Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven
biopharmaceutical group, today announced sales for the third
quarter of 2019.
Financial highlights
- Q3 2019 Group sales growth of +16.0% as reported and +14.5%1 at
constant exchange rates and consolidation scope, driven by
Specialty Care sales growth of 16.5%1, reflecting strong
double-digit momentum of Somatuline® (lanreotide) and the continued
growth from Cabometyx® (cabozantinib) and Decapeptyl®
(triptorelin)
- YTD Group sales growth of +15.7% as reported and +14.3%1 at
constant exchange rates and consolidation scope fueled by strong
Specialty Care sales growth of 16.8%1
- Full Year 2019 guidance confirmed with Group sales growth
greater than +14.0% at constant currency and consolidation scope1
and Core Operating margin at around 30.0% of net sales
Recent pipeline
highlights
- Positive interim Phase 1/2 clinical data evaluating Onivyde®
(liposomal irinotecan) as first-line treatment for metastatic
pancreatic cancer presented at ESMO 21st World Congress on
Gastrointestinal Cancer
- Positive interim data from seamless Phase 2/3 clinical trial
evaluating Onivyde as a second-line treatment for small cell lung
cancer (SCLC) presented at the IASLC 2019 World Conference on Lung
Cancer
- FDA approval of Dysport® (abobotulinumtoxinA) for the treatment
of upper limb spasticity in children two years of age and older,
excluding spasticity caused by cerebral palsy (CP)
- In-licensing of BLU-782 from Blueprint Medicines, a highly
selective ALK2 inhibitor in Phase 1 development for the treatment
of fibrodysplasia ossificans progressiva (FOP)
- Palovarotene regulatory submission to the FDA for the episodic
treatment of FOP now expected in Q1 2020 as a result of the
processing of additional supportive data.
Key figures
Unaudited IFRS consolidated
sales
Third Quarter
Nine Months
(in million euros)
2019
2018
%
Variation
%
Variation
at constant
currency and
consolidation
scope1
2019
2018
%
Variation
%
Variation at
constant currency
and consolidation
scope 1
Specialty Care
574.2
484.1
18.6%
16.5%
1,674.1
1,404.2
19.2%
16.8%
Consumer Healthcare2
70.6
71.9
-1.8%
0.1%
200.2
216.2
-7.4%
-2.4%
Group sales
644.7
555.9
16.0%
14.5%
1,874.3
1,620.4
15.7%
14.3%
1 Subsidiaries involved in the partnership between Ipsen and
Schwabe Group are consolidated in accordance with the equity method
starting 1 January, 2019. Year-on-year growth excluding foreign
exchange impact established by recalculating net sales for the
relevant period at the rate used for the previous period.
David Meek, Chief Executive Officer of Ipsen stated: “In
the third quarter, we continued to execute on our objectives with a
strong performance of our Specialty Care business, including
double-digit growth of Somatuline in both the U.S. and Europe. With
our excellent performance year-to-date, we are increasingly
confident in our ability to achieve our 2019 financial
guidance.
“We remain focused on the successful execution of the
palovarotene program to bring the first therapeutic treatment to
FOP patients as expeditiously as possible. We also continue to
deliver on our external innovation strategy. The recent
in-licensing of BLU-782 reinforces our leadership in FOP with a
different and potentially complementary mechanism of action to
palovarotene, expands our portfolio approach in this complex
ultra-rare bone disorder and leverages our clinical and commercial
capabilities. Advancing our pipeline remains a key focus going
forward to deliver on our growth strategy and to bring additional
value to patients and shareholders.”
