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CSL Ltd. Investor Presentation 2021

Aug 17, 2021

17854_rns_2021-08-17_99c01262-91a1-4906-9293-775443906c39.pdf

Investor Presentation

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For immediate release

18 August 2021

RESULTS PRESENTATION FOR THE FULL YEAR ENDED 30 JUNE 2021

Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY)

Please find attached the slides for the presentation on the full year results that will be given by the Chief Executive Officer and Chief Financial Officer shortly.

The live briefing will be webcast and can be viewed at https://csl.webcastcloud.com/event?eventid=cc1ba0b2-0ddc-4c36-a8bcda89aec8c6d8. Please note that this link will expire after the webcast concludes.

A recording of the webcast will be made available later in the day at: https://investors.csl.com/site/investors/financial-results-and-information

Authorised for lodgment by:

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Fiona Mead Company Secretary

For further information, please contact:

Investors:

Media:

Mark Dehring VP Investor Relations P: +61 3 9389 3407 E: [email protected]

Jimmy Baker

Communications, Asia Pacific P: +61 450 909 211 E: [email protected]

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CSL Limited 2021 Full Year Results 18 August, 2021

Paul Perreault Joy Linton CEO and Managing Director CFO

IMPORTANT NOTICE AND DISCLAIMER

This presentation contains summary information about CSL Limited (ACN 004 089 936) and its related bodies corporate (together, CSL ) and CSL's activities as at the date of this presentation. It is information given in summary form only and does not purport to be complete. It should be read in conjunction with CSL's other periodic corporate reports and continuous disclosure announcements filed with the Australian Securities Exchange ( ASX ), available at www.asx.com.au This presentation is for information purposes only and is not a prospectus or product disclosure statement, financial product or investment advice or a recommendation to acquire CSL shares or other securities.

Legal Notice

No representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, none of CSL or its directors, employees or agents, nor any other person, accepts liability for any loss arising from the use of this presentation or its contents or otherwise arising in connection with it, including, without limitation, any liability from fault or negligence on the part of CSL or its directors, employees, contractors or agents.

This presentation contains forward-looking statements in relation to CSL, including statements regarding CSL's intent, belief, goals, objectives, initiatives, commitments or current expectations with respect to CSL's business and operations, market conditions, results of operations and financial conditions, products in research and risk management practices. Forward-looking statements can generally be identified by the use of words such as "forecast", "estimate", "plan", "will", "anticipate", "may", "believe", "should", "expect", “project,” "intend", "outlook", "target", "assume" and "guidance" and other similar expressions.

The forward-looking statements are based on CSL's good faith assumptions as to the financial, market, risk, regulatory and other relevant environments that will exist and affect CSL's business and operations in the future. CSL does not give any assurance that the assumptions will prove to be correct. The forward-looking statements involve known and unknown risks, uncertainties and assumptions and other important factors, many of which are beyond the control of CSL, that could cause the actual results, performances or achievements of CSL to be materially different to future results, performances or achievements expressed or implied by the statements. . 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 or divestitures; research collaborations; litigation or government investigations, and CSL’s ability to protect its patents and other intellectual property.

Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as at the date of the presentation. Except as required by applicable laws or regulations, CSL does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in assumptions on which any such statement is based.

TRADEMARKS

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

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CEO Overview Paul Perreault CEO & Managing Director

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Highlights[1]

Revenue up 10% with net profit after tax up 10%

CSL Behring

Seqirus

  • HIZENTRA[® ] +15%

  • Seasonal influenza vaccines +41%

  • HAEGARDA[®] +14%

  • Record volume ~130 million doses distributed globally

  • KCENTRA[®] +7%

  • ALBUMIN +61%

  • Next generation influenza vaccine manufacturing facility to be constructed

  • Digital transformation initiatives

Critical operations maintained during COVID-19 pandemic demonstrating CSL’s resilience and agility

  • COVID-19 has produced a headwind for Behring and a tailwind for Seqirus

  • Plasma collections have been challenging however multiple initiatives are driving solid growth

  • Continued capital expenditure and R&D investment places CSL in a position to emerge strongly post COVID-19

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.

