- Group sales up 7.9%1 driven by solid 12.0%1
growth of Specialty care, notably due to Somatuline®
- Core Operating Income up 3.5%, in view of the investment in
neuroendocrine tumors
- Fully diluted core EPS up 7.0%
- 2015 objectives raised
Company Website:
http://www.ipsen.com
PARIS -- (Business Wire)
Regulatory News:
The Board of Directors of Ipsen (Euronext: IPN; ADR: IPSEY), chaired by
Marc de Garidel, met on 30 July 2015 to approve the financial statements
for the first half 2015, published today. The interim financial report,
with regard to regulated information, is available on the Group's
website, www.ipsen.com,
under the Regulated Information tab in the Investor Relations section.
The 2015 half year financial statements are subject to a limited review
by statutory auditors.
Extract of consolidated results for the first halves 2015 and
2014 | |
|
|
|
|
|
|
|
|
|
| |
(in million euros) |
|
| H1 2015 |
|
| H1 2014 |
|
| % change | |
Specialty care sales |
|
|
548.9
|
|
|
472.5
|
|
|
+12.0%1 | |
Primary care sales |
|
|
165.0
|
|
|
166.1
|
|
|
-3.7%1 | |
Group sales |
|
|
713.9
|
|
|
638.7
|
|
|
+7.9%1 | |
Core Operating Income |
|
|
167.6
|
|
|
162.0
|
|
|
+3.5%
| |
Core operating margin |
|
| 23.5% |
|
| 25.4% |
|
|
| |
|
|
|
|
|
|
|
|
|
| |
Consolidated net profit |
|
| 90.5 |
|
| 104.5 |
|
|
-13.4%
| |
Core EPS – fully diluted (€) |
|
| 1.50 |
|
| 1.40 |
|
|
+7.0%
| |
|
|
|
|
|
|
|
|
|
| |
Net operating cash-flow |
|
|
36.2
|
|
|
54.7
|
|
|
-33.8%
| |
Closing cash |
|
|
87.8
|
|
|
129.0*
|
|
|
-31.9%
| |
| | | | | | | | | |
|
* As of 30 June 2014, net closing cash included € 80m withdrawn from the
syndicated credit facility
Commenting on the first half 2015 performance, Marc de Garidel,
Chairman and Chief Executive Officer of Ipsen, stated: "Ipsen
posted a strong specialty care performance in the first half 2015.
Dysport® continues to benefit from solid
performance in aesthetics while Somatuline®
posted double digit growth across all geographies, with a remarkable
growth in North America. The good Somatuline®
momentum following the launch in neuroendocrine tumors (NET) allows us
to raise our specialty care sales and profitability objectives for
2015.” Marc de Garidel added: "We are pleased with
the recent FDA approval of Dysport® in adult
upper limb spasticity, which is a key step in our ambition to become
global leaders in the treatment of spasticity”.
1 Year-on-year sales growth excluding foreign exchange impacts
Review of the first half 2015 results
Note: unless stated otherwise, all variations in sales are stated
excluding foreign exchange impacts and are computed by restating the H1
2014 sales with the H1 2015 exchange rates.
In the first half 2015, Group sales reached €713.9 million, up
7.9% year-on-year. Specialty care sales reached €548.9 million,
up 12.0%, driven by:
-
The strong performance of Somatuline® in Europe and North
America;
-
The solid growth of Dysport®, driven by product supply to
Galderma for aesthetic use;
Decapeptyl® sales grew 0.8% over the period, negatively
impacted in the second quarter in China by a market slowdown and price
pressure in some regions.
In the first half 2015, primary care reached €165.0 million, down
3.7% year-on-year. Sales declined 7.7% in France, and 2.3%
internationally, affected by the setup of a new commercial model in
Algeria (where Ipsen now supplies the active ingredient instead of the
finished product) and by Smecta® and Tanakan®
sales decrease in China and Russia.
Core Operating Income totaled €167.6 million in the first half of
2015, up 3.5%. Core operating margin reached 23.5%, down 1.9 points
compared to the first half 2014, mainly impacted by the dilutive effect
resulting from the setup of an oncology sales force and the marketing
and medical investments necessary to promote Somatuline® Depot®
(lanreotide) 120 mg Injection in the United States in the treatment of
gastrointestinal and pancreatic neuroendocrine tumors (GEP NETs).
