The Ipsen Investment Case

Made public by

sourced by PitchSend

18 of 35

Creator

Ipsenusa logo
Ipsenusa

Category

Healthcare

Published

2022

Slides

Transcriptions

#1Ipsen 2020 / Gabo Morales/Pierre-Olivier / Menelaos Myrillas/CAPA Pictures FOCUS. TOGETHER. FOR PATIENTS & SOCIETY. BRING the full potential of our innovative medicines to patients BUILD a high-value sustainable pipeline BOOST a culture of collaboration & excellence DELIVER efficiencies to enable targeted investment & growth IPSEN Innovation for patient care Investor Presentation March 2022#2Disclaimer and safe harbor This presentation includes only summary information and does not purport to be comprehensive. Forward-looking statements, targets and estimates contained herein are for illustrative purposes only and are based on management's current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated in the summary information. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably given that a new medicine can appear to be promising at a preparatory stage of development or after clinical trials but never be launched on the market or be launched on the market but fail to sell notably for regulatory or competitive reasons. Ipsen must deal with or may have to deal with competition from generic medicines that may result in market-share losses, which could affect its level of growth in sales or profitability. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this presentation to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. All medicine names listed in this document are either licensed to Ipsen or are registered trademarks of Ipsen or its partners. The implementation of the strategy has to be submitted to the relevant staff representation authorities in each country concerned, in compliance with the specific procedures, terms and conditions set forth by each national legislation. In those countries in which public or private-health cover is provided, Ipsen is dependent on prices set for medicines, pricing and reimbursement-regime reforms and is vulnerable to the potential withdrawal of certain medicines from the list of reimbursable medicines by governments, and the relevant regulatory authorities in its locations. In light of the economic impact caused by the COVID-19 pandemic, there could be increased pressure on the pharmaceutical industry to lower medicine prices. Ipsen operates in certain geographical regions whose governmental finances, local currencies or inflation rates could erode the local competitiveness of Ipsen's medicines relative to competitors operating in local currency, and/or could be detrimental to Ipsen's margins in those regions where Ipsen's sales are billed in local currencies. In a number of countries, Ipsen markets its medicines via distributors or agents; some of these partners' financial strengths could be impacted by changing economic or market conditions, including impacts of the COVID-19 pandemic, potentially subjecting Ipsen to difficulties in recovering its receivables. Furthermore, in certain countries whose financial equilibrium is threatened by changing economic or market conditions, including impacts of the COVID-19 pandemic, and where Ipsen sells its medicines directly to hospitals, Ipsen could be forced to lengthen its payment terms or could experience difficulties in recovering its receivables in full. Ipsen also faces various risks and uncertainties inherent to its activities identified under the caption 'Risk Factors' in the Company's Universal Registration Document. All of the above risks could affect Ipsen's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. IPSEN Innovation for patient care 2#3Clear focus on three therapeutic areas A future built on Specialty Care Nadine Living with fibrodysplasia ossificans progressiva Berlin, Germany IPSEN Innovation