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CSL Ltd. Interim / Quarterly Report 2016

Feb 15, 2016

17854_rns_2016-02-15_b69b1b13-03ed-4628-a269-a3537e7166ff.pdf

Interim / Quarterly Report

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For immediate release 16 February 2016

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Half Year Result 2016

CSL Delivers Exceptional Performance

  • Double-digit sales growth in all plasma therapy groups

  • 1[st] shipment of Privigen[®] from new facility

  • Seqirus formed – No.2 global influenza vaccines manufacturer

CSL Limited (ASX:CSL; USOTC:CSLLY) today announced a net profit after tax (NPAT) of US$719 million for the six months ended 31 December 2015, up US$27 million or 4% on a reported basis when compared to the prior comparable period (PCP). Earnings per share (EPS) grew 9%. After excluding financials relating to the recently acquired Novartis influenza vaccines business, underlying[1] NPAT grew 7% and EPS grew 12%, at constant currency[2] .

HIGHLIGHTS

Financial

  • Sales US$3,056 million, up 11% on PCP

  • Underlying[1] sales up 9% at constant currency[2]

  • NPAT US$719 million, up 4% on PCP

  • Underlying NPAT up 7% at constant currency

  • Earnings per share US$1.55, up 9% on PCP

  • Underlying EPS up 12% at constant currency

  • Cashflow from operations US$705 million, up 8% on PCP

  • Interim dividend[3] of US$0.58 per share, unfranked for Australian tax purposes, payable on 15 April 2016

  • Converted to Australian currency, the interim dividend increased to approximately A$0.81 per share, up ~10% on PCP.

1 Underlying excludes financials relating to the Novartis influenza vaccines business (NVS-IV). NVS-IV was acquired on 31 July 2015.

2 Constant currency removes the impact of exchange rate movements to facilitate comparability of operational performance. See end note[(#)] for further detail.

3 For shareholders with an Australian registered address, dividends will be paid in A$ at an amount of A$0.814726 per share (at an exchange rate of A$1.4047/US$1.00), and for shareholders with a New Zealand registered address, dividends will be paid in NZD at an amount of NZ$0.874234 per share (at an exchange rate of NZ$1.5073/US$1.00). The exchange rates used are fixed at the date of dividend determination. All other shareholders will be paid in US$. As a result of the ASX’s announced intention to move to a T+2 settlement cycle, CSL’s ex-dividend date for its interim dividend will be 23 March 2016 (previously 22 March 2016)

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Page 2

16 February 2016

Operational

  • Product Portfolio

  • Double digit sales growth in all plasma therapy groups

  • CSL 654 (rIX-FP) – license under review in the U.S. and EU

  • CSL 627 (rVIII-SC) – license under review in the U.S.

  • Respreeza[® ] approved in the EU

  • CSL 362 (AML) – licensee (Janssen) commenced phase 2 study

  • CSL 112 (rHDL) – phase 2b fully enrolled

  • Operations

    • New Privigen[® ] manufacturing facility in Broadmeadows, Australia approved by U.S. FDA

      • First Privigen[®] shipment in December 2015
    • New sales office opened in Russia

  • Influenza

    • Novartis influenza vaccines acquisition closed

    • ‘Seqirus‘ launched – No. 2 global influenza vaccine manufacturer

    • o FLUAD[TM] approved by U.S. FDA

    • Quadrivalent influenza vaccines - licenses under regulatory review

  • Capital management

    • A$1 billion share buyback[4] underway

    • ~US$500 million private placement completed

    • New US$1.25 billion bank debt facilities negotiated

“CSL delivered an exceptional first half result, led by double-digit sales growth in all of our plasma therapy groups,” said CSL Chief Executive Officer and Managing Director Paul Perreault. “In particular we saw strong demand for our immunoglobulin products with subcutaneous immunoglobulin therapy, Hizentra[®] , growing at 31% and intravenous immunoglobulin therapy, Privigen[®] , up 13%.”

