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CSL Ltd. Interim / Quarterly Report 2022

Feb 15, 2022

17854_rns_2022-02-15_3ad785ab-a625-45f7-a0dc-a2084940a033.pdf

Interim / Quarterly Report

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For immediate release 16 February 2022

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RESULTS PRESENTATION FOR THE HALF YEAR ENDED 31 DECEMBER 2021

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

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

The briefing will be webcast and can be accessed in the “Investor” section of CSL’s website (www.CSL.com).

Authorised for lodgment by:

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Fiona Mead Company Secretary

For further information, please contact:

Investors:

Media:

Bernard Ronchi Investor Relations CSL Limited P: +61 3 9389 3470 E: [email protected]

Jimmy Baker Communications CSL Limited P: +61 450 909 211 E: [email protected]

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CSL Limited 2022 Half Year Results 16 February, 2022

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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1H22 Performance[1]

Revenue up 4% with net profit after tax down 5%

CSL has performed in line with expectations

As expected Ig & Albumin sales have been limited by COVID constrained plasma collections in FY21

Plasma collections have been returning and expected to underpin future sales growth

Strong performance by key specialty products and Idelvion

Agreement to acquire Vifor Pharma Ltd

CSL Behring CSL Behring Seqirus Seqirus
IDELVION® +17% Seasonal influenza vaccines +20%
KCENTRA® +15% Record volume of ~110 million
HAEGARDA® +7% doses distributed NH 21/22
Continued benefits of
HPV royalties +134% differentiated products
Immunoglobulin -9% FLUCELVAX® Quadrivalent:
18 new collection centres
opened

US and Argentina approval 6M+
indication
Continued investment into Commenced construction on
digital transformational tools new cell culture influenza vaccine
manufacturing facility

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 steady

Therapy Sales
$m
Change1
%
Immunoglobulins 1,977 (9%)
- IVIG 1,255 (11%)
- SCIG 722 (4%)
Albumin 571 1%
Haemophilia 587 5%
- Recombinants 372 12%
- Plasma 215 (6%)
Specialty 914 2%
- Peri-Operative Bleeding 465 8%
- Other Specialty 449 (4%)
Other2 307 97%
Total 4,356 0%

Revenue By Region[1]

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(23%)
ROW
5%
42%
Asia Pac
23%
North
US$4.4B
America
48% (4%)
EU / UK
24%
(11%)
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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 & Covid vaccines

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Immunoglobulins Sales down 9%[1]

  • Supply tightness has temporarily impacted growth

  • HIZENTRA[®]

  • Clear market leader in SCIG with ~60% market share

  • Continued steady uptake for CIDP in US:

    • ~three-quarters of targeted physicians have now utilised Hizentra to treat CIDP

    • Neurologists confidence increasing driven by independent guideline support, increased Medicare access and enhanced label dosing with long term efficacy from PATH extension study[2]

  • HIZENTRA[® ] and PRIVIGEN[®] remain market leaders in the EU

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Market

  • Supply tightness continues in COVID environment

  • 9-12 months plasma therapies manufacturing cycle

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. Combination of Medicare Part B reimbursement approval, updated Peripheral Nerve Society (PNS) treatment guidelines, PATH extension data

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Albumin

Sales up 1%[1]

China

  • Maintaining market leadership with brand differentiation and effective HCP engagement

  • Domestic and offshore players expand infrastructure and sales coverage to lower tier cities and hospitals

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

Other markets

  • EU declined as local manufacturers increasingly compete for volume

  • Decline in US as supply constraints stem from plasma collections

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Market

  • Preference for albumin over artificial colloids

  • Increased utilization in sepsis and liver disease patients

  • Competitive pressure

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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Haemophilia Sales up 5%[1]

Market

  • Ongoing market movement towards new generation products

Recombinant Coags

  • IDELVION[®] +17%:

  • Market leader in Haem B

  • Compelling clinical profile drives patient demand & market share

  • Extension study enhances long term efficacy and safety profile

  • Approval of 21 day dosing in EU, Switzerland, Japan and Canada

PD Coags

  - HUMATE[®] / HAEMATE[®] +2%:

     - Russia tender win

  - Decline in demand for

     - BERIATE[®] due to competitive pressure and switches to recombinant
  • AFSTYLA[®] -13%:

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.

  • Continued competitive market

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Specialty Products Sales up 2%[1]

HAE

HAEGARDA[®] +7%

  • Successful launches in multiple EU countries, Canada & Australia

  • 80% of US patients are long term users or returning patients from alternative therapies

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

BERINERT[®] -8%

  • Impacted by shift to HAEGARDA[®]

Hospital Products

  • KCENTRA[®] +15%

  • Return to pre-pandemic demand levels

  • RIASTAP[®] / HAEMOCOMPLETTAN[®] -7%

  • Competitive pressures in EU

  • Wound Healing +10%

ALPHA 1 -31%

  • ZEMAIRA[®] / RESPREEZA[®]

  • Supply interruptions

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1H22 Sales $914m
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Other
Zemaira
Wound
Healing
Haegarda
HAE
Riastap
Berinert
Kcentra
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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.