As of 30 June 2015, the Group recorded a €57 million impairment loss
to fully impair the intangible asset related to tasquinimod following
the decision to stop all clinical trials with the product as publicly
announced on 16 April, 2015.
Consolidated net profit was down 13.4% over the period. Core
earnings per share (see Appendix 4) grew 7.0% year-on-year to reach
€1.50 as of 30 June 2015, compared to €1.40 as of 30 June 2014.
Net operating cash-flow generated over the first half 2015
reached €36.2 million, compared to €54.7 million over the first half
2014, driven by an increase of the working capital requirement for
operating activities of €106.8 million in the first half 2015, compared
to an increase of €73.3 million in the first half 2014.
Closing cash reached €87.8 million over the period, after
dividend payment for €70.0 million, external growth for €37.3 million
with the acquisitions of OctreoPharm Sciences and Canbex Therapeutics,
and share buyback for €3.9 million. As of 30 June 2014, closing cash
reached €129.0 million, which included €80 million drawn from the
Group's syndicated credit line.
2015 objectives
The Group revises its objectives for 2015:
-
Upgrade of the Specialty care sales growth guidance at or above
14.0% year-on-year, driven by the strong performance of Somatuline®
following the launch in neuroendocrine tumors in the US and Europe;
-
Confirmation of the Primary care sales decline guidance between
-3.0% and 0.0% year-on-year;
As a result, the Group expects sales to grow above 9.5%.
-
Upgrade of the Core Operating margin guidance at or above 22.0% of
Group sales, reflecting the growth of specialty care and the
investments required to support the global launch of Somatuline®
and that of Dysport® in the US.
|
|
|
|
|
|
|
|
|
| |
|
|
| FY15 guidance (as of 03 March 2015)
|
|
| FY15 guidance (as of 29 April 2015)
|
|
| FY15 guidance (as of 31 July 2015)
| |
Specialty care sales growth
|
|
|
8.0% – 10.0%
|
|
|
10.0% – 12.0%
|
|
|
≥ 14.0%
| |
Primary care sales growth
|
|
|
(3.0%) – 0.0%
|
|
|
(3.0%) – 0.0%
|
|
|
(3.0%) – 0.0%
| |
Core Operating margin
|
|
|
19.0% – 20.0%
|
|
|
21.0% – 22.0%
|
|
|
≥ 22.0%
| |
| | | |
|
| |
|
| | |
Sales objectives are set at constant currency and drug-related sales
(active substances and raw materials) are from now on recorded in the
Primary Care sales line.
Update on the share buyback program initiated
on 3 June 2015
The board of Directors held on 30 July 2015 decided that the free share
plans could be covered not only through issuance of new shares but also
through the acquisition of existing shares. As a result, the 500 000
shares, or about 0.60% of the share capital, to be purchased within the
share buyback program initiated on 3 June 2015(1), which were
originally intended for cancellation to compensate dilution, will now be
allocated to cover the aforementioned free share plans. The shares
purchased within this program by 30 July 2015 will be cancelled.
(1) Mandate granted to Natixis, initiated on 3 June 2015 and
expiring 31 December 2015 (Press release issued on 3 June 2015)
Meeting, webcast and Conference Call (in English) for the financial
community
Ipsen will host an analyst meeting on Friday 31 July 2015 at 2:30 p.m.
(Paris time, GMT+1) at its headquarters in Boulogne-Billancourt
(France). A web conference (audio and video webcast) and conference call
will take place simultaneously. The web conference will be available at www.ipsen.com.
Participants in the conference call should dial in approximately 5 to 10
minutes prior to its start. No reservation is required to participate.
The conference ID is 954323. No access code is required. Phone
numbers to call in order to connect to the conference are: from France
and continental Europe +33 (0)17 0993 209, from UK +44 (0)207 1312 711
and from the United States +1 646 461 1757. A recording will be
available shortly after the call. Phone numbers to access the replay of
the conference are: from France and continental Europe +33 (0)17 0993
529, from UK +44 (0)207 031 4064 and from the United States +1 954 334
0342 and access code is 954323. This replay will be available for
one week following the meeting.