“This year CSL will mark its centenary as a very different organization to the one that was founded in 1916 to ensure Australia had its own supply of sera, antitoxins and vaccines. Today, we are an established and growing global biotherapeutics leader, developing and delivering innovative therapies for patients around the world. Seqirus, our influenza vaccine business, is the second largest provider in the world with a diverse product portfolio, broad global sales reach and manufacturing capabilities in both

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

16 February 2016

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Page 3

northern and southern hemispheres. Overall, CSL is well positioned for sustainable growth and continuing to deliver value to shareholders.”

OUTLOOK

Commenting on CSL’s outlook, Mr. Perreault said, “2016 is an exciting year for CSL. The licenses for our novel recombinant coagulation products are currently under review, and pending approval, we plan to introduce these to the market later this year. We have been investing in our commercial capabilities to support the launch and rollout of these products. We have also continued to invest in our research and development pipeline and our manufacturing spine to ensure we meet growing demand. Notwithstanding this additional expenditure and the current competitive market, I can reconfirm my previous guidance for FY16 of 5% profit growth at constant currency.”

Mr Perreault continued, “This guidance does not include financials associated with the acquisition of the Novartis influenza vaccines business, which we anticipate will report a loss in the range of approximately US$90 - 120 million this financial year. However, with the deal now closed a significant multi-year strategy has commenced to integrate this business and turn its performance around.”

Earnings per share growth for the Group is expected to exceed profit growth, benefiting from ongoing capital management activity.

In compiling the company’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[5] below.

5 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; 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.

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16 February 2016

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OPERATING REVIEW

CSL Behring sales of US$2.5 billion grew 10% in constant currency terms when compared to the prior comparable period.

Immunoglobulin product sales of US$1,181 million grew 13% in constant currency terms.

Intravenous immunoglobulin (IVIG) sales growth was underpinned by strong demand for Privigen[®] with sales growth of 13% over the prior comparable period. Privigen’s[®] expanded indication in Europe to include its use in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) was a significant contributor to growth in this region, especially in France and the UK. US sales into the Specialty Pharmacy segment also performed well.

Sales of subcutaneous immunoglobulin product, Hizentra[®] , was up 31% at constant currency, led by sales in the U.S. and Europe. New patient starts on Hizentra[® ] and those converting from IVIG were key drivers of growth.

Albumin sales of US$376 million grew 10% in constant currency terms, driven by ongoing strong global demand. Demand in China was of particular note with growth supported by the company’s ongoing successful sales penetration into Tier 2 and Tier 3 cities.

Haemophilia product sales of US$509 million increased 2% in constant currency terms. Plasma derived haemophilia sales grew 13% following successful tenders for the provision of Beriate[® ] in European countries, including Poland and Russia. Solid Humate[®] growth in the U.S. was underpinned by expanded use in surgeries and immune tolerance therapy. Biostate[®] sales lifted in Germany, France and the U.K. A decline in sales of Helixate[®] , CSL’s recombinant factor VIII, to a large extent offset the growth in plasma derived therapies as competition intensifies following the launch of new generation recombinant FVIII products.

Specialty products sales of US$466 million grew 14% in constant currency terms. Sales of Kcentra[®] (4 factor pro-thrombin complex concentrate) in the U.S. were particularly strong following an increased level of promotion and increasing brand awareness.

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16 February 2016

Following marketing authorization being granted for Respreeza[®] in Europe, this product was launched in Germany with plans for rollout in other European countries later this year. Respreeza[®] is a maintenance treatment for severe Alpha-1 Antitrypsin Deficiency patients and has been shown to slow the progression of emphysema.

Long term investment in a multi-site expansion program to meet future demand for therapies continues. In December the Board approved investment and construction of a new commercial scale manufacturing facility for recombinant coagulation factors in Lengnau, Switzerland. Also in December the first shipment of Privigen was made from a new manufacturing facility in Broadmeadows, Australia. Construction of a new albumin production facility at the same site continues. In Marburg, Germany a new quality control facility together with filling and packaging upgrades is nearing completion. At the Kankakee, U.S. site the construction of significant base fractionation plant is well progressed.

