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CSL Ltd. — Interim / Quarterly Report 2009
Feb 17, 2009
17854_rns_2009-02-17_8416e5c0-228c-4650-b369-30dd2fcd291d.pdf
Interim / Quarterly Report
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For immediate release 18 February 2009
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Interim Result Strong profit growth, up 44% to $502 million Underlying profit[1] up 24%
CSL Limited today announced a profit after tax of $502 million for the six months ended 31 December 2008, up 44% when compared to the six months ended 31 December 2007. This included a foreign currency benefit of $26 million and a number of favourable non operational items totalling $44 million in net profit after tax which also boosted the result. Adjusting for currency and the items above, underlying profit growth was 24%.
HIGHLIGHTS
Financial
-
Total revenue of $2.35 billion, up 25% when compared to the six months ended 31 December 2007, or up 14% at constant currency[2] ;
-
Human Papillomavirus Vaccine (HPV) royalties of $82 million;
-
Net profit after tax grew 44% to $502 million, or up 37% at constant currency;
-
Research and Development investment $153 million;
-
Strong balance sheet;
-
Operating cash flow up 52% to $445 million;
-
Earnings per share of 85.4 cents, up 35%;
-
Interim dividend up 30% to 30 cents per share, unfranked, payable on 9 April 2009.
Talecris Biotherapeutics Holdings Corp. (Talecris)
-
Regulatory process remains on track;
-
The parties ‘substantially complied’ with the US Federal Trade Commission’s (FTC) Second Request at the end of January 2009;
-
CSL is working diligently to assist the FTC in their review of the acquisition;
-
Finance secured following successful debt and equity raisings, of approximately US$1.5 billion each, to fund the proposed US$3.1 billion acquisition of Talecris.
1 Underlying profit excludes non operational beneficial items and the impact of exchange rate movements
2 Constant currency removes the impact of exchange rate movements to facilitate comparability
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18 February 2009
Operational
-
Plasma Therapies
-
Privigen[®] (10% liquid intravenous immunoglobulin) - new manufacturing facility pre-approval inspection by US FDA complete;
-
Market development of specialty plasma therapies.
-
GARDASIL[®]
-
Merck submits data to the US FDA for males ages 9 – 26 and females ages 27 – 45
-
Merck phase III trial on 9-valent vaccine;
-
New US Patent expires 2026;
-
Influenza
-
Expanded influenza vaccine facility approved by US FDA.
Dr McNamee, CSL’s Managing Director, said “This is a strong result for CSL in an extraordinary period of foreign exchange volatility and global economic upheaval.
“We have met key milestones in the approval process for increasing Privigen[®] manufacturing capacity. CSL is now well placed to accommodate and take advantage of the continued demand for core and specialty plasma therapies.
“Royalties from GARDASIL[®] continue to be an excellent contributor and I’m pleased to report that a new US patent now protects our intellectual property through to 2026.
“In relation to the company’s intentions to acquire plasma fractionator Talecris, the regulatory process remains on track and following the schedule we anticipated. We will work diligently with the US FTC in their review of the acquisition” Dr McNamee said.
BUSINESS REVIEW
Results overview
CSL Behring sales grew 33% to $1.8 billion (19% in US dollar terms) when compared to the six months ended 31 December 2007. Strong contribution from both core and specialty products has underpinned the growth.
Immunoglobulins grew 32% in US dollar terms with good growth in specialty products Cytogam[®] and Rhophylac[®] . Vivaglobin[® ] (subcutaneous Immunoglobulin), a product which provides the convenience of immunoglobulin self administration, attracted significant
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18 February 2009
patient growth. Global IVIG sales growth benefited equally from growth in price, volume and product mix as demand moves in favour of liquid presentations over lyophilised. The Critical Care segment grew 25% in US dollar terms underpinned by price and volume growth of albumin. Specialty products, particularly Haemocomplettan[® ] P, Beriplex[®] P/N and Berinert[® ] P, also made a strong contribution.
Haemophilia sales grew 6% in US dollar terms. Helixate[®] (recombinant factor VIII) grew 11% reflecting tenders won in the UK and Canada. Plasma derived FVIII sales grew only moderately with Beriate[®] sales up 12% but offset by supply issues with Monoclate[®] .
CSL Bioplasma sales were up 23% to $151 million driven by strong demand and improved pricing for albumin in China. Demand for plasma therapies from Indonesia, Malaysia and Taiwan was also strong. Australian sales grew by 5%.
CSL Biotherapies sales were down 6% to $251 million. Growth in influenza vaccine sales into the Northern Hemisphere was offset by reduced Australian sales of GARDASIL[®] , as previously foreshadowed. The current period includes GARDASIL[®] sales of $84 million compared with $143 million in the prior comparable period arising from strong demand during the initial take-up by women in the 18-26 year old cohort. Northern Hemisphere influenza vaccine sales totalled $74 million for the period.
Non operational items - net profit after tax was boosted by $44 million from a number of favourable items arising during the period. These included a net pre tax $14 million benefit of holding funds in anticipation of the closure of the Talecris deal, foreign exchange gains on hedging contracts and a number of ‘one-off’ tax adjustments.
Business development
Talecris
On 13 August 2008, CSL signed an agreement to acquire Talecris, a leading manufacturer and marketer of plasma-derived protein therapies from current owners Cerberus Partners, L.P. and Ampersand Ventures. The close of the acquisition is subject to customary regulatory approvals including the approval from US anti-trust authorities.
The parties have submitted their documents and information to the US Federal Trade Commission (FTC) and have certified ‘substantial compliance’ with the Second Request.
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18 February 2009
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CSL has secured debt and equity finance in anticipation of approval by the US FTC. However, a US$75m break fee, as previously advised, would be payable to the vendors, under certain circumstances, if anti trust approvals are not forthcoming within 12 months of signing the agreement.
