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CSL Ltd. — Interim / Quarterly Report 2018
Feb 13, 2018
17854_rns_2018-02-13_d1068dde-031f-4e16-9d91-85662c8632b6.pdf
Interim / Quarterly Report
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14 February 2018
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Half Year Result 2018[1]
CSL Limited (ASX:CSL; USOTC:CSLLY) today announced a reported net profit after tax (NPAT) of $1,086 million for the six months ended 31 December 2017, up 35% or 31% on a constant currency (CC)[2] basis. Earnings per share (EPS) grew 36% or 32% on a constant currency basis.
PERFORMANCE HIGHLIGHTS
Financial
-
Revenue $4,147 million, up 11% at CC[2]
-
Earnings before interest and tax (EBIT) $1,476 million, up 31% at CC
-
NPAT $1,086 million, up 31% at CC
-
EPS $2.40, up 32% at CC
-
Interim dividend[3] increased to $0.79 per share, up 23%
Operational CSL Behring
-
Immunoglobulin sales up 13% on trailing period at CC
-
Exceptionally strong demand for Idelvion[® ] (rFIX-FP)
-
Specialty Products sales up 19% on trailing period at CC
Seqirus
-
Seasonal influenza vaccine sales up 43% - strong QIV growth
-
Holly Springs cell culture facility – output up four fold
-
FLUAD[®] approved in the UK
1 All figures are expressed in US dollars unless otherwise stated.
2 Constant currency removes the impact of exchange rate movements, facilitating comparability of operational performance. For further detail please refer to CSL’s Financial Statements for the Half Year ended December 2017 (Directors’ Report).
3 For shareholders with an Australian registered address, the final dividend of US$0.79 will be unfranked for Australian tax purposes and paid on 13 April 2018 in A$ at an amount of A$1.004959 per share (at an exchange rate of A$1.2721/US$1.00). For shareholders with a New Zealand registered address, dividends will be paid in NZD at an amount of NZ$1.087830 per share (at an exchange rate of NZ$1.3770/US$1.00). The exchange rates used are fixed at the date of dividend determination. All other shareholders will be paid in US$. CSL also offers shareholders the opportunity to receive dividend payments in US$ by direct credit to a US bank account.
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Page 2
14 February 2018
Innovation
-
Privigen[®] (10% liquid IVIG) approved for CIDP in US
-
Hizentra[®] (SCIG) positive CHMP recommendation for CIDP in the EU
-
Proprietary stem cell gene therapy platform - Calimmune acquisition
-
Transplant franchise expanding – Vitaeris collaboration
Efficiency
-
Plasma collection centre openings on track
-
Major capital projects - start-up phase
-
Broadmeadows
-
Privigen module 4
-
Alburex[®] facility
-
-
Kankakee – base fractionation facility
“CSL’s focused execution of our strategic priorities delivered outstanding results in the first half, especially considering the strength of the prior comparable period,” said CSL Chief Executive Officer and Managing Director Paul Perreault. “Our results reflect the effectiveness of our patient-focused R&D pipeline, robust demand for our differentiated products, and market leadership positions around the world. Investments in R&D, production and commercial capabilities have positioned us well for sustainable growth and continue to deliver on our promise to patients with rare and serious diseases.”
“In the half, we successfully launched Haegarda[®] , a transformational therapy for patients with Hereditary Angioedema (HAE). Haegarda[®] provides unprecedented reduction in oedema attacks and significantly reduces the need for rescue medication,” Mr. Perreault noted.
“High demand continues for Idelvion[®] . Based on feedback from patients and healthcare providers it is clear that our next generation recombinant coagulation therapy, which has now been launched in 13 countries, is quickly becoming the new standard of care for Haemophilia B patients.”
“Our immunoglobulin products Hizentra[®] and Privigen[®] continued to deliver strong performance. To some extent their growth has been masked by atypical market conditions in the prior comparable period when some competitors experienced supply constraints. A comparison of the immunoglobulins sales to the trailing period (six months ended June 2017) saw the immunoglobulin portfolio growing 13%,” Mr. Perreault added.