Seqirus sales of US$519 million are reported for the first time, following the combination of CSL’s subsidiary bioCSL and Novartis influenza vaccines (NVS-IV) manufacturing business to form CSL’s new business unit Seqirus . NVS-IV was acquired on 31 July 2015 and Seqirus becomes the second largest manufacturer of influenza vaccines globally. Seqirus sales of influenza vaccine have been impacted by the mild season in the northern hemisphere.

CSL Intellectual Property revenue of US$64 million declined 29% in constant currency terms. The prior comparable period included a payment from CSL’s licensee Janssen Biotech Inc to develop and commercialise CSL 362, a product used to treat patients with acute myeloid leukaemia.

CAPITAL MANAGEMENT

Share Buyback

In October 2015, CSL announced its intention to conduct an on-market share buyback of up to A$1 billion. Under the Australian Securities Exchange listing rules this buyback[6] has a 12 month completion window. To date, CSL has repurchased approximately 2.4 million shares for approximately A$235 million, representing about 24% of the intended repurchase program.

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

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Page 6

16 February 2016

CSL’s balance sheet remains very sound and only modestly geared. Cash and cash equivalents totalled US$1,092 million at 31 December 2015.

During the first half of fiscal 2016 the company accessed the private placement market and raised the equivalent of approximately US$500 million as part of the company’s overall debt management program. CSL also re-negotiated its major bank facilities, totalling US$1.25 billion with a maturity of 5 years.

CHANGES TO CSL BOARD

Dr Megan Clark AC has been appointed a Director of the Company effective from 16 February 2016. For further information please see separate ASX announcement.

Additional details about CSL’s results are included in the company’s 4D statement, investor presentation slides and webcast, all of which can be found on the company’s website www.csl.com.au 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 Senior Director Public Affairs CSL Limited CSL Limited Telephone: +613 9389 3407 Telephone: +613 9389 3425 Email: [email protected] Mobile +614 0997 8314 Email: [email protected]

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Page 7

16 February 2016

Group Results US Dollars

Six months ended December
US$ Millions
Dec
2014
Reported
Dec
2015
Reported
Dec
2015
NVS-IV7
Dec
2015
Underlying8
Dec 2015
Underlying8
at CC#
Change
%
Sales
Other Revenue / Income
Total Revenue / Income
2,744
3,056
294
2,762
2,996
9.2%
96
80
4
76
79
2,841
3,136
298
2,838
3,075
8.2%
Earnings before Interest, Tax,
Depreciation & Amortisation
Depreciation/Amortisation
Earnings before Interest and
Tax
Gain on Acquisition
Net Interest Expense / (Income)
Tax Expense
Net Profit after Tax
Interim Dividend (US$)
Basic EPS (US$)
969
848
(112)
960
1,053
8.7%
91
102
9
93
102
878
746
(121)
867
952
8.3%
176
176
21
27
1
26
26
165
176
5
171
188
692
719
50
669
738
6.6%

0.58
1.43
0.58
1.55
1.59
12%

7 Novartis influenza vaccines acquisition as from 31 July 2015

8 Underlying excludes financials relating to the Novartis influenza vaccines business (NVS-IV)

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16 February 2016

(#) Constant currency removes the impact of exchange rate movements to facilitate comparability of operational performance. This is done in three 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”); (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”); and (c) adjusting for current year foreign currency gains and losses. The sum of translation currency effect, transaction currency effect and foreign currency gains and losses is the amount by which reported result is adjusted to calculate the operational result.


result.
Summary NPAT
Reported Net Profit after Tax $718.8m
Translation Currency Effect (a) $ 64.8m
Transaction Currency Effect (b) $ (9.8m)
Foreign Currency Gains and Losses (c) $ 13.7m
Constant Currency Net Profit after Tax * $787.5m

(a) Translation Currency Effect $64.8m

Average Exchange rates used for calculation in major currencies (six months to Dec 15/Dec 14) were as follows: USD/EUR (0.91/0.77); USD/CHF(0.97/0.93)

(b) Transaction Currency Effect ($9.8m)

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.

