On October 21, 2021 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales performance for the third quarter of 2021 and the year to date (Press release, Ipsen, OCT 21, 2021, View Source [SID1234591636]).
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!
Highlights
Total sales growth of 12.3% at CER[1] in the year to date, or 9.3% as reported, to €2,077.7m. In the third quarter, total sales of €727.4m represented growth of 14.9% at CER[1] and as reported
An increase in Specialty Care sales in the year to date of 12.5%[1] to €1,912.3m, driven by the growth of Somatuline (lanreotide), Cabometyx (cabozantinib), Decapeptyl (triptorelin) and Dysport (botulinum toxin type A)
Consumer Healthcare sales growth of 9.8%[1] in the year to date to €165.5m, reflecting the performance of Smecta (diosmectite) and the strong COVID-19 recovery
Strong business-development activity, with agreements in Oncology and Neuroscience
Full-year guidance upgraded:
Total sales growth[1] : greater than +11.0% (prior guidance: greater than +8.0%)
Core operating margin[2]: around 34% (prior guidance: around 32.0%)
David Loew, Chief Executive Officer, commented:
"We delivered a strong performance in the third quarter, reflecting the implementation of our new strategy and improving levels of commercial execution. Somatuline and Cabometyx growth was particularly encouraging, while strong sales of Dysport continue to underpin confidence in the potential of this important medicine. Despite regulatory delays for palovarotene in FOP, the replenishment of our pipeline gathered pace, with our external-innovation strategy providing an exciting platform for sustainable top-line growth.
We continue to maximize our brands, strengthen the pipeline and are driving efficiencies across our business. This strategy, built on our culture and an unrelenting focus on patients, is delivering strong results, giving us the confidence to upgrade this year’s guidance while remaining focused on the long-term Ipsen growth story."
FY 2021 guidance
Based on the strong performance in the year to date, the gradual easing of the COVID-19 pandemic and a limited impact from the launch of generic lanreotide in Europe, the Company today upgrades its financial guidance for FY 2021:
New guidance Prior guidance
Total sales growth[3] Greater than 11.0% Greater than 8.0%
Core operating margin[4] Around 34% Around 32.0%
Currency impact
Ipsen anticipates an unchanged adverse impact of 2% from currencies on total sales in FY 2021, based on the level of exchange rates at the end of September 2021.
Business development
Since the publication of the H1 2021 results announcement, Ipsen signed two agreements in line with its external-innovation focus on strengthening the pipeline:
METTL3 (Oncology)
In October 2021, Ipsen and Accent Therapeutics (Accent) signed an exclusive worldwide-collaboration agreement to research, develop, manufacture, and commercialize Accent’s pre-clinical stage METTL3 program. This collaboration reinforces Ipsen’s expansion into hematological malignancies, with a focus on acute myeloid leukemia.
Spherical Nucleic Acids (Neuroscience)
In August 2021, Ipsen entered into an exclusive collaboration agreement with Exicure to research, develop, and commercialize novel Spherical Nucleic Acids as potential investigational treatments for Huntington’s disease and Angelman syndrome.
Palovarotene
In August 2021, Ipsen withdrew the New Drug Application (NDA) for palovarotene in FOP[5], after discussions with the U.S. Food and Drug Administration (FDA). This followed ongoing dialogue with the FDA after the acceptance of the NDA for Priority Review, announced in May 2021. During the review and the ongoing dialogue, it was recognized that additional analyses and evaluation of data collected from Ipsen’s Phase III MOVE and FOP program would be required to progress and complete the review process. It was agreed that it would not be possible to complete this within the NDA review cycle. Upon successful completion of the additional data analyses, Ipsen currently anticipates regulatory resubmission in the U.S. in H1 2022. A ‘clock-stop’ was also granted by the European Medicines Agency.
Conference call
A conference call and webcast for investors and analysts will begin at 2:30pm Paris time today. Participants should dial in to the call early and can register here; a recording will be available on ipsen.com, while the webcast can be accessed here. The event ID is 4312698.
Calendar
The Company intends to publish its FY 2021 results on 11 February 2022.
Notes
All financial figures are in € millions (€m). The performance shown in this announcement covers the nine-month period to 30 September 2021 (the year to date or YTD 2021) and the three-month period to 30 September 2021 (the third quarter or Q3 2021), compared to nine-month period to 30 September 2020 (YTD 2020) and the three-month period to 30 September 2020 (Q3 2020) respectively, unless stated otherwise. Commentary is based on the performance in YTD 2021, unless stated otherwise.