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CSL Ltd. — AGM Information 2012
Oct 16, 2012
17854_rns_2012-10-16_0128bdb2-1ad1-4ab6-b22c-c1896bd0384e.pdf
AGM Information
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17 October 2012
To: The Manager Companies Company Announcements Office Australian Securities Exchange
Dear Sir/Madam
Chairman’s Address and Managing Director’s Presentation
Please find attached copies of the Chairman’s Address and Managing Director’s presentation slides to be presented at CSL’s Annual General Meeting which commences at 10.00 a.m. today.
The Chairman’s Address included an announcement that CSL will conduct a further on-market buyback of up to AU$900 million.
Yours faithfully
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Edward Bailey Company Secretary
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CSL Limited
Chairman’s Address
Annual General Meeting - Wednesday, 17 October 2012
“I am very pleased to report on CSL’s strong business performance this year which has been underpinned by new and improved therapies, entry to new markets, manufacturing capacity expansion, and our global research and development activities supporting existing products, market development and innovative new medicines.
“For the year ended 30 June, reported net profit after tax reached $983 million despite an unfavourable foreign exchange impact of $108 million. In constant currency, operational net profit after tax was $1.091 billion, up 16% on the prior year. Also, I am pleased to report that, for the first time, the Company achieved a US $1 billion profit result.
“CSL has maintained a strong balance sheet with $1.155 billion cash on hand against borrowings of $1.272 billion. Cash flow from operations for the year was a very strong $1.160 billion, up 14% on the prior year.
BUSINESS HIGHLIGHTS
“CSL Behring’s immunoglobulin portfolio sales continued its impressive growth, increasing 15% this year with sales of both intravenous Privigen® and subcutaneous Hizentra® continuing to grow. However, it should be noted that some of the growth in immunoglobulin sales has been due to the absence of a competitor that has now returned to the market place. Specialty products achieved solid growth in demand, and this included a particularly good US result for our Berinert® C1 esterase inhibitor.
“To meet strong global demand for our plasma products, CSL Behring has continued to upgrade and expand the capacity of our plasma collection centres and improve operational efficiencies. In addition, favourable market conditions for plasma recovered from whole blood collections continued to allow us to increase our purchased volumes.
“As the leading supplier of plasma fractionation services and plasma-derived products in the Asia Pacific region, CSL Biotherapies has completed an expansion of our plasma fractionation facility at Broadmeadows in Melbourne. This ensures that we remain well positioned to meet Australian and regional customer demand for plasma fractionation services into the future.
“The Australian Red Cross Blood Service now provides more than 500 tonnes of plasma to CSL for fractionation at our Broadmeadows facility – an increase of 35% since 2006.
“In November last year, the construction of our new Privigen® facility in Melbourne commenced. Due to become fully operational in 2016, this 15
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million gram capacity facility will enhance operational integration with CSL Behring worldwide to maximise single platform efficiencies and support the expected global demand for this market leading product.
“In addition, Factor VIII is being manufactured for international commercial markets using intermediates that have been supplied by CSL’s Northern Hemisphere facilities. This year we have also provided Factor VIII to a number of countries in Asia and South America.
“The strong growth of CSL Biotherapies’ Asian business this year was underpinned by the demand for albumin in China and plasma fractionation services provided to Hong Kong, Malaysia, Singapore and Taiwan. As a result of moves to more direct selling and the engagement of one of the region’s largest distributors, customer reach in China has also increased significantly.
“International sales of our influenza vaccine business continued to grow this year with CSL continuing to supply the United States, United Kingdom and Germany.
“Scientific investigations have continued into the cause of the paediatric adverse events that were associated with our Southern Hemisphere influenza vaccine in 2010. Preliminary conclusions from these investigations have been communicated widely and have been highly commended by a number of international experts. In relation to the Warning Letter received from the US Food and Drug Administration in May 2011, I am pleased to report that we have now closed-out the compliance issues identified in that letter at our influenza vaccine manufacturing site in Parkville, Melbourne.
“In September 2012, CSL Biotherapies was awarded a contract by the United States Department of Health and Human Services to supply pre-pandemic and pandemic vaccine antigens and related services to the US national stockpile. Under the terms of this contract, the US Government may request CSL Biotherapies to manufacture and store bulk antigen that can be used against influenza strains with pandemic potential. CSL Biotherapies may also be called upon to develop virus seeds for other manufacturers to formulate, fill and finish bulk antigen. As Australia’s only on-shore influenza vaccine manufacturer, CSL Biotherapies is already contracted by the Australian Government to manufacture vaccine in the event of an influenza pandemic.
