Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

CSL Ltd. Investor Presentation 2022

Oct 16, 2022

17854_rns_2022-10-16_161747e8-f707-4ff2-aa9c-f459cd1c0ede.pdf

Investor Presentation

Open in viewer

Opens in your device viewer

For immediate release

17 October 2023

==> picture [205 x 32] intentionally omitted <==

==> picture [90 x 67] intentionally omitted <==

==> picture [262 x 27] intentionally omitted <==

CSL Vifor Investor Briefing

CSL Limited (ASX:CSL; USOTC:CSLLY) will today be holding a CSL Vifor Investor Briefing.

Please find attached the presentation materials.

The briefing for investors and analysts will be held at 10.00am Australian Eastern Standard Time.

This briefing will be webcast on the Company website at www.csl.com in the ‘Investors’ section. An archived copy of the webcast will be uploaded to the site later that day.

Briefing materials can also be accessed in the ‘Investors’ section of the Company website at www.csl.com.

Authorised by Fiona Mead Company Secretary.

For further information, please contact:

Investors: Bernard Ronchi Stephen McKeon Director, Investor Relations Director, Investor Relations CSL Limited CSL Limited Telephone: +61 3 9389 3470 Mobile +61 402 231 696 Email: [email protected] Email: [email protected]

Media:

Jimmy Baker Communications, CSL Limited Mobile +61 450 909 211 Email: [email protected]

==> picture [99 x 7] intentionally omitted <==

CSL Vifor Investor Briefing

17 October 2022

1

IMPORTANT NOTICE AND DISCLAIMER

This presentation contains summary information about CSL Limited (ACN 051 588 348) 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 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, risk management practices, climate change and other environmental and energy transition scenarios. 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, advances in environmental protection processes, uncertainty and disruption caused by the COVID-19 pandemic 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.

2

2

Strategic Overview Paul Perreault CEO & Managing Director

==> picture [960 x 99] intentionally omitted <==

CSL 2030 strategy

==> picture [109 x 30] intentionally omitted <==

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

DISEASES OF IRON
DEFICIENCY
----- End of picture text -----

4

CSL Vifor Growth Opportunities Paul McKenzie Chief Operating Officer

==> picture [960 x 99] intentionally omitted <==

==> picture [292 x 173] intentionally omitted <==

The number of ID[1] patients without IDA[2] is estimated to be more than twice as many as the number of IDA patients[3,4]

Diseases of Iron Deficiency Significant global prevalence

==> picture [464 x 261] intentionally omitted <==

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

Iron
ID Anaemia
Deficiency
~1.2B people [5]
>3B people
----- End of picture text -----

1. ID = Iron Deficiency; 2. IDA = Iron Deficiency Anaemia, occurs when ID is sufficiently severe to reduce erythropoiesis; 3. Iron deficiency (Blood. 2019;133(1):30 – 39) – Anaemia still affected one third of the population, with approximately half of the cases resulting from iron deficiency. The estimate is that 1.24 billion individuals experience iron deficiency anaemia. The global prevalence of iron deficiency without anaemia remains elusive, although the suggested figure is at least double that of iron deficiency anaemia; 4. These numbers are estimates, most studies either have a geographical focus or are done in specific subpopulations. . 5. Blood. 2014 Jan 30;123(5):615-24.

6

Renal disease

A large growing opportunity

Renal market growing at low double digit CAGR

==> picture [73 x 50] intentionally omitted <==

~$13bn+

==> picture [117 x 102] intentionally omitted <==

~$25bn+

==> picture [116 x 196] intentionally omitted <==

Chronic Kidney Disease (CKD) is a leading cause of mortality and morbidity around the world.

  • Annual growth rate of ~8%

  • ~15% of adults suffer from CKD in the U.S.

  • Significant lack of access to therapies to support CKD patients

==> picture [219 x 9] intentionally omitted <==

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

2020 2026
----- End of picture text -----

Source: Evaluate Pharma, Marketwatch, Center for Disease Control and Prevention, Nature.com, Grand View Research, PubMed. (1) Based on estimated WW annual renal indication-related net sales.

