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Ipsen Delivers Strong H1 2021 Results and Upgrades Full-Year Guidance

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·29-min read
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PARIS, July 29, 2021--(BUSINESS WIRE)--Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, today announced its financial results for the first half of 2021:

  • Strong financial results

    • Total sales growth in H1 2021 of 11.0% at CER1, or 6.5% as reported, to €1,350.3m

      • Q2 2021 total sales growth of 16.8% at CER1, or 12.7% as reported, to €691.8m

    • Core operating income of €479.8m (H1 2020: €410.2m); IFRS operating income of €412.2m (H1 2020: €249.8m)

    • Core operating margin2: 35.5% (H1 2020: 32.3%). IFRS operating margin: 30.5% (H1 2020: 19.7%)

    • Healthy balance sheet: net debt down to €336.5m, a reduction of €188.7m versus December 2020

  • Delivering against the strategy

    • Maximizing the brands:

      • Speciality Care sales growth in H1 2021 of 11.2%1 to €1,244.5m

      • Consumer Healthcare sales growth in H1 2021 of 8.6%1 to €105.9m

    • Strengthening the pipeline:

      • Good progress in external innovation: agreements announced in early and mid-stage pipeline

      • Regulatory submission acceptance for palovarotene in FOP3 in the U.S. and E.U.

      • Regulatory approval and launch of first-line renal cell carcinoma indication for Cabometyx® (cabozantinib) in combination with nivolumab and positive Phase III results for Cabometyx® in differentiated thyroid cancer

    • Driving efficiencies:

      • Cost savings driven by reduced face-to-face activity as a result of the pandemic, and by some efficiency gains

      • Ratio of SG&A expenses to total sales declined to 35.8% (H1 2020: 37.0%)

    • Focus on culture:

      • Strong momentum with Ipsen’s ambitious CSR4 agenda

  • Full-year guidance upgraded

    • Total sales growth: greater than +8.0%1 (prior guidance: greater than +4.0%1)

    • Core operating margin: around 32.0% (prior guidance: greater than 30.0%)

David Loew, Chief Executive Officer, commented:
"Our strong results reflected the progress we are making with our new strategy. We continued to grow our brands, with particularly strong sales in the second quarter partly a result of the gradual lifting of pandemic confinement measures. We achieved the important regulatory approval and launch of the combination of Cabometyx® with nivolumab in first-line renal cell carcinoma and, while we were disappointed with the recent Phase III data readout in liver cancer, our pipeline continued to strengthen, with the positive Phase III results for Cabometyx® in thyroid cancer and the regulatory submission of palovarotene in FOP. This progress was coupled with recent licensing agreements in the early and mid-stage pipeline. I was also pleased with the efficiencies achieved throughout our business, with the focus on our culture also underpinning more exciting opportunities to benefit patients and society.

Our raised expectations for our full-year results reflect the strength of our business. In the near term, we await further regulatory steps for palovarotene in the U.S. and Europe, while we continue to anticipate launches of generic lanreotide in Europe this year. I expect Ipsen to continue to deliver, driven by a clear strategy, strong fundamentals and attractive growth opportunities, reinforced by an unrelenting focus on serving patients."

Review of results5

H1 2021

€m

Change

Actual

CER6

Total Sales

1,350.3

6.5%

11.0%

Specialty Care

1,244.5

6.6%

11.2%

Consumer Healthcare

105.9

4.7%

8.6%

Core Operating Income

479.8

17.0%

Core operating margin

35.5%

3.2% points

Core Consolidated Net Profit

359.8

21.2%

Core EPS7 (fully diluted)

€4.31

21.3%

IFRS Operating Income

412.2

65.0%

IFRS operating margin

30.5%

10.8% points

IFRS Consolidated Net Profit

303.3

36.2%

IFRS EPS (fully diluted)

€3.64

36.5%

  • Total sales growth in H1 2021 of 11.0% at CER6, or 6.5% as reported, to €1,350.3m. This included an increase in Specialty Care sales of 11.2%6 to €1,244.5m, driven by the growth of Cabometyx®, Decapeptyl® (triptorelin), Somatuline® (lanreotide) and Dysport® (botulinum toxin type A). Consumer Healthcare sales growth of 8.6%6 to €105.9m was partly a result of the reducing effects of the COVID-19 pandemic, particularly in China

  • Core operating income of €479.8m, up by 17.0%, partly reflected the strong growth in total sales and other revenue. The increase in SG&A costs to €483.4m was limited to 3.0%, with cost savings realized in selling expenses, a result of reduced travel, the full effect of virtual conferences and medical meetings, as well as efficiency gains from procurement savings, project prioritization, digital initiatives and manufacturing optimization

  • Core operating margin of 35.5%, an increase of 3.2 percentage points versus the first half of 2020

  • Core consolidated net profit of €359.8m, with growth of 21.2% reflecting the aforementioned increase in core operating income. Core EPS (fully diluted) grew by 21.3% to reach €4.31

  • IFRS operating income of €412.2m after amortization of intangible assets, impairment losses and other operating expenses. An IFRS operating income margin of 30.5% represented an increase of 11 percentage points compared to H1 2020, when an impairment loss on the intangible assets of palovarotene was recognized, following termination of the MO-Ped Phase II trial

  • IFRS consolidated net profit of €303.3m represented an increase of 36.2%. IFRS EPS (fully diluted) was up by 36.5% to €3.64

  • Free cash flow of €291.4m represented an increase of 24.9%, mainly driven by higher operating cash flow and a reduction in current income tax

  • Closing net debt came to €336.5m (H1 2020: €923.3m), with the improvement in H1 2021 primarily reflecting the generation of free cash flow

FY 2021 guidance
The Company today upgrades its financial guidance for FY 2021, which incorporates an assumed progressive global recovery from COVID-19 in the second half of the year. Subsequent to the July 2021 launch of generic lanreotide in Germany, further launches of generic lanreotide in Europe in the second half of the year are also assumed; Ipsen does not, however, anticipate the launch of octreotide or lanreotide generics in the U.S. in 2021.