CSL is working diligently to assist the US FTC in their review of the acquisition.
GARDASIL[®] – Human Papillomavirus Vaccine
CSL’s licensee Merck made a number of announcements regarding cervical cancer vaccine, GARDASIL[®] . They have submitted data to the US FDA seeking to expand the GARDASIL[®] label claim to include adult women ages 27 - 45 and males ages 9 - 26. The US FDA has since recommended that Merck submit additional data when the 48 month female study has been completed.
Merck has also announced that they are in phase III trials for a 9-valent vaccine. GARDASIL[®] is a quadrivalent vaccine.
In addition, during the period a US patent for HPV virus like particles was issued jointly to CSL and the University of Queensland, which is licensed to Merck and will drive royalties from the sale of GARDASIL[®] until 2026.
Specialty Plasma Products
The company’s ‘revenue per litre’ objective moved forward with market development in a number of specialty products.
-
RiaSTAP™ (fibrinogen) - In January 2009 the US Food and Drug Administration (FDA) granted marketing approval for RiaSTAP™, the first and only treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, a rare and potentially life threatening bleeding disorder.
-
Berinert[®] - EU mutual recognition procedure completed December 2008. CSL Behring is currently addressing questions raised by the US FDA that relate to the manufacturing process and clinical data.
-
Beriplex[®] – US trial initiated. European expansion ongoing.
Privigen[® ]
The company has a modularised plan to increase manufacturing capacity of Privigen[®] (10% liquid intravenous immunoglobulin). The 3 million gram per annum facility is now open and operating smoothly. During the period, the US FDA completed a pre-approval inspection of the new 10 million gram per annum facility. Final approval is anticipated
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18 February 2009
during the quarter ending June 2009. Construction of a further 10 million gram per annum facility, has commenced with operations anticipated to commence in 2011.
The company’s Privigen[®] strategy is to accommodate increasing global patient demand for IVIG as well as progressively migrating patients from Sandoglobulin[®] / Carimune[®] to liquid Privigen. Privigen[®] is the first and only proline stabilised IVIG that is ready for immediate use, not requiring refrigeration or reconstitution during its shelf life.
Influenza
Initial sales of influenza vaccine, manufactured at the expanded facility in Parkville, were made into the USA. During the period CSL’s influenza vaccine was launched into Germany and Ireland. A vaccine tender was won in Hong Kong and a product license was obtained from the Chinese Food and Drug Authority for adults 18-60 years of age.
Corporate Responsibility
In December 2008, CSL released its first global environment report which presents four years of performance data from its five manufacturing sites. Highlighted in the report are significant improvements in the rate at which CSL consumes natural resources and generates by-products in the manufacture of plasma therapies. This report is available on the company’s website.
OUTLOOK
Commenting on CSL’s outlook, Dr McNamee said “To-date there has been little to no impact on our sales arising from the global financial crisis. This is consistent with a product portfolio of life saving therapies and essential vaccines. However, we remain vigilant as the situation develops. Potential risks to our outlook include pressures on healthcare spend, debtors risk, foreign exchange volatility and ongoing access to long term debt.
“However, in this difficult economic environment, we anticipate broadly stable market conditions for CSL’s group of businesses.
“Research and Development spend of $153 million in the first half is expected to be similar in the second half with total spend for the year between $300 million to $310 million on a reported currency basis.
“In compiling our financial forecasts for 2009 we have determined several key variables in addition to the global financial crisis which may have a significant impact on guidance - in
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particular material price and volume movements on core plasma products, unforseen competitor activity, changes in healthcare regulations and reimbursement policies, royalties[3] arising from the sale of HPV, sales of GARDASIL[®] in Australia, enforcement of key intellectual property, the risk of regulatory action or litigation, the effective tax rate and foreign exchange movements.
“For the 2008/09 fiscal year we expect a net profit after tax figure of between $1.02 billion and $1.06 billion. Using fiscal year 2007/08 constant currency and excluding the benefit of a number of non operational items this equates to $810 million to $850 million, consistent with guidance at the company’s Annual General Meeting in October last year. We continue to believe the result will be toward the high end of this guidance, despite additional research and development investment and a reduction in expectations for GARDASIL[®] royalties,” Dr McNamee said.
For further information, please contact:
Mark Dehring Head of Investor Relations CSL Limited Telephone: +613 9389 2818 Email: [email protected]
3 Analyst consensus estimates on HPV royalties used in FY2009 forecast
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18 February 2009
Group Results
| Half year ended December | December 2008 December 2007 Change A$m A$m % |
|---|---|
| Sales Other Revenue Total Revenue Earnings before Interest, Tax, Depreciation & Amortisation Depreciation/Amortisation Earnings before Interest and Tax Net Interest Expense Tax Expense Net Profit after Tax Interim Dividend (cents) Basic EPS (cents) |
2,206.7 1,750.1 139.1 125.6 2,345.7 1,875.7 25% 701.5 572.8 22% 75.3 72.9 626.2 499.9 25% (13.6) 8.8 138.0 142.4 |
| 501.9 348.7 44% |
|
| 30.00 23.00 85.44 63.42 |
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CSL Limited
ABN: 99 051 588 348
ASX Half-year Information 31 December 2008
Lodged with the ASX under Listing Rule 4.2A. This information should be read in conjunction with the 30 June 2008 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 2008
(Previous corresponding period: Half-year ended 31 December 2007)
Results for Announcement to the Market
-
Revenues from continuing operations up 25.1% to $2,345,725,590
-
Profit from continuing operations after tax and net profit for the period attributable to members up 43.9% to $501,857,409.
Dividends
| Dividends | ||
|---|---|---|
| Amount per | Franked amount per | |
| security | security | |
| Interim dividend (declared subsequent to balance date) | 30.00¢ | Unfranked* |
| Interim dividend from the previous corresponding period | 23.00¢ | Unfranked |
| Final dividend (prior year) | 23.00¢ | 100% franked |
| Record datefordetermining entitlements to the dividend: | 16March 2009 |
* Non-resident withholding tax is not payable on this dividend as it will be declared to be wholly conduit foreign income.
