Clinical Trial Highlights

Made public by

sourced by PitchSend

11 of 30

Creator

Ipsenusa logo
Ipsenusa

Category

Healthcare

Published

June 2023

Slides

Transcriptions

#1IPSEN Innovation for patient care Ipsen 2022 / Sarah Palmer / CAPA Pictures Stephen Living with a neuroendocrine tumor, Ontario, Canada Investor presentation September 2023 Focus. Together. For patients & society#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. 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, potentially subjecting Ipsen to difficulties in recovering its receivables. Furthermore, in certain countries whose financial equilibrium is threatened by changing economic or market conditions, 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#3Highlights at H1 2023 results Consistent strong delivery on strategic roadmap Financial results H1 total-sales growth of 7.4% Growth platforms & newly acquired medicines now represent around two thirds of total sales Core operating margin of 34.0% Albireo Albireo acquisition completed in March Integration progressing well IPSEN Innovation for patient care I HIDO A Pipeline update Onivyde: SNDA accepted (U.S.) - 1L PDAC Bylvay: FDA approval (U.S.) - ALGS Palovarotene: favorable outcome from Advisory Committee (U.S.) - FOP Elafibranor: met primary endpoint (ELATIVE) - 2L PBC 2023 guidance upgraded Total-sales growth greater than 6.0%1 Core operating margin greater than 30.0%² All growth rates are at constant exchange rates. 1. Excludes anticipated adverse impact of around 3% from currencies, based on the average level of exchange rates in June 2023. 2. Excludes any potential impact of incremental investments from external-innovation transactions. Growth platforms: Dysport, Decapeptyl, Cabometyx and Onivyde; sNDA: supplemental New Drug Application; 1L: first line; PDAC: pancreatic ductal adenocarcinoma; ALGS: Alagille syndrome; FOP: fibrodysplasia ossificans progressiva; 2L: second line; PBC: primary biliary cholangitis. 3#4Sales performance Growth platforms continuing to excel; contributions from newly acquired medicines IPSEN Innovation for patient care H1 2023 Q2 2023 €m change €m change Dysport Decapeptyl 319 31.7% 165 38.3% 277 6.0% 147 11.0% Cabometyx 266 26.3% 135 22.1% Onivyde 78 -8.0% 41 -3.7% Growth platforms 940 17.7% 488 20.6% Bylvay 23 n/a 18 n/a Tazverik 19 n/a 9 n/a Newly acquired medicines 42 n/a 28 n/a Somatuline 529 -12.0% 266 -14.1% Other 27 -15.2% 14 -9.8% Total sales 1,537 7.4% 795 9.0% All growth rates are at constant exchange rates. Due to rounding, the sum of euro values may not agree to totals. 4#5Growth platforms: consistent strong performance Г Dysport® Clostridium botulinum Type A Toxin +31.7% Г CABOMETYX® (cabozantinib) tablets +26.3% Г Decapeptyl triptorelin +6.0% onivyde® (irinotecan liposome injection) +19.3% Further aesthetics-market growth, accompanied by favorable baseline effect Continued strong double- digit therapeutics growth across regions Strong volume uptakes across most geographies Momentum in first & second-line renal cell carcinoma China sales recovery post-COVID in Q2 Growth in Europe offset by adverse pricing Growth in the U.S. driven by market-share gains 1L PDAC pre-launch activities IPSEN Innovation for patient care All growth rates are at constant exchange rates. 1. North America only; excludes sales to ex-U.S. partner. Growth platforms: Dysport, Decapeptyl, Cabometyx and Onivyde; 1L: first line; PDAC: pancreatic ductal adenocarcinoma. 