4

CSL Behring Revenue up 6%[1]

Therapy Sales
$m
Change1
%
Immunoglobulins 4,238 3%
- IVIG 2,696 (3%)
- SCIG 1,542 15%
Albumin 1,071 61%
Haemophilia 1,107 (4%)
- Recombinants 674 0%
- Plasma 433 (9%)
Specialty 1,770 2%
- Peri-Operative Bleeding 847 5%
- Other Specialty 923 (1%)
Other2 388 (7%)
Total 8,574 6%

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Region [1]
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ROW
44% 6%
Asia Pac
18%
US$8.6B
North
America 5%
6% 49%
(6%)
EU
27%
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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. 2. Includes HPV royalties & Hyperimmunes

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Immunoglobulins

Sales up 3%[1]

  • Significant patient needs in core indications

  • • Strong growth in HIZENTRA[®] +15% driven by:

  • Increased preference for home treatment

  • Continued steady uptake for CIDP in US:

    • Only company with SCIG & IVIG treatments for CIDP

    • Orphan exclusivity

    • ~two-thirds of targeted physicians have now adopted HIZENTRA[®] to treat CIDP

  • Remains the clear market leader in SCIG with ~60% market

  • share

  • PRIVIGEN[®] impacted by accelerated shift to HIZENTRA[®]

Market

  • Global Ig demand remains strong

  • Supply tightness intensified by COVID-19

  • Customer order fulfilment process implemented to ensure equitable distribution

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.

6

Albumin

Sales up 61%[1]

China

  • New distribution model fully operational with sales now normalised: − direct management of 180+ distributors

  • geographic coverage expanded

  • increased penetration to retail pharmacy and lower tier cities/hospitals

  • COVID-19 reduced hospital operations in 1H, returned to normal in 2H

  • • Increasingly competitive environment

  • Market demand outlook - volume growth mid to high single digits

Market

  • Preference for albumin over artificial colloids

  • Increased utilization in sepsis and liver disease patients

  • Competitive pressure

Other markets

  • Volume growth in EU and emerging markets

  • Decline in US as supply constraints emerge

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.

7

Haemophilia Sales down 4%[1]

Market

  • Growth tempered by reduced doctor visits during COVID-19 pandemic

Recombinant Coags

  • IDELVION[®] +2%

  • Market leader in Haem B

  • Compelling clinical profile continuing to drive patient demand & market share

  • Continued launches, including France, Argentina & Singapore

  • AFSTYLA[®] -9%

  • Continued competitive market

PD Coags

  • HUMATE[®] +13%

  • Growth underpinned by increased share in vWF in US

  • Demand for BERIATE® & HAEMATE[®] continues to decline due to competitive pressure

  • MONONINE[®] to IDELVION[®] switches

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.

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Specialty Products Sales up 2%[1]

HAE

HAEGARDA[®] +14%

  • Strong global patient growth

  • Most patients on therapy since launch

  • Demand driven by shift from on-demand to prophylaxis treatment

  • Successful launches in EU, Canada & Australia

BERINERT[®] -5%

  • Impacted by shift to HAEGARDA[®]

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.

Hospital Products

  • KCENTRA[®] +7%

  • RIASTAP[®] -1%

  • Wound healing -19%

  • Growth tempered by reduced elective

procedures and trauma during COVID-19 pandemic

ALPHA-1 -26%

  • ZEMAIRA[®] / RESPREEZA[®]

  • Supply interruptions

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FY21 Sales $1.8B
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Other
Zemaira
Wound
Healing
Haegarda
Riastap
Berinert
Kcentra
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HAE
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Plasma Collections

25 new centresopened in FY21 up to new centres planned to open 40 in FY22

Challenges

  • Plasma collections adversely impacted by:

  • US stimulus, stayat-home orders, extended lockdowns

  • FY21 plasma collection volume down ~20% v FY20

  • Increased collection costs

Initiatives

  • Enhanced operating & marketing initiatives to attract lapsed and new donors

  • Strong adoption of new technology (donor app, kiosks, online)

  • • Industry leadership in new collection centres

  • Plasma hold period reduced from 60 to 45 days

  • Use of available finished goods inventory

  • • Collaboration with Terumo to deliver a new plasmapheresis platform

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Plasma Collections Initiatives driving donor growth

DONORS PER WEEK

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Annual tax season drop
• Pandemic and
lockdowns begin
Holiday
Season
• Vaccine momentum
• Further initiatives
• Stimulus burn-off
Initiatives
US fiscal
launched
stimulus
JAN FEB MAR APR MAY JUN JULY AUG SEP OCT NOV DEC
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Not to scale

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Seqirus Revenue up 30%[1]

Therapy Sales
$m
Change1
%
QIV 702 28%
Adjuvanted 629 60%
TIV 45 49%
Other / In-licence 176 (11%)
Total Product Sales 1,552 33%
Pandemic 160 5%
Other Income 24 35%
Total Revenue 1,736 30%

Region[1]

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Seasonal
ROW
Influenza
vaccines 6%
+41%
Asia
Pac
15%
US$1.7B
North
America
61%
30%
31%
58% EU
21%
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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.