7

Supporting patients along their journey

==> picture [663 x 217] intentionally omitted <==

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

Prevent Kidney Chronic Kidney
Dialysis
Damage Disease
Treatment
Treatment
----- End of picture text -----

==> picture [174 x 140] intentionally omitted <==

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

Transplant
----- End of picture text -----

8

CSL Vifor Overview Hervé Gisserot General Manager CSL Vifor

==> picture [960 x 99] intentionally omitted <==

Leading portfolio in target therapy areas

==> picture [846 x 315] intentionally omitted <==

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

Iron Dialysis Nephrology
2
1
In Market
3 4
5
(Ex-US)
6
Sparsentan
Heart failure outcome (EU, AU, NZ)
Pipeline SNF-472
study (Heart FID)
Vamifeport INS-3001
----- End of picture text -----

1. Licensed from F. Hoffman-La Roche AG. 2. Licensed from Pfizer Inc.

3. Licensed from ChemoCentryx, Inc.

4. Licensed from OPKO Health, Inc.

5. Licensed from Cara Therapeutics, Inc.

6. Licensed from Travere Therapeutics, Inc.

10

==> picture [292 x 173] intentionally omitted <==

Market Leader in High Dose IV Iron Segment[1]

  • 1B CHF in-market sales since 2019

  • 29% market share of overall Iron market (Global In-Market Sales (MAT Q1 2022)

  • 50% market share in high dose IV iron segment

  • More than 19 million patient years of exposure

Significant untapped potential with Ferinject[®] / Injectafer[®]

Majority of patients yet to be diagnosed & treated (EU5 only)

==> picture [523 x 264] intentionally omitted <==

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

-89%
-59%
-21%
-50%
5.3M
-33%
2.2M
1.8M
0.9M
0.6M
Patients with ID / IDA Diagnosed ID / IDA Treated for ID / IDA Treated with IV Iron Treated with
Ferinject®
----- End of picture text -----

  1. IQVIA MIDAS Quarterly panel, GERS, Insight Health, DN, DLI.; Average 2021 exchange rates have been applied. ID = Iron Deficiency. IDA = Iron Deficiency Anaemia.

11

Diseases of Iron Deficiency

Priorities to accelerate Ferinject[®] / Injectafer[®] growth

Disease areas of focus

Strategic priorities:

Focused targeting, amongst the many different patients suffering from ID and IDA

==> picture [83 x 86] intentionally omitted <==

==> picture [72 x 77] intentionally omitted <==

==> picture [51 x 74] intentionally omitted <==

Patient Blood Heart Failure Chronic Kidney Management (HF) Disease (PBM)

Maximise penetration ex-US

  • Explore potential revenue synergies with CSL Behring on PBM

  • Geographic expansion

Maximise penetration in the US

  • Improve access

  • Successfully launch HF indication with our partner American Regent (Daiichi Sankyo)

Explore other avenues for product differentiation

12

ID = Iron Deficiency. IDA = Iron Deficiency Anaemia.

Global Leadership in Nephrology Empowered by Unique Partnership with Fresenius Medical Care

CSL Vifor

==> picture [343 x 31] intentionally omitted <==

STRONG PHARMA EXPERTISE

• Clinical development 55% Stake

  • Manufacturing, regulatory and market access

  • Commercialisation

GLOBAL LEADER IN DIALYSIS ~350,000 >54 million >4,200 Kidney disease dialysis clinics[1] 45% patients[1] treatments p.a.[1] Stake

==> picture [45 x 51] intentionally omitted <==

==> picture [64 x 52] intentionally omitted <==

==> picture [44 x 55] intentionally omitted <==

GLOBAL LEADERSHIP IN NEPHROLOGY THROUGH: Close collaboration Access to patient data and on global scale faster clinical trial execution Disease insight and expertise

==> picture [317 x 27] intentionally omitted <==

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

Improving outcomes Attractive partner
via treatment algorithms for innovation
----- End of picture text -----

==> picture [52 x 55] intentionally omitted <==

==> picture [43 x 50] intentionally omitted <==

13

1. Figures as at 2020 per Fresenius Medical Care Factsheet 2020.

Structure of VFMCRP

Therapy group sales via VFMCRP FY22 ~ 75% Dialysis ~ 15% Nephrology ~ 20% Iron

~40% of Vifor Pharma total sales were derived through VFMCRP

Product Therapy Group JV Rights
US
US
Global
Global excluding Japan & Korea
Dialysis
Global excluding US & Japan
Global excluding US
EU, UK, CH, CAN, MEX, AU, KOR, JPN
Nephrology
Global (Nephrology)
Global (Nephrology)
Iron