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 2008
| Contents | Page |
|---|---|
| Directors’ Report | 3 |
| Auditor’s Independence Declaration | 5 |
| Income Statement | 6 |
| Balance Sheet | 7 |
| Statement of Recognised Income and Expense | 8 |
| Cash Flow Statement | 9 |
| Notes to the Financial Statements | 10 |
| Directors’ Declaration | 17 |
| Independent Review Report to the Members | 18 |
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 2008 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 2008.
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 A M Cipa Mr I A Renard Mr M A Renshaw Professor J Shine, AO Mr D J Simpson
Mr K J Roberts, AM, was a Director from the beginning of the financial year until his retirement on 15 October 2008.
Mr D W Anstice was appointed Director on 2 September 2008 and continues in office at the date of this report.
Review of Operations
In the half year ended 31 December 2008 total revenue for the Group was $2.35b, up 25% compared to the same period last year. Net profit after tax increased 44% to $502m. The result included a foreign currency benefit of $26m and a number of favourable non operational items totalling $44m. Adjusting for these items, underlying profit growth was 24%. Net operating cash flow was up 52% to $445m.
The Group’s operating results for the period reflected continuing demand for plasma therapies with CSL Behring sales growing 33% (or 19% in US dollar terms) to $1.8b when compared to the same period last year. This resulted in an improved EBITDA for the Group of $701.5m, an increase of 22% over the same period last year.
CSL Bioplasma sales grew 23% to $151m driven by strong demand and improved pricing for albumin in China. Demand for plasma therapies from Indonesia, Malaysia and Thailand was also strong. Australian sales grew by 5%.
CSL Biotherapies sales were down 6% to $251m. Growth in influenza vaccine sales into the Northern Hemisphere was offset by reduced Australian sales of GARDASIL[®] .
Sales of Human Papilloma Virus (HPV) vaccine by the Company’s licensees resulted in royalty income of $82m.
During the period, a US patent for HPV virus like particles was issued jointly to CSL and the University of Queensland. This patent is licensed to Merck and will drive royalties from the sale of GARDASIL[®] until 2026.
On 13 August 2008, CSL signed an agreement to acquire Talecris Biotherapeutics Holdings Corp. (Talecris), a leading manufacturer and marketer of plasma-derived protein therapies from current owners Cerberus Partners, L.P. and Ampersand Ventures. The close of the acquisition is subject to customary regulatory approvals including the approval from US anti-trust authorities.
3
CSL Limited Directors’ Report (continued)
During the period, CSL Behring continued to move forward with market development of a number of specialty products: RiaSTAP™ (fibrinogen), Berinert[®] and Beriplex[®] . The US FDA also completed a pre-approval inspection of the new 10 million gram per annum facility for Privigen[®] . Initial sales of CSL’s influenza vaccine, manufactured at the expanded facility in Parkville, were made into the USA and CSL’s influenza vaccine was also launched into Germany and Ireland.
A final dividend of 23¢ per ordinary share (fully franked) was paid out of retained profits for the year ended 30 June 2008 on 10 October 2008. The Directors have declared an interim dividend of 30¢ per ordinary share, unfranked, payable on 9 April 2009.
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
18 February 2009
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 2008, 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 18 February 2009
Liability limited by a scheme approved under Professional Standards Legislation
5
CSL Limited and its controlled entities Income Statement For the half-year ended 31 December 2008
| Consolidated Entity | Consolidated Entity | ||
|---|---|---|---|
| December | December | ||
| 2008 | 2007 | ||
| Notes | $000 | $000 | |
| Sales revenue | 2,206,655 | 1,750,079 | |
| Cost of sales | (1,192,431) | (945,389) | |
| Gross profit | 1,014,224 | 804,690 | |
| Other revenue | 4 | 139,071 | 125,594 |
| Other income | 4 | 19,145 | 2,755 |
| Research and development expenses | (153,034) | (89,307) |
|
| Selling and marketing expenses | (227,478) | (189,753) |
|
| General and administration expenses | 4 | (121,862) | (137,152) |
| Finance costs | 4 | (30,220) | (25,733) |
| Profit before income tax expense | 639,846 | 491,094 | |
| Income tax expense | 5 | (137,989) | (142,366) |
| Netprofit for theperiod | 12 | **501,857 ** | 348,728 |
| Earnings per share | Cents | Cents | |
| Basic earnings per share | 6 | 85.44 | 63.42 |
| Diluted earnings per share | 6 | 85.05 | 63.06 |
6
CSL Limited and its controlled entities Balance Sheet As at 31 December 2008
| Consolidated | Entity | ||
|---|---|---|---|
| December | June | ||
| 2008 | 2008 | ||
| Notes | $000 | $000 | |
| CURRENT ASSETS | |||
| Cash and cash equivalents | 7 | 2,732,394 | 701,590 |
| Trade and other receivables | 979,932 | 709,390 | |
| Current tax assets | 31,039 | - | |
| Inventories | 1,570,254 | 1,198,133 | |
| Other financial assets | 323 | 1,513 | |
| Total Current Assets | 5,313,942 | 2,610,626 | |
| NON-CURRENT ASSETS | |||
| Trade and other receivables | 11,322 | 8,160 | |
| Other financial assets | 10,625 | 8,442 | |
| Property, plant and equipment | 8 | 1,260,117 | 975,936 |
| Deferred tax assets | 243,060 | 173,238 | |
| Intangible assets | 1,192,447 | 910,510 | |
| Retirement benefit assets | - | 8,052 | |
| Total Non-Current Assets | 2,717,571 | 2,084,338 | |
| TOTAL ASSETS | 8,031,513 | 4,694,964 | |
| CURRENT LIABILITIES | |||
| Trade and other payables | 527,615 | 444,723 | |
| Interest-bearing liabilities | 9 | 20,020 | 128,052 |
| Current tax liabilities | 163,618 | 123,018 | |
| Provisions | 128,465 | 139,525 | |
