Latest news with #DavidLoew
Yahoo
16-04-2025
- Business
- Yahoo
Ipsen delivers strong sales in the first quarter 2025 and confirms its full-year guidance
Total sales growth of 11.6% at CER1, or 11.7% as reported, driven by all three therapeutic areas and including an increasing contribution from Iqirvo and Bylvay. Tovorafenib regulatory submission to EMA2 for pediatric low-grade glioma. Confirmation of full-year 2025 financial guidance. PARIS, FRANCE, 16 April 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents sales for the first quarter of 2025. Q1 2025 % change % change €m Actual CER1 Oncology 655.0 8.5% 8.0% Neuroscience 193.5 8.0% 9.6% Rare Disease 70.3 78.4% 74.6% Total Sales 918.8 11.7% 11.6% 'Ipsen has delivered a strong start to 2025, building further momentum in the transformation of our company,' commented David Loew, Chief Executive Officer, Ipsen. 'We continued to execute on our strategy with strong top-line growth and pipeline progression. I am pleased to see the rapid build-up of our Rare Cholestatic Liver disease franchise with two innovate medicines for five indications. 2025 is set to be an important year for Ipsen, with multiple launches underway and several milestones expected across our portfolio.'Ipsen is confirming financial guidance for full-year 2025: Total sales growth greater than 5.0%, at constant currency. Based on the average level of exchange rates in March 2025, a limited effect on total sales from currencies is expected. Core operating margin greater than 30.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities. Guidance includes expected negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe. It excludes any impact from potential late-stage (Phase III clinical development or later) business development anticipates several key milestones across its portfolio in 2025, including: Cabometyx (CABINET trial) – Regulatory decision in the European Union for advanced pancreatic (pNETs) and extra-pancreatic (epNETs) neuroendocrine tumors (NETs). fidrisertib (FALKON trial) – Readout of the pivotal Phase IIb trial in fibrodysplasia ossificans progressiva (FOP). LANT3 (LANTIC trial) – Proof-of-concept data readout, evaluating its potential in aesthetics. The regulatory filing for tovorafenib was accepted by EMA for review in the European Union, marking an important step forward in the development of this potential treatment for pediatric low-grade glioma and reinforcing Ipsen's commitment to innovation in rare and difficult-to-treat cancers. Ipsen also initiated the entry in Phase I of IPN01195, a RAF inhibitor, complementing IPN01194, an ERK inhibitor, and tovorafenib, two other assets targeting the MAPK announced on March 19th the successful completion of its inaugural Rated Public Bond of €500 million with a coupon of 3.875%, maturing in March 2032. Following the disclosure of the Investment Grade ratings from S&P and Moody's, this transaction was very well received and largely oversubscribed by a diversified and solid institutional investor base. This transaction is an important component of Ipsen's refinancing plan which included the successful renewal of €1,5 billion syndicated Revolving Credit Facility, extending Ipsen's debt maturity profile.A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found intends to publish its half-year results on July 31st, financial figures are in € millions (€m). The performance shown covers the three-month period to 31 March 2025 (Q1 2025, the quarter), compared to the three-month period to 31 March 2024 (Q1 2024), unless stated are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit Deojee +33 6 69 09 12 96 MediaSally Bain +1 857 320 0517Anne Liontas +33 7 67 34 72 96 Disclaimers and/or forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen's management strategy, 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 herein. 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. Use of the words 'believes', 'anticipates' and 'expects' and similar expressions are intended to identify forward-looking statements, including Ipsen's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen's patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen's activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen's partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen's business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen's latest Universal Registration Document, available on 1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.2 EMA: European Medicines Agency 3 Long-acting neurotoxinAttachment Ipsen PR_Q1 2025_15042025Sign in to access your portfolio
Yahoo
12-03-2025
- Business
- Yahoo
Ipsen appoints Olivia Brown as Executive Vice-President, Global Head of Neurotoxins
PARIS, FRANCE, March 12th, 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty care-driven company, announced today the appointment of Olivia Brown as, EVP, Global Head of Neurotoxins, effective April 1st, 2025. She will serve on Ipsen's Executive Leadership Team (ELT) and report directly to Chief Executive Officer David Loew. In this newly created role, she will lead Ipsen's global neurotoxins franchise, overseeing strategy and execution across both therapeutic and aesthetic indications. Over the last 30 years in the neurotoxins market, Ipsen has established itself as one of the leading players in neurosciences, successfully driving research, clinical development and growth based on significant manufacturing know-how and capacity. "We are delighted to welcome Olivia to Ipsen's Executive Leadership Team. With her deep expertise in neurotoxins, combined with her experience in global strategy and commercialization, she will be instrumental in further accelerating our growth and innovation in neurotoxins, both in the therapeutic and aesthetic space," said David Loew, CEO, Ipsen. 'With a robust portfolio of products and an attractive pipeline including the potential break-through innovation of the recombinant Long-Acting Neuro-Toxine (LANT) program, it is the right time for us to create an integrated franchise. The long acting neurotoxin was uniquely designed to bind to the receptors used by the BoNT B and to deliver the active light chain of the BoNT A, demonstrating in preclinical studies a longer duration of action and less tissue spread compared to currently available BoNT As. We believe LANT AB has the potential ability to deliver better outcomes for patients with an increased duration of action, leading to a potential reduction in injection frequency and enhanced tolerability.' Olivia brings over 20 years of global leadership experience in pharmaceuticals and medical aesthetics, with a strong track record in business transformation, market expansion, and product launches. Most recently, she was at Novartis, where she led the establishment of a new therapeutic area in Allergy & Immunology. Previously, she held senior leadership positions at Merz Aesthetics and Galderma, where she played a key role in expanding the global neurotoxins market."I am excited to join Ipsen at such an important time for its neurotoxins business. Ipsen has a strong foundation in innovation, and I look forward to working with the team to build on this success and drive further growth in this dynamic market,' said Olivia Brown. This appointment reflects Ipsen's continued investment in neurotoxin innovation, global expansion, and leadership in both therapeutic and aesthetic indications. * botulinum toxin type B (BoNT-B) ** botulinum toxin type A (BoNT-A) About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit Ipsen contacts Investors Alina LEVCHUK | + 41 79 572 8712 | Nicolas BOGLER | + 33 6 52 19 98 92 | Media Sally BAIN | + 1 857 320 0517 | Anne LIONTAS | + 33 7 67 34 72 96 | Disclaimers and/or Forward-Looking StatementsThe forward-looking statements, objectives and targets contained herein are based on Ipsen's management strategy, 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 herein. 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. Use of the words 'believes', 'anticipates' and 'expects' and similar expressions are intended to identify forward-looking statements, including Ipsen's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen's patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen's activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen's partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen's business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen's latest Universal Registration Document, available on Attachment PR_ELT Announcement_13032025Sign in to access your portfolio
Yahoo
14-02-2025
- Business
- Yahoo
Ipsen SA (IPSEF) Full Year 2024 Earnings Call Highlights: Strong Sales Growth and Strategic ...