Total sales

Growth greater than 8.0%8

Core operating margin

Around 32.0%9, excluding any potential impact of
incremental investments from external innovation

Currency impact
Based on the level of exchange rates at the end of June 2021, Ipsen anticipates an adverse impact of approximately 2% from currencies on total sales in FY 2021.

Research and development update
In May 2021, Ipsen announced that its New Drug Application for palovarotene had been accepted by the U.S. Food and Drug Administration (FDA). Palovarotene is an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation). The target regulatory action date assigned by the FDA under Priority Review status is 30 November 2021. Similar applications were accepted by the European Medicines Agency and Swissmedic.

During the period, Ipsen announced that it would exercise its option to collaborate with Exelixis on the COSMIC-311 Phase III pivotal trial of Cabometyx® in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer. Ipsen has an exclusive collaboration agreement with Exelixis for the commercialization of Cabometyx® outside the U.S. and Japan.

In June 2021, Ipsen and Exelixis announced that COSMIC-312, the ongoing pivotal Phase III trial evaluating Cabometyx® in combination with atezolizumab, versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma, met one of the primary endpoints, demonstrating significant improvement in progression-free survival (PFS) at the planned primary analysis. A prespecified interim analysis for the second primary endpoint of overall survival (OS), conducted at the same time as the primary analysis for PFS, showed a trend favoring the combination of Cabometyx® and atezolizumab, but did not reach statistical significance. Based on this preliminary OS data, it is anticipated that the probability of reaching statistical significance at the time of the final analysis is low.

Business development
Ipsen recently announced two agreements in line with its external-innovation focus on strengthening the pipeline:

- BKX-001 (Oncology)
In July 2021, Ipsen announced a licensing agreement with BAKX Therapeutics, providing Ipsen exclusive rights to develop, manufacture and commercialize BKX-001 as a potential treatment for leukemia, lymphoma and solid tumors.

- Mesdopetam (Neuroscience)
Earlier in July 2021, Ipsen also announced a licensing agreement with IRLAB, providing Ipsen exclusive development and commercial rights to mesdopetam, a novel dopamine D3-receptor antagonist, as a potential treatment option for people living with Parkinson’s disease experiencing levodopa-induced dyskinesia.

Company Social Responsibility
Ipsen’s CSR focus is on three areas: Employees, Communities and Environment. Examples of progress in the first half are shown below:

- Employees
Ipsen has established a balanced gender-target ratio for its Global Leadership Team by 2025. A similar timeframe has been established for the Executive Leadership Team at a minimum of 35% of both genders.

- Communities
The Company’s revolving credit facility (RCF) includes a key ESG10 element. Favorable results versus ESG-based targets by Ipsen are rewarded with charitable donations, one of which was recently awarded to International Health Partners, a charity supporting people in some of the world’s most challenging places to get the medicines they need.

- Environment
Ipsen is now using 100% green electricity across its sites in U.K., Ireland and France; 88% of Ipsen’s global electricity usage is now from renewable sources. The Company is also committed to the sustainable consumption of resources and will continue to increase energy efficiency within its operations.

Conference call
A conference call and webcast for investors and analysts will begin at 2:30pm 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 8026207.

Calendar
The Company intends to publish its year-to-date and third-quarter sales update on 21 October 2021.

Notes
All financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2021 (the first half or H1 2021) and the three-month period to 30 June 2021 (the second quarter or Q2 2021), compared to six-month period to 30 June 2020 (H1 2020) and the three-month period to 30 June 2020 (Q2 2020) respectively, unless stated otherwise. Commentary is based on the performance in H1 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 over €2.5bn in FY 2020, Ipsen sells more than 20 medicines in over 115 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.

Total sales by therapeutic area and product

H1 2021

Q2 2021

€m

% of
total
sales
11

Change

€m

Change

Actual

CER12

Actual

CER12

Total Specialty Care

1,244.5

92

6.6%

11.2%

632.9

12.1%

16.2%

Oncology

1,013.1

75

4.7%

8.9%

517.7

9.0%

13.0%

Somatuline®

561.4

42

-0.1%

5.2%

284.5

2.8%

8.0%

Decapeptyl®

222.5

16

15.0%

16.3%

116.2

19.9%

20.6%

Cabometyx®

166.8

12

22.0%

22.9%

83.6

29.8%

30.2%

Onivyde®

57.8

4

-7.6%

1.5%

31.3

-0.1%

9.9%

Other Oncology

4.5

-

-63.4%

-63.6%

2.1

-60.5%

-60.9%

Neuroscience

205.8

15

20.7%

28.3%

102.7

33.2%

38.2%

Dysport®

202.8

15

19.6%

27.1%

101.0

31.8%

36.6%

Rare Disease

25.6

2

-12.0%

-10.1%

12.6

-

2.0%

NutropinAq®

17.0

1

-11.2%

-11.3%

8.6

6.5%

6.0%

Increlex®

8.6

1

-13.6%

-7.7%

4.0

-11.7%

-5.3%

Total Consumer Healthcare

105.9

8

4.7%

8.6%

58.9

19.8%

23.1%

Smecta®

35.7

3

-5.6%

-1.8%

19.4

-2.8%

0.9%

Tanakan®

20.6

2

6.2%

11.8%

12.1

31.1%

34.9%

Forlax®

17.2

1

-12.8%

-11.2%

8.1

-18.0%

-16.8%

Fortrans/Eziclen®

16.7

1

40.9%

47.6%

9.9

97.6%

102.0%

Other Consumer Healthcare

15.7

1

27.0%

29.8%

9.4

85.3%

87.1%

Total Sales

1,350.3

100

6.5%

11.0%

691.8

12.7%

16.8%

Specialty Care
Sales in H1 2021 amounted to €1,244.5m, an increase of 11.2%12. Oncology and Neuroscience sales increased by 8.9%12 and 28.3%12 to €1,013.1m and €205.8m, respectively, while Rare Disease sales declined by 10.1%12 to €25.6m.