| Deferred government grants | 469 | 469 | |
| Derivative financial instruments | 1,245 | 167 | |
| Total Current Liabilities | **841,432 ** | 835,954 | |
| NON-CURRENT LIABILITIES | |||
| Interest bearing liabilities | 9 | 815,767 | 825,134 |
| Deferred tax liabilities | 142,494 | 93,677 | |
| Provisions | 47,381 | 41,553 | |
| Deferred government grants | 11,384 | 6,950 | |
| Retirement benefit liabilities | 175,700 | 85,571 | |
| Total Non-Current Liabilities | 1,192,726 | 1,052,885 | |
| TOTAL LIABILITIES | 2,034,158 | 1,888,839 | |
| NET ASSETS | 5,997,355 | 2,806,125 | |
| EQUITY | |||
| Contributed equity | 10 | 2,890,901 | 1,034,337 |
| Reserves | 11 | 891,437 | (134,299) |
| Retained earnings | 12 | 2,215,017 | 1,906,087 |
| TOTAL EQUITY | 5,997,355 | 2,806,125 |
7
CSL Limited and its controlled entities Statement of Recognised Income and Expense For the half year ended 31 December 2008
| Consolidated Entity | Consolidated Entity | ||
|---|---|---|---|
| December | December | ||
| 2008 | 2007 | ||
| Notes | $000 | $000 | |
| Net profitforthe period | 501,857 | 348,728 | |
| Exchange differences on translation of foreign operations, net | |||
| of hedges on net foreign investments | 11 | 1,006,045 | 71,693 |
| Gains (losses) on available-for-sale financial assets, net of tax | - | (2,957) | |
| Actuarialgains/(losses) ondefined benefit plans,net oftax | 12 | (54,234) | (5,309) |
| Netincome (expense)recognised directlyinequity | 951,811 | 63,427 | |
| Total recognised income and expense for the period | |||
| attributable to equityholders | 14 | 1,453,668 | 412,155 |
8
CSL Limited and its controlled entities Cash Flow Statement For the half-year ended 31 December 2008
| CSL Limited and its controlled entities Cash Flow Statement For the half-year ended 31 December 2008 |
|||
|---|---|---|---|
| Consolidated Entity | |||
| December | December | ||
| 2008 | 2007 | ||
| Notes | $000 | $000 | |
| Cash flows from Operating Activities | |||
| Receipts from customers (inclusive of goods and services tax) | 2,301,071 | 1,803,338 | |
| Payments to suppliers and employees (inclusive of goods and | |||
| services tax) | (1,712,289) | (1,399,452) | |
| 588,782 | 403,886 | ||
| Interest received | 28,884 | 16,285 | |
| Income taxes paid | (128,215) | (110,293) | |
| Borrowingcosts | (44,403) | (23,260) | |
| Net cash inflow from operatingactivities | 445,048 | 286,618 | |
| Cash flows from Investing Activities | |||
| Proceeds from sale of property, plant and equipment | 317 | 853 | |
| Payments for property, plant and equipment | 8 | (133,187) | (102,631) |
| Payments for intangible assets | (46,574) | - | |
| Payments for other investments | - | (42) | |
| Trust distribution received | - | 7,325 | |
| Payments for Onerous Contracts | - | (1,114) | |
| Net cash outflow from investingactivities | (179,444) | (95,609) | |
| Cash flows from Financing Activities | |||
| Proceeds from issue of shares | 1,854,704 | 9,852 | |
| Dividends paid | (138,510) | (100,840) | |
| Receipts (payments) on closure of foreign exchange hedges | (110,539) | 6,108 | |
| Repayment of borrowings | 9 | (395,364) | (35,633) |
| Net cash inflow(outflow)from financingactivities | 1,210,291 | (120,513) | |
| Net increase in cash and cash equivalents | 1,475,895 | 70,496 | |
| Cash and cash equivalents at the beginning of the period | 695,596 | 474,138 | |
| Exchange rate variations on foreign cash and cash equivalent | |||
| balances | 560,635 | 12,635 | |
| Cash and cash equivalents at the end of theperiod | 2,732,126 | 557,269 | |
| 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 | 2,732,394 | 559,747 |
| Bank overdrafts | (268) | (2,478) | |
| 2,732,126 | 557,269 |
9
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2008
1 Corporate Information
The financial report of CSL Limited (the Company) for the half-year ended 31 December 2008 was authorised for issue in accordance with a resolution of the directors on 18 February 2009. 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 2008.
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 2008 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 2008.
(d)
Basis of Consolidation
The half-year consolidated financial statements comprise the financial statements of CSL Limited and its subsidiaries as at 31 December 2008 ('the Group').
10
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2008
3 Segment Information
Primary Reporting - business segments
| December 2008 | December 2007 | |||||
|---|---|---|---|---|---|---|
| CSL | Other | Total | CSL | Other | Total | |
| Behring | Human | Human | Behring | Human | Human | |
| Health | Health | Health | Health | |||
| $000 | $000 | $000 | $000 | $000 | $000 | |
| External sales | 1,804,320 | 402,335 | 2,206,655 | 1,360,980 | 389,099 | 1,750,079 |
| Other external revenue | 7,805 | 87,406 | 95,211 | 2,899 | 105,813 | 108,712 |
| Segment revenue | 1,812,125 | 489,741 | 2,301,866 | 1,363,879 | 494,912 | 1,858,791 |
| Interest income | 43,860 | 16,882 | ||||
| Total revenue | 2,345,726 | 1,875,673 | ||||
| Segment earnings | 548,348 | 70,903 | 619,251 | 395,099 | 118,097 | 513,196 |
| Unallocated expenses net of other unallocated revenue and other income |
6,955 | (13,251) | ||||
| Profit from continuing activities before interest and income tax expense |
626,206 | 499,945 | ||||
| Interest income | 43,860 | 16,882 | ||||
| Finance costs | (30,220) | (25,733) | ||||
| Profit from continuing activities before income tax expense |
639,846 | 491,094 | ||||
| Income tax expense | (137,989) | (142,366) | ||||
| Net profit for the period | 501,857 | 348,728 |
Business Segments
The consolidated entity’s primary segment reporting format is business segments. The consolidated entity operates one segment – Human Health, the principal activity being to develop, manufacture and market biopharmaceutical products to the human health industry.
