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CSL Ltd. Annual Report 2015

Aug 11, 2015

17854_rns_2015-08-11_6501db1e-b84c-4108-98be-73adb1181e13.pdf

Annual Report

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12 August 2015

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Strong Full Year Result

Double digit growth in albumin and specialty products CSL becomes No.2 global influenza vaccines manufacturer New Privigen[®] facility completed Board to consider further share buyback

CSL Limited (ASX:CSL; USOTC:CSLLY) today announced a net profit after tax (NPAT) of US$1,379 million for the full year ended 30 June 2015, up 6% on a reported basis when compared to the prior comparable period (PCP). NPAT grew 10% on a constant currency[1] basis, after adjusting for the one-off costs[2] associated with the acquisition of the Novartis influenza vaccine business.

HIGHLIGHTS

Financial

  • Sales US$5,459 million, up 2% on PCP

  • Up 7% at constant currency[1]

  • EBIT US$1,758 million, up 7% on PCP

  • Up 12% at constant currency & after adjusting for acquisition costs[2]

  • NPAT US$1,379 million, up 6% on PCP

  • Up 10% at constant currency & after adjusting for acquisition costs

  • Earnings per share US$2.92, up 8% on PCP

  • Up 13% at constant currency & after adjusting for acquisition costs

  • Research and development investment was US$463 million

  • Final dividend[3] increased 10% to US$0.66 per share, unfranked for Australian tax purposes, payable on 2 October 2015

  • Converted to Australian currency, the final dividend increased to approximately A$0.90 per share, up 39% on PCP.

1 Constant currency removes the impact of exchange rate movements to facilitate comparability. See end note for further detail.

2 One-off costs totalling $22 million connected with the acquisition of the Novartis influenza vaccine business

3 For shareholders with an Australian registered address, dividends will be paid in A$ at an amount of A$0.899910 per share (at an exchange rate of A$1.3635/US$1.00), and for shareholders with a New Zealand registered address, dividends will be paid in NZD at an amount of NZ$1.006104 per share (at an exchange rate of NZ$1.5244/US$1.00). The exchange rates used are fixed at the date of dividend determination. All other shareholders will be paid in US$.

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Page 2

12 August 2015

Operational

  • Acquisition of Novartis‘ global influenza vaccine business

  • bioCSL business turnaround

  • Hizentra[® ] (subcutaneous immunoglobulin) - European Medical Agency & U.S. Food and Drug Administration (FDA) approved flexible dosing

  • CSL 654 (rIX-FP) - license application submitted to U.S. and European regulators

  • CSL 627 (rFVIII-SingleChain) – license application submitted to U.S. FDA

  • CSL 112 (rHDL) – global phase IIb clinical trial recruiting rapidly

  • Major capital projects completed

Capital Management

  • A$950 million share buyback completed

  • New buyback[4] foreshadowed

  • New private placement foreshadowed

“CSL’s solid 2015 results demonstrate our track record of delivering strong shareholder returns,” said CSL Chief Executive Officer and Managing Director, Paul Perreault. “Robust demand for our differentiated biotherapies continued, with albumin and specialty products growing at double digit rates. bioCSL is growing again with influenza vaccine sales increasing particularly well.”

“We fast tracked the acquisition of the Novartis influenza vaccines business, which lets us get on with integration much earlier,” Mr. Perreault said. “CSL is now the second largest influenza vaccine manufacturer in the world - a sector we understand deeply. The combined business has an extensive product portfolio, broad global sales reach, specialized R&D and scaled manufacturing, positioning the business very well to compete globally.”

“We also invested to support our future growth, completing a number of key projects and advancing our major multi-site facilities expansion program,” said Mr Perreault. “We recently ‘broke ground’ on our new recombinant coagulation manufacturing plant in Lengnau, Switzerland. We’ve completed validation runs in our new Privigen[®] facility in Broadmeadows, Australia and obtained U.S. FDA approval to commence operations in our recently completed base fractionation and albumin facility at Kankakee, in the U.S.,” Mr. Perreault added.

