Ipsen Presents Strong Full-Year 2021 Results and Enters Into Exclusive Negotiations to Divest Its Consumer Healthcare Business

• 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–(BUSINESS WIRE)–Regulatory News:

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

		FY 2021	FY 2020	Change
		€m	€m	Actual	CER1
Total Sales		2,868.9	2,591.6	10.7%	12.3%
Specialty Care		2,643.3	2,381.1	11.0%	12.7%
Consumer Healthcare		225.6	210.6	7.1%	8.1%
Core Operating Income		1,011.3	829.3	21.9%
Core operating margin		35.2%	32.0%	3.2% points
Core Consolidated Net Profit		758.1	610.5	24.2%
Core EPS5 (fully diluted)		€9.09	€7.31	24.5%
IFRS Operating Income		849.5	524.8	61.9%
IFRS operating margin		29.6%	20.2%	9.4% points
IFRS Consolidated Net Profit		646.7	548.9	17.8%
IFRS EPS5 (fully diluted)		€7.76	€6.57	18.1%

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 consumer-healthcare 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:

	FY 2021 guidance	FY 2021 actuals
Total-sales growth	Greater than 11.0%6	12.3%6
Core operating margin	Around 34%	35.2%

Full-year 2022 guidance

Ipsen has set its financial guidance for FY 2022, excluding any contribution from the CHC business^7:

• 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 transactions

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 development

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.

Consolidated financial statements

The Board of Directors approved the consolidated financial statements on 10 February 2022. Ipsen’s auditors performed an audit of the full-year 2021 consolidated financial statements. Ipsen’s Comprehensive audited Financial Statements will be available on 16 February 2022 on ipsen.com (regulated-information section).

Conference call

A conference call and webcast for investors and analysts will begin at 2pm Paris time today. Participants are encouraged to 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 2182326.

Calendar

Ipsen intends to publish its first-quarter sales update on 27 April 2022.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the twelve-month period to 31 December 2021 (the year or FY 2021) and the three-month period to 31 December 2021 (the fourth quarter or Q4 2021), compared to twelve-month period to 31 December 2020 (FY 2020) and the three-month period to 31 December 2020 (Q4 2020) respectively, unless stated otherwise. Commentary is based on the performance in FY 2021, unless stated otherwise.

Ipsen

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience; it also has a well-established Consumer Healthcare business. With total sales of €2.9bn in FY 2021, Ipsen sells more than 25 medicines in over 100 countries, with a direct commercial presence in more than 30 countries. 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 5,700 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.

2021 Financial Statements’ basis of preparation:

As of 31 December 2021, the management did not consider the sale of the Consumer Healthcare business as highly probable within 12 months. Therefore, the CHC business has not been presented as discontinued operations in Group 2021 financial Statements in accordance with IFRS 5. The financial metrics hereafter include CHC as continuing operations.

Total sales by therapeutic area and product
		Fourth Quarter					Full Year
		2021	2020	% change			2021	2020	% change
		€m	€m	Actual	CER10		€m	€m	Actual	CER10
Total Specialty Care		731.0	633.5	15.4%	13.2%		2,643.3	2,381.1	11.0%	12.7%
Oncology		588.1	523.2	12.4%	10.1%		2,153.5	1,969.8	9.3%	10.8%
Somatuline®		328.3	310.1	5.9%	3.6%		1,202.7	1,145.2	5.0%	7.1%
Decapeptyl®		127.0	102.5	23.9%	21.9%		459.6	390.5	17.7%	17.5%
Cabometyx®		96.0	75.3	27.4%	26.3%		354.6	288.9	22.7%	22.8%
Onivyde®		34.4	33.3	3.3%	-0.8%		127.4	123.3	3.3%	7.2%
Other Oncology		2.4	2.1	15.4%	14.2%		9.1	21.8	-58.2%	-58.5%
Neuroscience		131.1	97.6	34.3%	32.3%		440.7	356.1	23.8%	27.1%
Dysport®		129.3	96.3	34.4%	32.4%		434.6	353.2	23.1%	26.3%
Rare Diseases		11.8	12.6	-6.2%	-7.6%		49.1	55.2	-11.0%	-10.4%
NutropinAq®		7.5	8.4	-11.3%	-11.7%		32.0	36.2	-11.5%	-11.8%
Increlex®		4.3	4.2	4.0%	0.3%		17.1	19.0	-10.1%	-7.8%
Total Consumer Healthcare		60.2	56.6	6.3%	3.5%		225.6	210.6	7.1%	8.1%
Smecta®		25.2	22.9	10.0%	5.8%		88.8	80.9	9.7%	10.1%
Tanakan®		8.6	8.6	0.4%	-3.1%		36.6	35.2	3.9%	5.7%
Forlax®		10.1	9.0	12.1%	13.1%		36.0	39.0	-7.9%	-6.8%
Fortrans/Eziclen®		9.9	9.1	9.8%	5.8%		35.9	28.1	28.1%	29.1%
Other Consumer Healthcare		6.2	7.0	-10.9%	-11.0%		28.4	27.4	3.7%	5.1%
Total Sales		791.2	690.1	14.6%	12.4%		2,868.9	2,591.6	10.7%	12.3%