“We were very pleased that, in July 2012, the Australian Minister for Health announced that Australian schoolboys will be able to get the successful Gardasil® vaccine, which will protect them against developing a range of cancers and further enhance the effectiveness of this vaccine in women. Starting in the 2013 school year, the Australian Government will fund the vaccine for 12 and 13-year-old boys through school-based programs under the National Immunisation Program. Year 9 boys will also be able to get the vaccine at school under a catch-up program for the next two years.
“We have invested $355 million in research and development this year, continuing our strong commitment to this essential element of CSL’s strategy for growth. Our R&D investment is focused on the development of innovative new
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therapies for life-threatening diseases, market development activities to maximise opportunities for existing products, and life-cycle management to ensure existing products remain competitive through a continuous improvement program. Another critical R&D program objective is achieving regulatory approval and expanding the medically justified use of therapies in major regulatory jurisdictions.
“As part of our investment in new therapies, we are continuing to progress the development of a family of recombinant products to treat haemophilia and other coagulation disorders. These therapies include the extended half-life albumin fusion proteins recombinant FIX-FP, recombinant FVIIa-FP, and a unique single-chain recombinant FVIII product. Important milestones in the past year include commencement of the pivotal Phase II/III study of recombinant FIX-FP and Phase I studies for recombinant FVIIa-FP and recombinant FVIII-SC. Significant progress has also been made in earlier stage recombinant monoclonal antibody projects.
“The commissioning and validation process is well underway for CSL’s new state-of-the-art cell culture biotechnology facility at our Broadmeadows site in Melbourne. This facility will enhance our ability to take recombinant products into the clinic and ultimately to patients. We expect to produce our first development product in this facility in 2013.
“Dr Brian McNamee, our Managing Director, will provide greater detail on each of our business operations shortly, including our global research and development programs.
CORPORATE RESPONSIBILITY
“CSL is committed to conducting its business ethically and contributing to the economic, social and environmental well-being of our communities. We are very proud of our record in this area.
“In December 2011, we published our third Corporate Responsibility Report, as part of our commitment to providing shareholders and other stakeholders with comprehensive and balanced information about our economic, social and environmental performance. We aim to publish our fourth Corporate Responsibility Report next month.
“In addition to our listing on the Dow Jones Sustainability Asia Pacific Index for two consecutive years commencing in 2010, CSL was again identified as a sustainable development leader during the year by meeting the inclusion criteria for the FTSE4Good Index Series. Created by the global index company FTSE Group, this index and associated ratings measure the performance of companies that meet or exceed globally recognised environmental, social and governance standards and is designed to facilitate investment in companies that meet globally recognised corporate responsibility standards.
“CSL believes that supporting local and global communities through our products, financial resources and people, helps to build healthier and more
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sustainable communities. Our global community framework guides our contributions and support for our patient, biomedical and local communities.
“In 2011/12, CSL’s global community contributions increased by 32% to $35.4 million. We increased support in patient and biomedical communities, with 58% of total contributions allocated to initiatives that enhance the quality of life for patients and improve access to our biological medicines.
“In the reporting year, CSL Behring renewed its multi-year partnership with the World Federation of Haemophilia, with support for 58 new investigator-led studies across the United States and the European Union. Award programs continue to recognise the excellence in scientific research across diverse fields of biomedicine. In Australia, the 2011 CSL Florey Medal recognised the outstanding determination of Professor Graeme Clark in his life-changing discovery of the bionic ear.
“We look forward to continuing to report annually our performance in these important non-financial areas.
OUR PEOPLE
“Recognising that our talented and diverse workforce is a key competitive advantage, we are committed to seeking out and retaining the best people to ensure strong business growth and performance. We also give high priority to the development of talent and succession planning.
“CSL values diversity at all levels and in the area of gender diversity, we have a long history of implementing programs and policies supporting women in the workplace. We believe that our culture of inclusiveness across the organisation supports retention and career progression of qualified and experienced women. CSL management in all sites around the world is encouraged to implement diversity-related initiatives consistent with local laws, practices and culture.
“In 2011, your Board adopted a formal Diversity Policy requiring us to establish measurable objectives on gender diversity and, on at least an annual basis, assess and renew these objectives. The focus of this policy is to ensure that CSL continues to build strong and consistent systems and processes to further support women in the workplace. A copy of our Diversity Policy is available on the Company’s website.
“In 2011/12, 54% of the CSL Group’s employees were women, and females represented approximately 40% of the CSL Group’s management staff and approximately 30% of the CSL Group’s most senior positions (that is, Vice President level and above).