4 CSL reserves the right to suspend or terminate buy-backs at any time.

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12 August 2015

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Page 3

OUTLOOK (at FY15 exchange rates)

CSL expects strong underlying demand for its products to continue in FY16, with sales growth similar to gains achieved FY15. The Company said the market place will remain competitive, particularly as new manufacturers and products emerge.

“FY16 will be a critical year in investing in our sustainable growth,” Mr Perreault said. “We continue to invest substantially in our research and development pipeline. A major investment in our commercial capabilities will be made ahead of our anticipated launch of new recombinant coagulation products in 2017. Our significant capacity expansion coming on line in FY16 will trigger a lift in fixed asset depreciation. Notwithstanding these additional costs, we anticipate net profit after tax to grow by around 5%, with earnings per share growth to exceed profit growth.

“Given the accelerated close of the Novartis deal, we are not yet in a position to provide guidance on this business beyond what was announced[5] in October 2014. Consequently the gain on acquisition, integration costs and operational contribution are excluded from our guidance. We expect to provide an update on the outlook for this business in the coming months,” Mr. Perreault said.

In compiling CSL’s financial forecasts for the year ending 30 June 2016 a number of key variables which may have a significant impact on guidance have been identified and these have been included in the footnote[6] below.

5 On 27 October 2014, CSL announced the agreement to acquire Novartis’ influenza vaccines business. Estimates of the financial impacts of the deal were provided and can be found on the company website at www.csl.com.au/investors

6 Key variables that could cause CSL’s actual results to differ materially include: the success of research and development activities, decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; litigation or government investigations; and our ability to protect our patents and other intellectual property.

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Page 4

OPERATING REVIEW

CSL Behring sales of US$5,029 million increased 7% in constant currency terms when compared to the prior comparable period.

Immunoglobulin product sales of US$2,326 million grew 5% in constant currency terms, with ‘normal’ immunoglobulin volumes growing 8%.

Demand for intravenous immunoglobulin (IVIG) was led by Privigen[®] , with growth in Europe being particularly strong. Privigen’s expanded indication in Europe to include its use in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) has underpinned this growth. This dynamic has contributed to the average IVIG sales price being adversely affected as a greater proportion of sales were made into lower priced markets. The U.S. market remains competitive.

Demand for subcutaneous immunoglobulin (SCIG) was strong in both North American and European markets. CSL’s SCIG product, Hizentra[®] , offers patients the convenience of self-administration at home. In the U.S. the approval of flexible dosing has driven an increased penetration of the product into the Primary Immune Deficiency (PID) patient market.

Albumin sales of US$754 million rose 12% in constant currency terms, driven by ongoing global demand. China continued to drive albumin performance boosted by improved penetration into Tier 2 and Tier 3 cities. CSL’s uniquely broad suite of albumin presentations provides an attractive portfolio of choice to customers.

Haemophilia product sales of US$1,026 million grew 3% in constant currency terms. Plasma derived haemophilia sales increased 4%, notwithstanding an ongoing transition towards recombinant therapies. Growth was largely driven by demand for Beriate[®] in Brazil, Poland and Germany. Haemate[®] and Humate[®] sales grew in Eastern Europe, the Middle East, Africa and North America. Helixate[®] , CSL’s recombinant factor VIII, delivered modest growth following the successful introduction of a patient retention program. New entrants continue to make this market competitive.

Specialty products sales of US$923 million grew 15% in constant currency terms, tempered by a sales decline of wound healing products in Japan. The remaining group of specialty products grew 18%, driven largely by strong sales of Kcentra[®] , Berinert[®] and Zemaira[®] .

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12 August 2015

Kcentra[®] (4 factor pro-thrombin complex concentrate) continued to grow strongly following the launch of the surgical indication approved by the U.S. FDA. In December the U.S. Centres for Medicare and Medicaid Services approved an extension to the new technology add-on payment for Kcentra[®] through to September 2015, recognising its significant clinical advancement in reversing the effects of warfarin in patients who experience acute major bleeding.

