Ipsen Delivers Strong H1 2021 Results and Upgrades Full-Year Guidance
Ipsen (ADR: IPSEY) reported a strong financial performance for H1 2021, with total sales of €1,350.3 million, marking an 11.0% growth at constant exchange rates. Core operating income rose to €479.8 million (up 17.0% from H1 2020), with a core operating margin of 35.5%. Specialty Care sales increased by 11.2% to €1,244.5 million, while Consumer Healthcare grew by 8.6%. The company upgraded its FY 2021 guidance, expecting sales growth>8.0%. Net debt reduced significantly to €336.5 million, a decrease of €188.7 million from December 2020.
- Total sales reached €1,350.3 million, up 11.0% at CER.
- Core operating income increased 17.0% to €479.8 million.
- Core operating margin improved to 35.5%, up 3.2% points.
- Specialty Care sales grew 11.2% to €1,244.5 million.
- Consumer Healthcare sales expanded by 8.6% to €105.9 million.
- Net debt lowered to €336.5 million, reducing €188.7 million since December 2020.
- Full-year sales growth guidance upgraded to >8.0%.
- Disappointing Phase III data readout in liver cancer.
- Cautious outlook for generic launches in the U.S. in 2021.
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, or6.5% as reported, to€1,350.3m -
Q2 2021 total sales growth of
16.8% at CER1, or12.7% as reported, to€691.8m
-
Q2 2021 total sales growth of
-
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
-
Total sales growth in H1 2021 of
-
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
-
Speciality Care sales growth in H1 2021 of
-
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
-
Maximizing the brands:
-
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 than30.0% )
-
Total sales growth: greater than +
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 |
|
|
Specialty Care |
1,244.5 |
|
|
Consumer Healthcare |
105.9 |
|
|
|
|
|
|
Core Operating Income |
479.8 |
|
|
Core operating margin |
|
|
|
Core Consolidated Net Profit |
359.8 |
|
|
Core EPS7 (fully diluted) |
|
|
|
|
|
|
|
IFRS Operating Income |
412.2 |
|
|
IFRS operating margin |
|
|
|
IFRS Consolidated Net Profit |
303.3 |
|
|
IFRS EPS (fully diluted) |
|
|
|
-
Total sales growth in H1 2021 of
11.0% at CER6, or6.5% as reported, to€1,350.3m . This included an increase in Specialty Care sales of11.2% 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 of8.6% 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 by17.0% , partly reflected the strong growth in total sales and other revenue. The increase in SG&A costs to€483.4m was limited to3.0% , 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 of21.2% reflecting the aforementioned increase in core operating income. Core EPS (fully diluted) grew by21.3% 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 of30.5% 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 of36.2% . IFRS EPS (fully diluted) was up by36.5% to€3.64 -
Free cash flow of
€291.4m represented an increase of24.9% , 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 |
|
Core operating margin |
Around |
Currency impact
Based on the level of exchange rates at the end of June 2021, Ipsen anticipates an adverse impact of approximately
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
- 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
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
Total sales by therapeutic area and product
|
H1 2021 |
Q2 2021 |
||||||||||||
€m |
% of
|
Change |
€m |
Change |
||||||||||
Actual |
CER12 |
Actual |
CER12 |
|||||||||||
|
|
|
|
|
|
|
||||||||
