Slide 1: Strong Full Year Result
For immediate release 12 August 2015 Strong Full Year Result Double digit growth in albumin and specialty products CSL becomes No.2 global influenza vaccines manufacturer New Privigen® facility completed Board to consider further share buyback CSL Limited (ASX:CSL; USOTC:CSLLY) today announced a net
Slide 2: Operational and Capital Management Highlights
Page 2 12 August 2015 Operational • Acquisition of Novartis‘ global influenza vaccine business • bioCSL business turnaround • Hizentra® (subcutaneous immunoglobulin) - European Medical Agency & U.S. Food and Drug Administration (FDA) approved flexible dosing • CSL 654 (rIX-FP) - license application
Slide 3: Outlook (at FY15 exchange rates)
Page 3 12 August 2015 OUTLOOK (at FY15 exchange rates) CSL expects strong underlying demand for its products to continue in FY16, with sales growth similar to gains achieved FY15. The Company said the market place will remain competitive, particularly as new manufacturers and products emerge. “FY16
Slide 4: Operating Review
Page 4 12 August 2015 OPERATING REVIEW CSL Behring sales of US$5,029 million increased 7% in constant currency terms when compared to the prior comparable period. Immunoglobulin product sales of US$2,326 million grew 5% in constant currency terms, with ‘normal’ immunoglobulin volumes growing 8%. Dem
Slide 5: Operating Review (continued)
Page 5 12 August 2015 Kcentra® (4 factor pro-thrombin complex concentrate) continued to grow strongly following the launch of the surgical indication approved by the U.S. FDA. In December the U.S. Centres for Medicare and Medicaid Services approved an extension to the new technology add-on payment f
Slide 6: Capital management foreshadowed during FY16
Page 6 12 August 2015 June 2015, with interest bearing liabilities of US$2,281 million and undrawn debt facilities of $141 million. Capital management foreshadowed during FY16 In the interests of improving shareholder returns, CSL aims to maintain an efficient balance sheet. CSL has been pursuing an
Slide 7: Group Results
Page 7 12 August 2015 Group Results US Dollars Full year ended June Jun Jun Jun US$ Millions 2014 2015 2015 Change Reported Reported at CC# % Sales 5,335 5,459 5,733 7.5% Other Revenue / Income 169 154 156 Total Revenue / Income 5,504 5,613 5,889 7.0% Earnings before Interest, Tax, 1,832 1,939 1,994
Slide 8: Constant currency note and NPAT summary
Page 8 12 August 2015 (#) Constant currency removes the impact of exchange rate movements to facilitate comparability by restating the current period’s results at the prior comparable period’s rates. This is done in two parts: (a) by converting the current period net profit of entities in the group
Slide 9: CSL Limited FY15 Full Year Result
CSL Limited FY15 Full Year Result 12 August 2015
Slide 10: Legal Notice
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 o
Slide 11: Reported Financials
Reported Financials Sales US$5,459 million, up 2% (up 7% @CC1) EBIT US$1,758 million, up 7% (up 10% @CC) • Adjusted for acquisition costs2 up 12% @CC NPAT US$1,379 million, up 6% (up 8% @CC) • Adjusted for acquisition costs up 10% @CC R&D investment US$463 million EPS US$2.92, up 8% (up 11% @CC) • A
Slide 12: Highlights
Highlights • Acquisition of Novartis global influenza vaccines business • bioCSL business turnaround • Hizentra® - EMA & U.S. FDA approve flexible dosing • CSL 654 (rIX-FP) – license application submitted in U.S. & EU • CSL 627 (rFVIII-SC) – license application submitted in U.S. • CSL 112 (rHDL) – g