Strong demand for Berinert[®] continued. Berinert[®] (C1-esterase inhibitor concentrate) is used for the treatment of acute attacks in patients with hereditary angioedema. In 2012, the U.S. FDA approved a label expansion to include self-administration and now in excess of 75% of patients are self-administering Berinert[®] .

Zemaira[®] , which is used to treat Alpha-1 associated emphysema, grew strongly. CSL’s new DNA test kits have been invaluable for patient identification. More than 9,000 kits were processed during the year.

bioCSL sales of A$480 million grew 11% in constant currency terms. Influenza vaccine sales increased 18% to A$145 million. Contributing to this growth was the reestablishment of our in-house commercial capability. bioCSL’s influenza vaccines were first to market in the U.S., U.K., and Germany – an important competitive advantage.

CSL Intellectual Property revenue of US$137 million declined 5% in constant currency terms. This was driven by a reduction in royalties received on intellectual property associated with human papillomavirus vaccines, which contributed US$106 million to revenue.

CAPITAL MANAGEMENT

Share Buyback

During October 2014, CSL announced its intention to conduct an on-market share buyback of up to A$950 million. This program is now complete, with the repurchase of approximately 10.6 million shares representing approximately 2.2% of CSL’s shares on issue.

CSL’s balance sheet remains sound and modestly geared and the Company continues to deliver strong free cashflow. Cash and cash equivalents were US$557 million as at 30

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12 August 2015

June 2015, with interest bearing liabilities of US$2,281 million and undrawn debt facilities of $141 million.

Capital management foreshadowed during FY16

In the interests of improving shareholder returns, CSL aims to maintain an efficient balance sheet. CSL has been pursuing an objective of increasing its gearing to approximately one times net debt to EBITDA. At 30 June 2015, this gearing ratio stood at 0.9x. The Board of Directors is considering a further on market share buyback program of a similar amount to the most recent program.

During the first half of FY16, CSL intends to approach the U.S. private placement market to raise the equivalent of ~US$500 million as part of CSL’s overall debt management program.

Additional details about CSL’s results are included in the company’s 4E statement, investor presentation slides and webcast, all of which can be found on CSL’s website www.csl.com.au A glossary of medical terms can also be found on the website. For further information, please contact:

Investors: Media: Mark Dehring Sharon McHale Head of Investor Relations Head of Public Affairs CSL Limited CSL Limited Telephone: +613 9389 3407 Mobile +614 0997 8314 Email: [email protected] Email: [email protected]

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12 August 2015

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Group Results

US Dollars

Full year ended June
US$ Millions
Jun
2014
Reported
Jun
2015
Reported
Jun
2015
at CC#
Change
%
Sales
Other Revenue / Income
Total Revenue / Income
5,335
5,459
5,733
7.5%
169
154
156
5,504
5,613
5,889
7.0%
Earnings before Interest, Tax,
Depreciation & Amortisation
Depreciation/Amortisation
Earnings before Interest and Tax
Net Interest Expense / (Income)
Tax Expense
Reported Net Profit after Tax
Acquisition costs7
Adjusted Net Profit after Tax
Total Ordinary Dividend (US$)
Final Dividend (US$)
Basic EPS (US$)
1,832
1,939
1,994
8.8%
195
181
190
1,637
1,758
1,804
10.2%
33
44
44
297
335
348
1,307
-
1,307
1,379
22
1,401
1,412
22
1,434
8.0%
9.7%

1.13
0.60
2.70
1.24
0.66
2.92
2.99
10%
10%
11%

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7 One off costs associated with the acquisition of the Novartis influenza vaccine business

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12 August 2015

(#) Constant currency removes the impact of exchange rate movements to facilitate comparability by restating the current period’s results at the prior comparable period’s rates. This is done in two parts: (a) by converting the current period net profit of entities in the group that have reporting currencies other than US Dollars at the rates that were applicable to the prior comparable period (“translation currency effect”); and (b) by restating material transactions booked by the group that are impacted by exchange rate movements at the rate that would have applied to the transaction if it had occurred in the prior comparable period (“transaction currency effect”). The sum of translation currency effect and transaction currency effect is the amount by which reported result is adjusted to calculate the result at constant currency.