Total Specialty Care |
1,244.5 |
92 |
|
|
632.9 |
|
|
|||||||
Oncology |
1,013.1 |
75 |
|
|
517.7 |
|
|
|||||||
Somatuline® |
561.4 |
42 |
- |
|
284.5 |
|
|
|||||||
Decapeptyl® |
222.5 |
16 |
|
|
116.2 |
|
|
|||||||
Cabometyx® |
166.8 |
12 |
|
|
83.6 |
|
|
|||||||
Onivyde® |
57.8 |
4 |
- |
|
31.3 |
- |
|
|||||||
Other Oncology |
4.5 |
- |
- |
- |
2.1 |
- |
- |
|||||||
Neuroscience |
205.8 |
15 |
|
|
102.7 |
|
|
|||||||
Dysport® |
202.8 |
15 |
|
|
101.0 |
|
|
|||||||
Rare Disease |
25.6 |
2 |
- |
- |
12.6 |
- |
|
|||||||
NutropinAq® |
17.0 |
1 |
- |
- |
8.6 |
|
|
|||||||
Increlex® |
8.6 |
1 |
- |
- |
4.0 |
- |
- |
|||||||
|
||||||||||||||
Total Consumer Healthcare |
105.9 |
8 |
|
|
58.9 |
|
|
|||||||
Smecta® |
35.7 |
3 |
- |
- |
19.4 |
- |
|
|||||||
Tanakan® |
20.6 |
2 |
|
|
12.1 |
|
|
|||||||
Forlax® |
17.2 |
1 |
- |
- |
8.1 |
- |
- |
|||||||
Fortrans/Eziclen® |
16.7 |
1 |
|
|
9.9 |
|
|
|||||||
Other Consumer Healthcare |
15.7 |
1 |
|
|
9.4 |
|
|
|||||||
|
||||||||||||||
Total Sales |
1,350.3 |
100 |
|
|
691.8 |
|
|
Specialty Care
Sales in H1 2021 amounted to
Specialty Care comprised
Oncology
Sales of
Oncology sales in H1 2021 comprised
a) Somatuline® sales reached
b) Decapeptyl® sales in H1 2021 of
c) Cabometyx® sales in H1 2021 reached
d) Onivyde® sales in H1 2021 of
Neuroscience
Dysport® sales reached
Neuroscience sales comprised
Rare Disease
NutropinAq® (somatropin) sales in H1 2021 of
Rare Disease sales in H1 2021 comprised
Consumer Healthcare
Sales of
Consumer Healthcare sales in H1 2021 comprised
Total sales by geographical area
|
H1 2021 |
Q2 2021 |
||||||||||
€m |
Change |
€m |
Change |
|||||||||
Actual |
CER14 |
Actual |
CER14 |
|||||||||
|
||||||||||||
Major Western European Countries |
440.7 |
|
|
223.3 |
|
|
||||||
France |
155.4 |
|
|
80.9 |
|
|
||||||
Germany |
102.2 |
|
|
49.1 |
|
|
||||||
Italy |
65.4 |
|
|
32.5 |
|
|
||||||
Spain |
59.1 |
|
|
30.8 |
|
|
||||||
U.K. |
58.6 |
|
|
30.0 |
|
|
||||||
|
|
|
|
|
|
|
||||||
Other European Countries |
257.6 |
|
|
137.0 |
|
|
||||||
Eastern Europe |
118.8 |
|
|
64.8 |
|
|
||||||
Other Europe |
138.8 |
- |
- |
72.3 |
|
|
||||||
|
|
|
|
|
|
|
||||||
North America |
403.0 |
- |
|
196.1 |
- |
|
||||||
|
|
|
|
|
|
|
||||||
Rest of the World |
248.9 |
|
|
135.4 |
|
|
||||||
Asia |
126.3 |
|
|
72.4 |
|
|
||||||
Other Rest of the World |
122.6 |
|
|
63.1 |
|
|
||||||
|
|
|
|
|
|
|
||||||
Total Sales |
1,350.3 |
|
|
691.8 |
|
|
Major Western European countries
Sales in H1 2021 reached
a) France: sales of
b) Germany: sales reached
c) Italy: sales of
d) Spain: sales of
e) U.K.: sales reached
Other European countries
Sales in H1 2021 reached
In H1 2021, sales in other European countries comprised
North America
Sales of
In H1 2021, sales in North America comprised
Rest of the World
Sales in H1 2021 reached
In H1 2021, sales in the Rest of the World comprised
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
|
Change |
|
|
|
|
|
Total Sales |
1,350.3 |
|
|
Other revenue |
64.3 |
|
|
Total Revenue |
1,414.6 |
|
|
|
|
|
|
Cost of goods sold |
(250.6) |
- |
|
|
|
|
|
Selling expenses |
(384.3) |
- |
|
Research and development expenses |
(207.3) |
- |
|
General and administrative expenses |
(99.1) |
- |
|
|
|
|
|
Other core operating income |
6.6 |
|
|
Other core operating expenses |
- |
- |
- |
|
|
|
|
Core Operating Income |
479.8 |
|
|
|
|
|
|
Net financing expenses |
(11.4) |
- |
- |
Core other financial income and expenses |
(2.5) |
- |
- |
Core income taxes |
(106.3) |
- |
|
Share of net profit/(loss) from equity-accounted companies |
