Business Wire

PARIS--(BUSINESS WIRE)--Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, today presents its sales performance for the year to date and the third quarter of 2022.

Sales summary¹

Highlights

– Total-sales growth in the year to date of 9.5% at CER², or 15.5% as reported, driven by the growth platforms of Dysport^® (botulinum toxin type A), Decapeptyl^® (triptorelin), Cabometyx^® (cabozantinib) and Onivyde^® (irinotecan) increasing by 20.8%²; Somatuline^® (lanreotide) sales down by 2.8%²

– In the third quarter, total-sales growth of 7.6% at CER², or 16.0% as reported, boosted by an increase in Dysport sales of 43.3%², partly offset by a decline in Somatuline sales of 9.8%²

– Completion of the definitive merger agreement under which Ipsen acquired Epizyme, expanding Ipsen’s presence in Oncology

– Postponement of the U.S. FDA’s advisory-committee meeting for investigational palovarotene

– Full-year 2022 guidance confirmed, with total-sales growth greater than 7.0% at CER² and a core operating margin greater than 36.0% of total sales

David Loew, Chief Executive Officer, commented:

“I am proud of Ipsen’s performance so far this year as we continue to drive strong sales results. Our growth platforms have delivered a double-digit sales performance, reflecting improving commercial execution and the strength of our portfolio. These results have outweighed the adverse impact from competitive activity on Somatuline in the U.S. and Europe. Based on the strong sales momentum, we are confirming our guidance for the full year.

I was also delighted by the enhancement of our pipeline, portfolio and organization as a result of the recent acquisition of Epizyme. In the near term, we look forward to a number of milestones for our pipeline, including Phase III data readouts in Oncology. I am pleased with the sustained progress we are making as we continue to maximize our brands, strengthen our pipeline, drive efficiencies and focus on our culture.”

Full-year 2022 guidance

Ipsen has confirmed its financial guidance for FY 2022³:

– Total-sales growth greater than 7.0%, at constant exchange rates. Based on the average level of exchange rates in September 2022, an additional favorable impact on total sales of around 6% from currencies is expected

– Core operating margin greater than 36.0% of total sales

Business development

In August 2022, Ipsen and Epizyme, Inc. (Epizyme) announced that they had completed a definitive merger agreement under which Ipsen acquired Epizyme, a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies against novel epigenetic targets for cancer patients. Sales by Ipsen ofTazverik^® (tazemetostat), consolidated from 1 September 2022, have been reflected in this announcement.

Ipsen and Marengo Therapeutics, Inc. (Marengo) also announced in August 2022 a strategic partnership to advance two of Marengo’s preclinical STAR platform-generated candidates into the clinic. The collaboration will leverage Marengo’s proprietary R&D expertise of a novel mechanism of T-cell activation with Ipsen’s global Oncology footprint for clinical development and commercialization.

Palovarotene

In October 2022, the U.S. FDA announced its decision to postpone the planned Endocrinologic and Metabolic Drugs Advisory Committee meeting for investigational palovarotene until a later date to be confirmed; the original advisory-committee meeting was scheduled for 31 October 2022. The FDA informed Ipsen that the postponement related to an FDA request for new information on palovarotene clinical-trial data and did not relate to the safety profile of palovarotene. The Company is currently working to fulfil the request.

Conference call

A conference call and webcast for investors and analysts will begin today at 1.30pm, Paris time. Participants can access the call and its details by registering here; webcast details can be found here. A recording will be available on ipsen.com.

Calendar

Ipsen intends to publish its full-year results on 9 February 2023.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the nine-month period to 30 September 2022 (the year to date or YTD 2022) and the three-month period to 30 September 2022 (the third quarter or Q3 2022), compared to nine-month period to 30 September 2021 (YTD 2021) and the three-month period to 30 September 2021 (Q3 2021) respectively, unless stated otherwise. Commentary is based on the performance in YTD 2022, unless stated otherwise. The performance of Consumer HealthCare, divested in July 2022, has been excluded from all commentary and comparisons to prior performance.

Ipsen

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,000 colleagues worldwide and 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.

Commentary is based on the performance in YTD 2022, unless stated otherwise.

– Somatuline: in North America, sales fell by 3.6%⁴, despite continued demand growth, impacted by increased competition and adverse U.S. pricing, driven by an increased level of commercial rebates and unfavorable movements in channel mix, as well as lower wholesaler inventories. In Europe, sales declined by 9.3%⁴, reflecting the larger effects of the launches of generic lanreotide in more markets, including Germany, France, Spain and the Nordics. Sales in the Rest of the World grew by 34.5%⁴, a result of strong performances in several geographies, including Japan and Brazil

– Decapeptyl: the performance was mainly driven by continued volume growth across all countries, higher volumes in China and Korea and favorable shipment phasing in Algeria. In the third quarter, sales were supported by a strong performance in China, partly reflecting the impact of a loosening of COVID-19 lockdown restrictions

– Cabometyx: the performance reflected strong volume uptakes in renal cell carcinoma across most geographies, mainly as a second-line monotherapy and, more recently, as a first-line therapy in combination with nivolumab

– Onivyde: sales growth was primarily driven by a solid performance in the U.S., as well as sales to Ipsen’s ex-U.S. partner. The decline in sales in the third quarter reflected the impact of the phasing of 2022 sales to the partner

– Dysport: the performance in the year to date was driven by strong demand in most therapeutics markets, and similar growth in the aesthetics market, including increased sales to Ipsen’s partner, Galderma, especially in North America and Australia. The stronger growth in the third quarter was boosted by the catch-up from the recent manufacturing-capacity increase that benefitted supply to support aesthetics-market demand

– Tazverik: sales, which are in the U.S., were consolidated from 1 September 2022