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14 February 2018
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Page 3
“Seqirus continues to progress as planned. The Holly Springs facility, which produces a unique cell culture seasonal influenza vaccine, quadrupled the number of FLUCELVAX[®] doses produced this season. While significant work remains, our strategy for Seqirus is paying off.”
“Our emerging transplant franchise is developing well. We are investigating the use of current CSL products to treat patients with graft versus host disease or experiencing antibody mediated rejection. In addition we also entered into a collaboration with Vitaeris for a monoclonal antibody as part of our growing transplant capabilities,” Mr Perreault concluded.
OUTLOOK (at FY17 exchange rates)
Commenting on CSL’s outlook, Mr. Perreault said, “Solid ongoing demand for CSL Behring biotherapies is expected, including the strong patient uptake of our newly approved specialty product Haegarda[®] .”
“The haemophilia market continues to evolve and our new generation products, Idelvion[®] (rFIX-FP) and Afstyla[®] (rFVIII-SC) are well placed in the market. Looking forward, we expect Helixate[®] sales to decline as the product winds down. Competition in the factor VIII space remains intense as new entrants come to market.”
“An uneven profit profile for CSL is expected for the first and second half results, due to the seasonality of the influenza business and the timing of expenses – particularly research and development,” Mr. Perreault added.
“CSL Group’s net profit after tax for FY18 is now expected to be in the range of approximately $1,550 to $1,600 million at constant currency,” Mr. Perreault concluded.
In compiling the company’s financial forecasts for FY18, a number of key variables which may have a significant impact on guidance have been identified and these have been included the footnote[4] below.
4 Key variables that could cause actual results to differ materially include: the success and timing 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,
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Page 4
14 February 2018
CAPITAL MANAGEMENT
Capital management
During the first half of FY18, CSL completed a US private placement raising approximately US$700 million for general corporate purposes, as part of the company’s overall capital management program.
FURTHER INFORMATION
Additional details about CSL’s results are included in the company’s 4E statement, investor presentation slides and webcast, all of which can be found on CSL’s website www.csl.com.au A glossary of medical terms can also be found on the website. For further information, please contact:
Investors: Media: Mark Dehring Jemimah Brennan VP Investor Relations Head of Communications, Asia Pacific CSL Limited CSL Limited Telephone: +613 9389 3407 Mobile +61 412 635 483 Email: [email protected] Email: [email protected]
® Trademarks of CSL Limited or its affiliates.
distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and CSL’s ability to protect its patents and other intellectual property.
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14 February 2018
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Group Results
| Group Results | ||
|---|---|---|
| Half year ended Dec US$ Millions |
Dec 2016 Reported Dec 2017 Reported |
Dec 2017 at CC5 Change %5 |
| Sales Other Revenue / Income Total Revenue / Income |
3,553 3,999 124 148 3,677 4,147 |
|
| 3,941 11% |
||
| 147 | ||
| 4,088 11% |
||
| Earnings before Interest, Tax, Depreciation & Amortisation Depreciation/Amortisation Earnings before Interest and Tax Net Interest Expense Tax Expense Net Profit after Tax Interim Dividend EPS |
1,226 1,617 (131) (141) 1,095 1,476 (38) (52) (251) (338) |
|
| 1,575 28% |
||
| (138) | ||
| 1,437 31% |
||
| (52) | ||
| (330) | ||
| 806 1,086 |
1,055 31% |
|
| 0.64 1.77 0.79 2.40 |
||
| 2.33 23% 32.0% |
5 Constant currency removes the impact of exchange rate movements to facilitate comparability of operational performance. For further details please refer to CSL’s Financial Statements for the Half Year ended December 2017 (Directors’ Report).
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2018 Half Year Results 14 February 2018 Paul Perreault CEO & MD David Lamont CFO
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; acquisitions and divestments; research collaborations; 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.
