Ipsen Delivered Sales Growth and Margin Expansion in 2020 - Focused on Executing New Strategy and Delivering Financial Objectives in 2021

• Solid full year 2020 results in a COVID-19 environment, with Group sales growth of 3.0%¹ and Core Operating margin at 32.0%
• 2021 guidance of Group sales growth greater than 4.0% at constant currency and Core Operating margin greater than 30.0% of the sales
• 2021 priority to execute new Group strategy, highlighted by external innovation efforts to fuel future growth as well as pipeline advancements to maximize the value of Ipsen’s current portfolio

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

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, today announced its financial results for the full year 2020.

• Solid full year 2020 financial results in a COVID-19 environment
  • Group sales of €2.592 million, growing by 3.0%¹ at constant currency or 0.6% as reported, driven by Specialty Care sales growth of 5.9%¹, reflecting a resilient oncology portfolio, while Consumer Healthcare sales were down 21.3%¹ mostly due to the impact of COVID-19.
  • Core Operating margin at 32.0% of the sales, up 1.6 points. IFRS Operating margin at 20.1% of the sales, up 21.4 points.
  • Core consolidated net profit of €610.5 million, with fully diluted Core EPS growing by 8.4% to reach €7.31. IFRS Consolidated net profit showing a gain of €548.9 million, with IFRS net earnings per share of €6.57.
  • Sound financial structure, with a closing Net Debt of €525.3 million and a Net Debt to EBITDA ratio of 0.6x. Strong Free Cash Flow at €646.4 million, up 38%, mainly driven by higher Operating Cash Flow.
• Advancing solid pipeline in H2 2020
  • Cabometyx^® (cabozantinib) in combination with nivolumab for 1L renal cell carcinoma (RCC) filing with EMA based on successful Phase 3 CheckMate -9ER;
  • Onivyde^® (irinotecan liposome injection) received Fast Track designation from the FDA for 2L Small Cell Lung Cancer (SCLC);
  • Palovarotene on track for NDA and MAA submissions for fibrodysplasia ossificans progressiva (FOP).
• Proposed dividend of €1.00 per share² for the 2020 financial year, consistent with the prior year.
• 2021 guidance³ of Group sales growth greater than 4.0% at constant currency and Core Operating margin greater than 30.0% of the sales.
• Executing on new strategy presented in December 2020: Focus. Together. For patients and society.

David Loew, Chief Executive Officer of Ipsen, stated: “I am truly proud of Ipsen’s performance in 2020. We met our financial objectives, delivering steady top-line growth, significant core operating margin expansion and strong cash flow generation to fund our external innovation strategy. The fact these achievements took place against the backdrop of the pandemic is remarkable and speaks to the dedication and patient-centricity of our highly motivated employees. We made encouraging pipeline progress, especially in Oncology. In December we announced our new strategy which will drive long-term value for all our stakeholders: Focus. Together. For patients & society. While the world continues to face uncertain business conditions in 2021, I am confident that Ipsen will build on its strong foundations and execute on its strategy to deliver another successful year.”

New Strategy

Ipsen is executing on the four key pillars of its new strategy presented in December 2020:

• The Group is focused on maximizing the value of its current Specialty Care product portfolio through commercial excellence and geographic expansion. It aims to maximize its core brands and capture the full potential of its innovative oncology products. A strategic review of the Consumer Healthcare business is proceeding.
• Ipsen’s priority is to build a sustainable pipeline to drive long-term growth. Recent initiatives have prioritized the pipeline on the highest potential opportunities and progressed the transformation of the R&D organization. Ipsen is strengthening its external innovation efforts by targeting differentiated medicines in its three core therapeutics areas of Oncology, Rare Disease and Neuroscience, with a broader disease and modality scope than previously defined, and across all stages of clinical development.
• The company is committed to generating efficiencies through a focused and agile operating model. Leveraging smart spending, streamlined operations, manufacturing efficiencies and optimizing digitalization, the Group will be able to reinvest in R&D and external innovation to fuel future growth.
• Patients and society are at the core of Ipsen’s mission, starting with fully engaged employees and a culture of accountability to perform and compete in the long term. Ipsen is highly committed to its corporate social responsibility (CSR) initiatives which are centered around employees, community and the environment, as reflected throughout the organization and in the inclusion of responsibility metrics in management compensation.

Comparison of 2020 performance with financial objectives

The Group exceeded its Full Year 2020 guidance provided in July 2020 as shown in the table below:

2021 Financial guidance

The Group has set the following financial targets for the current year, assuming a progressive recovery from COVID-19 by H2 2021:

• Group sales growth year-on-year greater than 4.0% at constant currency¹, with an expected negative 3.0% impact of currency based on the level of exchange rates at the end of January 2021;
• Core Operating margin greater than 30.0% of the sales, excluding any potential impact of incremental investments from external innovation.