for patient care Our vision To be a leading global mid-sized biopharmaceutical company with a focus on transformative medicines in Oncology, Rare Disease and Neuroscience DIDA Oncology Rare Disease Neuroscience Strengthening the position Expanding the scope Consumer Healthcare: exclusive negotiations with Mayoly Spindler Excelling and accelerating 3#4The Ipsen investment case 0:00 Strong Specialty Care franchise Geographical footprint Advancing R&D pipeline strategy A External- innovation Sound financial structure and strong cash generation Opportunities for further growth across the three therapeutic areas A well-balanced and expanding presence around the world A good mix of new molecules and lifecycle management Seven transactions completed in 2021; momentum into 2022 Building €3.5bn of firepower¹ for external innovation IPSEN Innovation for patient care 1. By 2024; based on net debt below 2.0x EBITDA and Includes proceeds from the sale of the Consumer Healthcare business. 4#5FY 2021: headlines Executing the strategy MAXIMIZE our brands STRENGTHEN the pipeline DRIVE efficiencies FOCUS on culture Total sales growth of +12.3% to €2,869m, driven by Specialty Care growth of +12.7% Seven external-innovation agreements across every therapeutic area A record core operating margin of 35.2% A stronger leadership team driving Ipsen's growth IPSEN Innovation for patient care All growth rates are at constant exchange rates. 5#6Total sales +Time IPSEN Innovation for patient care A strong platform for sustainable growth External innovation Innovative brands Somatuline Core brands Transition post-SSA competition entry Drive growth of core & innovative brands Accelerate growth with external innovation 6#7Ipsen Specialty-Care sales: FY 2021 Somatuline autogel Oncology Neuroendocrine tumors 1,203 lanreotide Decapeptyl triptorelin Oncology Advanced metastatic prostate 460 cancer Dysport® Neuroscience ☑ Clostridium botulinum Type A Toxin Motor muscular disorders Medical aesthetics 435 CABOMETYX® (cabozantinib) tablets Oncology onivyde® Oncology Metastatic pancreatic cancer 127 (irinotecan liposome injection) RCC: monotherapy and in combination 355 IPSEN Innovation for patient care Other 64 Excludes Consumer Healthcare. RCC: renal cell carcinoma. 7#8A strong and expanding global footprint NORTH AMERICA 35% of total sales EUROPE5 31% of total sales REST OF WORLD 34% of total sales Compelling U.S. presence; strong commercial execution IPSEN Innovation for patient care 30+ countries with Ipsen presence Leveraging a significant European platform Attractive China infrastructure, emerging presence in new markets 100+ countries where Ipsen. medicines are marketed Based on FY 2021 Specialty Care sales; excludes Consumer Healthcare. EUROPE5: the U.K., France, Germany, Spain and Italy. 8#9Strong execution of the external-innovation strategy Seven transactions completed in 2021 across the three therapeutic areas Oncology Accent Therapeutics METTL3 Preclinical BAKX Therapeutics BKX-001 Preclinical Queen's University FLIP-inhibitor program Preclinical DUA Rare Disease Neuroscience IPSEN Innovation for patient care GENFIT elafibranor Phase III IRLAB mesdopetam Exicure Spherical Nucleic Acids BCH/UOS BoNT/X Phase llb Preclinical Preclinical BCH: Boston Children's Hospital; UOS: University of Stockholm; BoNT/X: a novel botulinum toxin serotype. 9#10Building a high-value sustainable pipeline Phase I Cabometyx + atezolizumab Solid tumors IPN59011 Phase II IPN60130 FOP Longer-acting neurotoxin mesdopetam PD-LID Ax IPN10200 Longer-acting neurotoxin Ax/Tx Phase III Cabometyx + atezolizumab 1L HCC Cabometyx + atezolizumab 2L NSCLC1 Cabometyx + atezolizumab 2L mCRPC2 Onivyde 2L SCLC1 Onivyde 1L PDAC² elafibranor² PBC Registration Cabometyx 2L RR DTC³ palovarotene FOP Dysport NDO IPSEN Innovation for patient care Oncology 1. Data Information shown as at the end of 2021. Rare Disease Neuroscience readout anticipated in H2 2022. 