Summary NPAT Reported Net Profit after Tax $1,379.0m Translation Currency Effect (a) $ 91.4m Transaction Currency Effect (b) $ (58.6m) Constant Currency Net Profit after Tax * $1,411.8m

(a) Translation Currency Effect $91.4m

Average exchange rates used for calculation in major currencies (twelve months to June 15/June 14) were as follows: USD/EUR (0.82/0.74); USD/CHF(0.94/0.91)

(b) Transaction Currency Effect ($58.6m)

Transaction currency effect is calculated by reference to the applicable prior comparable period exchange rates. The calculation takes into account the timing of sales both internally within the CSL Group (ie from a manufacturer to a distributor) and externally (ie to the final customer) and the relevant exchange rates applicable to each transaction.

Summary Sales Reported Sales $5,458.6m Currency Effect (c) $274.3m Constant Currency Sales * $5,732.9m

c) Constant Currency Effect $274.3m

Constant currency effect is presented as a single amount due to the complex and interrelated nature of currency impacts on sales.

  • Constant Currency Net Profit after Tax and Sales have not been audited or reviewed in accordance with Australian Auditing Standards.

® Trademarks of CSL Limited or its affiliates.

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CSL Limited FY15 Full Year Result 12 August 2015

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 approval of our products as well as their decisions regarding label claims; 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, access or tax; litigation or government investigations, 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.

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.

Trademarks

Except where otherwise noted, brand names designated by a ™ or ® throughout this presentation are trademarks either owned by and/or licensed to CSL or its affiliates.

2

Sales US$5,459 million, up 2% (up 7% @CC[1] ) EBIT US$1,758 million, up 7% (up 10% @CC)Adjusted for acquisition costs[2] up 12% @CC NPAT US$1,379 million, up 6% (up 8% @CC)Adjusted for acquisition costs up 10% @CC R&D investment US$463 million EPS US$2.92, up 8% (up 11% @CC)Adjusted for acquisition costs up 13% @CC Final dividend increased to US$0.66, unfranked (up 10%)

  • Converted to AUD ~$0.90, up 39%

1. Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability. See end note for further detail. 2. One off costs connected with the acquisition of the Novartis influenza business

3

  • Acquisition of Novartis global influenza vaccines business

  • bioCSL business turnaround

  • Hizentra[® ] - EMA & U.S. FDA approve flexible dosing

  • CSL 654 (rIX-FP) – license application submitted in U.S. & EU

  • CSL 627 (rFVIII-SC) – license application submitted in U.S.

  • CSL 112 (rHDL) – global phase IIb trial recruiting rapidly

  • A$950 million share buyback completed

  • New buyback* foreshadowed

  • New private placement foreshadowed

* CSL reserves the right to suspend or terminate buybacks at any time

4

Facilities Expansion Investing for Growth

Recombinant

  • Broke ground on rCOAG plant in Lengnau, Switzerland

  • Plasma

  • Completed validation runs for the new Privigen[®] facility in BMW

  • Construction underway for new albumin facility in BMW

  • Obtained FDA and other regulatory approvals for the new base fractionation and albumin facility in Kankakee

  • Broke ground on a new packaging facility in Marburg, Germany

  • Started project to expand Berinert[®] production capacity

Collections

  • 21 centres opened in the USA, plus 1 in Hungary, increasing the fleet in the US to 119 centres, or 128 centres globally

5

IPL Product 3%

Pharma & Groupings Vaccines Specialty 8% Products Other 16% 8% IVIG 29% Peri-op 8% Albumin 14% SCIG 9% pd Coag rFVIII Hyper 10%

6

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North America
41%
bioCSL 8%
Asia 10%
Europe 28%
ROW
13%
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FY15 US$5.5b

7

Financial outlook

  • Revenue growth

~ 7% @CC

  • Reported NPAT growth ~ 5% @CC

Excludes Novartis influenza vaccine business earnings, acquisition costs & gain on acquisition

  • EPS growth will exceed NPAT growth driven by past and current capital management initiatives

  • Board to consider a further on-market share buyback* of an amount similar to most recent program

Key variables that could cause actual results to differ materially include: the success of research and development activities, decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; litigation or government investigations; and our ability to protect our patents and other intellectual property.