“In October 2011, the Australian Government, through its Equal Opportunity for Women in the Workplace Agency, awarded CSL the 2011 Minister’s Award for Most Outstanding Equal Opportunity Initiative for the advancement of Women. This was awarded in recognition of CSL’s $5 million investment in an on-site childcare facility at its Parkville site. This award reinforces CSL’s ongoing
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commitment to a diverse workforce, by providing employees with the opportunity to advance their careers whilst balancing family responsibilities.
“This year, the CSL Board established a number of measurable objectives and reported progress against these objectives in the Corporate Governance Statement of our Annual Report. The Board has established further measurable objectives which will be reported on next year. One of these is, in line with Board succession plans, to increase the participation of females on the Board by appointing a new female director with appropriate skills, experience and expertise to commence on or before the 2013 Annual General Meeting.
CAPITAL MANAGEMENT
“Efficient capital management is a significant focus for your Board.
“In October 2011, CSL announced an on-market share buyback of up to $900 million which is now more than 94% complete with approximately 23.5 million shares repurchased for approximately $850 million. This latest buyback, CSL’s 5[th] buyback since 2005, contributed to a 4% boost to reported earnings per share and similar benefits have been derived from previous capital management initiatives. To date, as a result of these buybacks, CSL has repurchased approximately 19% of the Company’s shares on issue.
“In November 2011, CSL announced the completion of a debt refinancing program which included a US$750 million private placement in the US and the equivalent of approximately $800 million in lines of credit with our banks. These new funds have been or will be used to repay existing debt, fund CSL’s capital management plan including our on-market share buyback, and for general corporate purposes.
As foreshadowed with our Annual Results on 22 August 2012, the Board has considered new capital management initiatives. Today, I am pleased to announce that CSL will conduct a further on-market buyback of up to $900 million[1] , which we intend to complete over the next 12 months. This represents approximately 20 million shares or approximately 4% of the shares currently on issue.
“Through these buybacks, our shareholders benefit from improved investment return ratios, such as on earnings per share and return on equity.
US DOLLAR REPORTING
“As first announced in February 2011, CSL will be reporting in US dollars from the 2012-2013 financial year. US dollars are the pharmaceutical industry’s standard currency for reporting purposes and also reflects the increasing predominance of CSL’s worldwide sales and operations in US dollars.
“To assist shareholders during the transition, next week CSL intends to lodge with the Australian Securities Exchange the Company’s financial statements re-
1 CSL reserves the right to suspend or terminate buybacks at any time.
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stated in US Dollars for the first half and full year of 2011/12. We will also publish five years of historical key financial measures in US Dollars. This information will also be published at the same time on CSL’s website.
“Also, our shareholders with a registered address in Australian and New Zealand will continue to receive dividends in their local currencies. All other shareholders, consistent with the change to reporting in US dollars, will receive their dividends in US dollars.
OUTLOOK
“At the end of the first quarter of the current financial year, I can advise the Company is trading consistently with our expectations. Our broad portfolio of products, ongoing product development and geographic reach continue to ensure our business remains well positioned.
“When announcing our full year result in August, we anticipated 2012/13 profit growth of approximately 12%, using fiscal 2012 exchange rates. We re-affirm this guidance, noting that this outlook is subject to a number of other variables which were outlined when we announced the Company’s annual results in August.
DIVIDEND
“The Board has determined a final unfranked dividend of 47 cents per share. The dividend was paid to shareholders on 11 October. Total ordinary dividends for the year were 83 cents per share. This represents an increase of 3 cents per share from the previous year.
“As shareholders would know, franking is a function of Australian profits. As CSL’s business continues to grow successfully offshore, our ability to provide franked dividends declines. It remains CSL’s intention that available franking credits will be passed on to shareholders as and when they are generated.
CEO SUCCESSION
“This is also an appropriate time to mention that, as previously announced, after more than 20 years Dr Brian McNamee will be stepping aside as Managing Director and Chief Executive Officer prior to the next Annual General Meeting.
“Brian and the CSL Board have agreed on the timing for handover to his successor. Brian will leave CSL in July 2013, and will be succeeded by Mr Paul Perreault, who is currently President of CSL Behring.
“Paul joined CSL in 2004 and he has been a highly effective global leader in his current role, responsible for the manufacturing and commercial operations across more than 25 countries that deliver more than 85% of CSL Group revenues.
“I take this opportunity to acknowledge Brian’s extraordinary contribution to the Company and to the local and international pharmaceutical industry. When
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Brian took over in 1990, CSL was a domestic-focused government enterprise. Now CSL is one of the world’s largest manufacturers of plasma therapeutics. Brian’s leadership, drive and vision have been instrumental in building this exceptional Australian company founded on innovative research and development, operational excellence, consistent delivery and absolute commitment to patients.
