring | Licensing |
Health |
Elimination |
Group | |
| December | December |
December |
December |
December | |
| 2009 | 2009 |
2009 |
2009 |
2009 | |
| $000 | $000 |
$000 |
$000 |
$000 | |
| Sales to external customers | 1,789,187 | - |
528,205 |
- |
2,317,392 |
| Inter-segment sales | 57,361 | - |
275 |
(57,636) |
- |
| Other revenue / other Income (excl interest | |||||
| income) | 2,373 | 60,787 |
9,360 |
- |
72,520 |
| Total segment revenue | 1,848,921 | 60,787 |
537,840 |
(57,636) |
2,389,912 |
| Interest income | 25,061 | ||||
| Unallocated revenue / income | - | ||||
| Consolidated revenue | 2,414,973 | ||||
| Segment EBIT | 614,694 | 52,097 |
143,649 |
- |
810,440 |
| Unallocated revenue / income less | |||||
| unallocated costs | (14,311) | ||||
| Consolidated EBIT | 796,129 | ||||
| Interest income | 25,061 | ||||
| Finance costs | (9,846) | ||||
| Consolidated profit before tax | 811,344 | ||||
| Income tax expense | (193,950) | ||||
| Consolidated netprofit after tax | **617,394 ** | ||||
| Amortisation and impairment loss | 11,003 | - |
2,090 |
- |
13,093 |
| Depreciation | 46,611 | - |
17,758 |
- |
64,369 |
| Segment EBITDA | 672,308 | 52,097 |
163,497 |
- |
887,902 |
| Unallocated revenue / income less | |||||
| unallocated costs | (14,311) | ||||
| Unallocated depreciation and amortisation | 858 | ||||
| Consolidated EBITDA | 874,449 |
11
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2009
3 Segment information (continued)
| Intellectual | Other |
||||
|---|---|---|---|---|---|
| Property | Human |
Intersegment |
Consolidated | ||
| CSL Behring | Licensing |
Health |
Elimination |
Group | |
| December | December |
December |
December |
December | |
| 2008 | 2008 |
2008 |
2008 |
2008 | |
| $000 | $000 |
$000 |
$000 |
$000 | |
| Sales to external customers | 1,804,319 | - |
402,336 |
- |
2,206,655 |
| Inter-segment sales | 41,823 | - |
2,969 |
(44,792) |
- |
| Other revenue / other Income (excl interest | |||||
| income) | 7,805 | 84,226 |
3,785 |
- |
95,816 |
| Total segment revenue | 1,853,947 | 84,226 |
409,090 |
(44,792) |
2,302,471 |
| Interest income | 43,860 | ||||
| Unallocated revenue / income | 18,540 | ||||
| Consolidated revenue | 2,364,871 | ||||
| Segment EBIT | 532,175 | 71,846 |
13,922 |
- |
617,943 |
| Unallocated revenue / income less | |||||
| unallocated costs | 8,263 | ||||
| Consolidated EBIT | 626,206 | ||||
| Interest income | 43,860 | ||||
| Finance costs | (30,220) | ||||
| Consolidated profit before tax | 639,846 | ||||
| Income tax expense | (137,989) | ||||
| Consolidated netprofit after tax | **501,857 ** | ||||
| Amortisation and impairment loss | 14,760 | - |
2,090 |
- |
16,850 |
| Depreciation | 39,587 | - |
18,038 |
- |
57,625 |
| Segment EBITDA | 586,522 | 71,846 |
34,050 |
- |
692,418 |
| Unallocated revenue / income less | |||||
| unallocated costs | 8,263 | ||||
| Unallocated depreciation and amortisation | 834 | ||||
| Consolidated EBITDA | 701,515 |
| Geographic areas | United | Rest of world $000 |
||||
|---|---|---|---|---|---|---|
| Australia | States | Switzerland | Germany | Total | ||
| $000 | $000 | $000 | $000 | $000 | ||
| December 2009 External sales revenue |
311,815 | 896,821 | 74,689 | 361,630 | 672,437 | |
| 2,317,392 | ||||||
| December 2008 External sales revenue |
279,405 | 840,915 | 71,745 | 359,248 | 655,342 | |
| 2,206,655 |
12
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2009
4 Revenue, Income and Expenses from continuing operations
| Consolidated Entity | Consolidated Entity | ||
|---|---|---|---|
| December | December | ||
| 2009 | 2008 | ||
| $000 | $000 | ||
| (a) | Other Revenue | ||