2. Data readout anticipated in 2023. 3. Regulatory decision (EU) anticipated in H1 2022. Ax: aesthetics; Tx: therapeutics; FOP: fibrodysplasia ossificans progressiva; PD-LID: Parkinson's disease - levodopa-induced dyskinesia; HCC: hepatocellular carcinoma; NSCLC: non-small cell lung cancer; mCRPC: metastatic castration-resistant prostate cancer; SCLC: small-cell lung cancer; PDAC: pancreatic ductal adenocarcinoma; PBC: primary biliary cholangitis; RR DTC: radio- refractory differentiated thyroid cancer; NDO: neurogenic detrusor overactivity. 10#11Company social responsibility: highlights IPSEN Innovation for patient care Employees Females: comprised 42% of the GLT in 2021 - on track to reach gender balance by 2024 Employers' recognition through external and independent awards: 19 countries Communities Continued support of International Health Partners Ipsen in Motion: support of patient associations Ipsen Community Day Environment Halving absolute greenhouse- gas emissions1 by 2030 Working closely with partners to reduce science-based Scope 3 emissions by 2030 GLT: Global Leadership Team. 1. Scopes 1 and 2. 11#12FY 2021 financial highlights Operating leverage driving margin growth and strong cash generation Total sales Core operating margin Free cash flow Specialty Care €2.9bn Consumer Healthcare +12.3% Specialty Care +12.7% Consumer Healthcare +8.1% IPSEN Innovation for patient care 35.2% of total sales +3.2% points1 €807m +24.9%¹ Focus on efficiency Continued investment in R&D Strong EBITDA growth of 20.2%¹ Net debt at €126m Proposed² 2021 dividend per share of €1.20 All growth rates are at constant exchange rates, unless stated otherwise. 1. At actual exchange rates. 2. Decided by the Ipsen SA Board of Directors; to be proposed at the annual shareholder's meeting on 24 May 2022. 12#13Delivering efficiencies Improving the ratio of SG&A costs to total sales to 36.1% 2,576 2019 Total sales (Em) +11.4% SG&A costs (Єm) +1.5% 1,020 2019 39.6% 2019 Ratio (%) -3.5pts 2,869 2021 1,035 2021 36.1% 2021 Reducing the ratio by 3.5% pts since 2019, driven by: Efficiency gains from procurement savings, project prioritization, restructuring and digital initiatives Spending smart, simpler operations, accelerating transformation Reduced T&E and medical & marketing activities due to the pandemic Further efficiencies expected in 2022 to offset anticipated normalization and investment for growth IPSEN Innovation for patient care All growth rates and values are at actual exchange rates. 13#14Strong balance sheet and further cash generation Funding significant potential external innovation €m EBITDA 1,121 +20% Free cash flow 807 +25% Net debt 126 -76%1 Net debt to EBITDA of 0.1x Capital allocation prioritized to external innovation Firepower² for external innovation of €2.1bn at the end of FY 2021 IPSEN Innovation for patient care All growth rates are at actual exchange rates. 1. Versus 31 December 2020. 2. Based on net debt below 2.0x EBITDA. 14#15Consumer Healthcare Exclusive negotiations with Mayoly Spindler Delivering on the strategic roadmap IPSEN IPSEN CONSUMER Innovation for patient care HEALTHCARE IPSEN Innovation for patient care MAYOLY SPINDLER €350m on an enterprise-value basis, including an earnout contingent payment of €50m Expected to complete by the end of Q3 2022 Creation of a global consumer-healthcare platform Supports strategic focus on Specialty Care 15#16Core 2021 financials excluding CHC An improvement in the core operating profit margin to 37.1% Total Sales As reported €2,869m Excluding CHC €2,643m IPSEN Innovation for patient care R&D costs ratio SG&A costs ratio 14.9% 36.1% 16.1% Core operating margin As reported 35.2% Excluding CHC 37.1% 34.8% 16#17FY 2022 