5#6Somatuline sales: continuing to decline gradually Now around one third of total sales Somatuline quarterly sales growth Q1 Q2 2022 2023 2023 Q1 Q2 Q3 Q4 2022 2022 2022 2.9% 0% -0.7% -9.8% -9.8% |-13.3% -14.1% H1 2023 -12.0% sales growth North America -9.6% Solid volume-demand growth Ongoing adverse pricing Europe -21.7% Generic competition continuing to impact Somatuline autogel® lanreotide -8% -16% Rest of World +6.3% Solid underlying growth Several markets performing well, including Latin America IPSEN Innovation for patient care All growth rates are at constant exchange rates. Due to rounding, sum of percentages may not agree to totals. In this presentation, Europe is defined as the E.U., the U.K., Iceland, Liechtenstein, Norway and Switzerland. 6#7Recently acquired medicines IPSEN Innovation for patient care Г Г Bylvay (odevixibat) €23m TAZVERIK (tazemetostat) tablets 200 mg €19m Growth of 140%1 Strong momentum in North America and Europe Increasing number of treated PFIC patients Growth of 18% in commercial sales² Focus on all-comers, new-patient starts & duration of therapy Increasing share of office-based patients All growth rates are at constant exchange rates. 1. Reference to Albireo's published H1 2022 performance. 2.. Reference to Epizyme's published H1 2022 performance. PFIC: progressive familial intrahepatic cholestasis. 7#8Building high-value, sustainable pipeline Phase I IPN 60210 R/R multiple myeloma & R/R DLBCL IP N60260 Viral cholestatic disease Phase II TAZVERIK (various combinations) R/R malignancies TAZVERIK (+ hormonotherapy) mCRPC FIDRISERTIB FOP Phase III CABOMETYX + ATEZOLIZUMAB 2L mCRPC TAZVERIK + R2 2L FL ELAFIBRANOR 2L PBC Registration ONIVYDE + 5-FU/LV + OXALIPLATIN 1L PDAC BYLVAY Alagille syndrome PALOVAROTENE FOP ELAFIBRANOR PSC IPN 60250 BYLVAY Biliary atresia Oncology Rare Disease Neuroscience PSC IPN 10200 Longer-acting neurotoxin Ax IPN 10200 Longer-acting neurotoxin Tx Information shown as at end of June 2023. R/R: relapsed/refractory; DLBCL: diffuse large B-cell lymphoma; mCRPC: metastatic castration-resistant prostate cancer; FOP: fibrodysplasia ossificans progressiva; PSC: primary sclerosing cholangitis; Ax: aesthetics; Tx: therapeutics; 2L: second line; 1L: first line; R2: lenalidomide + rituximab; FL: follicular lymphoma; PBC: primary biliary cholangitis; PDAC: pancreatic ductal adenocarcinoma. 8 IPSEN Innovation for patient care#9Pipeline: near-term milestones IPSEN Innovation for patient care Palovarotene FDA PDUFA FOP 16 August Bylvay Regulatory decision (E.U.) ALGS H21 Onivyde FDA PDUFA 1L PDAC 13 February Cabometyx + atezolizumab Phase III data readout 2L mCRPC H2 Elafibranor Regulatory submission (U.S., E.U.) 2L PBC H2 1. Subject to the outcome of an appeal procedure. PDUFA: Prescription Drug User Fee Act; FOP: fibrodysplasia ossificans progressiva; ALGS: Alagille syndrome; 1L: first line; PDAC: pancreatic ductal adenocarcinoma; 2L: second line; mCRPC: metastatic castration-resistant prostate cancer; PBC: primary biliary cholangitis. 6#10H1 2023 financial highlights Total sales €1,537m +7.4% Core operating income €523m -7.9% Core operating margin¹ 34.0% -5.6% pts Core EPS² €4.73 -6.6% Free cash flow €371m +9.6% IPSEN Innovation for patient care Total-sales growth is at constant exchange rates; all other growth rates are at actual exchange rates. 1. As a ratio of core operating income to total sales. 2. Fully-diluted earnings per share. 