AbobotulinumtoxinA (Ipsen Biopharm Ltd)

Cancer specialist Ipsen is signing on to help grow the reach of tovorafenib outside the U.S. Just three months after scoring an accelerated FDA approval for Ojemda, Day One Biopharmaceuticals is teaming up with another fellow oncology specialist to grow the medicine's global reach. Thursday, Day One and Ipsen unveiled an ex-U.S. licensing agreement for tovorafenib (approved as Ojemda in the U.S.) in pediatric low-grade glioma (pLGG) and "any future indications developed by Day One." In exchange for regulatory and commercial rights to tovorafenib outside the U.S., Ipsen is forking over $111 million upfront, including a $40 million equity investment in Day One. Based on potential success down the road, Day One could be in line for up to $350 million in milestones plus "tiered double-digit royalties." In a release, Ipsen said its "deep heritage and expertise in oncology" will allow the company to "accelerate the delivery of this innovation as teams focus on regulatory activities outside the U.S." As the company noted, patients with pLGG suffer from symptoms including vision and speech problems, neurological symptoms, fatigue, nausea and more. The disease can "significantly" impact a child's development and quality of life. The deal comes three months after Ojemda secured accelerated FDA approval as a treatment for pLGG in patients 6 months and older whose tumors have a BRAF fusion or rearrangement, or a BRAF V600 mutation. In their Thursday release, Ipsen and Day One described pLGG as the "most common childhood brain tumor." In the disease, Day One's drug is going up against Novartis' combination of Tafinlar and Mekinist, which in 2023 scored its own FDA nod to treat pLGG cases with BRAF V600 mutations, a more restricted use. Ojemda is California-based Day One's first commercial product and carries a peak sales estimate of $750 million from analysts at JPMorgan. As for Ipsen, the company separately on Thursday presented its first-half financial results. The drugmaker's first-half sales grew 8% year over year, reaching 1,659 billion euros ($1.8 billion). During the first half, Ipsen said its Exelixis-partnered cancer med Cabometyx and Dysport for spasticity and cervical dystonia drove its sales growth, along with Bylvay for patients with Alagille syndrome and Onvyide for certain cancers. While the company's profit margin declined slightly during the first six months of the year, Ipsen attributed the decrease to higher R&D spending. With the first half in the books, Ipsen said it expects a full-year sales increase of 7% compared with its prior guidance of 6%.

PARIS, FRANCE, 25 July 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the first half of 2024. Business highlights U.S. regulatory approvals and launches of Onivyde® (irinotecan) in first-line pancreatic cancer and Iqirvo® (elafibranor) in second-line primary biliary cholangitis, respectivelyIn-licensing of tovorafenib​ outside the U.S.: an attractive addition to our Oncology pipelineMultiple early-stage external-innovation transactions across Oncology and Neuroscience Financial highlights Total-sales growth of 9.5% at CER1, or 8.0% as reported, driven by the performances of Cabometyx® (cabozantinib) and Dysport® (abobotulinumtoxinA), as well as contributions from Bylvay® (odevixibat) and Onivyde Core operating margin of 32.4%, a decline of 1.6% points, driven mainly by enhanced R&D investment. An unchanged IFRS operating margin of 19.2% Upgraded 2024 financial guidance: total-sales growth greater than 7.0% at CER1 (prior guidance: greater than 6.0% at CER1); core operating margin greater than 30.0% of total sales (prior guidance: around 30%) “Our strategic progress was illustrated by strong results in the first half, and we are well placed to deliver continued attractive growth over the medium term”, commented David Loew, Chief Executive Officer, Ipsen. “Across Oncology, Rare Disease and Neuroscience, we now have a comprehensive portfolio of medicines, with additional launches in key indications this year. Onivyde and Iqirvo are now being rolled out and we are confident in our ability to deliver on their potential. I was also delighted by a further expansion of our pipeline, including the recent in-licensing of the late-stage asset, tovorafenib, in pediatric Oncology. “Over the remainder of the year, we will remain sharply focused on the launches and commercial execution, as well as further opportunities to expand the pipeline. We have a clear and focused strategic roadmap and a culture of excellence in execution to enable us to make a real