Elafibranor

PARIS, FRANCE, 23 October 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its performance for the year to date and the third quarter of 2024. YTD 2024 YTD 2023 % change Q3 2024 Q3 2023 % change €m €m Actual CER1 €m €m Actual CER1 Oncology 1 829,8 1 744,1 4,9% 5,8% 604,0 574,5 5,1% 5,6% Neuroscience 536,4 489,0 9,7% 11,8% 181,9 164,8 10,4% 10,1% Rare Disease 129,7 76,0 70,7% 71,3% 50,8 33,2 53,1% 54,4% Total Sales 2 495,9 2 309,1 8,1% 9,2% 836,6 772,4 8,3% 8,6% Highlights Total-sales growth in the year to date of 9.2% at CER1, or 8.1% as reported, with notable performances from Dysport® (abobotulinumtoxinA), Cabometyx® (cabozantinib) and Bylvay® (odevixibat), with robust Somatuline® (lanreotide) sales, as well as the increasing contribution from the launches of Iqirvo® (elafibranor) in 2L PBC2 and Onivyde® (irinotecan) in 1L mPDAC3 Regulatory approvals in the E.U. of Iqirvo and Kayfanda® (odevixibat)Increased 2024 financial guidance: total-sales growth greater than 8.0% at CER1 (prior guidance: greater than 7.0% at CER1); core operating margin greater than 31.0% of total sales (prior guidance: greater than 30.0%) “Since the launch of our strategy in 2020, we have enjoyed uninterrupted growth. This quarter was no exception and was accompanied by further progress in the pipeline”, commented David Loew, Chief Executive Officer. “We have also continued to launch across several indications and lines of therapy, including the recent rollouts of Iqirvo and Onivyde, which are progressing well. Supported by the performance so far this year, we are further increasing our 2024 sales and margin guidance.” “We have built a track record of delivery, grounded in a strong foundation of external innovation, commercial excellence and our ongoing mission to offer more choices for patients.” Full-year 2024 guidance Based on the strong performance in the third quarter, Ipsen has further increased its financial guidance for 2024: Total-sales growth greater than 8.0%, at constant currency (prior guidance of greater than 7.0%). Based on the average level of exchange rates in September 2024, an adverse impact on total sales of around 1.5% from currencies is expectedCore operating margin greater than 31.0% of total sales (prior guidance of greater than 30.0%) Pipeline update In September 2024, the European Commission conditionally approved Iqirvo 80mg tablets for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a monotherapy in patients unable to tolerate UDCA. Iqirvo was approved in the same setting by the U.S. FDA in June 2024. In September 2024, the European Commission also approved Kayfanda as a treatment for pruritus in children from as young as six months of age who have Alagille syndrome (ALGS). Odevixibat, under the brand name Bylvay, is already marketed in the E.U. for the treatment of progressive familial intrahepatic cholestasis (PFIC), and in the U.S. and E.U. for PFIC, and in the U.S. for ALGS. In the same month, final results from the CABINET Phase III trial were presented at the 2024 European Society for Medical Oncology Congress and were published in the New England Journal of Medicine, reinforcing the efficacy benefits of Cabometyx in advanced neuroendocrine tumors. It was announced at that time that Ipsen had submitted an extension of indication Marketing Authorization to the European Medicines Agency. Business development In August 2024, Ipsen entered into an agreement to sell its rare pediatric disease Priority Review Voucher. As part of the agreement, Ipsen received a cash payment of $158m in the third quarter. In October 2024, Eton Pharmaceuticals entered into an agreement with Ipsen to acquire Increlex® (mecasermin injection). The transaction is expected to close before the end of 2024. Arbitration proceedings with Galderma As of 30 September 2024, two arbitration proceedings initiated by Galderma against Ipsen at the International Chamber of Commerce (ICC) were ongoing. The first dispute, initiated by Galderma in 2021, pertains to the territorial scope of the commercial partnership related to Azzalure® (abobotulinumtoxinA) and Dysport under an agreement signed in 2007 in the E.U., in certain Eastern European countries, and in Central Asia. The Tribunal of the ICC Internal Court of Arbitration issued a final award, in October 2024, dismissing most, if not all, of Galderma's claims in this first arbitration and ordered that Galderma bear the majority of the legal fees and arbitration costs incurred by Ipsen. A second dispute was initiated by Galderma in November 2023, related to the validity of Ipsen’s 2023 termination of a joint R&D collaboration agreement