Q1 2024 sales update
24 April 2024
Janice
Living with cervical dystonia, Tennessee, U.S.
Disclaimer 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.
2
Speakers
For Q&A | |
David Loew | Aymeric Le Chatelier |
CEO | CFO |
3
Today's highlights
Strong top-line growth
- Total sales +13.3%
- Growth platforms1 +16.2%
- Increased contribution from new medicines2
Launches progressing
- Onivyde: encouraging early start in 1L mPDAC
- Bylvay & Sohonos : launch on-going in the U.S.
- Elafibranor: launch preparation with PDUFA date in June and EMA decision in H2
Pipeline progress
- FDA regulatory approval in February for Onivyde in U.S. in 1L mPDAC
- Two pre-clinical transactions
2024 guidance3
confirmed
Total-sales growth >+6% at CER
Core operating margin ~30%
1L: first line; mPDAC: metastatic pancreatic ductal adenocarcinoma; PDUFA: Prescription Drug User Fee Act; ADC: antibody-drug conjugate. All growth rates at constant exchange rates (CER). 1 Dysport®, Decapeptyl®, Cabometyx® and Onivyde®. 2 Bylvay®, Tazverik® & Sohonos®.
3 Excludes any impact of any additional late-stage (Phase III clinical development or later) external-innovation opportunities and incorporates expectations for Somatuline of further
generic lanreotide products in the U.S & E.U - expected adverse impact of ~1% from currencies on sales, based on average level of exchange rates in March 2024. | 4 |
Q1 2024 sales
€m % change
Growth platforms1
New medicines2
Somatuline®
Other
509.7 16.2%
45.5 n/a
257.8 -1.3%
9.5 -20.5%
Total Sales | 822.4 | 13.3% |
All growth rates at constant exchange rates.
1 Dysport®, Decapeptyl®, Cabometyx® & Onivyde®.
2 Bylvay®, Tazverik® & Sohonos®.
Packaging Operator
Production
Signes, France
Somatuline sales: -1.3%
North | Rest of | |||||||
Europe | ||||||||
America | World | |||||||
-10.0% | +9.3% | +14.7% |
Market-share gains in a | Benefit from generic-competitor | Ongoing strong performance |
growing NET market | shortages in some markets | & share gains in |
non-generic markets, | ||
Continued adverse pricing from | including Latin America | |
Continued growth in markets | ||
channel mix & increased rebates | with no generic | |
NET: neuroendocrine tumors.
All growth rates at constant exchange rates. | |
In this presentation, Europe is defined as the E.U., the U.K., Iceland, Liechtenstein, Norway and Switzerland. | 6 |
Growth platforms: +16.2%
+19.3%
€177m
+22.2%
€155m
+2.6%
€131m
+14.8%1
€41m1
Strong performance across aesthetics & therapeutics
Growing & attractive
market dynamics
Robust volume performance | Strong growth | Positive early start |
supported by | in China | in 1L mPDAC |
share gains in 1L |
Favorable phasing in | Increased competitive | Market-share growth in |
Rest of World | activity & pricing pressure | post-gem setting |
in Europe |
Growth platforms: Dysport, Decapeptyl, Cabometyx & Onivyde; 1L: first line; mPDAC: metastatic pancreatic ductal adenocarcinoma. | |
All growth rates at constant exchange rates. | |
1 North America only; excludes sales to ex-U.S. partner. | 7 |
A good early start for Onivyde in 1L mPDAC
U.S. FDA approval: 13 February
Orphan Exclusivity in 1L to 2031
Positive uplift in post-launch demand
"The approval of this Onivyde regimen is an important milestone for people living with mPDAC, their families and healthcare providers."
Dr. Zev Wainberg, Professor of Medicine &
Co-Director of the UCLA GI Oncology
Program
1L: first line; mPDAC: metastatic pancreatic
ductal adenocarcinoma.
Significant | Potential |
potential, | to become new standard of |
with high unmet | care |
medical need | |
Patients | SoC |
`
AccessFeedback
Reimbursement | Encouraging |
& formulary entry | feedback across |
progressing well | academic & |
community centers |
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Dysport: strong growth across indications
Aesthetics
- Strong performance in all markets in Ipsen & partner territories, including U.S.
- Solid market growth `
- Phasing adversely impacted sales in Europe
+24.3%
€102m
Therapeutics
- Solid performance, driven by Rest of World & North America
- Continued growing market across indications
+12.9%
€75m
All growth rates at constant exchange rates. | 9 |
New medicines: increased contributions
€26m
€12m
€7m
Strong performance & patient uptake | Solid demand growth | Launch focus in U.S. on driving sense |
in PFIC, despite challenging pricing | in a challenging | of urgency to treat existing, |
mechanisms in Europe | FL landscape | diagnosed & identified patients |
Progressive expected uptake | Competitive environment | Geographic expansion |
in ALGS in U.S. | intensifying | planned |
PFIC: progressive familial intrahepatic cholestasis; ALGS: Alagille syndrome; FL: follicular lymphoma.
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Ipsen SA published this content on 24 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 24 April 2024 11:39:07 UTC.