(c) Foreign Currency Losses (13.7m)

Foreign currency losses recorded during the period

Summary Sales
Reported Sales $3,056.3m
Currency Effect
$ 234.0m
Constant Currency Sales * $3,290.3m
Less NVS-IV sales $ 294.6m
Underlying operational business sales @ CC $2,995.7m
  • Constant Currency Net Profit after Tax and Sales have not been audited or reviewed in accordance with Australian Auditing Standards.

®, TM Trademarks of CSL Limited or its affiliates.

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1

Legal Notice

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

Reported Financials

Sales US$3.1 billion, up 11%

  • Underlying[1] sales up 9% @CC[2]

  • NPAT US$719 million, up 4%

  • Underlying NPAT up 7% @CC

  • EPS US$1.55, up 9%

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  • Underlying EPS up 12% @CC

  • Cashflow from operations US$705 million, up 8% Interim dividend US$0.58, unfranked

    • Converted to A$0.81, up ~10%

1. Underlying excludes financials relating to the Novartis influenza vaccines business (NVS-IV) NVS-IV was acquired on 31 July 2015

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

3

Operational Highlights

Product Portfolio

  • Double digit sales growth in all plasma therapy groups

  • CSL 654 (rIX-FP) - license under review in U.S. & EU

  • CSL 627 (rVIII-SC) - license under review in U.S.

  • Respreeza[®] approved in EU

  • CSL 362 (AML) – licensee (Janssen) commenced Phase II study

  • CSL 112 (rHDL) - Phase IIb fully enrolled

4

Operational Highlights

Business Development

  • Operations

  • New Privigen[®] manufacturing facility approved by U.S. FDA

    • First shipment December 2015
  • New sales office opened in Russia

  • Influenza

  • Novartis influenza vaccines acquisition closed 31 July 2015

  • ‘Seqirus’ Launched – No. 2 global influenza vaccine manufacturer

  • FLUAD[TM] approved by U.S. FDA

  • Quadrivalent influenza vaccines – licenses under regulatory review

  • Capital Management

  • A$1 billion share buyback[1] underway

  • ~US$500 million private placement completed

  • New US$1.25 billion bank debt facilities negotiated

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

5

Group Sales

CSL 1H16 Sales US$3.1B

$1,181M Immunoglobulin Immunoglobulin $509M Haemophilia Haemophilia $466M Specialty Seqirus Specialty Products $376M Albumin Albumin $519M Seqirus Products

Broad portfolio of products

6

Broad Sales Reach

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

CSL 1H16 Sales US$3.1B
North
$1,456M North America
America
$844M Europe
Asia Europe $452M ROW
ROW $304M Asia
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7

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Business Unit Performance

8

CSL Behring

Product Sales up 10% @CC

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

US$M
US$2,537m
US$2,492m
2,500
2,000
Immunoglobulins
1,500
Haemophilia
1,000
Specialty
500
Albumin
0
Dec 14 Dec 15
Reported sales for the 6 month period
----- End of picture text -----

9

Immunoglobulins

Sales up 13% @CC

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

US$M
US$1,181m
1,200
US$1,122m
1,000
IVIG
800
600
400
SCIG
200
Hyper IG
0
Dec 14 Dec 15
Reported sales for the 6 month period
----- End of picture text -----

Highlights IVIG Privigen[®] up 13%

  • Ig IsoLo™ step added to manufacturing process

  • North America

  • Strong demand in the Specialty Pharmacy segment

  • Europe

• CIDP indication driving strong Privigen[®] demand SCIG up 31%

Strong growth for Hizentra[® ] from new patient starts and IVIG conversions

10

US$M

400

300

200

100

0

Albumin

US$359m

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Sales up 10% @CC

Highlights

US$376m

China

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  • 17% volume growth

  • Successful market penetration into Tier 2 & Tier 3 cities

US

  • Solid demand

  • Expansion of IDNs and large hospital contracts contributing to majority of growth