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Plasma Collections Volume Up 18%

new centres 18 opened in 1H22 up to new centres planned to open 35 in FY22

  • Driving Growth Contemporary topics • • Competitive donor fees Omicron variant disruption to

  • • operations Improved social mobility •

  • within COVID environment Competitive US employment

  • • environment Enhanced operating and •

  • marketing initiatives bringing Industrywide cost pressures back lapsed and attracting • Mexican border closure: new donors − Litigation ongoing

  • • Enhanced donor experience − Appealed standing decision

  • through increased use of − New complaint filed by border

  • technology center employees and donors

  • • Collaborating with industry as well as patients bodies to promote plasma • 510(k) submitted by Terumo to

  • donation

  • Appealed standing decision

  • − New complaint filed by border center employees and donors as well as patients

  • • 510(k) submitted by Terumo to US FDA for new plasmapheresis device

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Plasma Collections Improving

Donors Per Week

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• Annual tax season
• 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

2019 2020 2021

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Seqirus Revenue up 17%[1]

Therapy Sales
$m
Change1
%
Egg Based 184 (28%)
Cell Culture 490 11%
Adjuvanted Egg 838 48%
Other / In-licence 80 (10%)
Total Product Sales 1,592 18%
Pandemic 82 2%
Other Income 11 38%
Total Revenue 1,685 17%

Revenue By Region[1]

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Seasonal
Influenza 11%
vaccines
Asia
+20% Pac
EU / UK US$1.7B
63% 29% North
America 6%
17% 64%
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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.

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Seqirus

Operating Highlights

  • Record volume of ~110 million doses distributed NH 21/22

  • EU:

  • Strong growth in differentiated products

  • FLUAD[®] QIV[1] launched

  • Additional fill & finish capacity at Liverpool

  • US:

  • US seasonal influenza vaccines >$1 billion for the first time

  • Awarded new pandemic contract with US Govt for

    • development of two influenza candidates

Looking Forward

  • Next generation selfamplifying mRNA:

  • Phase 1 expected to commence cal. 2022

  • Construction commenced on clinical GMP mRNA facility in Holly Springs

  • FLUCELVAX[®] 6m+ age indication launch in US NH 22/23

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  • Holly Springs Fill & Finish operational NH 22/23

Artist impression

Construction commenced on cell culture influenza vaccine manufacturing facility in Australia

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1. Marketed as FLUAD TETRA[®]

R&D Highlights

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Immunology

  • Garadacimab (Anti-FXIIa) HAE

  • Phase III study enrolment completed (Last Patient In)

  • FDA confirmed Fast Track Eligibility

  • EMA Orphan Drug Designation granted

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Hematology

  • CSL888 (Haptoglobin) SAH US Orphan Drug Designation granted

  • Primary Endpoint achieved in EtranaDez (Haem B gene therapy) HOPE-B study

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Cardiovascular & Metabolic

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Respiratory

  • Garadacimab (Anti-FXIIa) IPF Phase II study initiated

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Influenza Vaccines

  • aQIVc (cell antigen + MF59[®] ) Phase II study complete

  • FLUCELVAX[®] Quadrivalent

  • US & Argentina approval 6M+ indication

  • FLUCELVAX[®] QUAD

  • Australia 2yr+ extension

  • New Zealand 9yr+ extension approval

  • FLUAD[®] Quadrivalent

  • Adults 50-64yr Phase III study enrolment completed

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Partnerships & Alliances

  • CSL, WEHI, & University of Melbourne secured State Government funding to create biotech start-up incubator in CSL’s new global headquarters, under construction, in Melbourne

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R&D Expansion

  • Melbourne: New HQ and R&D facilities under construction; on track for completion early 2023

  • Marburg: New seven storey R&D Campus to house 500 researchers set to open 2022

  • New Seqirus facility in Waltham to be operational in 2022; will host ~300 employees supporting CSL’s R&D portfolio including sa-mRNA technology platform

  • CSL112 (ApoA-1) 80% enrolment achieved

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Agreement to Acquire Vifor Pharma Ltd

  • Institutional placement for A$6.3 billion completed

  • Share Purchase Plan for A$750 million completed

On 14 December 2021, CSL announced a tender offer to acquire 100% of Vifor Pharma Ltd, a global specialty pharmaceutical company with leadership in renal disease and iron deficiency

  • Debt - $6 billion bridge in place to be replaced by long term funding in 1H calendar 2022

  • Tender offer for publicly held Vifor shares underway, closing 2 March 2022

  • Integration planning underway

  • Regulatory approvals and deal closure anticipated by the end of FY22

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Vifor
Pharma
Strengthens CSL’s Materially Enhances
Value Driven Scale and Free Cash
Strategy Flow
Compelling
Strategic
Rationale Builds a Significant Compelling
Renal Franchise Financial Profile
Extends the Reach of
CSL’s High Value
Pipeline
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CSL’s Rich Pipeline Aligns With Vifor’s Renal Framework