| Interest income | 25,061 | 43,860 | |
| Rent | 485 | 551 | |
| Royalties | 58,729 | 82,687 | |
| Sundry | 13,306 | 31,118 | |
| 97,581 | 158,216 | ||
| Sundry income in the comparative period includes $18,450,000 of foreign | |||
| exchange gains. | |||
| (b) | Finance Costs | ||
| Interest paid / payable | 9,846 | 30,220 | |
| (c) | Other Expenses | ||
| General and administration expenses: | |||
| Expense of share based payments | 8,676 | 8,020 | |
| Amortisation of intellectual property | 13,093 | 16,850 | |
| Other relevant expenses | |||
| Depreciation and amortisation of property, plant and equipment | 65,227 | 58,459 | |
| Net foreign exchange losses | 5,925 | - |
5 Income Tax
The reconciliation between income tax expense and the consolidated entity’s applicable tax rate is as follows:
| Profit from continuingactivities before income tax expense | 811,344 | 639,846 |
|---|---|---|
| Income tax calculated at 30% | 243,403 | 191,954 |
| Tax effect of non-assessable / non-deductible items | ||
| Research and development | (4,315) | (5,524) |
| Other (non-assessable revenue)/non-deductible expenses | 960 | (12,355) |
| (Utilisation of tax losses)/Unrecognised deferred tax assets | 47 | (4,021) |
| Revaluation of deferred tax balances due to income tax rate changes | 1,949 | 11,316 |
| Effects of different rates of tax on overseas income | (39,078) | (26,511) |
| Under(over) provision inpreviousyear | (9,016) | (16,870) |
| Income tax expense | 193,950 | 137,989 |
13
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2009
6 Earnings Per Share
| Consolidated Entity | Consolidated Entity | |
|---|---|---|
| December | December | |
| 2009 | 2008 | |
| $000 | $000 | |
| The following reflects the income and share information used in the | ||
| calculation of basic and diluted earnings per share: | ||
| Earnings usedincalculating basic earnings pershare | 617,394 | 501,857 |
| Number | of shares | |
| December | December | |
| 2009 | 2008 | |
| Weighted average number of ordinary shares used in the calculation of basic | ||
| earnings per share: | 580,605,173 | 587,377,003 |
| Effect of dilutive securities: | ||
| Share options | 462,041 | 722,778 |
| Performance rights | 1,361,487 | 1,994,738 |
| Globalemployee share plan | - | 4,048 |
| Adjusted weighted average number of ordinary shares used in calculating | ||
| diluted earnings pershare | 582,428,701 | 590,098,567 |
*Refer note 10 for a reconciliation of the movement in issued shares.
Conversions, calls, subscription or issues after 31 December 2009
Subsequent to the reporting date 27,654 ordinary shares were issued, as required under the Employee Performance Rights Plan. There have been no other ordinary shares issued since the reporting date and before the completion of this financial report. There have been no other conversions to, calls of, or subscriptions for ordinary shares or issues of potential ordinary shares since the reporting date and before the completion of this financial report.
7 Cash and cash equivalents
| Consolidated | Entity | |
|---|---|---|
| December | June | |
| 2009 | 2009 | |
| $000 | $000 | |
| Cash at bank and on hand | 312,286 | 410,278 |
| Cashdeposits | 643,518 | 2,117,819 |
| Totalcashand cashequivalents | 955,804 | 2,528,097 |
8 Property, Plant and Equipment
During the half-year ended 31 December 2009, the Group acquired assets with a cost of $119,520,175 (2008: $139,296,279).
14
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2009
9 Borrowings and repayments
For the half year ended 31 December 2009, the Group has repaid $211,512,000 of interest bearing debt and made $2,050,000 of finance lease repayments.