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

Dec 14 Dec 15
----- End of picture text -----

Reported sales for the 6 month period

11

Haemophilia

Sales up 2% @CC

US$M

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

600
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----- Start of picture text -----

US$558m
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Highlights

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US$509m
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----- Start of picture text -----

500
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400
300
200
100
0
----- End of picture text -----

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

Helixate [® ]
pd Coag
----- End of picture text -----

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

Dec 14 Dec 15
----- End of picture text -----

Recombinant (Helixate[®] )

  • Volumes declined as broader market transitions to new generation products

Plasma Derived

Beriate[® ] volume up 31%

  • Growth driven by Poland & Germany

  • Successful tenders in Russia & Iran

Volume growth arising in lower priced markets

Reported sales for the 6 month period

12

Specialty

Sales up 14% @CC

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

US$M
500
US$466m
US$443m
Highlights
AATD
400 Zemaira [® ] / Respreeza [®]

Launched in EU
HAE
300 Berinert [® ] P

Kcentra [[® ]] / Beriplex [[®]]
200
Acquired

Bleeding

Sales up ~40%
100 •
Other
0
Dec 14 Dec 15
Reported sales for the 6 month period
----- End of picture text -----

  • New patient starts in the US up 24%

  • Kcentra[[® ]] / Beriplex[[®]]

  • Ongoing demand growth

  • Increasing brand awareness

13

Seqirus

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

US$M
600 Seqirus
US$519m
500
400
NVS-IV [1 ]
bioCSL
300
US$252m
200 Influenza
100
Pharma
& vaccines
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Highlights

Integration

  • Novartis influenza vaccines acquisition completed 31 July 2015

  • Seqirus launched November 2015

  • Corporate office and global leadership team established

Operational

  • U.S. FDA approval for FLUAD[TM ]

  • Cell culture QIV filed with U.S. FDA

  • Afluria[®] QIV filed with U.S. FDA

  • Sales impacted by mild northern hemisphere influenza season

0

Dec 15

Dec 14

Reported sales for the 6 month period

1. Novartis influenza vaccines (NVS-IV ) sales for 5 months

14

Business Turnarounds

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

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

bioCSL
EBIT margin
15
10
5
0
-5
-10
-15
1H14 2H14 1H15 2H15 1H16
%
CSL Behring
40 EBIT margin
30
20
10
0
FY05 FY06 FY07 FY08 FY09
----- End of picture text -----

bioCSL was formed in 2013 to improve focus on operational efficiency and drive growth initiatives

CSL Behring was acquired in 2004

CSL is experienced turning around businesses

Business turnarounds take time

15

CSL Intellectual Property

Segment Revenue $64m, down 29% @CC

  • Decline in revenue arising from license payment relating to CSL 362

  • included in prior period

HPV royalties $63m

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

  • α

  • CSL 362 (anti-IL-3R mAb)

  • Exclusive worldwide license with Janssen Biotech Inc to develop and commercialise CSL 362

  • Phase 2 AML study commenced by Janssen July 2015

  • Commitment to exploratory study in SLE (Lupus) patients

16

R&D Update

rIX-FP

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

  • Adult and pediatric indications under review by EMA and FDA

  • Health Canada approval received in Jan 16

  • rVIII-SingleChain

  • Phase I/III data supports twice weekly prophylaxis

  • BLA accepted for review by FDA in July 15

  • MAA submitted to EMA in Dec 15

  • rVIIa-FP

  • Congenital deficiency Phase I/II and Phase II/III in patients with inhibitors continue

Hizentra[®]

  • Hizentra[®] flexible dosing registration in US

  • Hizentra[®] CIDP pivotal study recruitment completed

17

R&D Update

Beriplex[®]

  • Phase III study in Japan nearing completion

  • Exploring utility in treating bleeding patients receiving NOACs

  • Berinert[® ]

  • CSL 830 (subcut) pivotal Phase III study recruitment completed

  • Anti-FXIIa mAb pre-clinical development in HAE completed

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

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

  • Respreeza[®] approved by EMA in August 15

  • CSL 112 (reconstituted High Density Lipoprotein)