Specialty Care comprised 92% of total sales (H1 2020: 92%).

Oncology
Sales of €1,013.1m in H1 2021 represented growth of 8.9%12, reflecting continued market-share gains in most markets, and a market recovery in China underpinned the strong performance of Decapeptyl®, while there were also good results for Cabometyx® and Somatuline® globally.

Oncology sales in H1 2021 comprised 75% of total sales (H1 2020: 76%).

a) Somatuline® sales reached € 561.4 m in H1 2021, an increase of 5.2% 12 , driven by continued market-share gains in most markets and a limited impact from generic-octreotide sales in Europe. North America sales grew by 3.6% 12 , partly a reflection of a strong Q2 2020 performance impacted by end-user buying patterns; the performance in H1 2021 in North America was driven by encouraging volumes.

b) Decapeptyl® sales in H1 2021 of € 222.5 m reflected growth of 16.3% 13, mainly driven by China, which significantly recovered from the initial impacts in 2020 from COVID-19. The good performance in France and rest of Asia was mirrored by market-share gains.

c) Cabometyx® sales in H1 2021 reached € 166.8 m, up by 22.9% 13 , driven by a strong volume uptake across most geographies in both renal cell carcinoma and hepatocellular carcinoma. Following regulatory approval, Cabometyx®, in combination with nivolumab, was recently launched in Germany as a first-line treatment for patients with renal cell carcinoma.

d) Onivyde® sales in H1 2021 of € 57.8 m reflected an increase of 1.5% 13 , driven by higher sales to Ipsen’s ex-U.S. partner, Servier, offset by the impact of the pandemic on cancer treatment in the U.S.

Neuroscience
Dysport® sales reached €202.8m in H1 2021, up by 27.1%13, partly driven by an encouraging recovery from the pandemic in most markets, particularly in the second quarter, as well as a good performance in the North America and Europe therapeutics markets and growing aesthetics markets in Turkey, Russia and the Middle East. There was also a continued solid aesthetics performance from Ipsen’s partner, Galderma, in most of its markets.

Neuroscience sales comprised 15% of total sales in H1 2021 (H1 2020:13%).

Rare Disease
NutropinAq® (somatropin) sales in H1 2021 of €17.0m, a decline of 11.3%13, reflected competitive pressures across Europe. A decline in Increlex® (mecasermin) sales of 7.7%13 to €8.6m was partly a result of lower demand in the U.S., reflecting continued COVID-19 effects.

Rare Disease sales in H1 2021 comprised 2% of total sales (H1 2020: 2%).

Consumer Healthcare
Sales of €105.9m in H1 2021 reflected growth of 8.6%13, with a strong performance complemented by an element of phasing and by the 47.6%13 growth of Fortrans/Eziclen® (macrogol 4000) to €16.7m, mainly reflecting the reduced level of sales in the comparative period, particularly in China. There was also an 11.8%13 increase in sales of Tanakan® (ginkgo biloba extract) to €20.6m, driven by a good performance and a high level of deliveries in Vietnam. Smecta® (diosmectite) sales declined by 1.8%13 to €35.7m, with the recovery in China offset by generic-medicine pressure in France.

Consumer Healthcare sales in H1 2021 comprised 8% of total sales (H1 2020: 8%).

Total sales by geographical area

H1 2021

Q2 2021

€m

Change

€m

Change

Actual

CER14

Actual

CER14

Major Western European Countries

440.7

6.4%

6.6%

223.3

17.4%

17.4%

France

155.4

5.8%

6.7%

80.9

18.8%

20.1%

Germany

102.2

8.7%

8.7%

49.1

12.2%

12.2%

Italy

65.4

7.1%

7.1%

32.5

25.5%

25.5%

Spain

59.1

7.5%

7.5%

30.8

22.6%

22.6%

U.K.

58.6

2.2%

1.6%

30.0

9.7%

6.6%

Other European Countries

257.6

3.4%

8.0%

137.0

17.0%

20.9%

Eastern Europe

118.8

11.0%

19.6%

64.8

30.4%

37.1%

Other Europe

138.8

-2.4%

-0.5%

72.3

7.0%

9.1%

North America

403.0

-3.8%

4.9%

196.1

-3.6%

5.0%

Rest of the World

248.9

33.9%

38.3%

135.4

31.7%

33.4%

Asia

126.3

66.8%

68.6%

72.4

64.0%

65.3%

Other Rest of the World

122.6

11.4%

17.2%

63.1

7.4%

9.7%

Total Sales

1,350.3

6.5%

11.0%

691.8

12.7%

16.8%

Major Western European countries
Sales in H1 2021 reached €440.7m, an increase of 6.6%14. Major Western European countries comprised 33% of total sales in H1 2021 (H1 2020: 33%).

a) France: sales of € 155.4 m, an increase of 6.7% 14 , reflected a solid recovery from the pandemic with continued market-share gains for most Specialty Care medicines, offset by a low diarrhea market, impacting Consumer Healthcare.

b) Germany: sales reached € 102.2 m, up by 8.7% 14 , mainly driven by continued market-share gains for Cabometyx® and Somatuline®, with a limited impact from the sale of generic octreotide.

c) Italy: sales of € 65.4 m, up by 7.1% 14 , with a solid performance of Cabometyx®, along with an improved Consumer Healthcare performance.

d) Spain: sales of € 59.1 m reflected an increase of 7.5% 14 , driven by market-share gains for Somatuline® and Decapeptyl®.

e) U.K.: sales reached € 58.6 m, an increase of 1.6% 14 , driven by solid growth of Somatuline® due to market-share gains, partly offset by lower volumes of Decapeptyl®.