* CSL reserves the right to suspend or terminate buybacks at any time

8

US$M

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6,000
US$5,029m
US$4,926m
5,000
Specialty
Products
4,000
3,000 Immunoglobulins
2,000
Albumin
1,000
pdCoag
Helixate [® ]
0
Jun 14 Jun 15
Sales for the 12 month period
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9

US$M

2,500

2,000

1,500

1,000

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500
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0
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US$2,326m

US$2,320m

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IVIG
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----- Start of picture text -----

H er IG
yp
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Jun 15

Jun 14

Highlights Normal IG volume up 8%

IVIG

  • Europe

  • CIDP indication driving strong Privigen[®] demand

  • North America

  • Competitive pressure

  • 340B utilisation

SCIG

  • Ongoing strong demand for Hizentra[® ] in North American and European markets

  • Flexible dosing option and home care convenience underpinning demand

Sales for the 12 month period

10

US$M

1,400

1,200

1,000

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800
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600

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400
200
0
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US$1,204m

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US$1,122m
IVIG
SCIG
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Jun 15
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Dec 14

Highlights

2H v 1H 2015

  • Total 2H immunoglobulin sales up 13% over 1H @ CC

  • • ‘Normal’ immunoglobulin sales up 15% over 1H @ CC

  • • Marketing initiatives

Sales for the 6 month period

11

US$M

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800
US$754m
US$694m
700
600
Albumin
500
400
300
200
100
0
Jun 14 Jun 15
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Highlights

China

  • Ongoing strong demand

  • Improving penetration into Tier 2 & Tier 3 cities

US

  • Solid demand continues

  • Initiatives focusing on IDNs and large hospitals

Sales for the 12 month period

12

US$M

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1,200
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1,000
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800
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600
400
200
0
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Highlights

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US$1,064m
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PdFVIII

US$1,026m

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pdCoag
Helixate [® ]
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  • Growth in Beriate[®] – Brazil, Poland and Germany

  • Solid performance from Haemate[® ] /Humate[®]

  • Ongoing transition to recombinant therapies

  • Helixate[®]

  • Positive results with US patient retention program

  • New entrants

Jun 14 Jun 15 Sales for the 12 month period

13

US$M

1,000

900 800 700 600 500 400 300 200 100

0

US$923m Other Specialty Products

US$848m

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Peri-
Operative
Bleeding
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Jun 14 Jun 15

Highlights

Kcentra[®]

  • Ongoing strong demand in the U.S.

Berinert[® ] P

  • Self administration label driving new patient take-up.

  • Zemaira[®]

  • New patient acquisition

  • Launch of diagnostic testing program driving patient identification

Sales for the 12 month period

14

200

A$M[1 ]

600

500

400

300

A$433m

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A$480m

Pharma & vaccines

Highlights

Business turnaround initiatives driving a return to growth Influenza sales A$145m

  • Up 18% @CC

  • Increased U.S. sales following the re-establishment of in-house commercial operations

  • First to market in U.S., U.K. and Germany

QIV development

100

0

Jun 14

Influenza Vaccine

Jun 15

Zostavax* listed on Aust. NIP

Rapivab* commercialisation rights

Sales for the 12 month period

  • 1 Shown in Australian dollars to highlight operational performance * Zostavax is a trademark of Merck & Co. Inc.

15

Rapivab is a trademark of BioCryst Pharmaceuticals Inc..