guidance, excluding CHC Continued top-line growth and a robust core operating margin Total-sales growth greater than 2.0% at constant exchange rates Expected favorable impact of around 2% from currencies based on the level of exchange rates in January 2022 IPSEN Innovation for patient care Core operating margin greater than 35.0% of total sales Excludes any potential impact of incremental investments from external-innovation transactions Guidance assumptions Further generic-lanreotide launches in other countries in the E.U., as well as increased competition in the U.S. An ongoing global return to normal healthcare systems Assumes application of discontinued operations (Consumer Healthcare) from 1 January 2022 and compares to the FY 2021 operating performance excluding the contribution from the Consumer Healthcare business. 17#18Update of mid-term 2020-24 outlook Financial outlook reflects Specialty Care only1 Total sales CAGR between +4% & +6%2 At constant exchange rates and scope Assumes potential risk-adjusted additional indications Commitment to invest in R&D supported by SG&A efficiencies Higher R&D costs as a % of total sales driven by external innovation Reduced SG&A costs as a % of total sales driven by further efficiencies €3.5bn cumulative remaining firepower by 2024 for external innovation Based on net debt below 2.0x EBITDA Includes proceeds from the sale of the Consumer Healthcare business IPSEN Innovation for patient care 1. Assumes application of discontinued operations (Consumer Healthcare) from 1 January 2022 and compares to the FY 2020 operating performance excluding the contribution from the Consumer Healthcare business. 2. Prior outlook, outlined in 2020, included a total-sales 2020-24 CAGR of 2% to 5% at constant exchange rates. 18#19Conclusion Executing in line with our strategy Delivery of strong 2021 results Top-line growth across all core and innovative brands An expanded core operating margin Sound financial structure and strong cash generation € Clinical development milestones Cabometyx atezolizumab: 2L NSCLC Phase III data readout Onivyde: 2L SCLC Phase III data readout Palovarotene: FOP regulatory resubmission Mesdopetam: PD-LID Phase IIb data readout Business development opportunities Seven transactions in 2021 External innovation: the primary capital-allocation priority, underpinned by a strong financial position Across the three therapeutic areas Strengthened capacity and firepower to execute further IPSEN Innovation for patient care 19#20Appendix Janice Living with cervical dystonia Tennessee, USA IPSEN Innovation for patient care Ipsen 2019 / Matthew Bender/ CAPA Pictures#21IPSEN Innovation for patient care Nov-19 Mar-20 Jul-20 Nov-20 FY 2021: Oncology sales highlights Somatuline 1,145 Sales (Єm) +7.1% 1,203 2021 Somatuline autogel® lanreotide Continued attractive NET market growth recovering from the pandemic Expanding market share further with a limited impact from generic SSAs in 2021 Mar-21 Jul-21 2020 Global SSA market growth (volume in MEU): 10% 4% -2% rolling three months 2022 expectations Further launches of generic lanreotide in other countries in the E.U., as well as increased competition in the U.S. Nov-21 Somatuline sales growth at constant exchange rates. Absolute values are shown at actual exchange rates. NET: neuroendocrine tumors; SSA: somatostatin analog; MEU: monthly equivalent units. Source: in-market demand IQVIA MIDAS / GERS (FR). Global calculation based on the following: the U.S., the EU5, the Nordics excl. Denmark, Benelux, Poland, Portugal, Russia, Brazil and Canada. 