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2 | Driven by Our Promise[™]
Delivering on Strategy
Growth
Innovation
People & Culture
-
Ig sales up 13% on trailing period @ CC[1]
-
Exceptionally strong HAEGARDA[®] launch
-
IDELVION[®] fast becoming standard of care
-
Specialty Products up 19% on TP @ CC[1]
Influenza
-
Privigen[®] approved for CIDP in US
-
Hizentra[®] positive CHMP recommendation for CIDP in EU
-
Proprietary stem cell gene therapy platform
-
Calimmune acquisition
-
Appointments
-
Bill Campbell – Commercial
-
Elizabeth Walker – HR
-
Calimmune & Ruide integration
Efficiency
-
Emerging Transplant franchise
-
Seasonal influenza vaccine sales up 43% on PCP @ CC
-
Vitaeris collaboration
-
Collection centre openings on track
-
Major capital projects – start-up phase
-
-
Holly Springs
-
doses produced quadrupled
-
FLUAD[®] - UK approval
1. Growth shown at constant currency to remove the impact of exchange rate movements facilitating comparability of operational performance. See end note for further detail.
- 3 | Driven by Our Promise[™]
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CSL Behring Revenue – 1H18
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Growth
Therapeutic Group
| Therapy | PCP1 1H18 vs 1H17 |
TP1 1H18 vs 2H17 |
|---|---|---|
| Immunoglobulins | 7.4% | 12.6% |
| Haemophilia | 5.1% | 5.6% |
| Albumin | 3.9% | 8.3% |
| Specialty | 20.4% | 19.4% |
| Other | (23.3)% | (40.0)% |
| Total 8.1% 10.1% |
Atypical market 1H17 stronger TP growth
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Region
21%
EM
8%
11%
Asia Pac
17%
North 7%
US$3.4b America
46%
EU 27%
8%
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1. Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail. PCP – Prior Comparable Period. TP – Trailing Period.
- 4 | Driven by Our Promise[™]
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Strong Ig Growth
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Growth
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- Strong Ig growth, especially the US
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- Up 13% on TP @ CC[1] (atypical market conditions 1H17)
SCIG market leader
7 years and 51 countries
- CIDP is largest Ig indication
90,000 patient years
- Privigen[®] approved for CIDP in US
~5m exposures
-
Hizentra[®] CIDP approval exp. 1H CY18
-
Carimune[®] – migration to next generation products
Most prescribed SCIG worldwide 60% of new SCIG starts SCIG is the fastest growth segment
1. Growth/Numbers shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail.
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5 | Driven by Our Promise[™]
Haemophilia
US IDELVION[®] PATIENT GROWTH
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450
400
400 Wk 83
350
300
300 Wk 64
250
200
200 Wk 46
150
100
Wk 27
100
50
0
Patient Counts
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Growth
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-
Launched in 13 countries: exceptional growth
-
Market leadership in a number of countries
-
Japan exceeding patient expectations following 2 week prescription limit removed Dec 2017
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-
Launched in 13 countries
-
Very competitive market
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6 | Driven by Our Promise[™]
Specialty Products
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Very successful chronic drug launch in the US
-
Transformational product
-
Natural C1-INH replacing missing or dysfunctional protein
-
95% reduction in attacks
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Growth
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-
Up 32% on PCP in US
-
Warfarin still in high use
-
Continued significant use of fresh frozen plasma for reversal of bleeding
-
Strong launch and acceptance in Japan
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7 | Driven by Our Promise[™]
Efficiency
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Efficiency
Plasma Collections
-
Unparalleled growth in collection centre openings – on track
-
Latent efficiency gains in fleet as new centres mature
-
New Donor Management System rolled out
-
Plasma supply tightness continues
Major capital projects - start-up phase
-
Broadmeadows
-
Privigen[®] module 4
-
Alburex[®] facility
-
Kankakee base fractionation facility
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8 | Driven by Our Promise[™]
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Innovation
TRANSPLANT
-
Emerging franchise
-
High unmet need
-
Leverages existing products
-
Vitaeris collaboration
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CIDP
-
Privigen[®] approved in US
-
Hizentra[®]
-
positive EU recommendation
-
US approval anticipated 1H18
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Innovation
OTHER DEVELOPMENTS
-
Proprietary stem cell gene therapy platform - Calimmune acquisition
-
• CSL112 - Phase 3 study commencing 1H CY18
-
CSL730 (Fc Multimer) – Phase 1 trial commenced
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9 | Driven by Our Promise[™]
Seqirus Revenue – 1H18
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Influenza
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By presentation @CC [1] Region
$m
800
700
EM
600
(37%)
500 Other Asia Pac
Fluad 14%
400
TIV
300
QIV 15% 1H18 68%
EU 12% North
200 Pandemic US$0.8b America
100 70%
0
1
1H17 1H18CC
Switch to QIV & Fluad
creating revenue growth
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1. Growth shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail.