10 Contributed Equity
Movements in the contributed equity
| Number of | $000 | |
|---|---|---|
| Shares | ||
| Ordinary shares | ||
| Balance as at 1 July 2009 | 599,239,428 | 2,760,207 |
| Shares issued to CSL employees through participation in: | ||
| - Performance Option Plan and SESOP Option Plan | 214,695 | 3,200 |
| - Performance Rights Plan | 195,861 | - |
| - Global Employee Share Plan | 93,696 | 2,572 |
| Shares acquired under the Share Buy Back | (42,691,411) | (1,361,342) |
| Costs associated with the Share Buy Back | - | (722) |
| Taxbenefit attributable to prioryear’s capital raising costs | - | 9,341 |
| Balance as at 31 December 2009 | 557,052,269 | 1,413,256 |
11 Reserves
| Consolidated | Entity | |
|---|---|---|
| December | June | |
| 2009 | 2009 | |
| $000 | $000 | |
| Composition | ||
| Share based payments reserve (i) | 75,282 | 65,739 |
| Foreigncurrency translation reserve (ii) | (245,087) | (50,541) |
| (169,805) | 15,198 |
Nature and purpose of reserves
(i) Share based payments reserve
The share based payments reserve is used to recognise the fair value of options and performance rights issued but not exercised.
(ii) Foreign currency translation reserve
The results of foreign subsidiaries are translated into Australian dollars at average exchange rates. Assets and liabilities of foreign subsidiaries are translated to Australian dollars at exchange rates prevailing at balance date and resulting exchange differences are recognised in the foreign currency translation reserve in equity. On consolidation, exchange differences arising from the translation of any net investment in foreign entities, and of borrowings and other financial instruments designated as hedges of such investments, are taken to the foreign currency translation reserve in equity.
15
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2009
12 Dividends
| Consolidated Entity | Consolidated Entity | ||
|---|---|---|---|
| December | December | ||
| 2009 | 2008 | ||
| $000 | $000 | ||
| Ordinary shares | |||
| Dividends providedfororpaid during thehalf-year | 235,665 | 138,510 | |
| Dividends not recognised at the end of the half-year | |||
| Since the end of the half-year the directors have recommended the payment of | |||
| an interim dividend of 35 cents (2009 – 30.00 cents) per fully paid ordinary | |||
| share, unfranked. The aggregate amount of the proposed interim dividend | |||
| expected to be paid on 9 April 2010 out of retained earnings at 31 December | |||
| 2009, butnotrecognised as aliability at the end ofthehalf-year,is: | 194,968 | 180,899 | |
| 13 | NTA Backing | ||
| December | June | ||
| 2009 | 2009 | ||
| $ | $ | ||
| Net tangible asset backing perordinary security |
6.11 | 7.49 |
16
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2009
14 Share Based Payment Plans
On 1 October 2009, 1,162,640 share options and 387,880 performance rights were granted to senior executives under the CSL Performance Rights Plan. The exercise price of the options of $33.68 is equal to the 5 day volume weighted average market price of CSL Limited shares as traded on the Australian Stock Exchange in the one week before and ending on the grant date. The exercise price for the performance rights is Nil. The options and performance rights will become exercisable between 30 September 2011 and 30 September 2014. The fair value of the options and performance rights granted is estimated as at the date of grant using an adjusted form of the Black-Scholes model, taking into account the terms and conditions upon which the options and performance rights were granted. The following table lists the inputs to the model used for options and performance rights issued in the half-year ended 31 December 2009:
| December | |
|---|---|
| 2009 | |
| Dividend yield (%) | 1.5% |
| Expected volatility (%) | 33.0% |
| Risk-free interest rate (%) | 5.16% |
| Fair Value of Options | |
| 2 year vesting | $10.34 |
| 3 year vesting | $10.87 |
| 4 year vesting | $11.36 |
| Fair Value of Performance Rights | |
| 2 year vesting | $28.91 |
| 3 year vesting | $27.72 |
| 4 year vesting | $26.31 |
15 Commitments and contingencies
Litigation
The CSL Group has been served with a number of lawsuits filed in the US courts alleging that the Group and a competitor, along with an industry trade association, had conspired to restrict output and artificially increase the price for plasma-derived therapies in the US. These actions have been filed by or on behalf of individual hospital groups but all seek status to proceed as class actions on behalf of all persons similarly situated, and all actions have been centralised before a single US court for consolidated pre-trial proceedings. CSL believes these lawsuits are unsupported by fact and without merit, and CSL will robustly defend against them.