About Ipsen
Ipsen is a global specialty-driven biotechnological group with total
sales exceeding €1.2 billion in 2014. Ipsen sells more than 20 drugs in
more than 115 countries, with a direct commercial presence in 30
countries. Ipsen’s ambition is to become a leader in specialty
healthcare solutions for targeted debilitating diseases. Its development
strategy is supported by 3 franchises: neurology, endocrinology and
urology-oncology. Ipsen’s commitment to oncology is exemplified through
its growing portfolio of key therapies improving the care of patients
suffering from prostate cancer, bladder cancer and neuro-endocrine
tumors. Ipsen also has a significant presence in primary care. Moreover,
the Group has an active policy of partnerships. Ipsen's R&D is focused
on its innovative and differentiated technological platforms, peptides
and toxins, located in the heart of the leading biotechnological and
life sciences hubs (Les Ulis, France; Slough/Oxford, UK; Cambridge, US).
In 2014, R&D expenditure totaled close to €187 million, representing
about 15% of Group sales. The Group has more than 4,500 employees
worldwide. Ipsen’s shares are traded on segment A of Euronext Paris
(stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service
de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index.
Ipsen has implemented a Sponsored Level I American Depositary Receipt
(ADR) program, which trade on the over-the-counter market in the United
States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
Ipsen Forward Looking Statement
The forward-looking statements, objectives and targets contained herein
are based on the Group’s management strategy, current views and
assumptions. Such statements involve known and unknown risks and
uncertainties that may cause actual results, performance or events to
differ materially from those anticipated herein. All of the above risks
could affect the Group’s future ability to achieve its financial
targets, which were set assuming reasonable macroeconomic conditions
based on the information available today. Use of the words "believes,"
"anticipates" and "expects" and similar expressions are intended to
identify forward-looking statements, including the Group’s expectations
regarding future events, including regulatory filings and
determinations. Moreover, the targets described in this document were
prepared without taking into account external growth assumptions and
potential future acquisitions, which may alter these parameters. These
objectives are based on data and assumptions regarded as reasonable by
the Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual results
may depart significantly from these targets given the occurrence of
certain risks and uncertainties, notably the fact that a promising
product in early development phase or clinical trial may end up never
being launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. The Group must face or might face
competition from generic products that might translate into a loss of
market share. Furthermore, the Research and Development process involves
several stages each of which involves the substantial risk that the
Group may fail to achieve its objectives and be forced to abandon its
efforts with regards to a product in which it has invested significant
sums. Therefore, the Group cannot be certain that favourable 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 2014 Registration Document available on
its website (www.ipsen.com).
Comparison of consolidated sales for the second quarters and first
halves 2015 and 2014:
Sales by therapeutic area and by product
Note: Unless stated otherwise, all variations in sales are stated
excluding foreign exchange impacts.
The following table shows sales by therapeutic area and by product for
the second quarters and first halves 2015 and 2014:
|
| | |
|
|
| | | |
| | 2nd Quarter | | | | | First Half | |
|
|
|
|
|
|
|
|
|
|
| | | |
|
|
|
|
|
|
|
| |
(in millions euros)
|
|
| 2015 |
|
| 2014 |
|
|
% Variation
|
|
|
% Variation at constant currency
|
|
| | | | 2015 |
|
| 2014 |
|
|
% Variation
|
|
|
% Variation at constant currency
| |
|
|
| |
|
| |
|