The Human Health business segment has been further broken down into CSL Behring and Other Human Health to assist with external analysis of the financial statements. Other Human Health includes CSL Biotherapies and CSL Bioplasma.
Segment Accounting Policies
The consolidated entity accounts for intersegmental sales and transfers as if the sales or transfers were to third parties at current market prices.
Segment accounting policies are the same as the consolidated entity's policies. During the financial year, there were no changes in segment accounting policies that had a material effect on the segment information.
11
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2008
4 Revenue, Income and Expenses from continuing operations
| Consolidated Entity | Consolidated Entity | ||
|---|---|---|---|
| December | December | ||
| 2008 | 2007 | ||
| $000 | $000 | ||
| (a) | Other Revenue | ||
| Trust distributions | - | 7,325 | |
| Interest income | 43,860 | 16,882 | |
| Rent | 551 | 541 | |
| Royalties | 82,687 | 81,889 | |
| Sundry | 11,973 | 18,957 | |
| 139,071 | 125,594 | ||
| (b) | Other Income | ||
| Net gain on disposal of property, plant and equipment | - | 328 | |
| Net foreign exchange gains | 18,540 | - | |
| Government grants | 605 | 2,427 | |
| 19,145 | 2,755 | ||
| (c) | Finance Costs | ||
| Interest paid / payable | 30,220 | 25,560 | |
| Non-cash interest–unwinding ofdiscount | - | 173 | |
| 30,220 | 25,733 | ||
| (d) | Other Expenses | ||
| General and administration expenses: | |||
| Expense of share based payments | 8,020 | 6,838 | |
| Amortisation of intellectual property | 16,850 | 23,851 | |
| Other relevant expenses | |||
| Depreciation and amortisation of property, plant and equipment | 58,459 | 49,055 |
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 | 639,846 | 491,094 |
|---|---|---|
| Income tax calculated at 30% | 191,954 | 147,328 |
| Tax effect of non-assessable / non-deductible items | ||
| Research and development | (5,524) | (2,587) |
| Other (non-assessable revenue)/non-deductible expenses | (12,355) | 1,818 |
| (Utilisation of tax losses)/Unrecognised deferred tax assets | (4,021) | (3,662) |
| Revaluation of deferred tax balances due to income tax rate changes | 11,316 | - |
| Effects of different rates of tax on overseas income | (26,511) | 495 |
| Under(over) provision inpreviousyear | (16,870) | (1,026) |
| Income tax expense | 137,989 | 142,366 |
12
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2008
6 Earnings Per Share
| Consolidated Entity | Consolidated Entity | |
|---|---|---|
| December | December | |
| 2008 | 2007 | |
| $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 | 501,857 | 348,728 |
| Number | of shares | |
| December | December | |
| 2008 | 2007 | |
| Weighted average number of ordinary shares used in the calculation of basic | ||
| earnings per share: | 587,377,003 | 549,844,720 |
| Effect of dilutive securities: | ||
| Share options | 722,778 | 1,037,637 |
| Performance rights | 1,994,738 | 2,119,717 |
| Globalemployee share plan | 4,048 | 9,328 |
| Adjusted weighted average number of ordinary shares used in calculating | ||
| diluted earnings pershare | 590,098,567 | 553,011,402 |
*Refer note 10 for a reconciliation of the movement in issued shares.
Conversions, calls, subscription or issues after 31 December 2008
Subsequent to the reporting date 195 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 | |
| 2008 | 2008 | |
| $000 | $000 | |
| Cash at bank and on hand | 2,578,007 | 156,927 |
| Cashdeposits | 154,387 | 544,663 |
| Totalcashand cashequivalents | 2,732,394 | 701,590 |
8 Property, Plant and Equipment
During the half-year ended 31 December 2008, the Group acquired assets with a cost of $139,296,279 (2007: $102,789,423).
13
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2008
9 Borrowings and repayments
For the half year ended 31 December 2008, the Group has repaid $393,486,000 of interest bearing debt and made $1,878,000 of finance lease repayments.
10 Contributed Equity
Movements in the contributed equity
| Number of | $000 | |
|---|---|---|
| Shares | ||
| Ordinary shares | ||
| Balance as at 1 July 2008 | 550,400,606 | 1,034,337 |
| Shares issued to parties other than CSL employees | ||
| - Institutional Offer | 47,500,000 | 1,745,625 |
| - RetailOffer | 3,955,203 | 145,471 |
| Totalsharesissued to, and equityraisedfrom, parties otherthanCSLemployees | 51,455,203 | 1,891,096 |
| Shares issued to CSL employees through participation in: | ||
| - Performance Option Plan and SESOP Option Plan | 434,285 | 3,047 |
| - Performance Rights Plan | 634,496 | - |
| -Global Employee SharePlan | 72,350 | 2,261 |
| Sharesissued and equityraised pursuant to employee share plans | 1,141,131 | 5,308 |
| Capital raising costsin respect to theinstitutionalandretailoffers | - | (39,840) |
| Balance as at 31 December 2008 | 602,996,940 | 2,890,901 |
11 Reserves
| Consolidated | Entity | |
|---|---|---|
| December | June | |
| 2008 | 2008 | |
| $000 | $000 | |
| Composition | ||
| Share based payments reserve (i) | 56,760 | 37,253 |
| Foreigncurrency translation reserve (ii) | 834,677 | (171,552) |
| 891,437 | (134,299) |
Nature and purpose of reserves
(i) Share based payments reserve
The share based payments reserve is used to recognise the fair value of options, performance rights and global employee share plan rights issued but not exercised. Amounts are transferred to contributed equity when options and other equity instruments are exercised.
