• Strong 2021 financial performance with total-sales growth of 12.3% at CER¹ (growth of 10.7% as reported) and a core operating margin of 35.2% (IFRS operating margin of 29.6%)
• Exclusive negotiations with Mayoly Spindler to divest Ipsen’s Consumer Healthcare (CHC) business with a total enterprise value up to €350m and an anticipated closing of the transaction by the end of Q3 2022
• Full-year 2022 guidance, excluding CHC, with total-sales growth greater than 2.0% at CER¹ and a core operating margin greater than 35.0% of total sales
• Updated 2024 outlook, excluding CHC, with a total-sales 2020-24 CAGR² between 4% and 6% at constant currency and cumulative remaining firepower of €3.5bn by 2024, including the divestment of CHC
• Proposed dividend of €1.20 per share for the 2021 financial year³, a 20% increase versus the prior year

Paris (France), 11 February 2022 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, presents its financial results for FY 2021 and provides an update on the strategic review of its CHC business.

Extract of audited consolidated results for FY 2021 and FY 2020⁴ 

David Loew, Chief Executive Officer, commented:

“The strong results in 2021 are aligned with our strategic intent, with improving levels of commercial execution reflecting in excellent performances from every major brand. As the replenishment of our pipeline gathered pace, it was an exciting year for business development and our key clinical programs. Furthermore, sharpening our focus on Specialty Care, I am pleased that we have entered into exclusive negotiations to divest our Consumer Healthcare business.

We will continue to grow our business in 2022, and beyond, through our core and innovative brands as we manage the gradual erosion of Somatuline^® while in addition, supporting growth through external innovation. Based on our strategy and our improved execution, we are pleased to update our mid-term outlook, underpinning the strength of Ipsen’s growth story built on our culture and an unrelenting focus on patients.”

Exclusive negotiations to divest the Consumer Healthcare business

Following the decision of its Board of Directors held on 10 February 2022, Ipsen has entered into exclusive negotiations with Mayoly Spindler for the divestment of its global CHC business. This is a major step forward in the Company’s execution of its strategic roadmap presented in December 2020 towards building a more-focused Ipsen, centring on Specialty Care.

The combination of Ipsen’s and Mayoly Spindler’s respective CHC businesses will create a global consumerhealthcare platform with a critical size and the capacity to support its growth. The consideration for Ipsen’s CHC business represents an enterprise value of €350m, including an earnout contingent payment of €50m.

The proposed transaction will be submitted to the relevant employee-representation bodies and is expected to close before the end of Q3 2022, subject to regulatory approvals and customary closing conditions.

Delivering on strategy

Ipsen delivered successfully on its first year of the implementation of its strategy: Focus. Together. For patients and society. The key Specialty Care brands grew across all geographies, and alongside its expanding footprint in 2021, Ipsen began to invest in, and prepare for, a number of future launches.

It was a strong year of advancement of key R&D programs in Oncology, Rare Disease and Neuroscience, enhanced by the completion of seven external-innovation agreements. Ipsen also initiated a global program to drive efficiencies across the entire cost base, which started to deliver savings in 2021.

Further accomplishments were made in the Company Social Responsibility agenda, across the pillars of Employees, Communities and Environment. Ipsen increased the proportion of female leaders, now representing 42% of the full Global Leadership Team. Ipsen also announced the halving of absolute greenhouse-gas emissions of facilities and fleet (Scopes 1 and 2) by 2030, and will work closely with partners to deliver science-based Scope 3 emissions reductions by 2030.

Those achievements were the result of Ipsen’s evolving culture, underpinned by the strengthening of the Executive Leadership Team and the establishment of an asset-centric model. These successes provide excellent platforms for a culture of high performance, improved execution and a better and faster decision-making process.