“On behalf of the Board, I thank you Brian for the many outstanding qualities that you have brought, and continue to bring, to forging the direction and the extraordinary success of CSL and for your ongoing enthusiasm, guidance and insight in the lead up to your hand-over of responsibilities to Paul in 2013.
OUR THANKS TO MANAGEMENT AND STAFF
“Our business revolves around saving lives and improving the quality of life for people with serious and rare conditions, and all our activities are focused on this goal.
“On behalf of your Board, I would like to convey our appreciation for the work and dedication of our management and all our staff around the world to delivering life-enhancing medicines and driving our continuing business success.”
Professor John Shine, AO Chairman
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CSL Limited
Annual General Meeting
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17 October 2012
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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 Limited and its related bodies corporate (CSL) 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. Factors that could cause actual results to differ materially include: the success of research and development activities, decisions by regulatory authorities regarding whether and when to approve our products 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; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations 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 . 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 Australian Securities Exchange, 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.
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Financials
Reported total sales A$4.4 billion, up 12% at constant currency[1] (CC) Reported EBIT A$1,215 million, up 14% at CC Reported NPAT A $ 983 million, up 16% at CC
- Foreign currency headwind $108 million
• NPAT US$1 , 024 million[2] Reported EPS A189.2¢, up 21% at CC R&D investment A$355 million , up 13% at CC Cashflow from operations A$1,160 million, up 14% Stron g balance sheet - cash A $ 1 , 155m , borrowin g s A $ 1 , 272m A$900m on-market share buyback ~94% complete
• New on-market share buyback announced Final dividend increased to A47¢ (unfranked), total A83¢
- US $1 billion profit milestone reached -
1. Constant currency removes the impact of exchange rate movements to facilitate comparability. Also see FY2012 results materials.
3 2. Prepared by translating the result of all entities in the Group into US dollars using average exchange rates.
Moving to US dollar reporting in FY2013 - Profit growth in US dollars[1 ]
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FY07 to FY12 Reported NPAT Trend
Excluding One Offs (US$'m)
1200 $2 . 50
NPAT EPS
5yr EPS CAGR = 21%EPS CAGR = 21%
1000
5 y r NPAT CAGR = 19% $ 2.00
NPAT CAGR = 19%
800
$1.50
600
$1.00
400
$0.50
200
0 $-
2006/07 ACT 2007/08 ACT 2008/09 ACT 2009/10 ACT 2010/11 ACT 2011/12 ACT
$M S$'m EPS
US$
NPAT US
NPAT U
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1. Prepared by translating the result of all entities in the Group into US dollars using average exchange rates.
2. Chart excludes material ‘one-off’ transactions to reflect continuing operations
CSL Group FY2012 Sales US$4.6 Billion Key Products
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Pharma &
Global plasma
vaccines 9%
Specialty Sales US$4.2Bn
Products
14%
Other sp
Liquid IG 24%
6%
Peri-op 6%
Wound 2%
Lyo IG 6%
Albumin 10%
SCIG 7%
pd Coag 13% rFVIII
11%
Hyper IG 4%
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- Includes CSL Behring & Broadmeadows
Broad Geographic Sales Reach
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FY2012
ROW
.
7% US$4 6Bn
Australia
11%
North
America
Asia 9%
42%
Europe
31%
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Human Health
Business Unit Performance
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-
CSL Behring
-
Other Human Health
-
CSL Biotherapies and CSL Research & Development
• Int e ll ec t ua l Pr ope rt y Li ce n s in g
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CSL Behring product sales up 12% in USD terms
US$M
4,000 US$3,713m
+12%
US$3,313m Specialty
3,500
Products
3,000
2,500
Immunoglobulins
2,000
1 , 500
Albumin
1,000
pdCoag
500
Helixate [®]
0
Jun 11 Jun 12
Sales for the 12 month period
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Immunoglobulins
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US$M
Highlights
1,800 US$1,722m
+15%
IVIG
1,600
US$1,494m Other Growth
Volume
1,400
•
US , Canada , France & UK.