Other European countries
Sales in H1 2021 reached €257.6m, up by 8.0%14, mainly driven by higher Dysport® volumes in Russia and Greece, along with successful launches and market-share gains for Cabometyx®, offset by reduced Consumer Healthcare sales in Eastern Europe.

In H1 2021, sales in other European countries comprised 19% of total sales (H1 2020: 20%).

North America
Sales of €403.0m in H1 2021 reflected growth of 4.9%15, driven by continued growth of Somatuline®, despite an overall adverse impact from the pandemic on cancer treatment. Dysport® sales reflected a good performance in the aesthetics and therapeutics markets, after the significant impact of COVID-19 in H1 2020.

In H1 2021, sales in North America comprised 30% of total sales (H1 2020: 33%).

Rest of the World
Sales in H1 2021 reached €248.9m, an increase of 38.3%15, driven by a China recovery that resulted in strong Decapeptyl® and Consumer Healthcare sales. This was accompanied by a solid Dysport® performance in Latin America, Australia and the Middle East, as well as a good performance from Decapeptyl® in the rest of Asia.

In H1 2021, sales in the Rest of the World comprised 18% of total sales (H1 2020: 15%).

Comparison of core consolidated income statement

Core financial measures are performance indicators. A reconciliation between these indicators and IFRS aggregates is presented in Appendix 4 ‘Bridges from IFRS consolidated net profit to core consolidated net profit’.

H1 2021

€m

% of
total sales

Change

Total Sales

1,350.3

100%

6.5%

Other revenue

64.3

4.8%

66.3%

Total Revenue

1,414.6

104.8%

8.2%

Cost of goods sold

(250.6)

-18.6%

3.6%

Selling expenses

(384.3)

-28.5%

2.4%

Research and development expenses

(207.3)

-15.4%

8.8%

General and administrative expenses

(99.1)

-7.3%

5.4%

Other core operating income

6.6

0.5%

25.1%

Other core operating expenses

-

-

-92.1%

Core Operating Income

479.8

35.5%

17.0%

Net financing expenses

(11.4)

-0.8%

-16.5%

Core other financial income and expenses

(2.5)

-0.2%

-78.8%

Core income taxes

(106.3)

-7.9%

22.7%

Share of net profit/(loss) from equity-accounted companies

0.1

-

-106.0%

Core Consolidated Net Profit

359.8

26.6%

21.2%

- Attributable to attributable to Ipsen SA shareholders

360.5

26.7%

21.7%

- Attributable to non-controlling interests

(0.7)

-0.1%

n.a.

Core EPS (fully diluted): attributable to Ipsen SA shareholders (€)

4.31

-

21.3%

Reconciliation from core consolidated net profit to IFRS consolidated net profit

H1 2021

H1 2020

€m

€m

Core Consolidated Net Profit

359.8

297.0

Amortization of intangible assets (excluding software)

(30.7)

(32.0)

Other operating income and expenses

(16.8)

(14.2)

Restructuring costs

(3.0)

(10.8)

Impairment losses

-

(58.9)

Others

(6.0)

41.7

IFRS Consolidated Net Profit

303.3

222.7

IFRS EPS (fully diluted): attributable to Ipsen SA shareholders (€)

3.64

2.66

Total sales
Total sales grew in H1 2021 by 11.0% at CER16, or 6.5% as reported, to €1,350.3m.

Other revenue
Other revenue totaled €64.3m, an increase of 66.3%, reflecting the growth in royalties paid by partners, mainly by Galderma in respect of Dysport®.

Cost of goods sold
Cost of goods sold of €250.6m represented 18.6% of total sales (H1 2020: €241.8m, 19.1%), reflecting growth of 3.6%. The favorable mix impact of Specialty Care growth continued to drive a decline in the cost of goods sold as a percentage of total sales, despite an increase of royalties paid to partners, notably for Cabometyx®.

Selling expenses
Selling expenses increased by 2.4% to €384.3m, driven by the commercial efforts deployed to support Specialty Care growth, the recovery of activities postponed or cancelled mainly due to COVID-19 as well as the impact of the Company’s efficiency program. Selling expenses represented 28.5% of total sales, a decline of one percentage point.

Research and development expenses
Research and development expenses totaled €207.3m, representing growth of 8.8%. Investment in lifecycle management continued, including in Oncology for Onivyde® and Cabometyx® and in Neuroscience for Dysport®. Potential new medicines also benefited from investment, such as palovarotene in Rare Disease and next-generation neurotoxins in Neuroscience.

General and administrative expenses
General and administrative expenses increased by 5.4% to €99.1m, mainly driven by the reinforcement of the global IT strategy; the ratio to total sales was broadly stable at 7.3%.

Other core operating income and expenses
Other core operating income and expenses amounted to an income of €6.6m (H1 2020 income of €5.1m), primarily reflecting the impact of Ipsen’s currency-hedging policy.

Core operating income
Core operating income amounted to €479.8m, representing growth of 17.0% and comprised 35.5% of total sales (H1 2020: 32.3%).

Core net financing costs and other financial income and expense
Net financial costs declined by 16.5% to €11.4m. Other core financial expenses of €2.5m reflected a fall of 78.8%, mainly driven by favorable foreign-exchange differences and lower hedging costs.

