On July 25, 2024 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2024 (Press release, Ipsen, JUL 25, 2024, View Source [SID1234645090]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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, respectively
In-licensing of tovorafenib outside the U.S.: an attractive addition to our Oncology pipeline
Multiple 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 guidance
We 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 2024
In 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 statements
The 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 call
A 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.