21 23#22FY 2021: Oncology sales highlights Cabometyx Єm sales 100 50 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2020 2021 CABOMETYX® (cabozantinib) tablets FY 2021: +22.8% Strong volumes across most geographies TKI of choice in 2L RCC Combination in 1L RCC launched in Germany. Cabometyx 1L new-patient exit share now at 18% Reimbursement and launches in 1L RCC expected in other key E.U. countries in 2022 IPSEN Innovation for patient care All growth rates are at constant exchange rates. Absolute values are shown at actual exchange rates. TKI: tyrosine kinase inhibitor; 2L: second line; 1L: first line; RCC: renal cell carcinoma. Sources: IQVIA MIDAS / GERS (FR), KANTAR. 22 22#23FY 2021: Oncology sales highlights Decapeptyl and Onivyde €m sales +17.5% 460 391 Decapeptyl® triptorelin Excellent performance driven by recovery in China Further market-share gains elsewhere 2020 2021 Єm sales +7.2% IPSEN Innovation for patient care 123 2020 127 2021 onivyde® (irinotecan liposome injection) Higher sales to ex-U.S. partner and strong volume growth in the U.S. Continued impact from the pandemic on rates of diagnosis All growth rates are at constant exchange rates. Absolute values are shown at actual exchange rates. 23#24FY 2021: Neuroscience sales highlights Dysport €m sales +26.3% Dysport® Clostridium botulinum Type A Toxin Aesthetics Strong performance across all key Ipsen and Galderma markets Full recovery from the pandemic Market growth driven by favorable consumer dynamics 353 2020 435 2021 Therapeutics Strong performance supported by solid market growth Numbers of injections recovering towards pre-pandemic level Ipsen's focus on spasticity indications and the penetration of neurotoxins to address the significant unmet medical need IPSEN Innovation for patient care All growth rates at constant exchange rates. Absolute values are shown at actual exchange rates. 24 24#25Core P&L: leveraging strong sales growth FY 2021 €m FY 2020 Change €m Total Sales 2,868.9 2,591.6 10.7% Other revenue 130.2 94.5 37.8% Other revenue: growth in Cost of goods sold (538.0) (490.6) 9.6% Gross profit 2,461.2 2,195.6 12.1% % of total sales 85.8% 84.7% +1.1% pts R&D expenses (428.4) (405.6) % of total sales 14.9% 15.6% 5.6% -0.7% pts Selling expenses (835.7) (784.0) % of total sales 29.1% 30.3% G&A expenses (199.6) (187.8) 6.6% -1.1% pts 6.3% % of total sales 7.0% 7.2% -0.3% pts Other operating income 13.8 11.2 23.6% and expenses royalties paid by partners Gross profit margin ratio: +1.1% pts from favorable mix; improved volumes impacting manufacturing variances Research and development expenses ratio: 14.9%, supporting investment in lifecycle management and new molecules SG&A expenses ratio: efficiencies improving the ratio by 1.4% pts to 36.1% Core Operating Income 1,011.3 829.3 % of total sales 35.2% 32.0% 21.9% +3.2% pts IPSEN Innovation for patient care All growth rates are at actual exchange rates. 45 25#26Core P&L: excluding CHC FY 2021 Total Sales 2,868.9 As reported €m CHC €m Excluding CHC €m 225.6 2,643.3 105.4 Other revenue Cost of goods sold Gross profit 130.2 24.9 (538.0) (98.4) (439.6) 2,461.2 152.1 2,309.1 % of total sales 85.8% 67.4% 87.4% R&D expenses (428.4) (3.7) % of total sales 14.9% Selling expenses (835.7) (105.9) % of total sales 29.1% G&A expenses (199.6) (10.8) 1.7% 46.9% (424.7) 16.1% (729.8) 27.6% (188.8) % of total sales 7.0% 4.8% 7.1% Other operating income and 13.8 0.0 13.8 expenses Core Operating Income 1,011.3 31.7 979.5 % of total sales 35.2% 14.1% 37.1% IPSEN Innovation for patient care 26#27Oncology Key ongoing clinical-trial highlights Trial Population Patients Design Cabometyx COSMIC-312 1L HCC 740 Phase III NCT03755791 Cabometyx COSMIC-311 Phase III NCT03690388 Cabometyx CONTACT-01 Phase III NCT04471428 Sorafenib or Cabometyx + atezolizumab or Cabometyx Endpoints Primary: PFS, OS Secondary: PFS single- agent Cabometyx arm Placebo 2L RR DTC 300 or Primary: PFS, ORR Cabometyx Docetaxel or 2L NSCLC 350 Cabometyx + atezolizumab Primary: OS Secondary: PFS, ORR, DoR Status PFS primary endpoint met. Interim OS primary endpoint not met Final OS data readout expected H1 2022 PFS primary endpoint met. ORR primary endpoint not met EU regulatory decision anticipated H1 2022 Data readout anticipated H2 2022 IPSEN Innovation for patient care PFS: progression-free survival; OS: overall survival; ORR: objective response rate; DoR: duration of response. 