Third quarter 2019 sales
highlights
Note: Unless stated otherwise, all variations in sales are
stated excluding foreign exchange impacts (currency effects
established by recalculating net sales for the relevant period at
the exchange rates from the previous period)
(in million euros)
2019
2018
% Variation
%
Variation
at constant
currency and
consolidation
scope21
Specialty Care
574.2
484.1
18.6%
16.5%
Somatuline®
264.0
217.0
21.7%
18.8%
Decapeptyl®
98.9
89.2
10.9%
10.5%
Cabometyx®
64.5
38.8
66.5%
66.3%
Onivyde®
26.1
26.9
-3.0%
-7.3%
Dysport®
97.4
87.7
11.0%
8.8%
Consumer Healthcare
70.6
71.9
-1.8%
0.1%
Smecta®
34.1
32.8
4.1%
2.5%
Forlax®
10.5
9.5
10.6%
9.7%
Tanakan®
8.8
9.6
-8.8%
-10.0%
Group sales
644.7
555.9
16.0%
14.5%
Q3 2019 Group sales grew 14.5%1 to €644.7 million.
Sales of Specialty Care products reached €574.2 million,
up 16.5% year-on-year.
Somatuline sales reached €264.0
million, up 18.8%, year-on-year, driven by 20.0% growth in North
America, double-digit growth in key European countries and good
performance in Japan.
Decapeptyl sales reached €98.9
million, up 10.5% year-on-year, driven by volume and market share
gains in Europe and double-digit growth in China.
Cabometyx sales reached €64.5 million,
growing 66.3% year-on-year, driven by the good performance in all
launched European countries and additional launches in Asia and
Oceania.
Onivyde sales reached €26.1 million,
down 7.3% year-on-year, impacted by limited shipments to Ipsen’s
ex-U.S. partner in the third quarter.
Dysport sales reached €97.4 million,
up 8.8% year-on-year, driven by the solid performance in the U.S.
in the therapeutics and aesthetics markets, as well as growth from
Galderma in Europe.
Consumer Healthcare product sales totaled €70.6 million,
stable at +0.1%1, driven by Smecta growth of 2.5%
year-on-year, from the good performance in France and in China
despite the new hospital competitive pricing environment, and
Forlax growth of 9.7% year-on-year. Tanakan sales reached €8.8
million, down 10.0% year-on-year, due to competitive pressure in
emerging countries and a market slowdown in France.
Confirmation of Full Year 2019
guidance
- Group sales growth greater than +14.0% at constant
currency and consolidation scope1
- Impact of currencies estimated at +2.0% based on the current
level of exchange rates
- Impact of consolidation scope reflecting the consolidation
under the equity method for joint arrangements related to the
Schwabe partnership estimated at -1.0%
- Core Operating margin at around 30.0% of net sales
Conference call
Ipsen will hold a conference call Thursday, 24 October 2019 at
2:30 p.m. (Paris time, GMT+2). Participants should dial in to the
call approximately five to ten minutes prior to its start. No
reservation is required to participate in the conference call.
Standard International: +44 (0) 2071-928-000 France and
continental Europe: +33 (0) 1 76 70 07 94 UK: 08-445-718-892 U.S.:
1-6315-107-495 Conference ID: 5649858
A recording will be available for seven days on Ipsen’s
website.
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group
focused on innovation and Specialty Care. The group develops and
commercializes innovative medicines in three key therapeutic areas
- Oncology, Neuroscience and Rare Diseases. Its commitment to
Oncology is exemplified through its growing portfolio of key
therapies for prostate cancer, neuroendocrine tumors, renal cell
carcinoma and pancreatic cancer. Ipsen also has a well-established
Consumer Healthcare business. With total sales over €2.2billion in
2018, Ipsen sells more than 20 drugs in over 115 countries, with a
direct commercial presence in more than 30 countries. Ipsen's
R&D is focused on its innovative and differentiated
technological platforms located in the heart of the leading
biotechnological and life sciences hubs (Paris-Saclay, France;
Oxford, UK; Cambridge, US). The Group has about 5,700 employees
worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the
United States through a Sponsored Level I American Depositary
Receipt program (ADR: IPSEY). For more information on Ipsen, visit
www.ipsen.com.
Forward Looking Statement
The forward-looking statements, objectives and targets contained
herein are based on the Group’s management strategy, current views
and assumptions. Such statements involve known and unknown risks
and uncertainties t hat may cause actual results, performance or
events to differ materially from those anticipated herein. All of
the above risks could affect the Group’s future ability to achieve
its financial targets, which were set assuming reasonable
macroeconomic conditions based on the information available today.
Use of the words "believes", "anticipates" and "expects" and
similar expressions are intended to identify forward-looking
statements, including the Group’s expectations regarding future
events, including regulatory filings and determinations. Moreover,
the targets described in this document were prepared without taking
into account external growth assumptions and potential future
acquisitions, which may alter these parameters. These objectives
are based on data and assumptions regarded as reasonable by the
Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual
results may depart significantly from these targets given the
occurrence of certain risks and uncertainties, notably the fact
that a promising product in early development phase or clinical
trial may end up never being launched on the market or reaching its
commercial targets, notably for regulatory or competition reasons.
The Group must face or might face competition from generic products
that might translate into a loss of market share. Furthermore, the
Research and Development process involves several stages each of
which involves the substantial risk that the Group may fail to
achieve its objectives and be forced to abandon its efforts with
regards to a product in which it has invested significant sums.
Therefore, the Group cannot be certain that favorable results
obtained during pre-clinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will
be sufficient to demonstrate the safe and effective nature of the
product concerned. There can be no guarantees a product will
receive the necessary regulatory approvals or that the product will
prove to be commercially successful. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
forward-looking statements. Other risks and uncertainties include
but are not limited to, general industry conditions and
competition; general economic factors, including interest rate and
currency exchange rate fluctuations; the impact of pharmaceutical
industry regulation and health care legislation; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the Group's ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the Group’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
The Group also depends on third parties to develop and market some
of its products which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to the Group’s activities and financial results. The
Group cannot be certain that its partners will fulfil their
obligations. It might be unable to obtain any benefit from those
agreements. A default by any of the Group’s partners could generate
lower revenues than expected. Such situations could have a negative
impact on the Group’s business, financial position or performance.
The Group expressly disclaims any obligation or undertaking to
update or revise any forward-looking statements, targets or
estimates contained in this press release to reflect any change in
events, conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. The
Group’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers. The risks and uncertainties set out are not exhaustive
and the reader is advised to refer to the Group’s 2018 Registration
Document available on its website (www.ipsen.com).
Comparison of Consolidated Sales for the Third Quarter and
First nine months of 2019 and 2018:
All variations in sales are stated excluding foreign exchange
impacts, established by recalculating net sales for the relevant
period at the rates from the previous period.
Subsidiaries involved in the partnership between Ipsen and
Schwabe Group are consolidated in accordance with the equity method
starting 1 January, 2019. Group and Consumer Healthcare variations
in sales presented below are restated to exclude 2018 sales from
the Schwabe partnership.
Sales by therapeutic area and by product
3rd Quarter
9 Months
(in million euros)
2019
2018
%
Variation
% Variation at
constant currency
and consolidation
scope1
2019
2018
%
Variation
% Variation at
constant currency
and consolidation
scope1
Oncology
460.1
378.7
21.5%
19.5%
1,339.2
1,088.4
23.0%
20.3%
Somatuline®
264.0
217.0
21.7%
18.8%
742.9
619.5
19.9%
16.2%
Decapeptyl®
98.9
89.2
10.9%
10.5%
297.3
272.5
9.1%
8.8%
Cabometyx®
64.5
38.8
66.5%
66.3%
176.3
100.8
75.0%
74.9%
Onivyde®
26.1
26.9
-3.0%
-7.3%
100.5
75.8
32.6%
24.7%
Other Oncology
6.5
6.8
-4.0%
-4.0%
22.1
19.8
11.9%
11.6%
Neuroscience
98.0
88.3
11.1%
8.8%
285.8
262.8
8.7%
7.3%
Dysport®
97.4
87.7
11.0%
8.8%
283.6
260.5
8.9%
7.4%
Rare Diseases
16.0
17.1
-6.3%
-7.2%
49.2
53.1
-7.4%
-8.7%
NutropinAq®
10.2
11.3
-9.2%
-9.0%
32.1
35.4
-9.3%
-9.2%
Increlex®
5.8
5.9
-1.0%
-3.7%
17.1
17.7
-3.5%
-7.6%
Specialty Care
574.2
484.1
18.6%
16.5%
1,674.1
1,404.2
19.2%
16.8%
Smecta®
34.1
32.8
4.1%
2.5%
92.0
95.2
-3.4%
-4.2%
Forlax®
10.5
9.5
10.6%
9.7%
29.5
28.6
3.3%
2.9%
Tanakan®
8.8
9.6
-8.8%
-10.0%
26.4
25.5
3.4%
3.0%
Fortrans/Eziclen®
8.3
8.1
3.1%
1.5%
25.1
22.1
13.6%
12.9%
Other Consumer Healthcare
8.8
11.9
-25.9%
-8.5%
27.2
44.8
-24.3%
-17.0%
Consumer Healthcare
70.6
71.9
-1.8%
0.1%
200.2
216.2
-7.4%
-2.4%
Group Sales
644.7
555.9
16.0%
14.5%
1,874.3
1,620.4
15.7%
14.3%
In the first nine months of 2019, Group sales reached
€1,874.3 million, up 14.3%1, driven by Specialty Care sales growth
of 16.8%, while Consumer Healthcare sales decreased by 2.4%1.
Specialty Care sales amounted to €1,674.1 million, up
16.8%. Oncology and Neuroscience sales grew by 20.3% and 7.3%,
respectively, while Rare Diseases sales decreased by 8.7%. Over the
period, the relative weight of Specialty Care continued to increase
to reach 89.3% of total Group sales, compared to 86.7% in 2018.
In Oncology, sales reached €1,339.2 million, up 20.3%
year-on-year, driven by continued strong performance across major
products and geographies. Over the period, Oncology sales
represented 71.5% of total Group sales, compared to 67.2% in
2018.
Somatuline – Sales reached €742.9
million, up 16.2% year-on-year, driven by 19.8% growth in North
America primarily from volume growth, as well as by continued
double-digit growth in Europe.
Decapeptyl – Sales reached €297.3
million, up 8.8% year-on-year, driven mainly by volume growth in
Major Western European countries, good sales performance in China
and by higher sales in Asia, Middle East and Latin America.
Cabometyx – Sales reached €176.3
million, up 74.9% year-on-year, driven by good performance in all
European countries, as well as launches in Canada and in several
countries in Asia and Oceania.
Onivyde – Sales reached €100.5
million, up 24.7% year on year, including steady growing demand in
the U.S. and higher sales to Ipsen’s ex-U.S. partner.
In Neuroscience, sales of Dysport reached €283.6
million, up 7.4%, driven by the good performance in the U.S. and in
Europe in the therapeutics and aesthetics markets. Over the period,
Neuroscience sales represented 15.2% of total Group sales, compared
to 16.2% in 2018.
In Rare Diseases, sales of NutropinAq reached
€32.1 million, down 9.2% year-on-year, impacted by lower volumes
across Europe. Sales of Increlex reached €17.1 million, down
7.6% year-on-year mainly due to lower demand in the U.S. Over the
period, Rare Diseases sales represented 2.6% of total Group sales,
compared to 3.3% in 2018.
Consumer Healthcare sales reached €200.2 million, down
2.4%, impacted by a decline in Smecta sales of 4.2% year-on-year
mainly due to the new hospital competitive environment in China and
lower performance in Algeria. Fortrans/Eziclen sales were up 12.9%
year-on-year driven by China. Tanakan year-on-year growth reached
3.0%, due to the low 2018 Vietnam baseline and the good performance
in Russia. Over the period, Consumer Healthcare sales represented
10.7% of total Group sales, compared to 13.3% in 2018.
Sales by geographical area
3rd Quarter
9 Months
(in million euros)
2019
2018
%
Variation
% Variation
at constant
currency and
consolidation
scope1
2019
2018
%
Variation
% Variation
at constant
currency and
consolidation
scope1
France
71.2
67.5
5.5%
5.6%
240.1
201.2
19.3%
18.7%
Germany
47.1
42.0
12.2%
18.4%
141.7
133.0
6.5%
17.4%
Italy
27.8
25.5
9.2%
9.2%
87.8
78.6
11.7%
11.7%
Spain
26.3
22.3
17.7%
17.7%
77.1
66.3
16.2%
16.2%
United Kingdom
25.3
24.0
5.5%
6.8%
75.9
70.5
7.6%
7.5%
Major Western European
countries
197.8
181.3
9.1%
10.6%
622.5
549.7
13.2%
15.6%
Eastern Europe
54.7
48.4
12.9%
10.0%
156.2
141.0
10.8%
10.6%
Others Europe
70.7
57.6
22.7%
22.6%
198.4
185.5
7.0%
7.7%
Other European countries
125.4
106.0
18.3%
16.8%
354.6
326.5
8.6%
8.9%
North America
196.3
161.3
21.7%
16.6%
557.3
439.3
26.8%
19.4%
Asia
65.5
56.5
15.9%
14.6%
170.5
150.8
13.1%
11.7%
Other countries in the Rest of
the world
59.7
50.8
17.5%
16.2%
169.4
154.1
9.9%
9.3%
Rest of the World
125.2
107.3
16.7%
15.4%
339.9
304.9
11.5%
10.5%
Group Sales
644.7
555.9
16.0%
14.5%
1,874.3
1,620.4
15.7%
14.3%
Sales in Major Western European countries reached €622.5
million, up 15.6% year-on-year. Over the period, sales in Major
Western European countries represented 33.2% of total Group sales,
compared to 33.9% in 2018.
France – Sales reached €240.1 million,
up 18.7% year-on-year, driven by the continued Cabometyx ramp-up,
sustained growth of Somatuline and Decapeptyl, as well as the
contribution of Onivyde sales to Ipsen’s new ex-U.S. partner since
September 2018.
Germany – Sales reached €141.7
million, up 17.4% year-on-year, driven by Cabometyx supported by
the launch in first-line renal cell carcinoma (RCC) and second-line
hepatocellular cell carcinoma (HCC) and the continued solid volume
growth of Somatuline.
Italy – Sales reached €87.8 million,
up 11.7% year-on-year, mainly driven by the double-digit growth of
Decapeptyl and Somatuline and a solid performance of Cabometyx.
Spain – Sales reached €77.1 million,
up 16.2% year-on-year, driven by the increasing contribution from
Cabometyx and the strong growth of Somatuline.
United Kingdom – Sales reached €75.9
million, up 7.5% year-on-year, driven by the strong performance of
Somatuline and Decapeptyl.
Sales in Other European countries reached €354.6 million,
up 8.9% year-on-year, driven by the launch of Cabometyx in certain
countries, the strong growth of Somatuline and the continued solid
performance of Dysport. Over the period, sales in the region
represented 18.9% of total Group sales, compared to 20.1% in
2018.
Sales in North America reached €557.3 million, up 19.4%
year-on-year driven by continued strong demand growth of
Somatuline, steady growth of Onivyde and Dysport and the
contribution of the launch of Cabometyx in Canada. Over the period,
sales in North America represented 29.7% of total Group sales
compared to 27.1% in 2018.
Sales in the Rest of the World reached €339.9 million, up
10.5% year-on-year, driven by Cabometyx launches in some countries
and the good performance of Decapeptyl partly offset by lower
Consumer Healthcare sales in Algeria and China. Over the period,
sales in the Rest of the World represented 18.1% of total Group
sales compared to 18.8% in 2018.
1 Subsidiaries involved in the partnership between Ipsen and
Schwabe Group are consolidated in accordance with the equity method
starting 1 January, 2019. Year-on-year growth excluding foreign
exchange impact established by recalculating net sales for the
relevant period at the rate used for the previous period.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191023005915/en/
Media Christian Marcoux Senior Vice President,
Global Communications +33 (0)1 58 33 67 94
Christian.marcoux@ipsen.com
Financial Community Eugenia Litz Vice President,
Investor Relations +44 (0) 1753 627721 eugenia.litz@ipsen.com
Fanny Allaire Director, Ipsen France Hub, Global
Communications +33 (0) 1 58 33 58 96 Fanny.allaire@ipsen.com
Myriam Koutchinsky Investor Relations Manager +33 (0)1 58
33 51 04 myriam.koutchinsky@ipsen.com
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