This guidance assumes a phased launch of lanreotide generic in Europe by mid-2021 and a limited impact in case of a potential launch of octreotide or lanreotide generics in the U.S.

Review of full year 2020 results

Extract of audited consolidated results for the full year 2020 and 2019

Group sales reached €2,591.6 million, up 3.0%¹ year-on-year.

Specialty Care sales reached €2,381.1 million, up 5.9%¹, driven by the continued strong growth of Somatuline^® (lanreotide) and Cabometyx. Somatuline growth of 13.1%1 was driven by continued positive momentum in North America with a double-digit growth (17.0%¹) and solid performance throughout Europe despite the availability of the octreotide generic. Dysport^® (botulinum toxin type A) down by 3.4%¹, was impacted in most geographies by the closure of treatment centers resulting from COVID-19 despite a faster recovery in the aesthetics market. Decapeptyl^® (triptorelin) sales reflected good volume growth across Major European countries offset by lower volumes in China.

Consumer Healthcare sales reached €210.6 million, down 21.3%¹, mainly due to a decline in Smecta^® (diosmectite) sales impacted by COVID-19, the implementation of hospital central procurement in China and lower performance in France.

Core Operating Income reached €829.3 million in 2020, compared to €782.6 million in 2019, a growth of 6.0%, driven by sales growth, Group-wide efficiencies and costs savings with less travel, medical and marketing expenses due to COVID-19 partially offset by continued investment in R&D to advance key programs in Oncology, Rare Disease and Neuroscience.

Core Operating margin reached 32.0% of the sales, up 1.6 points compared to 2019.

Core consolidated net profit was €610.5 million in 2020, an increase of 8.4% versus €563.4 million in 2019, driven by higher Core Operating Income.

Fully diluted Core EPS (earnings per share) grew by 8.4% to reach €7.31, compared to €6.74 in 2019.

IFRS Fully diluted EPS was a net profit per share amounting to €6.57 versus a net loss of €0.61 in 2019.

Free Cash Flow reached €646.4 million, up by €178.7 million, mainly driven by higher Operating Cash Flow thanks to a lower level of capital expenditures and working capital partly offset by higher cash out from restructuring costs, financial result and current income tax.

Closing net debt reached €525.3 million at the end of 2020, as compared to closing net debt in 2019 of €1,115.6 million.

Conference call

Ipsen will hold a conference call Thursday, 11 February 2021 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately five to ten minutes prior to its start. No reservation is required to participate in the conference call.

Participants can register for the call on the link below:
http://emea.directeventreg.com/registration/8302029

Webcast link:
fullyear2020-ipsen.online-event.fr

Standard International: +44 (0) 2071 928 000
France and continental Europe: +33 (0) 1 76 70 07 94
UK: 08445 718 892
U.S.: (631) 510-7495

Conference ID: 8302029

A recording will be available for seven days on Ipsen’s website.

About Ipsen
Ipsen is a global mid-size biopharmaceutical company with a focus on transformative medicines in Oncology, Rare Disease and Neuroscience. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2020, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US; Shanghai, China). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.fr.

Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes", "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2019 Registration Document available on its website (www.ipsen.com).

Comparison of Consolidated Sales for the Fourth Quarter and Full Year 2020 and 2019

Sales by therapeutic area and by product

Full Year 2020 sales highlights

Group sales reached €2,591.6 million, up 3.0%¹, driven by Specialty Care sales growth of 5.9%¹, while Consumer Healthcare sales decreased by 21.3%¹.

Specialty Care sales amounted to €2,381.1 million, up 5.9%¹. Oncology sales grew by 8.5%¹ while Neuroscience and Rare Disease sales decreased by 3.3%¹ and 12.7%¹, respectively. Over the period, the relative weight of Specialty Care reached 91.9% of total Group sales, compared to 89.3% in 2019.

In Oncology, sales reached €1,969.8 million, up 8.5%¹ year-on-year, mainly driven by solid performance of Somatuline and Cabometyx partially offset by lower Decapeptyl sales in China due to COVID-19 and lower Onivyde sales to Ipsen’s ex-U.S. partner. Over the period, Oncology sales represented 76.0% of total Group sales, compared to 71.6% in 2019.

Somatuline – Sales reached €1,145.2 million, up 13.1%¹ year-on-year, driven by a 17.0%¹ increase in North America from solid volume growth despite adverse impacts of COVID-19 on patient diagnoses and treatment. Sales performance also reflected continued market share gains in most other geographies with a limited impact from the octreotide generic in Europe.

Decapeptyl – Sales reached €390.5 million, down 3.1%¹ year-on-year, mainly due to lower sales in China impacted by COVID-19 and competitive pressure offset by solid volume growth in Major Western European countries and Korea despite the impact of COVID-19 pandemic.