The consolidated entity is involved in litigation in the ordinary course of business. The directors believe that future payment of a material amount in respect of litigation is not probable. An estimate of the financial effect of this litigation cannot be calculated as it is not practicable at this stage. The consolidated entity has disclaimed liability for, and is vigorously defending, all current material claims and actions that have been made.
17
CSL Limited Directors’ Declarations
The directors declare that:
-
(a) the financial statements and notes of the consolidated entity are in accordance with the Corporations Act 2001, and:
-
(i) give a true and fair view of the financial position as at 31 December 2009 and the performance for the half-year ended on that date of the consolidated entity; and
-
(ii) comply with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations 2001 ; and
-
(b) in the directors' opinion there are reasonable grounds to believe that the company will be able to pay its debts as and when they become due and payable.
Made in accordance with a resolution of directors.
Elizabeth A Alexander Chairman
Brian A McNamee Managing Director
Melbourne
16 February 2010
18
==> picture [80 x 62] intentionally omitted <==
Independent Review report to the members of CSL Limited
Report on the Half-Year Financial Report
We have reviewed the accompanying half-year financial report of CSL Limited, which comprises the statement of financial position as at 31 December 2009, and the statement of comprehensive income, statement of changes in equity and statement of cash flows for the half-year ended on that date, other selected explanatory notes and the directors’ declaration of the consolidated entity comprising the company and the entities it controlled at the half-year end or from time to time during the half-year.
Directors’ Responsibility for the Half-Year Financial Report
The directors of the company are responsible for the preparation and fair presentation of the half-year financial report in accordance with Australian Accounting Standards (including the Australian Accounting Interpretations) and the Corporations Act 2001. This responsibility includes establishing and maintaining internal controls relevant to the preparation and fair presentation of the half-year financial report that is free from material misstatement, whether due to fraud or error; selecting and applying appropriate accounting policies; and making accounting estimates that are reasonable in the circumstances.
Auditor’s Responsibility
Our responsibility is to express a conclusion on the half-year financial report based on our review. We conducted our review in accordance with Auditing Standard on Review Engagements ASRE 2410 Review of Interim and Other Financial Reports Performed by the Independent Auditor of the Entity, in order to state whether, on the basis of the procedures described, we have become aware of any matter that makes us believe that the financial report is not in accordance with the Corporations Act 2001 including: giving a true and fair view of the consolidated entity’s financial position as at 31 December 2009 and its performance for the half-year ended on that date; and complying with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations 2001. As the auditor of CSL Limited and the entities it controlled during the half-year, ASRE 2410 requires that we comply with the ethical requirements relevant to the audit of the annual financial report.
A review of a half-year financial report consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with Australian Auditing Standards and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Independence
In conducting our review, we have complied with the independence requirements of the Corporations Act 2001. We have given to the directors of the company a written Auditor’s Independence Declaration, a copy of which is included in the Directors’ Report.
Conclusion
Based on our review, which is not an audit, we have not become aware of any matter that makes us believe that the half-year financial report of CSL Limited is not in accordance with the Corporations Act 2001, including:
-
i) giving a true and fair view of the consolidated entity’s financial position as at 31 December 2009 and of its performance for the half-year ended on that date; and
-
ii) complying with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations 2001.
Ernst & Young
Denis Thorn Partner Melbourne 16 February 2010
Liability limited by a scheme approved under Professional Standards Legislation.
17 February 2010
Disclaimer
Forward looking statements
The materials in this presentation speak only as of the date of these materials, and include forward looking statements about CSL’s financial results and estimates, business prospects and products in research, all of which involve substantial risks and uncertainties, many of which are outside the control of, and are unknown to, CSL. You can identify these forward looking statements by the fact that they use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “may,” “assume,” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Among the factors that could cause actual results to differ materially are the following: the success of research and development activities, decisions by regulatory authorities regarding whether and when to approve our drug applications as well as their decisions regarding labeling and other matters that would affect the commercial potential of our products; competitive developments affecting our products; the ability to successfully market new and existing products in Australia and other countries; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations throughout the world that affect product production, distribution, pricing, reimbursement or access; litigation or government investigations, including legal costs, settlement costs and the risk of adverse decisions or settlements; and CSL’s ability to protect its patents and other intellectual property throughout the world. The statements being made in this presentation do not constitute an offer to sell, or solicitation of an offer to buy, any securities of CSL.