Specialty Care

Specialty Care sales amounted to €2,643.3 million, an increase of 12.7%¹⁰, and comprised 92.1% of total sales (FY 2020: 91.9%).

Oncology

Oncology sales of €2,153.5 million represented a growth of 10.8%¹⁰ and comprised 75.1% of total sales (FY 2020: 76.0%).

1. Somatuline (lanreotide) sales of €1,202.7 million, an increase of 7.1% ¹⁰ , with a 7.4% ¹⁰ growth in North America reflecting strong volumes, even with the residual impact of COVID-19 on patient diagnoses and treatments. The performance was also a result of continued market-share gains in most other geographies with a limited impact from generic octreotide and lanreotide in Europe.
2. Decapeptyl (triptorelin) sales of €459.6 million reflected a growth of 17.5%¹¹, mainly driven by the performance in China, which significantly recovered from the impact of COVID-19, along with market-share gains in other countries including in the rest of Asia, France and Italy.
3. Cabometyx (cabozantinib) sales of €354.6 million, up by 22.8% ¹¹ , driven by a strong volume uptake across most geographies in both renal cell carcinoma and hepatocellular carcinoma indications.
4. Onivyde (irinotecan liposome injection) sales of €127.4 million, growing by 7.2% ¹¹ , driven by higher volumes in the U.S. and to Ipsen’s ex-U.S. partner despite negative impact from COVID-19 on patients.

Neuroscience

Neuroscience sales increased by 27.1%¹¹ to €440.7 million and comprised 15.4% of total sales (FY 2020: 13.7%).

Dysport (botulinum toxin type A) sales reached €434.6 million, up by 26.3%¹¹, driven by a solid recovery from the COVID-19 pandemic in most geographies and a strong performance both in aesthetics markets including in markets operated by Ipsen’s partner, Galderma and in therapeutics markets in Europe and North America.

Rare Disease

Rare Disease sales declined by 10.4%¹¹ to €49.1 million and comprised 1.7% of total sales (FY 2020: 2.1%).

NutropinAq (somatropin) sales of €32.0 million, a decline of 11.8%¹¹, reflected a slowdown in the market and competitive pressures across Europe. Increlex (mecasermin) sales of €17.1 million, a decrease of 7.8%¹¹, resulting from lower demand in the U.S., along with COVID-19 impact.

Consumer Healthcare

Sales of €225.6 million, an increase of 8.1%¹¹, driven by the growth of Smecta (diosmectite) and Fortrans/Eziclen (macrogol 4000) by 10.1%¹¹ and 29.1%¹¹ to €88.8 million and €35.9 million respectively, mainly driven by the COVID-19 recovery and the performance in Europe and China, as well as the growth of Tanakan (ginkgo biloba extract) by 5.7%¹¹ to €36.6 million, driven by the performance in Vietnam.

Consumer Healthcare sales comprised 7.9% of total sales (FY 2020: 8.1%).

Total sales by geographical area
		Fourth Quarter					Year To Date
		2021	2020	% change			2021	2020	% change
		€m	€m	Actual	CER12		€m	€m	Actual	CER12
Major Western European Countries		224.8	208.8	7.6%	6.6%		883.8	824.5	7.2%	6.8%
France		81.2	77.2	5.1%	4.5%		314.3	297.3	5.7%	6.0%
Germany		48.6	44.9	8.4%	8.4%		198.9	191.0	4.1%	4.1%
Italy		33.4	26.1	27.9%	27.9%		130.0	109.1	19.2%	19.2%
Spain		35.4	29.9	18.5%	18.5%		124.6	110.9	12.3%	12.3%
U.K.		26.1	30.6	-14.8%	-20.1%		116.1	116.2	-0.1%	-3.4%
Other European Countries		161.9	136.6	18.5%	17.8%		556.1	500.9	11.0%	13.5%
Eastern Europe		76.0	61.5	23.6%	20.0%		261.4	219.4	19.2%	22.5%
Others Europe		85.9	75.1	14.4%	16.0%		294.7	281.5	4.7%	6.4%
North America		266.5	234.2	13.8%	10.0%		916.3	857.6	6.8%	10.5%
Rest of the World		138.0	110.4	25.0%	21.7%		512.6	408.6	25.4%	26.0%
Asia		63.2	57.3	10.5%	5.8%		252.2	192.9	30.7%	28.9%
Other Rest of the World		74.7	53.2	40.6%	38.4%		260.4	215.7	20.7%	23.4%
Total Sales		791.2	690.1	14.6%	12.4%		2,868.9	2,591.6	10.7%	12.3%