Cabometyx – Sales reached €288.9 million, up 20.8%¹ year-on-year, driven by strong volume uptake across all geographies.

Onivyde – Sales reached €123.3 million, down 6.8%¹, due to a significant decline in sales to Ipsen’s ex-U.S. partner offset by growth in the U.S. despite COVID-19 impacting demand.

In Neuroscience, sales of Dysport reached €353.2 million, down 3.4%¹, impacted in most geographies by the closure of treatment centers and fewer injections resulting from COVID-19, despite a faster recovery in the aesthetics market. Over the period, Neuroscience sales represented 13.7% of total Group sales, compared to 15.2% in 2019.

In Rare Disease, sales of Nutropin AQ^® (somatropin) reached €36.2 million, down 13.2%¹ year-on-year, impacted by the market slowdown and competitive pressure across Europe. Sales of Increlex^® (mecasermin) reached €19.0 million, down 11.8%¹ year-on-year, mainly due to lower demand in the U.S. and impact from COVID-19. Over the period, Rare Disease sales represented 2.1% of total Group sales, compared to 2.5% in 2019.

Consumer Healthcare sales reached €210.6 million, down 21.3%¹, driven by a decrease of 33.0%¹ of Smecta sales significantly impacted by COVID-19, and the declining diarrhea market in all geographies due to social distancing measures from the pandemic. Smecta sales were also negatively impacted by the implementation of hospital central procurement in China and a lower performance in France. Fortrans/Eziclen^® (macrogol 4000) sales were down 20.6%¹ year-on-year, mainly due to the impact of COVID-19 in Eastern Europe, Russia and China. Tanakan^® (ginkgo biloba extract) sales were up 0.8%¹ year-on-year, driven by positive market dynamics in Russia. Over the period, Consumer Healthcare sales represented 8.1% of total Group sales, compared to 10.7% in 2019.

Sales by geographical area

Sales in Major Western European countries reached €824.5 million, down 1.1%¹ year-on-year. Over the period, sales in Major Western European countries represented 31.8% of total Group sales, compared to 32.4% in 2019.

France – Sales reached €297.3 million, down 7.3%¹ year-on-year, mainly due to the negative impact of COVID-19 on Consumer Healthcare products along with lower Onivyde sales to Ipsen’s ex-U.S. partner offset by continued solid volume growth of Cabometyx, Somatuline and Decapeptyl.

Germany – Sales reached €191.0 million, up 1.6%¹ year-on-year, driven by continued solid volume growth of Somatuline, with limited impact from the octreotide generic, and the strong performance of Cabometyx offset by lower volumes of Decapeptyl and Dysport impacted by COVID-19.

United Kingdom – Sales reached €116.2 million, up 11.8%¹ year-on-year, driven by solid performance across the Oncology portfolio slightly offset by lower Dysport impacted by COVID-19.

Spain – Sales reached €110.9 million, up 4.7%¹ year-on-year, driven by the growth of the Oncology portfolio with continued market share gains despite COVID-19.

Italy – Sales reached €109.1 million, down 5.7%¹ year-on-year, due to lower sales of Consumer Healthcare, Decapeptyl, Somatuline and Dysport impacted by COVID-19 despite solid Cabometyx growth.

Sales in Other European countries reached €500.9 million, up 4.3%¹ year-on-year, driven by the performance of Cabometyx and Somatuline in several countries including Russia, Greece and Poland. Over the period, sales in the region represented 19.3% of total Group sales, compared to 19.4% in 2019.

Sales in North America reached €857.6 million, up 12.7%¹ year-on-year, driven by the continued strong demand of Somatuline and the steady sales of Onivyde, despite a negative COVID-19 impact. Dysport sales remain stable with a decline in the therapeutics market due to COVID-19 offset by a fast recovery of the aesthetics market. Over the period, sales in North America represented 33.1% of total Group sales, compared to 30.1% in 2019.

Sales in the Rest of the World reached €408.6 million, down 7.2%¹ year-on-year, driven by the negative impact of COVID-19 affecting Smecta and Decapeptyl in China and Dysport in both aesthetics and therapeutics markets partly offset by the growth of Cabometyx and Somatuline across most geographies. Over the period, sales in the Rest of the World represented 15.8% of total Group sales, compared to 18.0% in 2019.

Comparison of Core consolidated income statement for 2020 and 2019

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”.

Financial Community
Eugenia Litz
Vice President, Investor Relations
+44 (0) 1753 627721
eugenia.litz@ipsen.com

Adrien Dupin de Saint Cyr
Investor Relations Manager
+33 (0)1 58 33 55 34
adrien.dupin.de.saint.cyr@ipsen.com

Media
Fanny Allaire
Director, Global Communications
+33 (0) 1 58 33 58 96
fanny.allaire@ipsen.com