(ii) Foreign currency translation reserve
The foreign currency translation reserve is used to record exchange differences arising from the translation of the financial statements of foreign operations and exchange gains and losses arising on those foreign currency borrowings which are designated as hedging the Company’s net investment in foreign operations. Since 30 June 2008, there has been a significant depreciation in the Australian dollar relative to the functional currencies in which many of the Group’s foreign operations report. As a result there has been a significant increase in the Group’s net assets in Australian dollars and similarly in the Group’s foreign currency translation reserve.
14
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2008
12 Retained Earnings
| Consolidated Entity | Consolidated Entity | ||
|---|---|---|---|
| December | December | ||
| 2008 | 2007 | ||
| $000 | $000 | ||
| Retained earnings as at the beginning of the period | 1,906,087 | 1,435,279 | |
| Net profit for the half year | 501,857 | 348,728 | |
| Dividends provided for or paid | (138,510) | (100,840) | |
| Transfers to reserves | (183) | - | |
| Actuarialgain/(loss) ondefined benefit plansnet oftax | (54,234) | (5,309) | |
| RetainedEarnings as at the end ofthe period | 2,215,017 | 1,677,858 | |
| 13 | Dividends |
| Ordinary shares Dividends providedfororpaid during thehalf-year |
Consolidated Entity December December 2008 2007 $000 $000 138,510 100,840 |
|---|---|
| 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 30 cents (2007 – 23.00 cents) per fully paid ordinary share, unfranked. The aggregate amount of the proposed interim dividend expected to be paid on 9 April 2009 out of retained earnings at 31 December 2008, butnotrecognised as aliability at the end ofthehalf-year,is: |
180,899 126,573 |
| 14 | Equity | ||
|---|---|---|---|
| Consolidated Entity | |||
| December | December | ||
| 2008 | 2007 | ||
| $000 | $000 | ||
| Total equity at the beginning of the reporting period | 2,806,125 | 2,268,849 | |
| Total recognised income and expense for the half year | 1,453,668 | 412,155 | |
| Movement in contributed equity | 1,856,564 | 8,660 | |
| Dividends paid | (138,510) | (100,840) | |
| Movementinshare based paymentreserve | 19,508 | 8,047 | |
| Totalequity at the end ofthereporting period | 5,997,355 | 2,596,871 |
| 15 | NTA Backing | ||
|---|---|---|---|
| December | June | ||
| 2008 | 2008 | ||
| $ | $ | ||
| Net tangible asset backing perordinary security | 7.97 | 3.44 |
15
CSL Limited and its controlled entities Notes to the financial statements For the half-year ended 31 December 2008
16 Share Based Payment Plans
On 1 October 2008, 794,721 share options and 287,860 performance rights were granted to senior executives under the CSL Performance Rights Plan. The exercise price of the options of $37.91 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 2010 and 30 September 2015. 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 2008:
| December | |
|---|---|
| 2008 | |
| Dividend yield (%) | 1.5% |
| Expected volatility (%) | 33.0% |
| Risk-free interest rate (%) | 5.2% |
| Fair Value of Options | |
| 2 year vesting | $13.31 |
| 3 year vesting | $13.58 |
| 4 year vesting | $13.85 |
| Fair Value of Performance Rights | |
| 2 year vesting | $33.30 |
| 3 year vesting | $31.72 |
| 4 year vesting | $30.15 |
17 Commitments and contingencies
Litigation
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.
Acquisition
As detailed in Note 36 in CSL Limited’s annual report for the year ended 30 June 2008, on 13 August 2008 CSL Limited signed an agreement to acquire all of the issued shares of Talecris Biotherapeutics Holdings Corp for cash consideration of US$3.1 billion less any net debt that may be assumed by CSL Limited, payable on completion of the acquisition. The completion of the agreement is subject to customary regulatory approvals. Notwithstanding that the outcome of regulatory reviews is outstanding, during the 6 months ended 31 December 2008, CSL Limited has raised, net of costs, $1.85 billion from institutional and retail investors and secured new, undrawn debt facilities to enable the acquisition to be funded. Of the equity raised, $115 million was used to pay down an existing debt facility that can be redrawn and $1.73 billion was converted at a rate of 0.87 into US$1.5 billion which has been placed on deposit ready to fund the acquisition if and when it should complete. In the event that the transaction is not approved by relevant regulatory authorities or does not close within 12 months of signing, CSL Limited will be obliged to pay the vendors a cash break fee of US$75m. This amount has not been provided for as at 31 December 2008.
16
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 2008 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
18 February 2009
17
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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 balance sheet as at 31 December 2008, and the income statement, statement of recognised income and expense and cash flow statement 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 2008 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 interim 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 2008 and of its performance for the six months 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 18 February 2009
Liability limited by a scheme approved under Professional Standards Legislation.