Major Western European countries

Sales reached €883.8 million, an increase of 6.8%¹². Major Western European countries comprised 30.8% of total sales (FY 2020: 31.8%).

1. France: sales of €314.3 million, an increase of 6.0% ¹² , reflecting continued market-share gains for Decapeptyl and Somatuline, along with a solid performance and recovery from the pandemic for Dysport.
2. Germany: sales reached €198.9 million, up by 4.1% ¹² , mainly driven by continued market-share gains for Cabometyx and Somatuline with only a limited impact from the launch of generic lanreotide.
3. Italy: sales of €130.0 million, up by 19.2% ¹² , mainly a result of a solid Cabometyx and Decapeptyl performance.
4. Spain: sales of €124.6 million reflected growth of 12.3% ¹² , driven by market-share gains for Somatuline and Decapeptyl.
5. U.K.: sales reached €116.1 million, a decrease of 3.4% ¹² , mainly due lower volumes of Decapeptyl despite positive performance of Somatuline.

Other European countries

Sales reached €556.1 million, an increase of 13.5%¹², driven by a strong Dysport performance in Russia and Turkey, market-share gains and successful launches of Cabometyx, along with growing Consumer Healthcare sales in Eastern Europe.

Other European countries sales comprised 19.4% of total sales (FY 2020: 19.3%).

North America

Sales of €916.3 million reflected a growth of 10.5%¹³ driven by continued strong Somatuline, Onivyde and Cabometyx demand, despite a residual impact of COVID-19 on patient diagnoses and treatments. Solid Dysport sales reflected good performances in both aesthetics and therapeutics markets.

North America sales comprised 31.9% of total sales (FY 2020: 33.1%).

Rest of the World

Sales reached €512.6 million, an increase of 26.0%¹³, driven by the China recovery that resulted in strong Decapeptyl and Consumer Healthcare sales, a solid Dysport performance in Latin America and the Middle East, continued good Decapeptyl performance in South Korea and Taiwan, along with strong Cabometyx volume growth in Brazil and Mexico.

Rest of the World sales comprised 17.9% of total sales (FY 2020: 15.8%).

Comparison of core consolidated income statement
Core financial measures are performance indicators. Reconciliation between these indicators and IFRS aggregates is presented in Appendix 4 ‘Bridges from IFRS consolidated net profit to Core consolidated net profit’.
		FY 2021		FY 2020		% change
		€m	% of sales	€m	% of sales
Sales		2,868.9	100.0%	2,591.6	100.0%	10.7%
Other revenue		130.2	4.5%	94.5	3.6%	37.8%
Revenue		2,999.1	104.5%	2,686.2	103.6%	11.6%
Cost of goods sold		(538.0)	(18.8)%	(490.6)	(18.9)%	9.6%
Selling expenses		(835.7)	(29.1)%	(784.0)	(30.3)%	6.6%
Research and development expenses		(428.4)	(14.9)%	(405.6)	(15.6)%	5.6%
General and administrative expenses		(199.6)	(7.0)%	(187.8)	(7.2)%	6.3%
Other core operating income		13.9	0.5%	11.8	0.5%	N.A.
Other core operating expenses		(0.1)	—	(0.6)	—	N.A.
Core Operating Income		1,011.3	35.2%	829.3	32.0%	21.9%
Net financing costs		(21.3)	(0.7)%	(24.7)	(1.0)%	(13.8)%
Core other financial income and expense		(14.3)	(0.5)%	(19.6)	(0.8)%	(27.2)%
Core income taxes		(217.9)	(7.6)%	(172.9)	(6.7)%	26.0%
Share of net profit/(loss) from equity-accounted companies		0.4	—	(1.5)	(0.1)%	(124.5)%
Core consolidated net profit		758.1	26.4%	610.5	23.6%	24.2%
– Attributable to shareholders of Ipsen S.A.		758.0	26.4%	609.6	23.5%	24.3%
– Attributable to non-controlling interests		0.1	—	0.9	—	(86.5)%
Core EPS fully diluted – attributable to Ipsen S.A. shareholders (in € per share)		9.09		7.31		24.5%