12

Seqirus

Operating Highlights

  • Significant growth in seasonal influenza vaccines driven by ongoing shift to differentiated products

  • Record volume ~130 million doses distributed globally

  • FLUAD[®] QIV launched in the US

  • FLUCELVAX[® ] launched in Australia

  • Extended influenza pandemic agreements with UK, Sweden, Switzerland & Canada

  • Provided support for COVID-19 vaccines and supply of MF59

Looking Forward

  • Next generation self-amplifying mRNA – Phase 1 expected to commence in 2022

  • FLUAD[®] QIV launch in EU NH 21/22

  • FLUCELVAX[®] 6m+ age indication in US

  • Fill & Finish expansion projects

  • Liverpool operational NH 21/22

  • Holly Springs operational NH 22/23

Artist impression

Next generation influenza vaccine manufacturing facility to be constructed in Australia

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R&D Highlights

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Immunology

  • PRIVIGEN[®] for CIDP launched in Japan

  • HAEGARDA[®] approval for paediatric patients (US, AU & CA)

  • HAEGARDA[®] ODD approved in Japan

  • First patients enrolled in Garadacimab Phase III studies

Hematology

  • uniQure announced positive data from Phase III trial of EtranaDez

  • Anti-trust clearance received; licence agreement with uniQure completed for EtranaDez

  • CSL889 Hemopexin ODD approved in EU & US

  • CSL889 Hemopexin fast track designation for SCD approved by US FDA; first patient enrolled in Phase I study

  • IDELVION[®] 21 day extended dosing option approved in Japan

  • Recombinant FIX approved in Mexico as IDELVIAN

  • AFSTLYA[®] approved in Great Britain, Russia & Mexico

Respiratory

  • First patient enrolled in CSL787 Nebulised Ig Phase I study

Transplant

  • Last patient dosed in Part 1 of CSL964 for prevention of GvHD study

Influenza Vaccines

Cardiovascular and Metabolic

  • CSL112 (ApoA-1) Phase III study (AEGIS-II) >13,000 patients enrolled, successful completion of 1[st] & 2[nd] futility analyses

  • First patient enrolled in CSL346 Anti-VEG-B DKD Phase II study

  • Commencement of aQIVc Phase II study

  • Pre-clinical assessment of self-amplifying mRNA vaccine for seasonal & pandemic influenza

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Financials Joy Linton CFO

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Financial Highlights Net profit after tax

+13% $2,375m reported FX$68m

$2,103 m

+10% @CC[1]

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China GSP

  • Albumin sales normalised

COVID

  • Company Response (R&D, manufacturing, cost control measures)

  • Reduced social mobility impacting therapy demand, plasma collections & HPV royalties

  • Strong influenza vaccine demand

Accounting

  • Fixed cost absorption Seqirus v CSL Behring

  • 9-12 month plasma manufacturing cycle

  • SaaS

  • Impairments

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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.

16

Financial Highlights CSL Group

FY20
Reported
FY21
Reported
FY21
at CC
1
Change
%
Total Revenue 9,151 10,310 10,026 10%1
Gross Profit 5,226 5,843 5,675 9%1
GP margin 57.1% 56.7% 56.6%
EBIT 2,717 3,130 3,025 11%1
EBIT margin 29.7% 30.4% 30.2%
NPAT 2,103 2,375 2,307 10%1
Cashflow from Operations 2,488 3,622 46%
ROIC 21.6% 21.2%
EPS ($) 4.63 5.22 5.07 10%1
DPS ($) 2.02 2.22 10%

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

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Financial Highlights Segments

CSL Behring

CSL Behring
US$ Millions FY20
Reported
FY21
Reported
Change
% at CC
1
Sales 7,661 8,428 7%
Other
Revenue
193 146 -25%
Total
Revenue
7,854 8,574 6%
Gross Profit 4,540 4,848 3%
GP margin 57.8% 56.5%
EBIT 2,451 2,647 2%
EBIT margin 31.2% 30.9%

Seqirus

Seqirus
US$ Millions FY20
Reported
FY21
Reported
Change
% at CC
1
Sales 1,136 1,552 33%
Other
Revenue
161 184 9%
Total
Revenue
1,297 1,736 30%
Gross Profit 686 996 43%
GP margin 52.9% 57.3%
EBIT 265 483 95%
EBIT margin 20.4% 27.8%

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.