Core income taxes
Core income tax expense of €106.3m, an increase of 22.7%, reflected a core effective tax rate of 22.8% (H1 2020: 22.5%).

Core consolidated net profit
Core consolidated net profit increased by 21.2% to €359.8m, with €360.5m fully attributable to Ipsen SA shareholders.

Core EPS
Core EPS (fully diluted) came to €4.31, representing growth of 21.3%.

From core financial measures to IFRS reported figures

Reconciliations between IFRS June 2021 and June 2020 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) in the first half amounted to €41.0m before tax (H1 2020: €43.9m).

Other operating income and expenses and restructuring costs
Other non-core operating income and expenses in the first half totaled an expense of €22.7m before tax, primarily reflecting Ipsen’s transformation programs, including the discontinuation of deprioritized research programs in line with the Company’s strategy (H1 2020: an expense of €19.2m).

Restructuring costs
Restructuring expenses in the first half amounted to €4.0m. In H1 2020, restructuring costs before tax came to €15.4m, mainly impacted by Consumer Healthcare transformation projects and by the relocation of the Onivyde® manufacturing site from Cambridge, Massachusetts, U.S. to Signes, France.

Impairment losses
No impairment loss or gain was recognized in the first half. In H1 2020, Ipsen recognized an impairment loss of €81.7m before tax, mainly on the intangible assets of palovarotene following the decision to terminate the MO-Ped trial related to the multiple osteochondromas indication.

Others
Other financial income and expenses in the first half included financial income of €2.6m before tax, mainly due to the change in fair value in equity investments. In H1 2020, other financial income and expenses included financial income of €45.0m before tax related to the Contingent Value Right (CVR) and milestones’ revaluation for Clementia.

IFRS financial measures

Operating income
Operating income in the first half totaled €412.2m (H1 2020: €249.8m) with an operating margin of 30.5%, up by 11 percentage points.

Consolidated net profit
Consolidated net profit of €303.3m in the first half represented an increase of 36.2%.

EPS
EPS (fully diluted) in the first half increased by 36.5% to €3.64.

Operating segments: core operating income by therapeutic area

Segmental information is presented according to Ipsen’s two operating segments, Specialty Care and Consumer Healthcare. All costs allocated to these two segments are presented in the key performance indicators. Corporate overhead expenses and the impact of the Company’s currency-hedging policy are not allocated to the two operating segments.

Core operating income is the indicator used by Ipsen to measure operating performance and to allocate resources. Total sales, total revenue and core operating income are presented by therapeutic area for H1 2021 versus H1 2020 in the following table:

H1 2021

Change

€m

€m

%

Specialty Care

Total sales

1,244.5

77.3

6.6%

Total revenue

1,296.3

101.7

8.5%

Core operating income

570.5

67.0

13.3%

Core operating margin

45.8%

Consumer Healthcare

Total sales

105.9

4.7

4.7%

Total revenue

118.3

5.9

5.3%

Core operating income

15.6

10.0

179.9%

Core operating margin

14.7%

Total Unallocated

Core operating income

(106.2)

(7.3)

7.4%

Total

Total sales

1,350.3

82.0

6.5%

Total revenue

1,414.6

107.7

8.2%

Core operating income

479.8

69.7

17.0%

Core operating margin

35.5%

In H1 2021, Specialty Care sales grew to €1,244.5m, up by 6.6% (11.2% at CER17), reaching 92.2% of total sales (H1 2020: 92.0%). Core operating income for Specialty Care increased by 13.3% to €570.5m, representing 45.8% of total sales (H1 2020: 43.1%). The improvement reflected the continued growth of Somatuline® in the U.S. and Europe, Dysport® and Decapeptyl® from COVID-19 recovery, the contribution of Cabometyx®, as well as an increase in research & development investment and in selling expenses.

Consumer Healthcare sales in the first half increased by 4.7% (8.6% at CER17) to €105.9m. Core operating income for Consumer Healthcare amounted to €15.6m, representing 14.7% of total sales (H1 2020: 5.5%), reflecting higher sales that were partly driven by the COVID-19 recovery in China, higher other revenue, coupled with a decline in commercial investments.

Unallocated core operating income in the first half amounted to a negative €106.2m (H1 2020: negative €98.9m), partly a result of the reinforcement of the global IT strategy, somewhat offset by the favorable impact in H1 2021 from the currency-hedging policy.

Net cash flow and financing

Ipsen had a net debt decline of €188.7m in H1 2021, bringing closing net debt to €336.5m.

H1 2021

H1 2020

€m

€m

Opening Net Cash/(Debt)

(525.3)

(1,115.6)

Core Operating Income

479.8

410.2

Non-cash items

74.3

69.4

Change in operating working-capital requirement

(67.5)

(16.8)

(Increase)/decrease in other working capital requirement

(28.7)

(37.8)

Net capex (excluding milestones paid)

(58.2)

(56.3)

Dividends received from entities accounted for using the equity method

-

-

Operating Cash Flow

399.7

368.7

Other non-core operating income and expenses and restructuring costs (cash)

(27.9)

(15.5)

Financial income (cash)

(13.5)

(24.8)

Current income tax (P&L, excluding provisions for tax contingencies)

(67.9)

(99.4)

Other operating cash flow

0.9

4.3

Free Cash Flow

291.4

233.3

Distributions paid

(83.1)

(83.5)

Net investments (business development and milestones)

7.8

(4.4)

Share buyback

(5.8)

(6.1)

FX on net indebtedness and change in earn-out

(22.4)

49.5

Other

0.8

3.5

Shareholders Return and External Growth Operations

(102.6)

(41.0)

Change in Net Cash/(Debt)

188.7

192.3

Closing Net Cash/(Debt)

(336.5)

(923.3)

Operating cash flow
Operating cash flow increased by 8.4% in the first half to €399.7m, driven by higher core operating income (up by €69.7m) and higher working-capital requirements.