Slide 13: Facilities Expansion: Investing for Growth
Facilities Expansion Investing for Growth Recombinant • Broke ground on rCOAG plant in Lengnau, Switzerland Plasma • Completed validation runs for the new Privigen® facility in BMW • Construction underway for new albumin facility in BMW • Obtained FDA and other regulatory approvals for the new base
Slide 14: Group Revenue FY15 US$5.6b
Group Revenue FY15 US$5.6b IPL 3% Product Pharma & Groupings Vaccines Specialty 8% Products 16% Other 8% IVIG 29% Peri-op 8% Albumin 14% SCIG 9% pd Coag rFVIII Hyper 10% IG 3% 8% 6
Slide 15: Broad Sales Reach
Broad Sales Reach FY15 US$5.5b North America 41% bioCSL 8% Asia 10% Europe 28% ROW 13% 7
Slide 16: Outlook for FY16
Outlook for FY16 @ FY15 exchange rates Financial outlook • Revenue growth ~ 7% @CC • Reported NPAT growth ~ 5% @CC Excludes Novartis influenza vaccine business earnings, acquisition costs & gain on acquisition • EPS growth will exceed NPAT growth driven by past and current capital management initiat
Slide 17: CSL Behring Product Sales up 7% @ CC
CSL Behring Product Sales up 7% @ CC US$M 6,000 US$4,926m US$5,029m 5,000 Specialty Products 4,000 3,000 Immunoglobulins 2,000 Albumin 1,000 pdCoag Helixate® 0 Jun 14 Sales for the 12 month period Jun 15 9
Slide 18: Immunoglobulins Sales up 5% @CC
Immunoglobulins Sales up 5% @CC US$M Highlights 2,500 US$2,320m US$2,326m Normal IG volume up 8% IVIG 2,000 • Europe • CIDP indication driving strong Privigen® demand 1,500 • North America IVIG • Competitive pressure • 340B utilisation 1,000 SCIG • Ongoing strong demand for Hizentra® in North Americ
Slide 19: Immunoglobulins Strong 2H growth
Immunoglobulins Strong 2H growth US$M 1,400 US$1,204m Highlights 1,200 US$1,122m 2H v 1H 2015 1,000 • Total 2H immunoglobulin sales up 13% over 1H @ CC 800 IVIG • ‘Normal’ immunoglobulin sales up 15% over 1H @ CC 600 • Marketing initiatives 400 200 SCIG Hyper IG 0 Dec 14 Jun 15 Sales for the 6 month
Slide 20: Albumin Sales up 12% @ CC
Albumin Sales up 12% @ CC US$M 800 US$754m US$694m Highlights 700 China 600 Albumin • Ongoing strong demand 500 • Improving penetration into Tier 2 & Tier 3 cities 400 US 300 • Solid demand continues • Initiatives focusing on IDNs 200 and large hospitals 100 0 Jun 14 Jun 15 Sales for the 12 month pe
Slide 21: Haemophilia Sales up 3% @ CC
Haemophilia Sales up 3% @ CC US$M Highlights 1,200 US$1,064m PdFVIII US$1,026m 1,000 • Growth in Beriate® – Brazil, pdCoag Poland and Germany 800 • Solid performance from Haemate® /Humate® 600 • Ongoing transition to recombinant therapies 400 Helixate® Helixate® • Positive results with US 200 patien
Slide 22: Specialty Products Sales up 15% @CC
Specialty Products Sales up 15% @CC US$M 1,000 Highlights US$923m 900 US$848m Kcentra® 800 Other • Ongoing strong demand in the Specialty U.S. 700 Products Berinert® P 600 • Self administration label driving 500 new patient take-up. 400 Zemaira® 300 Peri- • New patient acquisition Operative • Launch
Slide 23: bioCSL Sales up 11% @CC
bioCSL Sales up 11% @CC A$M1 Highlights 600 Business turnaround initiatives A$480m driving a return to growth 500 A$433m Influenza sales A$145m Pharma • Up 18% @CC 400 & vaccines • Increased U.S. sales following the re-establishment of in-house 300 commercial operations • First to market in U.S., U.