0.1 |
- |
- |
|
|
|
|
Core Consolidated Net Profit |
359.8 |
|
|
- Attributable to attributable to Ipsen SA shareholders |
360.5 |
|
|
- Attributable to non-controlling interests |
(0.7) |
- |
n.a. |
|
|
|
|
Core EPS (fully diluted): attributable to Ipsen SA shareholders (€) |
4.31 |
- |
|
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
Other revenue
Other revenue totaled
Cost of goods sold
Cost of goods sold of
Selling expenses
Selling expenses increased by
Research and development expenses
Research and development expenses totaled
General and administrative expenses
General and administrative expenses increased by
Other core operating income and expenses
Other core operating income and expenses amounted to an income of
Core operating income
Core operating income amounted to
Core net financing costs and other financial income and expense
Net financial costs declined by
Core income taxes
Core income tax expense of
Core consolidated net profit
Core consolidated net profit increased by
Core EPS
Core EPS (fully diluted) came to
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
Other operating income and expenses and restructuring costs
Other non-core operating income and expenses in the first half totaled an expense of
Restructuring costs
Restructuring expenses in the first half amounted to
Impairment losses
No impairment loss or gain was recognized in the first half. In H1 2020, Ipsen recognized an impairment loss of
Others
Other financial income and expenses in the first half included financial income of
IFRS financial measures
Operating income
Operating income in the first half totaled
Consolidated net profit
Consolidated net profit of
EPS
EPS (fully diluted) in the first half increased by
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 |
|
|
Total revenue |
1,296.3 |
101.7 |
|
|
Core operating income |
570.5 |
67.0 |
|
|
Core operating margin |
|
|
|
|
|
||||
Consumer Healthcare |
|
|
|
|
Total sales |
105.9 |
4.7 |
|
|
Total revenue |
118.3 |
5.9 |
|
|
Core operating income |
15.6 |
10.0 |
|
|
Core operating margin |
|
|
|
|
|
||||
Total Unallocated |
|
|
|
|
Core operating income |
(106.2) |
(7.3) |
|
|
|
||||
Total |
|
|
|
|
Total sales |
1,350.3 |
82.0 |
|
|
Total revenue |
1,414.6 |
107.7 |
|
|
Core operating income |
479.8 |
69.7 |
|
|
Core operating margin |
|
|
|
In H1 2021, Specialty Care sales grew to
Consumer Healthcare sales in the first half increased by
Unallocated core operating income in the first half amounted to a negative
Net cash flow and financing
Ipsen had a net debt decline of
|
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
Non-cash items increased by
Working-capital requirements for operating activities in the first half increased by
Net capital expenditure amounted to
Free cash flow
The increase in free cash flow in the first half to
Shareholders return and external growth operations
In H1 2021, the distribution payout to Ipsen SA shareholders amounted to
Net investments of
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
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
€1.5b n, 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 |
(12.0) |
(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
|
Other operating
|
Restructuring |
Impairment
|
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
|
Other operating
|
Restructuring |
Impairment
|
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
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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