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Financial Highlights Reported Expenses

FY21 Change @ CC
1
Change @ CC
1
$m $m %
Research &
Development
1,001 47 5%
Sales & Marketing 980 59 7%
General & Admin 732 35 5%
Finance (Net) 167 10 7%
ETR FY21
19.8%
FY20
18.3%

Modest expense growth over full year

  • Uplift in 2H as foreshadowed

R&D

  • Programs paused 1H, now recommenced

Sales and Marketing

  • Uplift in commercial launch activities

General Admin

  • Adoption of SaaS policy

Tax

  • ETR up reflecting geographic profit mix

  • FY22 ETR est. ~18 – 20%

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

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Inventory Active management

$M Inventory

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Key Insights

  • Inventory as a percentage of revenue relatively steady despite dynamic environment

  • Higher raw materials component driven by increased plasma cost

  • Active management of finished goods

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Key Capital Projects Completion Timeline

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FY22 FY23 FY24 FY25 FY26 FY27
Marburg
Base Frac Broadmeadows: Mod 1 & 2 Broadmeadows: Mod 3
Future Base Frac
Zemaira Fill/Finish – Thermo Fisher
Bulk &
Future IG Modules
Finishing
Broadmeadows Albumin Expansion
Lengnau
Plasma Centers (Continuous)
Other
CSL 112
R&D Marburg
Fill & Finish –
Holly Springs
Seqirus
Biotech Facility
New Plasma Donor Management System
Tech
Enterprise Process Management
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CSL Strategy and Values

Strategic Overview Core Patient Focus Innovation Integrity Collaboration Superior Values We deliver on We turn innovative We walk the talk We are stronger Performance our promise to thinking into together We take pride in patients solutions our results

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CSL is committed to a healthier world . Our vision is a sustainable future for our employees, communities, patients and donors, inspired by innovative science and a values-driven culture

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- CSL Sustainability Vision

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Outlook for FY22[1]

CSL Behring

  • Underlying IG demand expected to remain strong

  • IG & albumin sales reliant on current plasma collections and cycle times

  • Plasma collections expected to improve with CSL plasma initiatives and COVID-19 vaccine rollout

Seqirus

  • Seqirus’ product differentiation and COVID-19 expected to drive strong demand for influenza vaccines

CSL Group Margin

• Gross margin easing expected following increased plasma collection costs, partially offset by modest margin expansion arising from growth in differentiated influenza vaccines

FY22[1] Outlook

Revenue Growth c. 2 - 5% @CC[2] NPAT c. $2,150 - $2,250m @CC[2]

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. See end note for further detail.

COVID-19 is a once in a lifetime event. I’m proud of our company’s response and confident of a return to strong growth

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CSL Contacts

Mark Dehring VP Investor Relations  +61 3 9389 3407 [email protected]

Bernard Ronchi Investor Relations  +61 3 9389 3470 [email protected]

Stephen McKeon Investor Relations  +61 3 9389 6798 [email protected]

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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 $2,375.0m Translation currency effect (a) $ (23.3m) Transaction currency effect (b) $ (25.4m) Foreign Currency (gains) & losses (c) $ (19.8m) Constant currency net profit after tax * $2,306.5m

a) Translation Currency Effect $(23.3m)

Average Exchange rates used for calculation in major currencies (12 months to Jun 21/Jun 20) were as follows:

USD/EUR (0.84/0.90); USD/AUD (1.35/1.49); USD/CHF (0.91/0.98); USD/CNY (6.65/7.03).

b) Transaction Currency Effect $(25.4m)

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 Gain ($19.8m)

Foreign currency gains recorded during the period.

Summary Revenue
Reported revenue $10,310.0m
Currency effect $ (284.2m)
Constant currency revenue* $10,025.8m

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  • 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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