  • AEGIS-I Phase IIb study fully recruited

  • Planning for Phase III commenced

18

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Financials

19

1H16 Profit Growth

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

US$M
1,000 NVS-IV [2 ]
Gain on
+7% acquisition One off $788m
800
$738m $176m items Operational FX $69m
$692m
FX $69m ($64m) NPAT
($62m)
600
$669m $719m
400
200 1H15 1H16 1H16
Reported Reported Reported
NPAT Underlying NPAT
NPAT [1 ]
0
----- End of picture text -----

1. Underlying excludes financials relating to the Novartis influenza vaccines business (NVS-IV) 2. NVS-IV was acquired on 31 July 2015

20

Effective Capital Management

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

shares m Shares on issue x Net debt/EBITDA
700 1.5
Target ~1x
600 1
500
0.5
400
0
300
-0.5
200
-1
100
0 -1.5
FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY09 FY10 FY11 FY12 FY13 FY14 FY15
US$
3.5 EPS
• 3.0
27% of shares repurchased
over the last 10 years 2.5
2.0

Buyback program continues to 1.5
drive EPS accretion 1.0
0.5

WACC continues to reduce
0.0
FY09 FY10 FY11 FY12 FY13 FY14 FY15
----- End of picture text -----

21

Debt Maturity Profile

US$M

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

1,400
~US$500m private placement completed
October 2015
1,200

weighted average fixed rate of 1.43%
1,000 • average life of 9.4 years
New Bank Debt Facilities
800

~US$1.25b with maturity of 5 years
600
400
200
0
FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24 FY25 FY26 FY27
Private Placement Bank Debt Undrawn
----- End of picture text -----

~US$500m private placement completed October 2015

  • weighted average fixed rate of 1.43%

  • ~US$1.25b with maturity of 5 years

22

Continued Investment[1 ]

  • Selling & Marketing up 18% @CC[2 ] Expansion of commercial +$43m operations

  • Expanding geographic sales reach

Research & Development

Flat @CC

  • 1H / 2H phasing

Depreciation & Amortisation Net financing costs

• Up 12% @CC Multi-site capacity expansion +$11m • Up 22% @CC Private Placement

1. Reflects movements in the underlying business. Excludes financials relating to the Novartis influenza vaccines business (NVS-IV) 2. Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability of operational performance

23

Capital Expenditure

==> picture [522 x 334] intentionally omitted <==

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

US$M
700
Estimate
600
Seqirus
500
400
Growth Growth
56% 58% CSL
300
Ex-Seqirus
200
Maintenance Maintenance
100
44% 42%
0
FY14 FY15 FY16
----- End of picture text -----

24

Outlook for FY16[1 ]

CSL[2 ] Revenue growth ~7% @CC[4 ] NPAT growth ~5% @CC[4 ]

  • CSL[2] guidance reaffirmed

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

NVS-IV[3] (11 Months)

Revenue ~US$360m[5 ] ~ NPAT (US$90-120m)

• NVS-IV gain on acquisition less acquisition related one-off costs ~US$90 million

  • 1 For forward looking statements, refer to Legal Notice on page 2

  • 2 Excludes Novartis influenza vaccines business (NVS-IV)

  • 3 Influenza vaccine business acquired from Novartis 31 July 2015

  • 4 Constant Currency (CC) removes the impact of exchange rates movements to facilitate comparability

  • 5 Excludes gain on acquisition ~US$176m

25

CSL Strategy for Profitable Growth

  • CSL 112 – new treatment paradigm in ACS

  • CSL 830 – HAE

  • Future Growth

  • Pipeline Pipeline antibodiesTargeted business development

  • Drive Seqirus business to profitability

  • Seqirus Successfully launch pipeline vaccines Sustained Financial

  • Growth Performance

  • DriversLaunch recombinant coagulation factors

  • CSLMaintain leadership in Ig and albumin

  • BehringGrow high-margin specialty products

  • Relentless commitment to lowest cost base

  • Core Plasma Remain ahead of the demand curveOrganic growth of core plasma products