18 February 2009
Disclaimer
Forward looking statements
The materials in this presentation speak only as of the date of these materials, and include forward looking statements about our financial results and estimates, business prospects and products in research that involve substantial risks and uncertainties, many of which are outside the control of, and are unknown to, CSL. You can identify these 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 current growth products; the ability to successfully market new and existing products in Australia and other countries; difficulties or delays in manufacturing; trade buying patterns, fluctuations in interest and currency exchange rates; legislation or regulations throughout the world that affect product production, distribution, pricing, reimbursement or access; legal defense costs, insurance expenses, settlement costs and the risk of an adverse decision or settlement relating to product liability, patent protection or governmental investigations, growth in costs and expenses; 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
Total revenue $2.35bn up 25% (14% at constant currency) • HPV royalties $82m EBIT $626m up 25% (18% at constant currency) Effective tax rate 21.6% NPAT $502m up 44%, underlying* up 24% R&D Investment increased to $153m Strong balance sheet Operating cashflow $445m up 52% EPS 85.4 cents up 35% Interim dividend 30 cents (unfranked) up 30%
-
Constant currency removes the impact of exchange rate movements to facilitate comparability
-
** Underlying excludes non operational beneficial items and the impact of currency movements
3
Talecris
Regulatory process remains on track
-
The parties have submitted their documents and information to the US FTC and have certified ‘substantial compliance’ with the Second Request
-
CSL is working diligently to assist the US FTC in their review of the acquisition
Finance secured
-
Equity finance raised in August 2008 of A$1.75bn was exchanged for USD at a rate of 87c to the USD
-
Debt finance now in place – 11 banks with a total of facility of US$1.5bn. Rate ~115bp above LIBOR
4
.
Global Financial Crisis
Vigilance regarding potential impact from Global Financial Crisis (GFC)
Little to no impact to-date consistent with majority of products in portfolio being life saving in nature
Potential GFC risk to outlook
-
Healthcare spending pressures
-
Debtors risk
-
FX volatility
-
Ongoing access to long term debt
5
.
Reported Outlook for FY2009
Revenue
$4.6bn – $4.7bn
R&D Net profit after tax*
$300m – $310m
$1,020m - $1,060m
Est. foreign currency NPAT impact**
~$170m
Reported outlook excludes impacts of Talecris transaction closure
Outlook statements are subject to:
Material price and volume movements on core plasma products, unforeseen competitor activity, changes in healthcare regulations and reimbursement policies, royalties* arising from the sale of HPV, sales of GARDASIL® in Australia, enforcement of key intellectual property, the risk of regulatory action or litigation, the effective tax rate, foreign exchange movements and the impact arising from the global financial crisis.
- Analyst consensus estimates for HPV royalties used in FY2009 forecast
** See slide 28 for new FX ready reckoner
6
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----- Start of picture text -----
Human Health
Business Unit Performance
----- End of picture text -----
-
CSL Behring
-
Other Human Health
-
CSL Bioplasma
-
CSL Biotherapies
-
CSL Research & Development
CSL Behring
-
Sales US$1,405m (A$1,804m)
-
Up 19% in $US, up 18% at constant currency
-
December 2008 boosted by timing of sales
-
EBITDA US$460m, EBITDA margin ~33%
-
Strong contribution from core and specialty products
-
Optimizing product mix
-
30% of IVIG now Privigen[®] & European liquid
-
Privigen[®] pre-approval inspection complete
-
Final approval anticipated June 2009 quarter
-
RiaSTAP™approved January 2009
8
CSL Behring – Sales up 19% in $US
==> picture [538 x 380] intentionally omitted <==
----- Start of picture text -----
US$1,405m
1,400 Other
US$1,182m
1,200
Immuno-
globulins
1,000
800 Wound H
Critical
600
Care
400
pdCoag
200
Helixate
0
Dec 07 Sales for the 6 month period Dec 08
----- End of picture text -----
9
Immunoglobulins
==> picture [310 x 383] intentionally omitted <==
----- Start of picture text -----
600
US$530m
500
Specific IG
US$402m
400
300 Immuno -
globulins
200
100
0
Dec 07 Dec 08
Sales for the 6 month period
----- End of picture text -----
Highlights
-
Growth in Cytogam[®] , Rhophylac[®] & Vivaglobin[®]
-
Global growth in IVIG arising equally from product mix, price and volume strength
-
IVIG volume up 11%
-
Privigen[®] – IgLab Module 1
-
FDA approval anticipated Q2 calendar 2009
-
Swiss Medic approved January 2009
10
Critical Care
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----- Start of picture text -----
300
US$268m
250
US$214m
Specialty
200 Critical Care
150
100
Albumin
50
0
Dec 07 Dec 08
Sales for the 6 month period
----- End of picture text -----
Highlights
• Albumin growth arising equally from price & volume
-
Strong contribution and growth in specialty products such as, Haemocomplettan[®] P, Beriplex[®] P/N and Berinert[®] P
-
FDA approves RiaSTAP™
11
Haemophilia
600 Highlights US$480m 500 US$453m PD Coagulation • Moderate sales growth 400 • Beriate[®] pdCoag up 12% • 300 Haemate[®] P /Humate-P[®] ITT patient treatment conclusions 200 • Monoclate[®] restocking in 2H09 Helixate 100 Helixate[®] • Up 11% 0 • Dec 07 Dec 08 Canadian & UK tenders Sales for the 6 month period
12
CSL Behring
Outlook for FY2009
Sales growth in USD approx. ~15% at const. currency
-
Continued demand growth for IVIG
-
Supply / demand balance
-
Continued transition to Privigen[®]
-
Sales of ~3m grams Privigen[®]
-
Continued focus on subcutaneous
-
Vivaglobin[®] patient numbers
-
IG 20% formulation development
13
CSL Bioplasma
Sales A$151m up 23% (19% at constant currency)
-
Strong Albumin demand and improved pricing in China
-
Increased sales in SE Asia
-
Australian sales up 5%
-
Biostate[®] approved for von Willebrands disease in Australia
-
10% IVIG clinical trials completed
14
CSL Biotherapies
-
Sales A$251m down 6% (5% at constant currency) GARDASIL[®] Australia / New Zealand
-
GARDASIL[®] sales $84m (1H08 $143m)
-
1H08 included strong initial take up of 18-26yo cohort
-
New Zealand included for first time
Northern Hemisphere influenza sales $74m
-
US sales of 3.5m – 4.0m doses
-
Launch into Germany & Ireland
Pharmaceutical products growth – urology, dermatology
15
Merck’s GARDASIL[®]
New indications submitted for FDA review
-
Efficacy in women ages 27 - 45 years
-
Efficacy in males - submitted to FDA in December 2008
-
R&D: 9-Valent HPV Vaccine, 5 additional oncogenic HPV types
-
Cover 87-92% cervical cancer
-
Anticipate filing BLA in 2012
New US patent expires 2026
HPV royalties 1H09 $82m
- FY2009 estimates* lowered to $185m
* Analyst consensus estimates for HPV royalties used in FY2009 forecast.