10#11Core P&L Strong sales growth and significant investment for growth Γ €m H1 2023 H1 2022 Change Total Sales 1,536.6 1,433.7 7.2% Other revenue 86.5 64.2 34.8% Total sales Limited impact of currencies Other revenue Cost of goods sold (269.9) (242.1) 11.5% Favorable impact from license rights to Onivyde Gross Profit 1,353.3 1,255.8 7.8% % of total sales 88.1% 87.6% 0.5pts R&D expenses % of total sales SG&A expenses (290.2) (207.2) 40.1% 18.9% 14.5% 4.4pts Cost of goods sold Adverse mix of royalties paid R&D expenses Investment from pipeline (552.6) (487.3) 13.4% assets of Epizyme & Albireo % of total sales 36.0% 34.7% 13.0pts SG&A expenses Commercial investment for Other operating income and expenses 12.7 6.5 94.9% Core Operating Income 523.2 568.0 -7.9% growth including Tazverik & Bylvay launch activity % of total sales 34.0% 39.6% -5.6pts IPSEN Innovation for patient care All growth rates are at actual exchange rates. 11#12H1 core operating margin evolution Reflected dilutive impact from recent acquisitions 39.6% Core Operating margin (as a % of total sales) -0.7% -7.6% Base business • . 2.1% 0.5% 34.0% H1 2022 Base business Acquisitions Onivyde rights FX H1 2023 Contribution of growth platforms Pre-launch & RoW commercial activities & existing pipeline investment Gradual decline of Somatuline Acquisitions · . Epizyme & Albireo dilutive impact based on commercial & R&D investments Limited synergies to date Onivyde rights • Upfront fee from licence rights with ex- U.S. partner for 1L PDAC Strong underlying level of core operating margin at 34% of total sales IPSEN Innovation for patient care 1L: first line; PDAC: pancreatic ductal adenocarcinoma. 12#13Core operating income to consolidated net profit €m H1 2023 H1 2022 Change Core Operating Income 523.2 568.0 -7.9% Amortization of intangible assets (90.7) (46.6) 94.6% Restructuring and other operating (125.0) (20.0) n/a expense Impairment losses (11.9) 0.0 n/a IFRS Operating Income 295.6 501.3 -42.2% Net financing expenses (12.0) (9.5) -27.0% Other financial income (22.1) (0.5) n/a Income taxes and other (66.4) (109.1) -39.2% Net profit from discontinued operations 0.0 12.1 n/a IFRS Consolidated Net Profit Core earnings per share 195.1 394.3 -50.5% €4.73 €5.06 -6.6% IPSEN Innovation for patient care All growth rates are at actual exchange rates. Amortization of intangible assets Increase mainly from Bylvay & Tazverik Restructuring & other operating expense Mainly related to Albireo integration & transaction costs, other transformation programs and discontinuation of clinical trials Core earnings per share In line with core operating income with core effective tax rate at 20.4% 13#14Cash flow & net debt €m Opening Net Cash/(Debt)1 Free cash flow Dividend H1 2023 H1 2022 398.8 28.0 371.5 339.0 (99.6) (100.2) Net investments (945.9) (101.9) Change in cash from discontinued 13.9 6.1 activities Other (share buyback, FX, discontinued) (10.9) (2.8) Change in net cash (671.0) 140.3 Closing Net Cash/(Debt)1 (272.2) 168.2 IPSEN Innovation for patient care Γ Solid free cash flow: growing by 9.6% Strong balance sheet: closing net debt of €0.3bn Significant firepower² for external innovation: €1.7bn at end of H1 2023 Due to rounding, sum of euro values may not agree to totals. 1. Net cash/(debt) excluding contingent liabilities (earnouts and contingent value rights), previously part of net cash/(debt) definition. Opening H1 2023 net cash of €398.8m adjusted to exclude contingent liabilities (vs. closing H1 2022 reported net cash of €168.2m). 