Non-cash items increased by 7.1% in the first half to €74.3m (H1 2020: €69.4m) and mainly included the amortization of tangible assets and provisions.

Working-capital requirements for operating activities in the first half increased by €67.5m (H1 2020: €16.8m), mainly from higher trade receivables. Other working-capital requirements increased by €28.7m in the first half, mainly driven by variable compensation payments to colleagues in H1 2021.

Net capital expenditure amounted to €58.2m in the first half (H1 2020: €56.3m), and mainly included projects to increase efficiency at industrial sites in the U.K. and France, along with company investments in IT and digital projects.

Free cash flow
The increase in free cash flow in the first half to €291.4m (H1 2020: €233.3m) was mainly a result of higher operating cash flow combined with lower current income tax.

Shareholders return and external growth operations
In H1 2021, the distribution payout to Ipsen SA shareholders amounted to €82.9m.

Net investments of €7.8m in the first half mainly related to Onivyde®’s commercial milestones received for €20.8m and to the proceeds from the divestiture in equity-accounted companies for €21.4m, partly offset by additional milestone payments of €33.9m to Exelixis.

Foreign exchange on net indebtedness and change in earn-out adversely impacted net debt mainly due to a higher USD versus EUR on indebtedness, compared to a favorable impact of €49.5m on net debt in the first half of 2020, which included the aforementioned CVR and milestone revaluation in respect of Clementia.

Reconciliation of cash and cash equivalents and net cash

H1 2021

H1 2020

€m

€m

Current Financial Assets (derivative instruments on financial operations)

0.2

0.7

Closing Cash and Cash Equivalents

726.1

420.8

Non-current loans

(550.2)

(565.6)

Other financial liabilities (excluding derivative instruments)18

(221.1)

(227.0)

Non-Current Financial Liabilities

(771.3)

(792.6)

Credit lines and bank loans

(150.3)

(267.9)

Financial liabilities (excluding derivative instruments)

(141.2)

(284.3)

Current Financial Liabilities

(291.5)

(552.2)

Debt

(1,062.8)

(1,344.8)

Net Debt19

(336.5)

(923.3)

Analysis of cash

  • On 16 June 2016, Ipsen SA issued €300m in unsecured, seven-year public bonds

  • On 24 May 2019, Ipsen SA signed an initial five-year RCF of €1.5bn, which was extended in 2020 to May 2025, and in 2021 to May 2026

  • On 23 July 2019, Ipsen SA also issued $300m through a U.S. Private Placement (USPP) in two tranches of seven and 10-year maturities

  • Ipsen must comply with a net debt / EBITDA covenant to remain below 3.5 times at each financial closing in both the RCF and the USPP. The RCF also includes specific indicators linked to ESG, assessed annually

  • Ipsen has fully complied with its covenant ratio for the RCF and the USPP

  • On 30 June 2021, the RCF was utilized for €150.3m and the Ipsen SA issuance program of Negotiable EUropean Commercial Paper of €600m was drawn for €100.0m

Appendix 1: consolidated income statement

H1 2021

H1 2020

€m

€m

Total Sales

1,350.3

1,268.3

Other revenue

64.3

38.6

Total Revenue

1,414.6

1,306.9

Cost of goods sold

(250.6)

(241.8)

Selling expenses

(384.3)

(375.4)

Research and development expenses

(207.3)

(190.6)

General and administrative expenses

(99.1)

(94.0)

Other operating income

25.8

8.2

Other operating expenses

(82.9)

(66.2)

Restructuring costs

(4.0)

(15.4)

Impairment losses

(81.7)

Operating Income

412.2

249.8

Investment income

0.6

1.1

Financing expenses

(14.7)

Net financing expenses

(11.4)

(13.6)

Other financial income and expenses

0.1

33.9

Income taxes

(99.0)

(47.5)

Share of net profit/(loss) from equity-accounted companies

0.1

(1.3)

Net profit (loss) from Continuing Operations

302.1

221.3

Net profit (loss) from discontinued operations

1.2

1.4

Consolidated net profit (loss)

303.3

222.7

- Attributable to Ipsen SA shareholders

304.0

221.9

- Attributable to non-controlling interests

(0.7)

0.8

Basic EPS, continuing operations (€)

3.66

2.65

Diluted EPS, continuing operations (€)

3.62

2.65

Basic EPS, discontinued operations (€)

0.01

0.02

Diluted EPS, discontinued operations (€)

0.01

0.02

Basic EPS (€)

3.67

2.67

Diluted EPS (€)

3.64

2.66

Appendix 2: consolidated balance sheet before allocation of net profit

30 June 2021

31 December 2020

€m

€m

ASSETS

Goodwill

604.4

592.8

Other intangible assets

1,142.4

1,121.1

Property, plant & equipment

645.7

646.6

Equity investments

90.3

84.5

Investments in equity-accounted companies

13.8

19.1

Non-current financial assets

24.7

23.1

Deferred tax assets

231.0

247.4

Other non-current assets

4.9

3.8

Total non-current assets

2,757.3

2,738.4

Inventories

232.7

213.9

Trade receivables

554.6

476.2

Current tax assets

91.7

83.6

Current financial assets

2.1

48.9

Other current assets

142.1

113.7

Cash and cash equivalents

737.5

642.5

Assets of disposal group classified as held for sale

3.6

-

Total current assets

1,764.2

1,578.8

TOTAL ASSETS

4,521.5

4,317.2

EQUITY AND LIABILITIES

Share capital

83.8

83.8

Additional paid-in capital and consolidated reserves

2,013.4

1,546.8

Net profit (loss) for the period

304.0

548.0

Foreign exchange differences

(14.6)