| |
|
| | | | | | |
|
| |
|
|
|
| | | |
Urology-oncology
| | | 90,8 | | | 90,6 | | | 0,2% | | | -5,3% | | | | | 178,0 | | | 168,8 |
| 5,4% |
|
| 1,0% | |
of which Hexvix® | | |
4,5
| | |
3,9
| | |
14,8%
| | |
13,8%
| | | | |
8,8
| | |
8,3
| |
5,4%
| | |
4,6%
| |
of which Decapeptyl® | | |
86,3
| | |
86,7
| | |
-0,4%
| | |
-6,1%
| | | | |
169,2
| | |
160,5
| |
5,4%
| | |
0,8%
| |
Endocrinology
| | | 120,1 | | | 88,9 | | | 35,2% | | | 29,1% | | | | | 229,8 | | | 175,1 | | 31,2% | | | 26,0% | |
of which Somatuline® | | |
98,9
| | |
70,8
| | |
39,7%
| | |
32,9%
| | | | |
188,2
| | |
139,3
| |
35,2%
| | |
29,1%
| |
of which NutropinAq® | | |
15,9
| | |
15,1
| | |
5,6%
| | |
4,5%
| | | | |
31,7
| | |
30,9
| |
2,6%
| | |
1,7%
| |
of which Increlex® | | |
5,3
| | |
3,0
| | |
76,2%
| | |
56,8%
| | | | |
9,9
| | |
5,0
| |
99,2%
| | |
83,1%
| |
Neurology
| | | 72,3 | | | 67,8 | | | 6,5% | | | 4,2% | | | | | 141,1 | | | 128,6 | | 9,7% | | | 7,4% | |
of which Dysport® | | |
72,0
| | |
67,8
| | |
6,1%
| | |
3,8%
| | | | |
140,6
| | |
128,6
| |
9,3%
| | |
7,0%
| |
Specialty care | | | 283,2 | | | 247,3 | | | 14,5% | | | 9,7% | | | | | 548,9 | | | 472,5 | | 16,2% | | | 12,0% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
Gastroenterology
| | | 54,6 | | | 58,7 | | | -7,0% | | | -13,4% | | | | | 113,8 | | | 110,6 | | 2,9% | | | -3,3% | |
of which Smecta® | | |
26,4
| | |
30,5
| | |
-13,5%
| | |
-20,6%
| | | | |
62,3
| | |
60,8
| |
2,6%
| | |
-5,1%
| |
of which Forlax® | | |
9,7
| | |
10,5
| | |
-7,3%
| | |
-9,5%
| | | | |
18,8
| | |
18,8
| |
-0,3%
| | |
-2,0%
| |
Cognitive disorders
| | | 13,7 | | | 14,9 | | | -8,2% | | | -7,6% | | | | | 24,2 | | | 31,2 | | -22,5% | | | -17,4% | |
of which Tanakan® | | |
13,7
| | |
14,9
| | |
-8,2%
| | |
-7,6%
| | | | |
24,2
| | |
31,2
| |
-22,5%
| | |
-17,4%
| |
Cardiovascular
| | | 4,4 | | | 5,8 | | | -24,5% | | | -25,0% | | | | | 9,4 | | | 11,3 | | -16,6% | | | -16,9% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
Other Primary Care
| | | 2,5 | | | 2,8 | | | -9,3% | | | -8,4% | | | | | 5,5 | | | 5,7 | | -4,4% | | | -4,4% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
Drug-related Sales*
| | | 5,5 | | | 3,3 | | | 65,3% | | | 64,5% | | | | | 12,1 | | | 7,4 | | 64,9% | | | 64,2% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
Primary care | | | 80,6 | | | 85,5 | | | -5,7% | | | -10,2% | | | | | 165,0 | | | 166,1 | | -0,7% | | | -3,7% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
Group Sales |
|
| 363,8 |
|
| 332,7 |
|
| 9,3% |
|
| 4,5% | | | | | 713,9 |
|
| 638,7 |
| 11,8% |
|
| 7,9% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
* From January 2015 onwards, Drug-related sales (active ingredients and
raw materials) are recorded within Primary care sales.
In the second quarter 2015, sales of Specialty care products
reached €283.2 million, up 9.7% year-on-year. In the first half 2015,
sales amounted to €548.9 million, up 12.0%. Sales in urology-oncology,
endocrinology, and neurology grew by respectively 1.0%, 26.0% and 7.4%.
In the first half 2015, the relative weight of specialty care products
continued to increase to reach 76.9% of total Group sales, compared to
74.0% the previous year.
In Urology-oncology, sales of Decapeptyl®
reached €86.3 million in the second quarter 2015, down 6.1%
year-on-year, affected by a sales decrease in China, in a context of
market slowdown and price pressure in some regions. In the first half
2015, sales amounted to €169.2 million, up 0.8%, in a declining European
pharmaceutical market affected by a more frequent use of co-payment in
Southern Europe and continued price reductions, notably an 11.0% cut as
of 1st January 2015 in Greece and a 3.0% cut as of 1st
February 2015 in France and more than 20% in Algeria. In the first half
2015, sales of Hexvix® amounted to €8.8
million, up 4.6% compared to the previous year, driven by solid
performance in France and Germany, where customer demand was strong in
the second quarter. Germany represented around 70% of this product’s
sales. Over the period, sales in Urology-oncology represented 24.9% of
total Group sales, compared to 26.4% the previous year.