•
1,200 US ‘Privigen Promise’
guaranteeing supply
1,000 IVIG SCIG demand
P i i
r v gen • US PID patient demand
800
•
Migration to Hizentra [®] from
Vivaglobin [®]
600
Other growth drivers
•
Sales mix
400
SCIG •
Rhophylac [®] growth
200 • C ompe tit or re urn ng t i
Specific IG
0
Jun 12
Jun 11
Sales for the 12 month period
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Albumin
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500US$M
US$448m
450
+15%
Asia Highlights
400 US$391m
350 Growth
•
Continuing strong demand
300
in Asia
US$314m
•
250 US$286m US Hospital demand
•
Germany clinical usage re-
200 evaluation
150
100
50
0
Jun 11 Jun 12
Sales for the 12 month period
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- CSL Behring albumin sold in Asia by CSL Biotherapies
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Haemophilia
US$M
1,200 +5%
Highlights
US$1,058m
US$1 012m,
1,000
Growth
PdFVIII
800 pdCoag •
Volume up 15%
•
Haemate demand for ITT
600 patient treatment in Europe
•
Mix shift to Beriate [®] in lower
priced emerging markets
400
Heli x ate [®]
Helixate
•
Demand growth in USA
200
0
Jun 11 Jun 12
Sales for the 12 month period
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S
pecialty Products
US$M
US$618m
+18%
600 Highlights
US$522m
Other
500 Specialty Peri-operative Bleeding
Products • Growing awareness of changing
treatment paradigm for POB
400
•
BleedingHaemocomplettan [® ] /
RiaSTAP [®] - EU demand
• ®
300 Corifact - Launch in US
Peri- •
Beriplex [®] - Launch in Canada
Operative
200 Bleeding
Oth er
•
Berinert [® ] P - US self
100 administration approval &
Wound laryngeal indication
•
Healing Zemaira [® ] - US patient growth
0
Jun 11 Jun 12
Sales for the 12 month period
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Other Human Health – CSL Biotherapies
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A$M
A$685m
A$627m
900 +10%
A$813m Highlights
800
A$735m
Albumin demand growth in Asia
700
Asia [#]
Broadmeadows plasma therapy
600
sales A$266m
Aust.
500
Plasma Influenza sales A $ 141m followin g
400 solid US and European demand
300 Gardasil [] sales in Aust. & NZ of
Pharma
A$33m following growth in
200 &
Australian NIP and private
Vaccines
100 markets
0
Jun 11 Jun 12
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-
Gardasil is a trademark of Merck & Co. Inc
-
# CSL Behring albumin sold in Asia by CSL Biotherapies
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Commitment to Research & Development
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US$M
400
350
USD CAGR
300
20%
250
200
150
100
50
0
2007 2008 2009 2010 2011 2012
R&D Investment
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R&D Highlights
Berinert[® ] (C1 esterase inhibitor)
- Phase II study of high concentration subcutaneous formulation
Hizentra[®]
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Immunoglobulins
Breakthrough Specialty
medicines Products
Haemophilia
Products
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-
Commencement of Phase III study in CIDP
-
rIX-FP (rec fusion protein linking factor IX with albumin)
-
Commencement of phase II/III pivotal study
-
Phase I data demonstrate >5x half life extension
-
rVIII-SingleChain
-
Commencement of phase I/III trial
-
rVIIa-FP (rec fusion protein linking factor VIIa with albumin) • Commencement of phase I trial
-
RiaSTAP[™ ] (Fibrinogen)
-
Phase III aortic surgery study initiated
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Outlook for FY2013 @ 11/12 exchange rates
US dollar reporting commencing FY2013
• Historical financials in US dollars to be lodged with ASX next week Further on-market share buyback[1] of up to A$900m
-
Operational integration of Broadmeadows facility with CSL Behring Financial outlook
-
~ 10% @ CC ~15% @ CC
-
Revenue growth
-
R&D investment growth
-
~12% @ CC ( FY2012 NPAT US$1 , 024m )
-
Net p rofit after tax g rowth ~12% @ CC ( FY2012 NPAT US$1 , 024m )
-
• EPS expected to exceed NPAT growth driven by past and current capital management initiatives[1]
Outlook statements are subject to:
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, implementation of the Company’s influenza strategy and plasma therapy life cycle management strategies, enforcement of key intellectual property, regulatory risk , liti g ation , the effective tax rate and forei g n exchan g e movements.
1. CSL reserves the right to suspend or terminate buybacks at any time
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CSL Growth Strategy
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Biotech
AML, RA
New Plasma
Specialty products
Fractions
RiaSTAP [®] , Beriplex [®] ,
Cytogam [®] , Berinert [®] , rHDL
Zemaira [®]
Immunoglobulins
Pr v geni i ® Hizentra ®
Recombinant
Coagulation
Emerging markets Factors
Albumin, FVIII rIX-FP, rVIIa-FP,
rVIII-SingleChain
Market growth
All products
R&D capabilities - Financial strength
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