14

set on a Dialysis – Korsuva[®] / Kapruvia[®] strong growth trajectory

Key points

  • Moderate to severe pruritus affects ~40% of dialysis

  • patients[1]

  • High unmet need with strong impact on quality of life

==> picture [288 x 276] intentionally omitted <==

  • Highly under-recognised and under-reported

  • Korsuva[®] - first product approved for pruritus in the US

  • Kapruvia[®] - multiple EU launches ongoing

85% unaided awareness

94% intend to prescribe

  • Promising uptake in the US

  • US policy shaping efforts underway to improve future

  • access

Source: Spherix Global Insights (US Sept 2022)

  1. Sukul N, et al,. Self-reported Pruritus and Clinical, Dialysis-Related, and Patient-Reported Outcomes in Hemodialysis Patients Kidney Medicine.,2021;3(1):42–53

15

Nephrology – building out our capability with significant growth opportunity

Tavneos[®] launching in many countries in 2023

==> picture [138 x 43] intentionally omitted <==

Continue successful uptake and launch in multiple countries

==> picture [82 x 43] intentionally omitted <==

US Payer coverage continuously improving, driving omnichannel pull through Launch in France in FY23

Sparsentan In phase 3 development for treatment of IgA Nephropathy (IgAN) & Focal Segmental Glomerulosclerosis (FSGS)

==> picture [564 x 296] intentionally omitted <==

16

Expect >10% revenue growth into the medium term

==> picture [37 x 37] intentionally omitted <==

Diseases of Iron Deficiency:

  • HF approval for Injectafer[®] in the US, expected to boost sales from 2023

  • Maximisation of Ferinject[®] potential in Europe and rest of world

Dialysis:

Key drivers of growth

  • Commercial uptake for Korsuva[®] /Kapruvia[®] in the US / EU

  • Increasing US share of Erythropoiesis-Stimulating Agent (ESA)

  • Gradual reduction of COVID-19 over-mortality in dialysis patients

==> picture [45 x 37] intentionally omitted <==

Nephrology:

  • Veltassa[®] growth driven by new patients and better access in the US

  • Solid launch of Tavneos[®] and Sparsentan

17

William Mezzanotte MD Executive Vice President, Head of R&D and Chief Medical Officer

==> picture [960 x 99] intentionally omitted <==

Opportunities across the CSL portfolio

==> picture [847 x 425] intentionally omitted <==

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

Iron Dialysis Nephrology
2
1
In Market
3 4
5
(Ex-US)
Sparsentan 6
Heart failure outcome (EU, AU, NZ)
Pipeline SNF-472
study (Heart FID)
Vamifeport INS-3001
Diabetic Kidney Disease
MACE (CSL 346)
Explore other areas for
CSL product differentiation (CSL300)
Transplant Rejection
(CSL 300)
1. Licensed from F. Hoffman-La Roche AG. 4. Licensed from OPKO Health, Inc.
19 2. Licensed from Pfizer Inc. 5. Licensed from Cara Therapeutics, Inc.
3. Licensed from ChemoCentryx, Inc. 6. Licensed from Travere Therapeutics, Inc.
----- End of picture text -----

Supporting chronic kidney disease patients along their journey

==> picture [819 x 423] intentionally omitted <==

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

Prevent Kidney Chronic Kidney
Dialysis
Damage Disease Transplant
Treatment
Treatment
CSL346
CSL112
Sparsentan CSL300 CSL300
CSL Immunology Portfolio INS-3001 SNF-472
20
Pipeline
----- End of picture text -----

Financials Joy Linton CFO

==> picture [960 x 99] intentionally omitted <==

New segment reporting

Segment Result

  • Gross profit (excluding amortisation and/or impairment of acquired intellectual property) less sales and marketing expenses.

Op. Profit (EBIT) before minorities

  • At group level only

  • Segment results less group R&D and group admin expenses.