No representation, warranty or assurance (express or implied) is given or made in relation to any forward looking statement by any person (including CSL). In particular, no representation, warranty or assurance (express or implied) is given in relation to any underlying assumption or that any forward looking statement will be achieved. Actual future events may vary materially from the forward looking statements and the assumptions on which the forward looking statements are based. Given these uncertainties, readers are cautioned to not place undue reliance on such forward looking statements.
Subject to any continuing obligations under applicable law or any relevant listing rules of the ASX, CSL disclaims any obligation or undertaking to disseminate any updates or revisions to any forward looking statements in these materials to reflect any change in expectations in relation to any forward looking statements or any change in events, conditions or circumstances on which any such statement is based. Nothing in these materials shall under any circumstances create an implication that there has been no change in the affairs of CSL since the date of these materials.
2
Highlights - Financial
Total sales $2.3 billion EBIT $796 million (up 37% at constant currency) Effective tax rate 24% NPAT $617 million up 23% (up 32% at constant currency) R&D investment $147m Operating cashflow $491 million up 10% Strong balance sheet On market share buyback 86% complete EPS 106.3 cents up 24% Interim dividend 35 cents (unfranked) up 17%
* Constant currency removes the impact of exchange rate movements to facilitate comparability
3
Highlights - Operational
-
Australian Fractionation Agreement to 2017 Berinert[®]
-
US FDA marketing approval
-
European MRP complete
-
Australian TGA & Health Canada approval
-
Hizentra™- application to US FDA Afluria
-
US FDA approves for use in paediatric population
-
Agreement with Merck & Co., Inc., for US distribution
-
Panvax[®] (H1N1) - successful development and registration GARDASIL[®] - Merck data related to use by women aged 27 – 45
4
Outlook for FY2010 - no change
At current exchange rates
-
Net profit after tax
-
$970m - $1,070m
At FY 08/09 exchange rates
-
Revenue
-
$4.9bn – $5.2bn
-
R&D
~$320m - $340m
-
Net profit after tax*
-
$1,160m - $1,260m
-
(Up 14-24% on FY2009 underlying operational profit)
Outlook statements are subject to:
Material price and volume movements on core plasma products, competitor activity, changes in healthcare regulations and reimbursement policies, HPV royalties, successful implementation of the company’s influenza expansion strategy and plasma therapy life cycle management strategies, enforcement of key intellectual property, the risk of regulatory action or litigation, the effective tax rate and foreign exchange movements.
- See slides 23 & 29 for FX guide
5
-
CSL Behring
-
CSL Biotherapies
-
Intellectual Property Licensing
-
CSL Research & Development
CSL Behring
Sales US$1,545m (A$1,789m) up 10% at CC* EBITDA margin ~35%
Optimizing product mix – take up of Privigen[®] & Vivaglobin[®]
Growth in emerging markets & specialty products Agreement with GSK for distribution of plasma therapies in Russia
US FDA approves prophylaxis use of Helixate[®] for children
Berinert[®] - US FDA, TGA and Health Canada approval. EU MRP completion
Hizentra™(IgPro20) – US FDA action date Q1 2010
- Constant currency (cc) removes the impact of exchange rate movements to facilitate comparability
7
CSL Behring – Product sales up 10% in CC terms
==> picture [545 x 379] intentionally omitted <==
----- Start of picture text -----
US$1,545m
1,600
US$1,406m Other
1,400
Immuno-
1,200 globulins
1,000
Wound H
800
Critical
600 Care
400
pdCoag
200
Helixate
0
Dec 08 Dec 09
Sales for the 6 month period
----- End of picture text -----
8
CSL Behring – Product sales, Geographic split Sales for the 6 Month period ended Dec 09 – US$1,545m
==> picture [413 x 300] intentionally omitted <==
----- Start of picture text -----
RoW
12%
Japan
6%
USA
42%
Europe
pdCoag
40%
Helixate
----- End of picture text -----
9
Immunoglobulins
==> picture [653 x 403] intentionally omitted <==