2. Based on net debt below 2.0x 12 months' rolling EBITDA and including contingent liabilities. L 14 14#15Upgraded FY 2023 guidance IPSEN Innovation for patient care Γ Total-sales growth greater than 6.0% at constant exchange rates Γ Core operating margin greater than 30.0% of total sales Expected adverse impact of around 3% from currencies, based on average level of exchange rates in June 2023 Excludes any potential impact of incremental investments from external-innovation transactions 15#16Conclusion Strategic roadmap driving growth story IPSEN Innovation for patient care Γ DO DELIVERING FURTHER STRONG RESULTS ADVANCING PIPELINE Growth platforms & newly acquired medicines driving sales growth A strong core operating margin Cash generation supporting a robust balance sheet Several programs added to pipeline Favorable developments in first half of year Anticipated regulatory decisions in near term Capital-markets day: 7 December 2023, London L 16#17APPENDIX IPSEN Innovation for patient care 17#18A strong global footprint NORTH AMERICA 32% OF TOTAL SALES 40+ countries with Ipsen presence Γ REST OF WORLD 28% OF TOTAL SALES L EUROPE 40% OF TOTAL SALES 110+ countries where Ipsen medicines are marketed IPSEN Innovation for patient care Based on H1 2023 total sales. In this presentation, Europe is defined as the E.U., the U.K., Iceland, Liechtenstein, Norway and Switzerland. 18 L#19H1 2023 total sales: fx rates L IPSEN Innovation for patient care H1 2023 sales by currency Γ CNY Other 25.0% 34.3% CNY GBP 3.8% 4.8% USD 32.2% EUR Average rate changes (H1 2023 vs. H1 2022) USD: 1.08 1% BRL: 5.48 1% AUD: 1.60 CNY: 7.48 TRY: 21.49 -5% -6% -32% USD BRL AUD CNY TRY Unfavorable -0.2% impact L 19#20Oncology Key ongoing clinical-trial highlights TRIAL POPULATION PATIENTS DESIGN PRIMARY ENDPOINT(S) Cabometyx CONTACT-02 2L mCRPC 580 Second novel hormonal therapy (abiraterone & prednisone or enzalutamide) STATUS Recruiting¹ PFS, OS Phase III NCT04446117 Onivyde NAPOLI-3 Phase III NCT04083235 or Cabometyx + atezolizumab PFS primary endpoint met Nab-paclitaxel + gemcitabine or 1L PDAC 770 OS Onivyde + 5-FU/LV + oxaliplatin U.S. PDUFA date 13 February 2024 R/R FL: following Tazverik SYMPHONY-1 Phase III NCT04224493 at least one prior systemic Placebo + R² chemotherapy, immunotherapy, or 540 or Tazverik + R2 PFS Recruiting1 chemo- IPSEN Innovation for patient care immunotherapy 1. Recruitment status as per ct.gov, June 2023. 2L: second line; mCRPC: metastatic castration-resistant prostate cancer; PFS: progression-free survival; OS: overall survival; 1L: first line; PDAC: pancreatic ductal adenocarcinoma; R/R: relapsed/refractory; FL: follicular lymphoma; R2: lenalidomide + rituximab. 20#21Oncology Key ongoing clinical-trial highlights TRIAL POPULATION PATIENTS DESIGN PRIMARY ENDPOINT(S) STATUS Tazverik ARIA Tazverik in various Phase Ib/II R/R hematologic malignancies 156 combinations: multi-cohort Phase lb: dosing, safety Phase II: ORR Recruiting1 NCT05205252 IPN 60210 Phase I/lb NCT05121103 R/R multiple myeloma & R/R DLBCL 96 IPN60210 Treatment-emergent adverse events, dosing & ORR Tazverik CELLO-1 Phase Ib/II NCT04179864 IPSEN Innovation for patient care mCRPC: patients who have not Enzalutamide + Tazverik Phase lb: dosing, safety or 104 received chemotherapy abiraterone/prednisone + Tazverik Phase II: rPFS Tazverik + enzalutamide 1. Recruitment