10 | Driven by Our Promise[™]
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Seqirus – Operational Highlights
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Influenza
-
Approval of FLUAD in the UK
-
The only recommended vaccine for 65+ in 2018/19 season
-
First use of cell-specific virus seed in production of FLUCELVAX
-
Holly Springs cell culture facility – output up four fold
-
Submission of cell-based QIV dossier for EU registration
-
Preparations underway for 2019/20 season launch
-
Near completion of formulation suite in Liverpool, with further expansion planned in fill & finish
~~-~~ Strategy on track
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11 | Driven by Our Promise[™]
Financials David Lamont - CFO
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12 | Driven by Our Promise[™]
Financial Highlights - NPAT
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NPAT
1,200
$1,086m
+35% FX $31m
NPAT $1,055m
@CC [1]
$806m
800
+31%
@CC¹
1H18
1H17
400
0
US$m
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1 Constant Currency (CC) removes the impact of exchange rate movements facilitating comparability of operational performance. See end note for further detail.
13 | Driven by Our Promise[™]
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Financial Highlights - Group
| Half year ended Dec US$ Millions |
1H17 Reported |
1H18 Reported |
1H18 at CC1 |
Change % |
|---|---|---|---|---|
| Total Revenue | 3,677 | 4,147 | 4,088 | 11%1 |
| EBIT EBIT margin |
1,095 29.8% |
1,476 35.6% |
1,437 35.1% |
31%1 |
| NPAT | 806 | 1,086 | 1,055 | 31%1 |
| Cashflow from Ops | 664 | 840 | - | 27% |
| ROIC2 | 31.2% | 32.8% | - | - |
| EPS | 1.77 | 2.40 | 2.33 | 32%1 |
| DPS | 0.64 | 0.79 | - | 23% |
1 Constant Currency (CC) removes the impact of exchange rate movements facilitating comparability of operational performance. See end note for further detail. 2 Annualised.
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14 | Driven by Our Promise[™]
Financial Highlights - Segments
CSL Behring
Seqirus
| US$ Millions | 1H17 Reported |
1H18 Reported |
Change % at CC1 |
|---|---|---|---|
| Sales | 2,976 | 3,289 | 9% |
| Other Rev. | 81 | 67 | (16%) |
| Total Rev. | 3,057 | 3,356 | 8% |
| EBIT EBIT margin |
1,098 35.9% |
1,291 38.5% |
15% |
| US$ Millions | 1H17 Reported |
1H18 Reported |
Change % at CC1 |
|---|---|---|---|
| Sales | 577 | 710 | 22% |
| Other Rev. | 43 | 81 | 86% |
| Total Rev. | 620 | 791 | 26% |
| EBIT EBIT margin |
(3) (0.5%) |
185 23.3% |
- |
1 Constant Currency (CC) removes the impact of exchange rate movements facilitating comparability of operational performance. See end note for further detail.