Total Sales Growth: 9.9% at constant exchange rates, exceeding EUR3.4 billion. Core Operating Margin: 32.6%. Core Operating Income: EUR1.1 billion, a growth of 10.8%. Free Cash Flow: EUR774 million, an increase of 8.9%. Revenue from Ex-Somatuline Portfolio: Grew by 12.2%. Cabometyx Sales: Increased by 13.3% for the full year. ONIVYDE Sales: Grew 23.7% for the full year. Fidrisertib Sales: Rose by 24%. Dysport Sales Growth: 9.2% for the full year. Bylvay Sales: EUR136 million. IQIRVO Sales: EUR22 million. R&D Costs: Increased by 10.9%, exceeding 20% of sales. SG&A Costs: Increased by 3.3%, with a ratio to sales at 34.4%. Net Cash Position: EUR160 million at the end of December. Dividend Increase: From EUR1.2 to EUR1.4 per share. Warning! GuruFocus has detected 4 Warning Signs with IPSEF. Release Date: February 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Ipsen SA (IPSEF) reported a 9.9% increase in total sales for 2024, driven by strong performance in their ex-somatuline portfolio. The company achieved a core operating margin of 32.6%, reflecting efficient cost management and strong sales performance. Ipsen SA (IPSEF) received a positive FDA decision for ONIVYDE in first-line pancreatic ductal adenocarcinoma, with subsequent approvals in the US and EU. The company anticipates significant pipeline milestones in 2025, including potential approvals for Cabometyx in neuroendocrine tumors and Tovorafenib in Europe. Ipsen SA (IPSEF) has a strong balance sheet with no debt and EUR 2.3 billion available for external innovation, indicating financial stability and capacity for growth. Ipsen SA (IPSEF) faces increased competition and pricing pressure for Cabometyx in Europe and China, impacting sales growth. The company recognized an impairment loss of EUR 281 million related to Sohonos due to lower-than-anticipated patient uptake. Somatuline is expected to face accelerated erosion due to increased generic competition, impacting profitability. The aesthetics market in the US is experiencing some softening, which could affect future growth prospects for Dysport. Ipsen SA (IPSEF) anticipates a contraction in core operating profit margin in 2025 due to increased R&D expenses and competitive pressures. Q: Could you provide more details on the expected erosion pattern for Somatuline in 2025 and the current state of generic competition in Europe and the US? A: David Loew, CEO: The erosion pattern for Somatuline is expected to accelerate compared to historical levels due to anticipated market entry by additional generics, likely around mid-year. In Europe and the US, we have seen significant shortages from existing generics, but we expect increased competition and accelerated erosion moving forward. Q: Can you explain the drivers behind the expected margin contraction in 2025 and how it will phase between H1 and H2? A: Aymeric le Chatelier, CFO: The margin contraction is primarily due to increased erosion from Somatuline and continued investment in R&D and SG&A to support ongoing and future launches. H1 margins will be higher due to lower costs and less impact from generics, while H2 will see more erosion and investment, leading to lower margins. Q: How is the launch of IQIRVO progressing, and what are the competitive dynamics in the market? A: David Loew, CEO: The IQIRVO launch is progressing well, with most patients being de novo second-line. We are seeing good feedback from prescribers despite competition from Gilead. We have increased our field force and presented new data on fatigue, which affects 80% of PBC patients. Q: What is the current market share for ONIVYDE in first-line pancreatic cancer, and what is the potential for growth in the community setting? A: David Loew, CEO: ONIVYDE is used by 32% of large academic centers, with growth primarily from the first-line setting. The patient flow is about 50-50 between academic and community settings, indicating significant potential for growth in community practices. Q: What are your expectations for the growth trajectory of IQIRVO in 2025, and how does it compare to Gilead's product? A: David Loew, CEO: We anticipate market expansion and are sticking to our peak sales guidance for IQIRVO. While we can't comment on Gilead's trajectory, we are pleased with our current uptake and expect continued growth. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