16
R&D progress since December 2008 briefing
R&D Investment 1H09 - $153m, FY2009 outlook ~$300m - $310m Influenza
Data monitoring committee reviewed data and determined a second year of clinical end point study is required. Additional $21m 1H09
Replacement Therapies Berinert[®] P (C1 esterase inhibitor)
-
CSL Behring addressing questions from the FDA arising from BLA
-
Questions relate to process used to manufacture C1-INH and on the clinical data in the BLA
RiaSTAP™- FDA approval Jan 2009
-
EU submission ~Feb 2009
-
Reconstituted HDL
-
Appointment of Global Strategic Director of Cardiovascular Therapeutics
17
Financial Detail
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NPAT 1H09 – up 44% on 1H08
| 600 | |||||||
|---|---|---|---|---|---|---|---|
| 500 | $502m FX +$26m |
Notable items Reported NPAT |
$502m | ||||
| Non op. | |||||||
| 400 | $349m | $432m | NPAT at constant currency | $476m | |||
| 300 | +24% | 1H09 NPAT non operational - Net ‘Talecris’ financing |
items: $7m |
||||
| 200 | - FX gains on Hedges - Tax ‘one-offs’ |
$13m $24m |
|||||
| 100 | $44m | ||||||
| 0 | Dec 07 | Dec 08 | NPAT underlying | $432m | |||
| NPAT for the 6 month period |
19
Strong Financial Fundamentals
• Cashflow from operations
-
Cash on hand
-
Interest bearing liabilities
-
Net interest income
-
Capital expenditure
-
$445m (up 52%)
$2.7bn
$835m
$13.6m
$133m
20
Effective Tax Rate
Effective tax rate 1H09
Forecast Effective tax rates 2H09 Effective tax rate FY2009
21.6%
~25%
~23%
21
| FY2009 outlook | FY2009 outlook | Reported NPAT$1,020 | -1,060m | |||
|---|---|---|---|---|---|---|
| 1,200 | $1,020 to 1,060m |
NPAT at CC* $850 – 890m | ||||
| 1,000 | FX ~$170m |
Non operational items - Net ‘Talecris’ financing |
$9m | |||
| 800 | $702m | $810m Non – op. |
- FX gains on Hedges - Tax ‘one-offs’ |
$13m $24m |
||
| 400 600 |
+15% to 21% |
to 850m (CC excl. one-offs) |
NPAT at CC excl. non operational$810 |
~$45m –850m |
||
| 200 | Includes adverse impact of: - Influenza trial extension |
|||||
| 0 | FY2008 | FY2009 | - HPV Royalties Total |
~$40m | ||
| NPAT for the 12 month period |
* Constant Currency (CC) is calculated using prior comparable period exchange rates ie in this case FY2008
22
Net Talecris Financing – FY 2009
AUD
Forecast interest on US$1.5bn $35m Less
Bridging facility Commitment fee Borrowing amortisation Net Talecris financing Tax Financing post tax
$8m
$6m $3m
$18m
$9m
$9m
2H09 interest income on US$1.5bn to attract current US interest rates ie <1% pa
23
Talecris Transaction Impact
P&L (pre tax) Close Does not close Break Fee Nil US$75m Transaction costs Capitalised US$25-30m Integration provision US$120m Nil Cash FX Gain Nil ~A$550m*
* If exchanged into AUD as at December 2008.
24
Appendix
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Group Results
| Group Results | |
|---|---|
| Half year ended December | Change % December 2007 A$m December 2008 A$m |
| Net Profit Net Interest Income/Expense Tax Expense Depreciation/Amortisation Earnings before Interest and Tax Earnings before Interest, Tax, Depreciation & Amortisation Sales Other Revenue Total Revenue |
8.8 142.4 (13.6) 138.0 25% 72.9 499.9 75.3 626.2 22% 572.8 701.5 25% 1,750.1 125.6 1,875.7 2,206.7 139.1 2,345.7 |
| 44% 348.7 501.9 |
|
| Interim Dividend (cents) Basic EPS (cents) |
23.00 63.42 30.00 85.44 |
26
CSL Behring Sales
| CSL Behring Sales | |
|---|---|
| Half year ended December | Change % 1H09 USD$M 1H08 USD$M |
| Total Sales rFVIII pdCoag Specialty Critical Care Albumin Wound Healing Immunoglobulins Specific IG Other |
11 2 22 28 15 33 24 16 220 260 133 133 55 453 77 74 199 254 111 104 48 340 62 64 |
| 19% 1,405 1,182 |
|
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Foreign Currency Benefit FY2009
Foreign Exchange (post tax) $m FY Fcst Translation ~160 ~ - Transaction 0 10 Total ~170
Translation Sensitivity 2H09 NPAT only (ie 6 months)
2H09 1% chg • AUD/USD* 0.67 +/- $1.6m 1% movement in • AUD/EUR 0.52 +/- $1.9m key currency pairs • AUD/CHF 0.78 +/- $2.0m
- Rates used to calculate reported outlook for FY2009
** Includes HPV Royalties
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