26

CSL Limited 2016 Half Year Result 16 February 2016

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

27

Group Results

Adjusted for NVS-IV

Half year ended December
US$ Millions
Dec
2014
Reported
Dec
2015
Reported
Dec
2015
NVS-IV2
Dec
2015
Underlying1
Dec 2015
Underlying1
at CC3
Change
%
Sales
Other Revenue / Income
Total Revenue / Income
2,744
96
2,841
3,056
80
3,136
294
4
298
2,762
76
2,838
2,996
79
3,075
9.2%
8.2%
Earnings before Interest, Tax,
Depreciation & Amortisation
Depreciation/Amortisation
Earnings before Interest and Tax
Gain on Acquisition
Net Interest Expense / (Income)
Tax Expense
Reported Net Profit after Tax
Interim Dividend (US$)
Basic EPS (US$)
969
848
(112)
960
1,053
8.7%
91
878
102
746
9
(121)
93
867
102
952
8.3%
21
165
176
27
176
176
1
5
26
171
26
188
692
719
50
669
738
6.6%
0.58
1.43
0.58
1.55
1.59
12%

1. Underlying excludes financials relating to the Novartis influenza vaccines business

2. Novartis influenza vaccines acquisition as from 31 July 2015

3. Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability of operational performance.

28

CSL Behring Sales

Half year ended December
US$ Millions
Dec
2014
Dec
2015
Dec
2015
CC1
Change
%
Immunoglobulins
Albumin
Haemophilia
- Recombinants
- Plasma
Specialty
Total Product Sales
Other sales (mainly plasma)
Total Sales
1,122
359
558
250
308
443
1,181
376
509
203
306
466
1,269
395
569
221
348
506
13.2%
10.1%
2.0%
(11.5%)
12.9%
14.2%
2,482
2,532
2,740
10.4%
10
2,492
5
2,537

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

29

Financial Appendix[1 ]

**CSL2 ** **CSL2 ** NVS-IV3
(11 months)
Full Year ended June FY15 FY16 FY16
US$ Millions Actual Guidance Guidance
Total Revenue 5,613 ~7% @CC4 ~3605
Reported Net Profit after Tax 1,379 ~(90-120)
NVS-IV gain on acquisition
less acquisition related one-off costs
~90
Adjusted Net Profit after Tax 1,401 ~5% @CC4 ~(180-210)
FX Impact6 ~(100)
  • 1 For forward looking statements, refer to Legal Notice on page 2

  • 2 Excludes Novartis influenza vaccines business (NVS-IV)

  • 3 Influenza vaccine business acquired from Novartis 31 July 2015

  • 4 Constant Currency (CC) removes the impact of exchange rates movements to facilitate comparability

  • 5 Excludes gain on acquisition ~US$176m

  • 6 Assumes current rates remain steady for the remainder of the year, giving rise to the unfavourable full year FX impact

30

Notes

(#) Constant currency removes the impact of exchange rate movements to facilitate comparability of operational performance. This is done in three 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”); (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”); and (c) adjusting for current year foreign currency gains and losses. The sum of translation currency effect, transaction currency effect and foreign currency gains and losses is the amount by which reported result is adjusted to calculate the operational result.

Summary NPAT Reported Net Profit after Tax $718.8m Translation Currency Effect (a) $ 64.8m Transaction Currency Effect (b) $ (9.8m) Foreign Currency Gains and Losses (c) $ 13.7m Constant Currency Net Profit after Tax * $787.5m

(a) Translation Currency Effect $64.8m

Average Exchange rates used for calculation in major currencies (six months to Dec 15/Dec 14) were as follows: USD/EUR (0.91/0.77); USD/CHF(0.97/0.93)

(b) Transaction Currency Effect ($9.8m)

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.

(c) Foreign Currency Losses (13.7m)

Foreign currency losses recorded during the period

Summary Sales Reported Sales $3,056.3m Currency Effect $ 234.0m Constant Currency Sales * $3,290.3m Less NVS-IV sales $ 294.6m Underlying operational business sales @ CC $2,995.7m

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