Comparison of 2021 performance to guidance

Ipsen exceeded its full-year 2021 guidance, upgraded in October 2021:

Full-year 2022 guidance

Ipsen has set its financial guidance for FY 2022, excluding any contribution from the CHC business⁷:

• Total-sales growth greater than 2.0%, at constant currency. Based on the level of exchange rates in January 2022, Ipsen anticipates an additional favorable impact of 2% from currencies  
• Core operating margin greater than 35.0% of total sales, excluding any potential impact of incremental investments from future external-innovation transaction

This guidance incorporates expectations for Somatuline of further launches of generic lanreotide in other countries in the E.U., as well as increased competition in the U.S.

Update of mid-term 2020-24 outlook

Ipsen today updates its outlook for 2020-24 to exclude any contribution from the CHC business⁸ and based on the strong performance delivered in 2021:

• Total-sales 2020-24 compound annual growth rate between +4% and +6%⁹ at constant currency and assuming risk-adjusted potential additional indications
•  Continued commitment to invest in R&D supported by SG&A efficiencies:
  • Reduced SG&A expenses as a percentage of total sales, driven by further focus and optimization
  • Higher R&D expenses as a percentage of total sales, driven by the external-innovation strategy

To support the external-innovation strategy, Ipsen anticipates cumulative remaining firepower of €3.5bn by 2024, including the divestment of the CHC business. The calculation is based on net debt at 2.0 x EBITDA.

Palovarotene

In January 2022, Ipsen announced the first regulatory approval for palovarotene worldwide with Health Canada approving Sohonos^TM (palovarotene capsules). Ipsen plans to make a resubmission for palovarotene in fibrodysplasia ossificans progressiva to the U.S. FDA in H1 2022 and to continue the review process with the European Medicines Agency after the ‘clock-stop’ period. Discussions are progressing with other regulatory authorities around the world.

Business devlopment

In December 2021, Ipsen announced an exclusive licensing agreement for elafibranor, which is in Phase III
development in primary biliary cholangitis (PBC), as part of a long-term global partnership with GENFIT. PBC is
a rare, progressive, chronic autoimmune disease of the liver. Data from the ELATIVE Phase III trial are anticipated
in 2023. Under the agreement, Ipsen will pay GENFIT up to €480m, including an upfront cash payment of €120m.
In total, seven external-innovation agreements were completed in 2021, covering preclinical to late-stage clinical
development as well as each therapeutic area, namely Oncology, Rare Disease and Neuroscience.

Galderma arbitration

Galderma initiated arbitration proceedings against Ipsen at the ICC International Court of Arbitration; arbitrators
were appointed in the fourth quarter of 2021. This request for arbitration is related to Galderma-developed liquid
toxin, QM-1114 for which Ipsen, in its capacity as marketing-authorization holder and owner of the intellectual
property since 2014, has a different view to the regulatory-submission strategy. There is also a difference of
opinion on the territorial scope of the partnership under the 2007 agreement. The outcome of the cases cannot
be predicted at this preliminary stage of the proceedings. Ipsen intends to fully defend and vindicate its rights
against Galderma’s allegations.

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. Compound annual growth rate.
3. Decided by the Ipsen SA Board of Directors; to be proposed at the annual shareholder’s meeting on 24 May 2022.
4. Basis of preparation for reported Financial Statements including the CHC business as continuing operations.
5. Earnings per share.
6. 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.
7. Assuming presentation of the CHC business as discontinued operations starting in 2022 and comparing to the FY 2021 operating performance excluding the contribution of the CHC business (as presented in the section ‘Core Measures excluding contribution from CHC’ thereafter).
8. Assuming presentation of the CHC business as discontinued operations starting in 2022 and comparing to the FY 2020 operating performance, excluding the contribution from the CHC business (as presented in the section ‘Core Measures excluding contribution from the CHC business’ thereafter).
9. Prior outlook, outlined in December 2020, included a total-sales 2020-24 compound annual growth rate of 2% to 5% at CER.

Attachment

• FY-2021-–-Results-announcement