NPATA

attributable to equity holders

  • Statutory net profit after tax (NPAT) before amortisation and impairment of acquired intellectual property, business acquisition and integration costs and other acquisition accounting adjustments.

  • It excludes NPATA attributable to non-controlling interests and discontinued operations.

NPAT

attributable to equity holders

  • Statutory net profit after tax (NPAT) excluding NPAT attributable to noncontrolling interests and discontinued operations.

22

Vifor Pharma[1] realigned to June year end - unaudited

US$m FY21 FY22
Revenue 1,886.8 1,910.4
- Iron 899.7 1,001.8
- Dialysis 734.7 693.3
- Nephrology 128.4 127.6
- Other 124.0 87.8
Gross Profit 1,378.1 1,445.1
_%_2 70.0% 72.6%
Sales & Marketing (444.6) (439.2)
Segment Result 933.5 1,005.9
_%_2,3,4 47.4% 50.5%

Revenue By Region

==> picture [229 x 231] intentionally omitted <==

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

Other
Asia
Pacific
North
FY22 America
53%
$1.9B
EU / UK
34%
----- End of picture text -----

1. The 12 month to June figures have been compiled from Vifor Pharma management accounts as if the year end was 30 June (historically Vifor has a December year end) and exclude discontinued operations to facilitate comparability of operational performance. As a result these financials are pro-forma in nature and are unaudited.

2. Calculated as % of Total Operating Revenue

3. Refer to Appendix 1. Reconciling items to NPAT include G&A, R&D, amortisation & impairment of acquired IP, interest, tax and non controlling interest 4. Gross profit (excluding amortisation and/or impairment of acquired intellectual property) less sales & marketing expenses

23

- Outlook[1] including CSL Vifor

FY23 NPAT guidance

CSL Vifor NPAT [2] (11 Months)

~$2,400 – $2,500m (Unchanged) ~$300m - $330m

Net incremental interest

Amortisation of acquired IP [2,4]

  • (~$170m - $200m) ~$140m - $170m

New FY23 NPATA guidance[1] Growth[3]

~$2,700 – $2,800m (includes CSL Vifor) 13 – 18%

Excludes one off acquisition adjustments

  • Acquired inventory uplift[2,4]

~($140m – 160m)

  • Transaction costs ($200m over 12 to 18 months)

  • ~($120m - $140m)

1. Outlook is provided at Constant Currency (CC) to remove the impact of exchange rate movements to facilitate comparability. Full year FX impact expected to be ~$200m unfavourable, assuming FX rates as at end September remained steady for the balance of the financial year

2. Attributable to CSL shareholders

3. FY22 NPATA $2,381m (reported NPAT $2,255m + impairment of IP $87m + transaction costs $37m + amortisation of acquired IP $2m. at FY22 Actual rates) 4. Non cash item

24

Key value catalysts

==> picture [41 x 40] intentionally omitted <==

Near-term

==> picture [42 x 42] intentionally omitted <==

Mid-term

==> picture [39 x 39] intentionally omitted <==

Long-term

  • Injectafer[®] initial change in label for heart failure

  • Program of launches Korsuva[®] /Kapruvia[®] , Tavneos[®] , Sparsentan

  • SNF472 Ph III read out in CUA[1]

  • SNF472 Ph III read out in PAD-ESKD[2]

  • Maximise Ferinject[® ] ex US

  • Injectafer[®] incorporating HF FID into label

  • Leveraging VFMCRP to accelerate changes in medical practices

  • Leveraging VFMCRP and CSL relationships for the pipeline

Cost Synergies

Indications / Geographic expansion

R&D Opportunities

1. CUA = Calcific Uremic Arteriolopathy

2. PAD-ESKD = Peripheral Arterial Disease - End Stage Kidney Disease

25

Driving sustainable growth

  • Diseases of Iron deficiency – untapped potential in patient blood management, heart failure, women’s health and fatigue

  • Dialysis – VFMCRP JV #1 dialysis products provider, providing extensive real world evidence data, disease insights and expertise

  • Nephrology – emerging growth engine with renal market expected to grow at low double digits in the mid term

  • R&D – Opportunities across the CSL portfolio

CSL Vifor is expected to provide low to mid teens NPATA per share accretion in the mid term