----- Start of picture text -----
650
US$574m
600 Highlights
US$531m
550
500
Immunoglobulin up 9% at CC
450
Growth
Immuno -
400
globulin •
350 Mix – Privigen [[®]] , Vivaglobin [[®]]
300 •
Vol - Privigen [[®]] , Vivaglobin [[®]]
250 Rhophylac [[®]]
200
•
Growth in Canada, EU and
150
Brazil
100
50
Specific IG
0
Dec 08 Dec 09
Sales for the 6 month period
----- End of picture text -----
-
Mix – Privigen[[®]] , Vivaglobin[[®]]
-
Vol - Privigen[[®]] , Vivaglobin[[®]] , Rhophylac[[®]]
10
Critical Care
350 Highlights US$307m 300 US$280m Up 8% at CC Albumin growth 250 Specialty Critical Care Volume across geographies 200 Strong contribution and growth in specialty products such as, 150 Haemocomplettan[®] P, 100 Albumin Berinert[®] P and Beriplex[®] P/N 50 0 Dec 08 Dec 09 Sales for the 6 month period
11
Haemophilia
==> picture [646 x 387] intentionally omitted <==
----- Start of picture text -----
600
Highlights
US$530m
Up 10% in CC terms
US$480m
500
PdCoag
•
400 pdCoag Strong US demand for Humate
•
Central European ITT increase
300 •
Canada tender ramp up
Helixate [®]
200
•
Helixate Strong demand in US
100 •
Western European tender wins
•
Canada tender ramp up
0
Dec 08 Dec 09
Sales for the 6 month period
----- End of picture text -----
12
Plasma Proteins Strategy
==> picture [678 x 404] intentionally omitted <==
----- Start of picture text -----
Specialty Products
Extend and develop new registrations
and new markets:
Other
• Berinert [®] P
•
Zemaira [®]
C1 Est. •
Riastap [®]
•
Cytogam [®]
Fibrinogen • Beriplex [®] P/N
•
Rhophlylac [®]
•
Identify new plasma-derived
PCC
opportunities
Factor IX
Core Products
API Marginal Products
Grow Marginal Product
Franchises with a balanced
litre strategy
Factor VIII
•
IG Strategy:
•
Albumin Carimune [®] to Privigen [®] ,
•
Vivaglobin [®] to Hizentra [®]
•
Immunoglobulins FVIII Strategy: develop vWF
globally, access and expand
pdFVIII markets
VOLUME PROCESSED
Inframarginal Products
REVENUE PER LITRE
----- End of picture text -----
* Illustrative, not to scale
13
CSL Behring
Outlook for FY2010
Sales growth in USD approx. ~10% at const. currency
-
Leverage the three product IG portfolio
-
Hizentra™(SCIG 20%) US FDA action date
-
1H 2010
-
US IG sales impacted by market dynamics
US Healthcare reform – watching brief
14
CSL Biotherapies - Financial
Sales A$528m up 31% Revenues from H N 1 1 $160m GARDASIL[®] Australia
-
Successful conclusion of catch-up programs
-
Ongoing Australian/NZ cohort ~$30-35m pa
-
Influenza sales $91m, up 22%
-
Growth in US and Germany
15
CSL Biotherapies - Operational
Australian domiciled businesses merged to form CSL Biotherapies Aust. Fractionation Agreement to 31 December 2017 Afluria[®] distribution agreement with Merck in USA Pandemic Influenza vaccine (H1N1), Panvax[®]
-
Successful development and registration of vaccine
-
Significant contribution to sales
-
US Order Modification
16
CSL Intellectual Property Licensing
Segment EBIT $52m HPV royalties $58m
-
Merck submits data to the US FDA related to the use of GARDASIL[®] in women aged 27 – 45
-
Outlook for HPV royalties FY 2010 ~$120m α
-
CAM3001 (GM-CSFR )
-
Phase I in Rheumatoid Arthritis complete
-
Medimmume/AstraZeneca to commence ph II 1H 2010
-
Periodontal disease vaccine
-
Research agreement with Sanofi pasteur
-
Option to an exclusive worldwide license
17
R&D Regulatory Progress
Privigen [®] - plant approved Berinert[®] P (C1 esterase inhibitor)
- US & Australian approval
• Canada – application under review Beriate [®] approved in Russia RiaSTAP™- US & German approval Hizentra (IgPro20)
-
US submitted in April, Action date Q1 2010
-
EMEA submission 1H 2010
Afluria[®] US paediatric approval, Kankakee filling line approved Pandemic (H1N1) Approved in Australia, US, Singapore, Germany and by WHO
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Financial Detail
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1H 2010 Operational Profit – up 46% on 1H09
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----- Start of picture text -----
FX impact
$663m
+46% Reported NPAT $617m
Foreign currency -ve $46m
Non op.