Reconciliation from core consolidated net profit to IFRS consolidated net profit
		FY 2021	FY 2020
		€m	€m
Core consolidated net profit		758.1	610.5
Amortization of intangible assets (excluding software)		(61.7)	(62.9)
Other operating income and expenses		(36.5)	(13.4)
Restructuring costs		(14.7)	(32.7)
Impairment losses		(6.5)	(109.2)
Others		8.1	156.6
IFRS consolidated net profit		646.7	548.9
IFRS EPS fully diluted – attributable to Ipsen S.A. shareholders (in € per share)		7.76	6.57

Total sales

Total sales grew by 10.7% as reported to €2,868.9 million.

Other revenue

Other revenue totaled €130.2 million an increase of 37.8%, reflecting the growth in royalties paid by partners, mainly by Galderma in respect of Dysport.

Cost of goods sold

Cost of goods sold of €538.0 million represented 18.8% of total sales (FY 2020: €490.6 million, 18.9%), reflecting a growth of 9.6% thanks to the favorable mix impact from Specialty Care growth, despite an increase of royalties paid to partners, notably for Cabometyx.

Selling expenses

Selling expenses increased by 6.6% to €835.7 million, compared to lower 2020 baseline impacted by COVID-19 restrictions. The increase is driven by inflation, the commercial efforts deployed to support Specialty Care growth offset by the impact of the Company’s efficiency program. Selling expenses represented 29.1% of total sales, an improvement of 1.1 points.

Research and development expenses

Research and development expenses totaled €428.4 million, representing a growth of 5,6% driven by investment in Oncology mainly for Onivyde and Cabometyx, in Rare Disease for palovarotene and in Neuroscience notably for next-generation neurotoxins. R&D expenses represented 14.9% of total sales, a decline of 0.7 points.

General and administrative expenses

General and administrative expenses increased by 6.3% to €199.6 million, to support growth platforms in the organization. General and administrative represented 7.0% of total sales, an improvement of 0.3 points.

Other core operating income and expenses

Other core operating income and expenses amounted to an income of €13.8 million (FY 2020: income of €11.2 million), primarily reflecting the impact of Ipsen’s currency-hedging policy.

Core operating income

Core operating income amounted to €1,011.3 million, representing growth of 21.9% and comprised 35.2% of total sales (FY 2020: 32.0%).

Core net financing costs and other financial income and expense

The Group incurred net financial expenses of €35.6 million, versus €44.4 million in 2020.

Net financing costs decreased by €3.4 million to €21.3 million, driven by lower costs mainly attributable to the reduction of the Revolving Credit Facility (“RCF”).

Other financial income and expense decreased by €5.3 million to €14.3 million, mainly from lower hedging costs.

Core income taxes

Core income tax expense of €217.9 million, an increase of 26.0% resulted from a Core effective tax rate of 22.3% (FY 2020: 22.0%).

Core consolidated net profit

Core consolidated net profit increased by 24.2% to €758.1 million with €758.0 million fully attributable to Ipsen S.A. shareholders. This compares to Core consolidated net profit of €610.5 million in 2020, with €609.6 million fully attributable to Ipsen S.A. shareholders.

Core EPS¹⁴

Core EPS fully diluted came to €9.09, representing growth of 24.5% (FY 2020: €7.31).

From core financial measures to IFRS reported figures

Reconciliations between IFRS results and the Core financial measures are presented in Appendix 4.

The main reconciling items between Core consolidated net profit and IFRS consolidated net profit were:

Amortization of intangible assets (excluding software)

Amortization of intangible assets (excluding software) amounted to €82.3 million before tax, compared to €86.5 million before tax in 2020.

Other operating income and expenses

Other non-core operating income and expenses amounted to an expense of €50.

Contacts

Investors
Craig Marks
Vice President, Investor Relations

+44 7584 349 193

Adrien Dupin de Saint-Cyr
Investor Relations Manager

+33 6 64 26 17 49

Media
Gwenan White
Executive Vice President, Communications and Public Affairs

+44 7876 391 429

Ioana Piscociu
Senior Manager, Global Media Relations

+33 6 69 09 12 96

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