Segment Revenue $137m, down 5% @CC HPV royalties $106m

  • Registration of 9-valent HPV vaccine in US by Merck

  • CSL362 (anti-IL-3Ra mAb)

  • Exclusive worldwide license with Janssen Biotech Inc to develop and commercialise CSL362

  • Janssen is expected to commence the Phase II study in August 2015

  • Collaborative research to support use in additional indications

  • CAM3001 (GM-CSFRa)

  • Medimmune/AstraZeneca continue Phase IIb studies in rheumatoid arthritis

  • Positive additional Phase II data

16

rIX-FP

  • rIX-FP Phase III efficacy data supports 7-14 day dosing

  • BLA accepted for review by FDA in February

  • MAA review procedure commenced by EMA in March

  • rVIII-SingleChain

  • Phase I/III data supports twice weekly dosing

  • BLA accepted for review by FDA in July

  • rVIIa-FP

  • Congenital deficiency Phase I/II commenced

  • Phase II/III in patients with inhibitors commenced

  • Hizentra[®]

  • Hizentra[®] flexible dosing registration in EU and US

  • Hizentra[®] CIDP orphan drug designation in US

17

Beriplex[®]

  • Commencement of Beriplex[® ] Japan Phase III study

  • Berinert[® ]

  • Pivotal Phase III subcutaneous prophylaxis study recruiting well

  • Zemaira[®] /Respreeza[®] (Alpha1-Proteinase Inhibitor)

  • Patients with AATD treated with Respreeza[®] have lower annual rate of lung density decline

  • EMA CHMP recommended granting marketing authorisation for Respreeza[®] to treat patients with AATD in June

  • CSL112 (reconstituted High Density Lipoprotein)

  • Phase IIa data supports mechanism of action & further development

  • Commencement of AEGIS-I Phase IIb study

  • Recruiting rapidly

18

Business Performance FY15

Financial Detail

US$M

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1,500
1,450
1,400
1,350
1,300
1,250
1,200
1,150
1,100
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FX Acquisition +10% Settlement

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Jun 15
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Jun 14
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Adjusted profit up 10% @ CC FY15

  • FX headwind $33m

  • One off costs connected with the acquisition of the Novartis influenza business $22m

Operational profit up 6.5% @ CC FY14

  • US Class action settlement

20

Margin Development

%

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----- Start of picture text -----

45
40
EBITDAR&D Margin
35
30
25 EBIT Margin
20
Margin
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* Earnings before interest, taxes, depreciation, amortisation and research & development

Cashflow from operations $1.36 billion

Capital expenditure $414m

Working Capital

FY14 FY15

  • Cash cycle (days)

  • • Free cashflow

281 300 $948m $1,016m

Financial Strength

FY14 FY15

  • Cash on hand

  • • Undrawn debt

$609m $557m

$192m $141m

  • Net debt

$1,282m $1,724m

- Balance Sheet Strength -

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US$M 800 Private Placement 700 Bank Debt 600 Undrawn 500 400 300 200 100 0 Maturity Profile

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Gearing

X

1.5 1.0 0.5 0.0

~ Target Net Debt / EBITDA

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-0.5 -1.0 -1.5 FY09 FY10 FY11 FY12 FY13 FY14 FY15

  • Accumulated effect of buybacks since FY05 on current period EPS ~23%

  • Gearing target ~1x Net debt/EBITDA

  • Gearing @FY15 ~0.9x

  • New on-market share buyback foreshadowed

  • Similar amount to most recent program

  • New U.S. private placement foreshadowed

  • Equivalent ~US$500m

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Deal closed 31 July 2015

Financial consolidation 1H16

  • Too early to provide better guidance than that provided in October 2014

  • $22m incurred in FY15, majority of balance expected to be incurred in FY16

  • Gain on acquisition yet to be determined

  • Anticipate providing updated guidance in coming months

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FY16 NPAT growth ~ 5% @ CC Excl. Novartis influenza vaccine business Notable items Ongoing demand for therapies