NPAT at constant currency $663m
$454m
H N
1 1 sales
HPV royalties
Australian Gardasil [®]
programs
Dec 08 Dec 09
NPAT for the 6 month period
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* Based on 1H09 exchange rates
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Strong Financial Fundamentals
1H10 1H09 % Cashflow from operations $491m $445m +10% Net interest income $ 15m $ 14m Capital expenditure $120m $133m Dec 09 Jun 09 Cash & Equivalents $956m $2,528m Interest bearing liabilities $459m $ 718m Inventory turns 1.5 1.6 Days debtors 63 60
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Capital Management
On Market Buyback
Commenced 23 June 2009
-
12 month window to complete
-
Up to 54.9m shares, ~ 9% of issued capital
-
As at 17 February 2010
-
~47 million repurchased for ~$1.5 billion
-
~86% complete
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FX Impact on FY2010 Guidance*
Foreign Exchange (post tax) FY10 Est.
Translation -ve $100m - – Transaction ve $80m $90m Total -ve $180m – $190m
Net profit after tax NPAT FY2010 at constant currency $1,160m - $1,260m Up 14-24% on FY09 underlying operational profit Est. foreign currency NPAT impact -ve $180m - $190m (NPAT FY2010 at current rates $970m – $1,070m)
* Full year impact
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NPAT Phasing
Phasing 1H v 2H Panvax[®] (H1N1) CSL Behring sales pull forward Influenza vaccine seasonality R&D phasing Behring transaction FX
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CSL Growth Strategy
Royalties & Licensing HPV
Market Development
Influenza H N 1 1 Privigen[®] Pro20 Specialty products RiaSTAP[™] Zemaira[®] Cytogam[®] vWF Beriplex[®] etc Expanded geographies
ISCOMATRIX[®] adjuvant Technology partnering
Global Specialty Bio- pharmaceutical Company
Novel Products
Biotech rCoag CSL 360 Plasma rHDL
Plasma sector growth Global focus Growth in R&D investment New products – unmet medical needs
Financial Strength Identify Complementary Assets
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Appendix
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Group Results
| Group Results | |
|---|---|
| Half year ended December | Change % December 2008 A$m December 2009 A$m |
| Net Profit Net Interest Income/Expense Tax Expense Depreciation/Amortisation Earnings before Interest and Tax Earnings before Interest, Tax, Depreciation & Amortisation Sales Other Revenue Total Revenue |
(13.7) 138.0 (15.2) 193.9 28% 75.3 626.2 78.3 796.1 25% 701.5 874.4 2% 2,206.7 158.2 2,364.9 2,317.4 97.6 2,415.0 |
| 23% 501.9 617.4 |
|
| Interim Dividend (cents) Basic EPS (cents) |
30.00 85.44 35.00 106.65 |
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CSL Behring Sales
| Half year ended December | 1H10 USD$M CC Change % 1H10 USD$M 1H09 USD$M |
|---|---|
| rFVIII pdCoag Specialty Critical Care Albumin Wound Healing Immunoglobulins Specific IG Other Product Sales |
246 282 156 144 46 492 80 41 12 8 7 8 7 9 - - 247 283 161 147 50 494 80 42 220 260 146 133 43 451 80 21 |
| Total Product Sales Other sales (mainly plasma) Total Sales |
1,487 10 1,504 41 1,545 1,354 52 1,406 |
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Foreign Exchange Translation Sensitivity 2H10
NPAT FY2010 at current FX rates $970m - $1,070m
- 1% movement in key currency pairs impacts guidance as follows -
Current 1% chg
AUD/USD* 0.90 +/- $1.2m AUD/EUR 0.60 +/- $2.0m AUD/CHF 0.92 +/- $1.6m
- Table shows full 6 month impact
* Includes HPV Royalties
29