(59.6)

Equity attributable to Ipsen SA shareholders

2,386.6

2,119.1

Equity attributable to non-controlling interests

1.7

2.7

Total shareholders' equity

2,388.3

2,121.7

Retirement benefit obligation

56.9

63.7

Non-current provisions

49.3

32.0

Other non-current financial liabilities

771.2

761.6

Deferred tax liabilities

92.1

79.9

Other non-current liabilities

46.6

45.1

Total non-current liabilities

1,016.1

982.3

Current provisions

42.7

45.7

Current financial liabilities

297.0

408.6

Trade payables

518.6

495.2

Current tax liabilities

5.6

10.8

Other current liabilities

241.7

250.0

Bank overdrafts

11.5

2.8

Liabilities related to assets held for sale

Total current liabilities

1,117.0

1,213.1

TOTAL EQUITY & LIABILITIES

4,521.5

4,317.2

Appendix 3.1: consolidated statement of cash flow

30 June 2021

30 June 2020

€m

€m

Consolidated Net Profit

303.3

222.7

Share of profit (loss) from equity-accounted companies

(0.1)

4.3

Net Profit (Loss) before Share from Equity-Accounted Companies

303.2

227.0

Non-Cash and Non-Operating Items:

- Depreciation, amortization, provisions

110.3

116.5

- Impairment losses included in operating income and net financial income

-

81.5

- Change in fair value of financial derivatives

2.3

3.9

- Net gains or losses on disposals of non-current assets

1.5

2.6

- Unrealized foreign-exchange differences

(4.7)

4.0

- Change in deferred taxes

31.1

(51.9)

- Share-based payment expense

18.8

10.6

- Other non-cash items

(7.6)

(39.8)

Cash Flow from Operating Activities before Changes in Working-Capital Requirement

454.9

354.3

- (Increase)/decrease in inventories

(15.9)

(10.2)

- (Increase)/decrease in trade receivables

(68.4)

21.1

- Increase/(decrease) in trade payables

16.7

(27.8)

- Net change in income tax liability

(8.1)

(2.1)

- Net change in other operating assets and liabilities

(22.1)

(41.9)

Change in Working-Capital Requirement Related to Operating Activities

(97.7)

(60.7)

NET CASH PROVIDED (USED) BY OPERATING ACTIVITIES

357.2

293.6

Acquisition of property, plant & equipment

(34.1)

(33.3)

Acquisition of intangible assets

(44.5)

(18.3)

Proceeds from disposal of intangible assets and property, plant & equipment

0.1

-

Acquisition of shares in non-consolidated companies

(7.8)

(3.2)

Payments to post-employment benefit plans

(0.7)

(2.3)

Impact of changes in the consolidation scope

21.4

-

Change in working capital related to investment activities

(14.5)

(7.7)

Other cash flow related to investment activities

2.6

(1.5)

NET CASH PROVIDED (USED) BY INVESTMENT ACTIVITIES

(77.6)

(66.3)

Additional long-term borrowings

12.2

5.7

Repayment of long-term borrowings

(0.7)

(0.7)

Net change in short-term borrowings

(114.5)

(55.7)

Capital increase

-

-

Treasury shares

(5.8)

(6.0)

Distributions paid by Ipsen SA

(82.9)

(83.2)

Dividends paid by subsidiaries to non-controlling interests

(0.2)

(0.3)

Change in working capital related to financing activities

(2.8)

(4.9)

NET CASH PROVIDED (USED) BY FINANCING ACTIVITIES

(194.6)

(145.2)

CHANGE IN CASH AND CASH EQUIVALENTS

85.0

82.1

OPENING CASH AND CASH EQUIVALENTS

639.6

339.0

Impact of exchange rate fluctuations

1.4

(0.3)

CLOSING CASH AND CASH EQUIVALENTS

726.1

420.8

Appendix 3.2: consolidated net cash flow statement

H1 2021

H1 2020

€m

€m

Opening Net Cash/(Debt)

(525.3)

(1,115.6)

CORE OPERATING INCOME

479.8

410.2

Non-Cash Items

74.3

69.4

(Increase)/decrease in inventories

(15.9)

(10.2)

(Increase)/decrease in trade receivables

(68.4)

21.1

Increase/(decrease) in trade payables

16.7

(27.8)

Change in Operating Working-Capital Requirement

(67.5)

(16.8)

Change in income tax liability

(8.2)

(2.1)

Change in other operating assets and liabilities (excluding milestones received)

(20.5)

(35.7)

Other Changes in Working-Capital Requirement

(28.7)

(37.8)

Acquisition of property, plant & equipment

(34.1)

(33.3)

Acquisition of intangible assets (excluding milestones paid)

(10.1)

(8.2)

Disposal of fixed assets

0.1

-

Change in working capital related to investment activities

(14.1)

(14.8)

Net Capex (excluding milestones paid)

(58.2)

(56.3)

Dividends Received from Entities Accounted for Using the Equity Method

-

-

Operating Cash Flow

399.7

368.7

Other non-core operating income and expenses and restructuring costs

(27.9)

(15.5)

Financial income

(13.5)

(24.8)

Current income tax

(67.9)

(99.4)

Other operating cash flow

0.9

4.3

Free Cash Flow

291.4

233.3

Distributions Paid (Including Payout to Non-Controlling Interests)

(83.1)

(83.5)

Acquisition of shares in non-consolidated companies20

(7.8)

(3.4)

Acquisition of other financial assets

-

-

Impact of changes in consolidation scope

21.4

-

Milestones paid21

(34.9)

(2.8)

Milestones received

25.0

1.8

Other business-development operations

4.0

-

Net Investments (Business Development and Milestones)

7.8

(4.4)

Share buyback

(5.8)