27#28Oncology Key ongoing clinical-trial highlights Trial Cabometyx CONTACT-02 Phase III NCT04446117 Cabometyx Phase lb NCT03170960 Onivyde NAPOLI-3 Phase III NCT04083235 Onivyde RESILIENT Phase III NCT03088813 IPSEN Innovation for patient care Population Patients 2L CRPC 580 Solid tumors 1,732 Design Second novel hormonal therapy (abiraterone and prednisone or enzalutamide) or Cabometyx + atezolizumab Cabometyx+atezolizumab Endpoints Primary: OS, PFS Additional endpoints: ORR, prostate-specific antigen response rate and duration of response Primary: maximum tolerated dose / recommended dose, ORR Status Data anticipated 2023 Recruiting Secondary: safety Nab-paclitaxel + gemcitabine or 1L PDAC 750 Onivyde + 5-FU/LV + oxaliplatin Primary: OS Secondary: PFS, ORR, Data anticipated 2023 Topotecan 2L SCLC 461 or Onivyde safety Primary: OS Secondary: PFS, ORR, safety Data anticipated H2 2022 28#29Rare Disease Key ongoing clinical-trial highlights Trial Palovarotene Population Patients MOVE Phase III FOP (chronic) 107 NCT03312634 IPN60130 Design Palovarotene - 5mg QD and upon flare-up, 20mg QD for 28 days, followed by 10mg for 56 days Placebo or FALKON Phase II FOP (chronic) ~90 two dosing regimens of IPN60130 NCT05039515 Elafibranor ELATIVE Phase III NCT04526665 Placebo PBC 150 or elafibranor Endpoints Primary: annualized change in new HO volume Secondary: subjects with new HO, number of body regions with HO, subjects with flare-ups, rate of flare-ups, safety Primary: annualized change in new HO volume and safety Secondary: change in HO volume in new HO lesions, number of new HO lesions, rate and number of flare-up days, number of body regions with HO, pain intensity Response to treatment defined as ALP < 1.67 x ULN and total bilirubin ≤ ULN and ALP decrease ≥ 15 percent Status H1 2022 regulatory resubmission (US) H1 2022 'clock-stop' expiry (EU) First patient commenced dosing Q1 2022 Data anticipated 2023 IPSEN Innovation for patient care QD: once a day; HO: heterotopic ossification; ULN: upper limit normal; ALP: alkaline phosphatase. 29 29#30Neuroscience Key ongoing clinical-trial highlights Trial Population Levodopa-induced Patients Design Endpoints Status Mesdopetam dyskinesia in Phase llb NCT04435431 140 Parkinson's Mesdopetam or placebo Change in average daily hours of ON-time without troublesome Data anticipated H2 2022 dyskinesia disease IPN59011 Ax Moderate to LONG-SET Phase I/II NCT04736745 IPN10200 Ax LANTIC Phase I/II Dose escalation and dose finding severe upper 424 facial lines versus Dysport or placebo Primary: Safety Secondary: Efficacy Recruiting Moderate to severe upper 424 facial lines NCT04821089 Dose escalation and dose finding versus Dysport or placebo Primary: Safety Secondary: Efficacy Recruiting IPN10200 Tx Adult patients with LANTIMA Phase I/II NCT04752774 upper limb spasticity 209 Dose escalation and dose finding versus Dysport or placebo Primary: Safety Secondary: Efficacy Recruiting IPSEN Innovation for patient care 1. Good 'ON-time' is the time that people living with Parkinson's disease experience improved Parkinsonian symptoms and no dyskinesia. 30#31THANK YOU IPSEN Innovation for patient care#32Craig Marks Vice President, Investor Relations +44 7564 349 193 [email protected] Adrien Dupin de Saint-Cyr Investor Relations Manager +33 6 64 26 17 49 [email protected] IPSEN Innovation for patient care 22 32#33Follow us www.ipsen.com ☑ f in ▸ IPSEN Innovation for patient care

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare