On April 2022 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales performance for the first quarter of 2022 (Presentation, Ipsen, APR 27, 2022, View Source [SID1234613078]).
Highlights
− A strong first-quarter total-sales performance, with growth of 9.6% at CER1
(12.5% as reported) to
€687.9m, driven by Decapeptyl (triptorelin), Dysport (botulinum toxin type A), Cabometyx
(cabozantinib) and Onivyde (irinotecan liposome injection) double-digit growth and flat sales of
Somatuline (lanreotide)
− Confirmation of full-year guidance for 2022, with total-sales growth greater than 2.0% at CER1 and a core
operating margin greater than 35.0% of total sales
− Transaction announced in February 2022 for the divestment of the Consumer HealthCare (CHC) business
anticipated to be completed by end of Q3 2022
Q1 2022 total sales
Total sales in this announcement are unaudited IFRS consolidated sales and reflect Specialty Care sales only,
in accordance with IFRS 5.
First Quarter
2022 2021 % change
€m €m Actual CER1
Oncology 556.4 495.4 12.3% 8.9%
Neuroscience 120.2 103.1 16.6% 15.7%
Rare Disease 11.3 13.1 -13.4% -15.0%
Total 687.9 611.5 12.5% 9.6%
David Loew, Chief Executive Officer, commented:
"The execution of our strategy was reflected in our first-quarter performance across the business. The strong
sales were in line with our expectations, with Decapeptyl, Dysport, Cabometyx and Onivyde all delivering
double-digit growth. Our guidance for the year, which assumes increasing levels of competition for Somatuline,
is underpinned by our strong platform of growth across these core and innovative medicines.
Alongside the anticipated U.S. regulatory resubmission for palovarotene in the first half of the year, we look
forward to a number of important data readouts in the second half, while our pipeline will continue to be
replenished through the external-innovation strategy. It is an exciting time for Ipsen as we deliver on our
strategy, produce strong results, expand our pipeline and focus together, for patients and society."
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
Full-year 2022 guidance
Ipsen today confirms its financial guidance for FY 2022, which excludes any contribution from CHC:
− Total-sales growth greater than 2.0%, at CER2
. Based on the level of exchange rates in Q1 2022, Ipsen
anticipates an additional favorable impact of 2% from currencies in the year
− Core operating margin greater than 35.0% of total sales, excluding any potential impact of incremental
investments from future external-innovation transactions
This guidance incorporates expectations for Somatuline of further launches of generic lanreotide in other
countries in the E.U., as well as increased competition in the U.S.
Ongoing conflict in Ukraine
Ipsen is firmly committed to the safety and care of its employees and to providing essential support and access
to its treatments and medicines for patients.
Since the beginning of the conflict in Ukraine, Ipsen’s immediate actions have been to ensure that all
colleagues are safe and to limit any impact on the supply of medicines. The Company has also provided
humanitarian relief via a donation of €1.5m in favor of two highly reputed humanitarian organizations: Tulipe,
a pharmaceutical distributor managing donations from health companies to meet the emergency needs of
populations in distress, and The Red Cross.
Ipsen’s position is to continue to serve patients with their healthcare needs, regardless of their country origin
and in compliance with applicable laws. In Russia, the Company has, however, suspended several promotional
activities, including advertising. No new clinical trials will be initiated in Russia.
In 2021, Ipsen’s Specialty Care sales in Russia and Ukraine were less than 3.0% of total Specialty Care sales.
Consumer HealthCare
In February 2022, Ipsen announced that it had entered into exclusive negotiations with Mayoly Spindler for the
divestment of its global CHC business, a major step forward in the Company’s execution of its strategic
roadmap towards building a more-focused Ipsen, centering on Specialty Care. Ipsen confirms that the
transaction is anticipated to close by the end of Q3 2022, subject to regulatory approvals and customary closing
conditions.
Conference call
A conference call and webcast for investors and analysts will begin at 2pm Paris time today. Participants should
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 9681287.
Calendar
The Company intends to publish its H1 2022 results on 28 July 2022.
Notes
All financial figures are in € millions (€m). The performance shown in this announcement covers the threemonth period to 31 March 2022 (the quarter or Q1 2022), compared to the three-month period to 31 March
2021 (Q1 2021).
2 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange
rates used for the prior period.
3
Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology,
Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in
over 100 countries. Alongside its external-innovation strategy, 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, excluding its Consumer HealthCare business, has around 4,500 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.
Contacts
Investors
Craig Marks
Vice President, Investor Relations
+44 (0)7584 349 193
Adrien Dupin de Saint-Cyr
Investor Relations Manager
+33 6 64 26 17 49
Media
Mai Tran
Global Communications Director
+ 33 6 64 74 70 80
Ioana Piscociu
Senior Manager, Global Media Relations
+33 6 69 09 12 96
4
Sales by therapeutic area and medicine
Total sales in this announcement are unaudited IFRS consolidated sales and reflect Specialty Care sales only,
in accordance with IFRS 5.
A breakdown of medicine sales by geographical area is shown in the appendix.
First Quarter
2022 2021 % change
€m €m Actual CER3
Oncology 556.4 495.4 12.3% 8.9%
Somatuline 286.0 277.0 3.3% -0.7%
Decapeptyl 129.2 106.3 21.6% 19.0%
Cabometyx 98.9 83.3 18.8% 18.5%
Onivyde 40.1 26.5 51.4% 40.9%
Other Oncology 2.2 2.4 -8.5% -9.2%
Neuroscience 120.2 103.1 16.6% 15.7%
Dysport 118.4 101.8 16.3% 15.2%
Other Neuroscience 1.7 1.3 34.4% 49.8%
Rare Disease 11.3 13.1 -13.4% -15.0%
NutropinAq 7.1 8.5 -15.8% -16.1%
Increlex 4.2 4.6 -9.0% -13.0%
Total Sales 687.9 611.5 12.5% 9.6%
Oncology
Oncology sales of €556.4m represented growth of 8.9%3 and comprised 80.9% of total sales in the quarter
(Q1 2021: 81.0%).
a) Somatuline sales declined by 0.7%3
to €286.0m. In North America, sales fell by 6.9%3
, with
encouraging volume growth supported by continued market-share gains more than offset by adverse
pricing, primarily a result of unfavorable movements in channel mix, as well as changes in wholesalerbuying patterns. In Europe, effects from the launch of generic lanreotide in some European markets
reduced sales growth to 0.4%3
, while sales in the Rest of the World grew by 39.3%3
.
b) Decapeptyl sales of €129.2m represented growth of 19.0%3
, mainly driven by market growth and
inventory in China, along with continued market-share gains in Europe, primarily in France and Italy.
c) Cabometyx sales reached €98.9m, up by 18.5%3
, driven by a strong volume uptake across most
geographies, mainly in the renal cell carcinoma indication.
d) Onivyde sales of €40.1m, growing by 40.9%3
, were primarily driven by sales to Ipsen’s ex-U.S.
partner, as well as market-share gains and volume growth in the U.S.
3 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange
rates used for the prior period.
5
Neuroscience
Neuroscience sales increased by 15.7%4
to €120.2m and comprised 17.5% of total sales in the quarter
(Q1 2021: 16.9%).
Dysport sales reached €118.4m, up by 15.2%4
, driven by a continued strong performance in most aesthetics
markets, including those operated by Ipsen’s partner, Galderma, as well as therapeutics markets in Europe,
North America and the Middle East.
Rare Disease
Rare Disease sales declined by 15.0%4
to €11.3m and comprised 1.6% of total sales in the quarter (Q1 2021:
2.1%).
NutropinAq (somatropin) sales of €7.1m, a decline of 16.1%4
, reflected competitive pressures across Europe.
Increlex (mecasermin) sales of €4.2m, a decrease of 13.0%4
, were impacted by lower demand in the U.S.
Sales by geographical area
A breakdown of medicine sales by geographical area is shown in the appendix.
First Quarter
2022 2021 % change
€m €m Actual CER4
North America 226.4 207.0 9.4% 1.8%
Europe5 304.7 288.8 5.5% 4.8%
Rest of the World 156.9 115.7 35.5% 35.4%
Total Sales 687.9 611.5 12.5% 9.6%
North America
Sales of €226.4m in the quarter reflected growth of 1.8%4
, driven by strong performances from Dysport and
Onivyde, offset by the Somatuline sales decline of 6.9%4
.
North America sales comprised 32.9% of total sales in the quarter (Q1 2021: 33.8%).
Europe
Sales reached €304.7m in the quarter, an increase of 4.8%4
, mainly driven by Decapeptyl’s market-share
uptakes in major countries and Cabometyx, with solid performances in both France and Spain. Effects from
the launch of generic lanreotide in some European markets reduced Somatuline sales growth to 0.4%4
, while
Dysport sales were impacted by shipment phasing to Ipsen’s partner, Galderma.
Sales in Europe comprised 44.3% of total sales in the quarter (Q1 2021: 47.2%).
4 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange
rates used for the prior period.
5
In this announcement, Europe is defined as the E.U., the U.K., Iceland, Liechtenstein, Norway and Switzerland.
6
Rest of the World
Sales reached €156.9m in the quarter, an increase of 35.4%6
, driven by solid volumes growth in Oncology and
Neuroscience. Decapeptyl sales increased by 31.6%6
, reflecting volume uptakes in Asia, partly reflecting
inventory increases in China, while Cabometyx and Somatuline delivered further market-share gains across
several countries. Dysport sales were primarily driven by solid performances in aesthetics markets across all
geographies, as well as continued growth in therapeutics markets.
Rest of the World sales comprised 22.8% of total sales in the quarter (Q1 2021: 18.9%).
Consumer HealthCare
CHC sales of €54.7m, an increase of 14.8%6
, were driven by the growth of Smecta (diosmectite), reflecting
the COVID-19 recovery and the performance in Europe, China and Vietnam.
Total sales in this announcement exclude CHC sales, in accordance with IFRS 5.
6 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange
rates used for the prior period.
7
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 medicine 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 medicine 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 medicine 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 medicine concerned. There can be no guarantees a medicine
will receive the necessary regulatory approvals or that the medicine 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 healthcare
legislation; global trends toward healthcare cost containment; technological advances, new medicine and
patents attained by competitors; challenges inherent in new-medicine 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 medicines; 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
medicines 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 2021 Universal Registration Document,
available on ipsen.com.
8
Appendix: geographic breakdown of total sales by medicine
First Quarter
Total North America Europe7 Rest of the World
2022 2021 % change 2022 2021 % change 2022 2021 % change 2022 2021 % change
€m €m Actual CER8 €m €m Actual CER8 €m €m Actual CER8 €m €m Actual CER8
Oncology 556.4 495.4 12.3% 8.9% 184.3 176.2 4.6% -2.7% 267.9 247.1 8.4% 7.6% 104.3 72.1 44.6% 42.1%
Somatuline 286.0 277.0 3.3% -0.7% 151.5 151.5 0.0% -6.9% 105.5 104.4 1.1% 0.4% 29.0 21.1 37.3% 39.3%
Decapeptyl 129.2 106.3 21.6% 19.0% – – – – 73.7 66.0 11.7% 11.3% 55.5 40.3 37.9% 31.6%
Cabometyx 98.9 83.3 18.8% 18.5% 4.0 3.3 19.0% 10.7% 75.2 69.2 8.8% 8.3% 19.7 10.8 82.7% 85.9%
Onivyde 40.1 26.5 51.4% 40.9% 28.7 21.2 35.0% 25.6% 11.4 5.3 117.4% 103.0% – – – –
Other Oncology 2.2 2.4 -8.5% -9.2% 0.1 0.2 -39.7% -43.9% 2.0 2.3 -12.6% -12.9% 0.1 0.0 n.a. n.a.
Neuroscience 120.2 103.1 16.6% 15.7% 39.5 27.9 41.7% 32.5% 28.4 31.9 -11.0% -11.5% 52.3 43.3 20.8% 24.5%
Dysport 118.4 101.8 16.3% 15.2% 39.5 27.9 41.7% 32.5% 28.4 31.9 -11.0% -11.5% 50.5 42.0 20.4% 23.7%
Other Neuroscience 1.7 1.3 34.4% 49.8% – – – – – – – – 1.7 1.3 34.4% 49.8%
Rare Disease 11.3 13.1 -13.4% -15.0% 2.6 2.9 -10.1% -16.4% 8.4 9.8 -14.5% -14.7% 0.3 0.3 -11.4% -11.4%
NutropinAq 7.1 8.5 -15.8% -16.1% – – – – 6.8 8.2 -16.5% -16.8% 0.3 0.3 7.6% 7.2%
Increlex 4.2 4.6 -9.0% -13.0% 2.6 2.9 -10.1% -16.4% 1.5 1.6 -3.8% -4.0% 0.0 0.1 -67.1% -67.3%
Total Sales 687.9 611.5 12.5% 9.6% 226.4 207.0 9.4% 1.8% 304.7 288.8 5.5% 4.8% 156.9 115.7 35.5% 35.4%
7
In this announcement, Europe is defined as the E.U., the U.K., Iceland, Liechtenstein, Norway and Switzerland.
8 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.

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