  • Sales expected to grow ~7% @ CC

  • Investment in growth, incremental ~$50m • Preparation for rCOAG launches

  • New capacity coming on-line

FY17 - anticipate

  • Full year rCOAGs sales contribution

  • Launch of subcutaneous C1-INH

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Business Growth

Biotech mAbs in core therapeutic segments

CSL112 New treatment paradigm in ACS High margin contributor Recombinant Coagulation Factors rIX-FP, rVIII-SC, rVIIa-FP, rVWF Specialty Products Multiple high margin contributors: RiaSTAP[ ®] , Kcentra[ ® ] , CytoGam[®] , Berinert[®] , Zemaira[®] Core Products Relentless Commitment to lowest cost base; Operational and Financial Strength and Efficiency. Continued Ig and Albumin growth through innovation and market expansion

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CSL Limited FY15 Full Year Result 12 August 2015

Contact - Mark Dehring Head of Investor Relations Telephone: +613 9389 3407 Email: [email protected]


US Dollars
Full year ended June
US$ Millions
Jun
2014
Reported
Jun
2015
Reported
Jun
2015
at CC1
Change
%
Sales
Other Revenue / Income
Total Revenue / Income
5,335
169
5,504
5,459
154
5,613
5,733
156
5,889
7.5%
7.0%
Earnings before Interest, Tax,
Depreciation & Amortisation
Depreciation/Amortisation
Earnings before Interest and Tax
Net Interest Expense / (Income)
Tax Expense
Reported Net Profit after Tax
Acquisition costs2
Adjusted Net Profit after Tax
Total Ordinary Dividend
Final Dividend (US$)
Basic EPS (US$)
1,832
1,939
1,994
8.8%
195
1,637
181
1,758
190
1,804
10.2%
33
297
44
335
44
348
1,307
-
1,379
22
1,412
22
8.0%
1,307
1,401
1,434
9.7%
1.13
0.60
2.70
1.24
0.66
2.92
2.99
10%
10%
11%

1. Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability. See end note for further detail. 2. One off costs connected with the acquisition of the Novartis influenza vaccine business

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Full year ended June FY14
USD$M
FY15
USD$M
FY15
USD$M
CC1
Change
%
rFVIII
pdCoag
Albumin
Immunoglobulins
Specialty Products
- Peri-operative bleeding
- Other specialty products
Total Product Sales
Other sales (mainly plasma)
Total Sales
491
573
694
2,320
848
414
434
468
558
754
2,326
923
450
473
495
597
778
2,430
977
483
494
1%
4%
12%
5%
15%
17%
14%
4,926
5,029
5,276
7%
15
4,941
18
5,047

1. Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability. See end note for further detail.

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Notes

(#) Constant currency removes the impact of exchange rate movements to facilitate comparability by restating the current year’s results at the prior year’s rates. This is done in two parts: (a) by converting the current year net profit of entities in the group that have reporting currencies other than US Dollars at the rates that were applicable to the prior year (“translation currency effect”); and (b) by restating material transactions booked by the group that are impacted by exchange rate movements at the rate that would have applied to the transaction if it had occurred in the prior year (“transaction currency effect”). The sum of translation currency effect and transaction currency effect is the amount by which reported net profit is adjusted to calculate the result at constant currency.

Summary NPAT

Reported Net Profit after Tax $1,379.0m Translation Currency Effect (a) $ 91.4m Transaction Currency Effect (b) $ (58.6m) Constant Currency Net Profit after Tax * $1,411.8m

(a) Translation Currency Effect $91.4m

Average exchange rates used for calculation in major currencies (twelve months to June 15/June 14) were as follows: USD/EUR (0.82/0.74); USD/CHF(0.94/0.91)

(b) Transaction Currency Effect ($58.6m)

Transaction currency effect is calculated by reference to the applicable prior year exchange rates. The calculation takes into account the timing of sales both internally within the CSL Group (ie from a manufacturer to a distributor) and externally (ie to the final customer) and the relevant exchange rates applicable to each transaction.

Summary Sales Reported Sales $5,458.6m Currency Effect (c) $274.3m Constant Currency Sales * $5,732.9m

c) Constant Currency Effect $274.3m

Constant currency effect is presented as a single amount due to the complex and interrelated nature of currency impacts on sales.

  • Constant Currency Net Profit after Tax and Sales have not been audited or reviewed in accordance with Australian Auditing Standards.

31