Slide 24: CSL Intellectual Property Licensing
CSL Intellectual Property Licensing Segment Revenue $137m, down 5% @CC HPV royalties $106m • Registration of 9-valent HPV vaccine in US by Merck CSL362 (anti-IL-3Ra mAb) • Exclusive worldwide license with Janssen Biotech Inc to develop and commercialise CSL362 • Janssen is expected to commence the P
Slide 25: R&D Update
R&D Update rIX-FP • rIX-FP Phase III efficacy data supports 7-14 day dosing • BLA accepted for review by FDA in February • MAA review procedure commenced by EMA in March rVIII-SingleChain • Phase I/III data supports twice weekly dosing • BLA accepted for review by FDA in July rVIIa-FP • Congenital d
Slide 26: R&D Update
R&D Update Beriplex® • Commencement of Beriplex® Japan Phase III study Berinert® • Pivotal Phase III subcutaneous prophylaxis study recruiting well Zemaira®/Respreeza® (Alpha1-Proteinase Inhibitor) • Patients with AATD treated with Respreeza® have lower annual rate of lung density decline • EMA CHMP
Slide 27: Business Performance FY15 Financial Detail
Business Performance FY15 Financial Detail
Slide 28: FY15 Adjusted Profit growth Up 10% @CC
FY15 Adjusted Profit growth Up 10% @CC US$M 1,500 Adjusted profit up 10% @ CC 1,450 FY15 FX 1,400 Acquisition • FX headwind $33m +10% • One off costs connected with 1,350 the acquisition of the Novartis Settlement influenza business $22m 1,300 1,250 Operational profit up 6.5% @ CC 1,200 FY14 • US Cl
Slide 29: Margin Development
Margin Development % 45 40 EBITDAR&D* Margin 35 Margin 30 25 EBIT Margin 20 * Earnings before interest, taxes, depreciation, amortisation and research & development 21
Slide 30: Financial Discipline
Financial Discipline Cashflow from operations $1.36 billion Capital expenditure $414m Working Capital FY14 FY15 • Cash cycle (days) 281 300 • Free cashflow $948m $1,016m Financial Strength FY14 FY15 • Cash on hand $609m $557m • Undrawn debt $192m $141m • Net debt $1,282m $1,724m 22 - Balance Sheet S
Slide 31: Debt Maturity Profile
Maturity Profile US$M 800 Private Placement 700 Bank Debt 600 Undrawn 500 Debt 400 300 200 100 0 Maturity Profile 23
Slide 32: Balance Sheet Management Gearing
Balance Sheet Management X Gearing • Accumulated effect of 1.5 buybacks since FY05 on ~ Target current period EPS ~23% 1.0 • Gearing target ~1x Net debt/EBITDA 0.5 • Gearing @FY15 ~0.9x Net Debt / EBITDA • New on-market share 0.0 buyback foreshadowed • Similar amount to most -0.5 recent program • Ne
Slide 33: Seqirus
Seqirus™ Deal closed 31 July 2015 Financial consolidation 1H16 Too early to provide better guidance than that provided in October 2014 • $22m incurred in FY15, majority of balance expected to be incurred in FY16 • Gain on acquisition yet to be determined • Anticipate providing updated guidance in co
Slide 34: Looking Forward
Looking Forward FY16 NPAT growth ~ 5% @ CC Excl. Novartis influenza vaccine business Notable items Ongoing demand for therapies • Sales expected to grow ~7% @ CC Investment in growth, incremental ~$50m • Preparation for rCOAG launches • New capacity coming on-line FY17 - anticipate • Full year rCOAG
Slide 35: Business Growth
Business Growth Biotech mAbs in core therapeutic segments CSL112 New treatment paradigm in ACS High margin contributor Recombinant Coagulation Factors rIX-FP, rVIII-SC, rVIIa-FP, rVWF Specialty Products Multiple high margin contributors: RiaSTAP ®, Kcentra ® , CytoGam®, Berinert®, Zemaira® Core Prod
Slide 36: CSL Limited FY15 Full Year Result
CSL Limited FY15 Full Year Result 12 August 2015 Contact - Mark Dehring Head of Investor Relations Telephone: +613 9389 3407 Email: mark.dehring@CSL.com.au
Slide 37: Group Results
Group Results US Dollars Full year ended June Jun Jun Jun Change US$ Millions 2014 2015 2015 % Reported Reported at CC1 Sales 5,335 5,459 5,733 7.5% Other Revenue / Income 169 154 156 Total Revenue / Income 5,504 5,613 5,889 7.0% Earnings before Interest, Tax, 1,832 1,939 1,994 8.8% Depreciation & A
Slide 38: CSL Behring Sales
CSL Behring Sales US Dollars Full year ended June FY14 FY15 FY15 Change USD$M USD$M USD$M % CC1 rFVIII 491 468 495 1% pdCoag 573 558 597 4% Albumin 694 754 778 12% Immunoglobulins 2,320 2,326 2,430 5% Specialty Products 848 923 977 15% - Peri-operative bleeding 414 450 483 17% - Other specialty prod
Slide 39: Notes
Notes (#)Constant currency removes the impact of exchange rate movements to facilitate comparability by restating the current year’s results at the prior year’s rates. This is done in two parts: (a) by converting the current year net profit of entities in the group that have reporting currencies oth