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CKD Complications AKI (Ischemia – Reperfusion) Dialysis
1
Vadadustat
INS-3001
Multiple Potential SNF-472
2
assets (Preclinical
& Clinical) 3
Vadadustat [4]
5
3
1
CSL964 CSL964
Sparsentan [6] GvHD treatment GvHD prevention
(Phase 3) (Phase 3)
7
CSL346 Clazakizumab
Diabetic kidney Ab-mediated
disease (Phase 2) rejection (Phase 3)
Preserving Renal Function Transplant
1. Licensed from F. Hoffman-La Roche AG. 5. Licensed from Cara Therapeutics, Inc.
2. Licensed from OPKO Health, Inc. 6. Licensed from Travere Therapeutics, Inc.
3. Licensed from Pfizer Inc. 7. Licensed from ChemoCentryx.
4. Licensed from Akebia Therapeutics, Inc., subject to certain conditions and
limited to selling Vadadustat to certain providers within the US dialysis market.
ESRD
ND-CKD
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pipeline assets

Financials Joy Linton CFO

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Financial Highlights Net profit after tax

-3%

reported

$1,810m

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$1,760m

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$1,722m @CC[1]

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-5%
@CC [1]
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1H21 1H22
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FX$38m

  • CSL has performed in line with expectations

  • Increased collections costs

  • Higher fixed cost absorption on lower plasma volumes

  • Includes $17m Vifor transaction costs

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 CSL Group

1H21
Reported
1H22
Reported
1H22
at CC
1
Change
%
Total Revenue 5,739 6,041 5,993 4%1
Gross Profit 3,472 3,449 3,417 (2%)1
GP margin 60.5% 57.1% 57.0%
EBIT 2,358 2,215 2,165 (8%)1
EBIT margin 41.1% 36.7% 36.1%
NPAT 1,810 1,760 1,722 (5%)1
Cashflow from Operations 2,321 1,427 (39%)
EPS ($) 3.98 3.85 3.77 (5%)1
DPS ($) 1.04 1.04 0%

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 1H21
Reported
1H22
Reported
Change
% at CC
1
Sales 4,256 4,216 (2%)
Other
Revenue
59 140 139%
Total
Revenue
4,315 4,356 0%
Gross Profit 2,539 2,353 (8%)
GP margin 58.8% 54.0%
EBIT 1,665 1,331 (22%)
EBIT margin 38.6% 30.6%

Seqirus

Seqirus
US$ Millions 1H21
Reported
1H22
Reported
Change
% at CC
1
Sales 1,340 1,592 18%
Other
Revenue
85 93 6%
Total
Revenue
1,425 1,685 17%
Gross Profit 933 1,096 17%
GP margin 65.5% 65.0%
EBIT 693 884 24%
EBIT margin 48.7% 52.5%

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

1H22 Change @ CC
1
Change @ CC
1
$m $m %
Research &
Development
486 57 13%
Sales & Marketing 432 16 4%
General & Admin 317 64 24%
Finance (Net) 70 (40) (38%)
ETR 17.9%

R&D

  • Trials resuming post COVID pause

  • FY22 est. 10-11% of revenue

Sales and Marketing

  • Modest uplift in advance of commercial launches

General Admin

  • Higher I&T/SaaS

  • Vifor acquisition costs

Finance

  • Movement in unrealised FX on debt

Tax

  • 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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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.

Our Sustainability Strategy

  • Sustainability Strategy approved by the Board in 2021

  • Executive Sustainability Committee representing all areas of the business

  • Focused on 3 key strategic pillars – Environment, Social and Sustainable Workplace

  • Good progress on defining meaningful and achievable targets

  • Ensure long term sustainability and growth for all our stakeholders

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Outlook

FY22 result heavily skewed to 1H

CSL Behring

  • Improving plasma collections expected to underpin stronger Ig and albumin sales

Seqirus

  • 80% of sales in 1H, with expenses falling more evenly over the year giving rise to a loss in 2H, consistent with seasonality

CSL Group

  • Guidance includes ~$90 -$110m Vifor transaction costs

FY22 progressing in line with expectations Positive mid-term outlook as COVID recedes Promising cluster of R&D programs nearing completion

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FY22 [1] Outlook
Guidance
Reaffirmed
NPAT
~$2,150 - $2,250m @CC [2]
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  • 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. See end note for further detail

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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 $1,760.3m Translation currency effect (a) $ (9.0m) Transaction currency effect (b) $ (21.7m) Foreign Currency (gains) & losses (c) $ (7.4m) Constant currency net profit after tax * $1,722.2m

a) Translation Currency Effect $(9.0m)

Average Exchange rates used for calculation in major currencies (6 months to Dec 21/Dec 20) were as follows: USD/EUR (0.86/0.85); USD/AUD (1.36/1.40); USD/CHF (0.92/0.92); USD/CNY (6.44/6.83); USD/GBP (0.73/0.77).

b) Transaction Currency Effect $(21.7m)

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 ($7.4m)

Foreign currency gains recorded during the period.

Summary Revenue Reported revenue $6,041.2m Currency effect $ (47.9m) Constant currency revenue* $5,993.3m

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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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