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15 | Driven by Our Promise[™]
Margin Growth
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%
Margin drivers
50
•
Ig mix shift
40 EBITDA Margin
•
Transition of Haemophilia portfolio
30 • Growth in speciality products
‒
Haegarda [®] & Kcentra [®]
20
•
Uneven expenditure phasing
10
•
Strong seasonal Seqirus performance
0
16 | Driven by Our Promise [™]
1H15 2H15 1H16 2H16 1H17 2H17 1H18
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Debt Maturity Profile
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$m 800
Private Placement
New US$700m private placement
New Private Placement
600 Bank Debt • Completed October 2017
•
Weighted average fixed rate of 3.36%
•
Average life of 13.1 years
400
Total debt portfolio
200 •
Weighted average rate of ~2.7%
0
17 | Driven by Our Promise [™]
FY18 FY19 FY20 FY21 FY22 FY23 FY24 FY25 FY26 FY27 FY28 FY29 FY30 FY31 FY32 FY33 FY34 FY35 FY36 FY37 FY38
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Outlook for FY18[1]
NPAT updated to range ~$1,550m to $1,600m @ CC[2,3]
-
Business environment expectations 2H18
-
Continued strong demand for plasma therapy products
-
Transitioning of Haemophilia portfolio
-
Uneven expenditure phasing
Innovation 2H[1]
CSL112 Phase 3 commencing Hizentra[®] CIDP approval
-
Accelerated R&D investment 2H
-
Seqirus seasonality – loss making 2H
-
1 For forward looking statements, refer to Legal Notice on page 2
-
2 Constant Currency (CC) removes the impact of exchange rates movements to facilitate comparability
-
18 | 3 Full year FX impact is expected to be ~$10m favourable, Driven by Our Promise[™] assuming current rates remain steady for the remainder of the year
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Financial Appendix
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19 | Driven by Our Promise[™]
CSL Behring Sales
| Growth Efficiency Influenza Innovation Half year ended December US$ Millions Immunoglobulins Albumin Haemophilia - Recombinants - Plasma Specialty Total Product Sales Other sales (mainly plasma) Total Sales |
Dec 2016 Dec 2017 Dec 2017 CC1 Change %1 |
|---|---|
| 1,426 433 234 282 588 1,558 452 260 297 717 1,532 450 254 288 708 7% 4% 8% 2% 20% |
|
| 2,963 3,284 3,232 9% |
|
| 13 2,976 5 3,289 5 3,237 |
1 Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability. See end note for further detail.
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20 | Driven by Our Promise[™]
Seqirus Sales
| Growth Effic~~iency~~ Influenza Innovation Half year ended December US$ Millions QIV TIV Adjuvanted Pandemic Other / In-licence Total Revenue |
Dec 2016 Dec 2017 Dec 2017 CC1 Change %1 |
|---|---|
| 51 317 56 41 155 308 171 131 60 121 308 168 129 59 120 504% -47% 130% 44% -23% |
|
| 620 791 784 26% |
1 Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability. See end note for further detail.
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21 | Driven by Our Promise[™]
Notes
(#) Constant currency removes the impact of exchange rate movements to facilitate comparability of operational performance for the Group. This is done in three 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 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) by 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 net profit is adjusted to calculate the operational result.
Summary NPAT
Reported net profit after tax $1,086.3m Translation currency effect (a) $ (19.0m) Transaction currency effect (b) $ 21.3m Foreign Currency (gains) & losses (c) $ (33.5m) Constant currency net profit after tax * $1,055.1m
a) Translation Currency Effect $(19.0m)
Average Exchange rates used for calculation in major currencies (Six months to Dec 17/Dec 16) were as follows: USD/EUR (0.85/0.91); USD/CHF (0.97/0.99).
b) Transaction Currency Effect $21.3m
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.
c) Foreign Currency Gains ($33.5m)
Foreign currency gains recorded during the period.
Summary Sales Reported sales $3,998.5m Currency effect $ (57.4m) Constant currency sales* $3,941.1m
- Constant currency net profit after tax and constant currency sales have not been audited or reviewed in accordance with Australian Auditing Standards.
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22 | Driven by Our Promise[™]
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CSL Limited
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Contact: Mark Dehring VP Investor Relations Ph: +61 3 9389 3407 E: [email protected]
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