entered into in 2014 under the parties’ respective early-stage neurotoxin programs, including the development of IPN10200. At this stage, Ipsen cannot reasonably predict any potential financial impact from this final remaining arbitration process, for which it intends to fully defend and vindicate its rights. Conference call 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 here. Calendar Ipsen intends to publish its full-year and fourth-quarter results on 13 February 2025. Notes All financial figures are in € millions (€m). The performance shown in this announcement covers the nine-month period to 30 September 2024 (YTD 2024) and the three-month period to 30 September 2024 (Q3 2024), compared to the nine-month period to 30 September 2023 (YTD 2023) and the three-month period to 30 September 2023 (Q3 2023), respectively. Commentary is based on the performance in YTD 2024, unless stated otherwise. About Ipsen Ipsen is 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 fuelled 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 Jennifer Smith-Parker +44 (0) 7843 137 764Anne Liontas +33 7 67 34 72 96 1 At constant exchange rates (CER), which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.2 Second-line primary biliary cholangitis.3 First-line metastatic pancreatic ductal adenocarcinoma. Attachment Ipsen - YTD 2024 sales announcement

The original FDA full approval decision date was 15 October, but this has been delayed. Credit: Tada Images via Shutterstock. Intercept Pharmaceuticals will have to keep waiting for a decision about Ocaliva (obeticholic acid) after the US Food and Drug Administration (FDA) has asked for more time to determine whether to grant the drug full approval. It’s been a rocky ride for the rare liver disease drug, and now its subsidiary is also facing delays despite the original Prescription Drug User Fee Act (PDUFA) date for the drug’s supplemental New Drug Application (sNDA) being on 15 October. The treatment is only available to primary biliary cholangitis (PBC) patients through accelerated approval in the US. The FDA did not provide a new anticipated action date, however, Intercept’s president Vivek Devaraj said: “We will continue to engage with the FDA regarding our pending application.” Bologna, Italy-based Alfasigma inherited the drug as part of its $794m acquisition of Intercept Pharmaceuticals in September 2023 and the company has continued operating as a subsidiary of Alfasigma. However, the treatment has faced a series of setbacks since its 2016 accelerated approval. In 2018, the FDA had to add a boxed warning after Ocaliva was being incorrectly dosed as a daily treatment, instead of a weekly treatment. A September 2024 FDA advisory committee (AdCom) recommended against full approval for Ocaliva by a 13-1 vote, concluding that confirmatory evidence did not verify the treatment provided clinical benefit. In a separate vote, panellists voted 10-1 that the benefits of Ocaliva did not outweigh its risks, with three abstentions. In the same month, the European Commission (EC) withdrew Ocaliva’s conditional marketing authorisation as a second-line treatment for patients with PBC. This followed a June recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, which reassessed the benefit-risk profile of the drug. In a surprise decision just days later, the President of the General Court of the European Union overruled the decision, allowing Ocaliva to remain on the market. See Also: Testosterone by M et P Pharma for Male Hypogonadism: Likelihood of Approval Integrin Alpha M drugs in development, 2024 PBC is a chronic autoimmune disease where the immune system attacks the small bile ducts in the liver, causing bile buildup, liver inflammation, and eventually scarring or cirrhosis. Ocaliva activates the farnesoid X receptor (FXR) to reduce bile acid production and promote its removal. Ocaliva now faces competition in the PBC space. In August 2024, the FDA granted accelerated approval to Gilead’s Livdelzi (seladelpar), a drug it inherited as part of the $4.3bn CymaBay Therapeutics deal in March 2024. According to GlobalData forecasts, Livdelzi is set to generate $558m in 2030. Before it was acquired by Alfasigma, Ocaliva earned $285.7m in 2022, as per Intercept’s financials. GlobalData is the parent company of Pharmaceutical Technology. In September 2024, the EC gave Ipsen’s Iqirvo (elafibranor) the green light for the treatment of PBC in combination with ursodeoxycholic acid in adults who do not respond adequately to ursodeoxycholic acid alone. The decision in Europe follows an accelerated approval granted by the FDA in June this year.