difference for patients and society.” Extract of consolidated results for H1 2024 and H1 20232: H1 2024 H1 2023 % change €m €m Actual CER3 Total Sales 1,659.3 1,536.6 8.0% 9.5% Core Operating Income 538.0 523.2 2.8% Core operating margin 32.4% 34.0% -1.6% pts Core Consolidated Net Profit 399.4 393.0 1.6% Core earnings per share (fully diluted) €4.78 €4.73 1.2% IFRS Operating Income 317.8 295.6 7.5% IFRS operating margin 19.2% 19.2% - IFRS Consolidated Net Profit 232.3 195.1 19.1% IFRS earnings per share (fully diluted) €2.78 €2.35 18.4% Free Cash Flow 393.5 371.5 5.9% Closing net debt (6.8) (272.2) n/a Full-year 2024 guidanceWe have upgraded our financial guidance for 2024: Total-sales growth greater than 7.0%, at constant currency (prior guidance: greater than 6.0% at constant currency). Based on the average level of exchange rates in June 2024, an adverse impact on total sales of around 1% from currencies is expected Core operating margin greater than 30.0% of total sales (prior guidance: around 30%) Pipeline update since Q1 2024In June 2024, we received an accelerated approval from the U.S. FDA for Iqirvo 80 mg tablets for the treatment of primary biliary cholangitis, in combination with ursodeoxycholic acid (UDCA), in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Iqirvo was, shortly thereafter, available for prescription and delivery. A decision in the E.U. is anticipated later this year. In June 2024, we announced the expansion of our collaboration and license agreement with Exelixis, Inc. for the development of Cabometyx® (cabozantinib) in advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic neuroendocrine tumors. This expansion is based on positive outcomes from the CABINET Phase III trial. In June 2024, we announced an extension of our ongoing oncology research partnership with Marengo Therapeutics, Inc., to include TriSTAR, Marengo’s next-generation, precision T-cell engager technology. Under the terms of the agreement, we will assume responsibility for all activities, following development-candidate nomination. In July 2024, we announced an exclusive global licensing agreement with Foreseen Biotechnology for FS001, an antibody-drug conjugate with first-in-class potential. Under the terms of the agreement, we will assume responsibility for Phase I preparation activities. We also announced today a new global partnership outside the U.S with Day One Biopharmaceuticals for tovorafenib, an oral, once-weekly, type II RAF inhibitor for pediatric low-grade glioma. This is the most common form of childhood brain cancer. Under the terms of the agreement, we will be responsible for the regulatory and commercial activities for tovorafenib in all territories outside of the U.S. Consolidated financial statementsThe Board of Directors approved the condensed consolidated financial statements on 24 July 2024. The Company’s auditors performed a limited review of the H1 2024 condensed consolidated financial statements. The interim financial report, with regards to the regulated information, will be available on ipsen.com in due course, under the Reports and Accounts tab in the Investor Relations section. Conference callA conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here. CalendarIpsen intends to publish its year-to-date and third-quarter sales update on 24 October 2024. NotesAll financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2024 (H1 2024) and the three-month period to 30 June 2024 (Q2 2024), compared to the six-month period to 30 June 2023 (H1 2023) and the three-month period to 30 June 2023 (Q2 2023), respectively. Commentary is based on the performance in H1 2024, unless stated otherwise. 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 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 ipsen.com.Ipsen contacts Investors Craig Marks +44 (0)7584 349 193 Nicolas Bogler +33 6 52 19 98 92 Media Amy Wolf +41 79 576 07 23 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; possible failure of products launches; and the exposure to litigation, including patent litigation, and/or regulatory actions; and risks of tax adjustments given the regular audits from tax authorities considering Ipsen’s M&A activities and its presence in multiple geographies. 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 ipsen.com. 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 Extract of consolidated results. The Company’s auditors performed a limited review of the condensed consolidated financial statements.3 At 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. Attachment Ipsen PR_H1 2024 results announcement_25072024