status as per ct.gov, June 2023. R/R: relapsed/refractory; ORR: objective response rate; DLBCL: diffuse large B-cell lymphoma; mCRPC: metastatic castration-resistant prostate cancer; rPFS: radiographic progression-free survival. Recruiting1 Active, not recruiting1 21 23#22Rare Disease Key ongoing clinical-trial highlights TRIAL POPULATION PATIENTS DESIGN Elafibranor ELATIVE Phase III 2L PBC 161 Placebo or elafibranor NCT04526665 PRIMARY ENDPOINT Response to treatment defined as ALP < 1.67 x ULN and total bilirubin ≤ ULN and ALP decrease ≥ 15 percent STATUS Primary endpoint met Bylvay ASSERT Alagille syndrome Phase III 33 63 Placebo or Change from baseline in scratching score U.S. regulatory approval June 2023 Bylvay NCT04674761 Bylvay BOLD Biliary atresia 205 Placebo or Phase III Bylvay NCT04336722 Proportion of patients who are alive and have not undergone a liver transplant after 104 weeks of study treatment Recruiting¹ IPSEN Innovation for patient care 1. Recruitment status as per ct.gov, June 2023. 2L: second line; PBC: primary biliary cholangitis; ALP: alkaline phosphatase; ULN: upper limit normal; PDUFA: Prescription Drug User Fee Act. 22 22#23Rare Disease Key ongoing clinical-trial highlights TRIAL POPULATION PATIENTS DESIGN Palovarotene MOVE Phase III NCT03312634 Fidrisertib FALKON Phase II NCT05039515 IPSEN Innovation for patient care FOP (chronic) 107 PRIMARY ENDPOINT(S) STATUS Palovarotene - 5mg QD and upon flare-up, 20mg QD for 28 days, followed by 10mg for 56 days Annualized change in new HO volume U.S. regulatory approval August 2023 Placebo or FOP (chronic) 00 90 two dosing regimens Annualized change in new HO volume and safety of fidrisertib First patient commenced dosing Q1 2022 FOP: fibrodysplasia ossificans progressiva; QD: once a day; HO: heterotopic ossification; P DUFA: Prescription Drug User Fee Act. 23#24Rare Disease Key ongoing clinical-trial highlights TRIAL POPULATION PATIENTS DESIGN PRIMARY ENDPOINT(S) STATUS IPN 60250 Phase II NCT05642468 10mg IPN60250 tablet QD for 12 weeks Primary sclerosing cholangitis 12 Treatment-related adverse events Recruiting1 30mg (3x10 mg) IPN60250 tablets QD for 12 weeks Elafibranor ELMWOOD Phase II NCT05627362 Primary sclerosing cholangitis IPN 60260 Phase I ISRCTN13265717 IPSEN Innovation for patient care Placebo 60 60 or elafibranor Viral cholestatic 108 disease Interventional Safety, significant changes in physical examination findings, laboratory parameters, vital signs, electrocardiogram readings Recruiting1 To be confirmed Recruiting¹ 1. Recruitment status as per ct.gov, June 2023. QD: once a day. 24 24#25Neuroscience Key ongoing clinical-trial highlights TRIAL POPULATION PATIENTS DESIGN PRIMARY ENDPOINT STATUS IPN10200 Ax LANTIC Moderate to severe upper 424 Phase II facial lines NCT04821089 Dose escalation & dose finding versus Dysport or placebo Safety First patient commenced dosing Q1 2023 IPN 10200 Tx Dose escalation & Adult patients with LANTIMA upper-limb 209 Phase II NCT04752774 spasticity dose finding versus Dysport or placebo Safety First patient commenced dosing Q2 2023 IPSEN Innovation for patient care 45 25#26THANK YOU#27Investor Relations Craig MARKS Vice President, Investor Relations +44 7564 349 193 [email protected] Nicolas BOGLER Investor Relations Senior Manager +33 6 52 19 98 92 [email protected] IPSEN Innovation for patient care 22 27#287 Follow us www.ipsen.com fin

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