==> picture [256 x 290] intentionally omitted <==

==> picture [141 x 31] intentionally omitted <==

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

New FY23 Outlook [1]
including CSL Vifor
----- End of picture text -----

==> picture [125 x 12] intentionally omitted <==

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

Revenue Growth
----- End of picture text -----

==> picture [124 x 15] intentionally omitted <==

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

~ 28 - 30% @CC [2, 3]
----- End of picture text -----

NPATA[4]

==> picture [190 x 32] intentionally omitted <==

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

~$2,700m - $2,800m @CC [2 ]
(13% - 18% growth)
----- End of picture text -----

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

  • 2 Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability.

  • 3 Includes 100% of VFMCRP JV revenue

26

4 Management incentives will be aligned with NPATA

==> picture [101 x 89] intentionally omitted <==

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]

==> picture [960 x 90] intentionally omitted <==

Appendix 1

New segment note format

US$m CSL Behring
CSL Seqirus
CSL Vifor
Consolidated Entity
2022
2021
2022
2021
2022
2021
2022
2021
Continuing operations
Sales and service revenue
Influenza pandemic facility reservation fees
Royalty and license revenue
Other income
8,359.6
8,427.8
1,776.7
1,551.7
-
-
10,136.3
9,979.5
-
-
162.2
160.1
-
-
162.2
160.1
194.6
125.7
-
-
-
-
194.6
125.7
44.2
20.3
24.6
24.4
-
-
68.8
44.7
Total segment revenue 8,598.4
8,573.8
1,963.5
1,736.2
-
-
10,561.9
10,310.0
Segment gross profit1
Segmentgrossprofit1%
4,581.5
4,847.6
1,153.1
996.6
-
-
5,734.6
5,844.2
53.3%
56.5%
58.7%
57.4%
-
-
54.3%
56.7%
Sales and marketingexpenses (774.0)
(808.1)
(186.7)
(172.1)
-
-
(960.7)
(980.2)
Segment operating result
Segment operating result %
3,807.5
4,039.5
966.4
824.5
-
-
4,773.9
4,864.0
44.3%
47.1%
49.2%
47.5%
-
-
45.2%
47.2%
Research and development expenses
General and administration expenses1
(1,043.6)
(981.5)
(648.0)
(731.7)
Operating profit(EBIT)1 3,082.3
3,150.8
Financial costs
Financial income
(165.2)
(170.8)
17.4
3.9
Profit before tax1
Income tax expense1
2,934.5
2,983.9
(553.8)
(592.7)
Underlying netprofit after tax(NPATA)1 2,380.7
2,391.2
- Amortisation and impairment of acquired intellectual property
- Acquisition accounting adjustments
- Acquisition and integration costs
- Income tax credit on above adjustments
(114.9)
(20.8)
-
-
(40.0)
-
28.9
4.6
Statutory netprofit after tax 2,254.7
2,375.0

1. NPATA is defined as the statutory net profit after tax before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and acquisition accounting related adjustments. The reconciliation between the NPATA to the statutory results is presented above.

28

continued New Segment note format

==> picture [803 x 243] intentionally omitted <==

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

CSL Behring CSL Seqirus CSL Vifor Consolidated Entity
US$m 2022 2021 2022 2021 2022 2021 2022 2021
Amortisation 96.8 95.9
Depreciation 445.7 399.4
Impairment 125.8 94.3
EBITDA 3,595.7 3,719.6
NPATA 1 2,380.7 2,391.2
- Attributable to equity holders of CSL1 2,380.7 2,391.2
- 1 - -
Attributable to non-controlling interests
Statutory net profit after tax 2,254.7 2,375.0
-
Attributable to equity holders of CSL 2,254.7 2,375.0
- - -
Attributable to non-controlling interests
Basic earnings per share (EPS)
- NPATA1 basic EPS (US$)2 5.08 4.97
- Statutory basic EPS (US$)2 4.81 4.94
----- End of picture text -----

1. NPATA is defined as the statutory net profit after tax before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and acquisition accounting related adjustments. The reconciliation between the NPATA to the statutory results is presented above.

2.FY21 pro forma EPS was adjusted for new shares issued in FY22 to fund Vifor's acquisition.

29