(6.1)

FX on net indebtedness and change in earn-out

(22.4)

49.5

Other

0.8

3.5

Shareholders Return and External-Growth Operations

(102.6)

(41.0)

CHANGE IN NET CASH/(DEBT)

188.7

192.3

Closing Net Cash/(Debt)

(336.5)

(923.3)

Appendix 4: bridges from IFRS Consolidated Net Profit to Core Consolidated Net Profit

H1 2021

IFRS

Core

H1 2021

Amortization of
intangible assets
(excl. software)

Other operating
income or
expenses

Restructuring

Impairment
losses

Other

H1 2021

€m

€m

€m

€m

€m

€m

€m

Total Sales

1,350.3

1,350.3

Other revenue

64.3

64.3

Total Revenue

1,414.6

1,414.6

Cost of goods sold

(250.6)

(250.6)

Selling expenses

(384.3)

(384.3)

Research and development expenses

(207.3)

(207.3)

General and administrative expenses

(99.1)

(99.1)

Other operating income

25.8

(19.2)

6.6

Other operating expenses

(82.9)

41.0

41.9

Restructuring costs

(4.0)

4.0

Impairment losses

Operating Income

412.2

41.0

22.7

4.0

479.8

Net financing expenses

(11.4)

(11.4)

Other financial income and expenses

0.1

(2.6)

(2.5)

Income taxes

(99.0)

(10.3)

(5.9)

(0.9)

9.8

(106.3)

Share of profit/(loss) from equity-accounted companies

0.1

0.1

Net Profit/(Loss) from Continuing Operations

302.1

30.7

16.8

3.0

7.2

359.8

Net profit/(loss) from discontinued operations

1.2

(1.2)

Consolidated Net Profit

303.3

30.7

16.8

3.0

6.0

359.8

– Attributable to Ipsen SA shareholders

304.0

30.7

16.8

3.0

6.0

360.5

– Attributable to non-controlling interests

(0.7)

(0.7)

EPS (fully diluted): attributable to Ipsen SA shareholders (€)

3.64

0.37

0.20

0.04

0.00

0.07

4.31

The reconciliation items between core consolidated net profit and IFRS consolidated net profit are described in the paragraph ‘From core financial measures to IFRS reported figures’.

H1 2020

IFRS

Core

H1 2020

Amortization of
intangible assets
(excl. software)

Other operating
income or
expenses

Restructuring

Impairment
losses

Other

H1 2020

€m

€m

€m

€m

€m

€m

€m

Total Sales

1,268.3

1,268.3

Other revenue

38.6

38.6

Total Revenue

1,306.9

1,306.9

Cost of goods sold

(241.8)

(241.8)

Selling expenses

(375.4)

(375.4)

Research and development expenses

(190.6)

(190.6)

General and administrative expenses

(94.0)

(94.0)

Other operating income

8.2

(2.9)

5.3

Other operating expenses

(66.2)

43.9

22.2

(0.2)

Restructuring costs

(15.4)

15.4

Impairment losses

(81.7)

81.7

Operating Income

249.8

43.9

19.2

15.4

81.7

410.2

Net financing expenses

(13.6)

(13.6)

Other financial income and expenses

33.9

(45.5)

(11.6)

Income taxes

(47.5)

(11.9)

(5.0)

(4.6)

(22.8)

5.2

(86.6)

Share of profit/(loss) from equity-accounted companies

(1.3)

(1.3)

Net Profit/(Loss) from Continuing Operations

221.3

32.0

14.2

10.8

58.9

(40.3)

297.0

Net profit/(loss) from discontinued operations

1.4

(1.4)

Consolidated Net Profit

222.7

32.0

14.2

10.8

58.9

(41.7)

297.0

– Attributable to Ipsen SA shareholders

221.9

32.0

14.2

10.8

58.9

(41.7)

296.2

– Attributable to non-controlling interests

0.8

0.8

EPS (fully diluted): attributable to Ipsen SA shareholders (€)

2.66

0.38

0.17

0.13

0.71

(0.50)

3.55

Forward-looking statements
The forward-looking statements, objectives and targets contained herein are based on Ipsen’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 Ipsen’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 Ipsen’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 Ipsen. 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. Ipsen 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 Ipsen 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, Ipsen cannot be certain that favorable results obtained during preclinical 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; Ipsen'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 Ipsen’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen 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 Ipsen’s activities and financial results. Ipsen 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 Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen 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. Ipsen’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 Ipsen’s 2020 Universal Registration Document, available on ipsen.com.

_________________
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 Operating margin defined as a ratio of operating income to total sales.
3 Fibrodysplasia ossificans progressiva.
4 Company social responsibility.
5 Extract of audited consolidated results. The Company’s auditors performed a limited review of the accounts.
6 Excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
7 Earnings per share.
8 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.
9 As a ratio of core operating income to total sales.
10 Environmental, Social, and Governance.
11 Due to rounding, the sum of percentages may not agree to totals.
12 Excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
13 Excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
14 Excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
15 Excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
16 Excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
17 Excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
18 Financial liabilities mainly exclude €4.5m in derivative instruments related to commercial operations (H1 2020: €5.3m).
19 Derivative instruments booked in financial assets and related to financial operations, cash and cash equivalents, less bank overdrafts, bank loans and other financial liabilities and excluding financial-derivative instruments on commercial operations.
20 Acquisition of shares in non-consolidated companies mainly reflected investments in external innovation funds.
21 The milestones paid were recorded as an increase in intangible assets on the consolidation balance sheet. The transactions were included in the ‘Acquisition of intangible assets’ line item in the consolidated statement of cash flow (see Appendix 3.1).

View source version on businesswire.com: https://www.businesswire.com/news/home/20210728006140/en/

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