In Endocrinology, sales reached €120.1 million in the second
quarter 2015, up 29.1% year-on-year. In the first half 2015, sales
amounted to €229.8, up 26.0%, and represented 32.2% of total Group
sales, compared to 27.4% the previous year.
Somatuline® – In the second quarter 2015, sales
reached €98.9 million, up 32.9% year-on-year. In the first half 2015,
sales of Somatuline® amounted to €188.2 million, up 29.1%,
with strong growth in Europe and in North America, driven by the launch
in neuroendocrine tumors. The product also registered good performance
in Europe, notably in Germany, the UK, Spain and France.
NutropinAq® – In the second quarter 2015, sales
reached €15.9 million, up 4.5% year-on-year. In the first half 2015,
sales of NutropinAq® amounted to €31.7 million, up 1.7%,
compared to the previous year.
Increlex® – In the second quarter 2015, sales
reached €5.3 million, up sharply compared to the same period in 2014. In
the first half 2015, sales of Increlex® amounted to €9.9
million, benefitting from a favorable comparison base with a low first
half 2014 following the shortage situation that started mid-June 2013 in
the United States and in August 2013 in Europe. Supply gradually resumed
in Europe in early 2014 and in the United States in June 2014.
In Neurology, Dysport® sales reached
€72.0 million in the second quarter 2015, up 3.8% year-on-year. Second
quarter 2015 growth was affected by a slowdown of pharmaceutical market
in Brazil. In the first half 2015, sales amounted to €140.6 million, up
7.0%, driven by product supply to Galderma for aesthetic use and by the
solid performance in Russia and Mexico. Neurology sales represented
19.8% of total Group sales in the first half 2015, compared to 20.1% a
year earlier.
In the second quarter 2015, sales of Primary care products
reached €80.6 million, down 10.2% year-on-year, mainly affected by Smecta®
sales decrease in China, Russia, Algeria (where Ipsen now supplies the
active ingredient instead of the finished product) and Vietnam (where
most of the first half sales were anticipated in the first quarter ahead
of the import license renewal). In the first half 2015, sales amounted
to €165.0 million, down 3.7%, penalized by the 7.7% decline in French
sales, affected by the price cut on Smecta® in July 2014 and
by the continued erosion of Tanakan® sales. Internationally,
sales decreased 2.3%, affected by Smecta® and Tanakan®
sales decrease in China and Russia. Primary care sales in France
accounted for 25.3% of the Group’s total primary care sales, compared to
27.2% the previous year.
In Gastroenterology, sales reached €54.6 million in the second
quarter 2015, down 13.4% year-on-year. In the first half 2015, sales
amounted to €113.8 million euros, down 3.3%.
Smecta® – In the second quarter 2015, sales
reached €26.4 million, down 20.6% year-on-year. In the first half 2015,
sales amounted to €62.3 million euros, down 5.1%. Sales were negatively
impacted by a significant destocking effect in China’s distribution
channel in the second quarter, in a context of price pressure in some
regions. Moreover, sales growth in Vietnam only partially offset the
termination of direct sales in Algeria, now replaced by sales of the
active principle to a local manufacturer, which are recorded in
“Drug-related sales”. Sales were also affected in France by a 7.5% price
cut implemented in July 2014.
Forlax® – In the second quarter 2015, sales
reached €9.7 million, down 9.5% year-on-year, affected by a continued
decline in France, where it still suffers from the “Tiers-Payant1”
regulation. In the first half 2015, sales amounted to €18.8 million
euros, down 2.0%, supported by growing sales to our partners marketing
the generic versions of the product and from the good performance in
Algeria and in Russia.
In the cognitive disorders area, sales of Tanakan®reached €13.7 million euros in the second quarter 2015, down 7.6%
year-on-year. Sales in the first half 2015 amounted to €24.2 million
euros, down 17.4%, affected by the performance in Russia due to greater
competition and declining local sales, and in France, where the product
suffers from heavy competitive pressure.
In the cardiovascular area, sales reached €4.4 million euros in
the second quarter 2015, down 25.0% year-on-year. In the first half
2015, sales amounted to €9.4 million euros, down 16.9%, mainly impacted
by the decline of Nisis® / Nisisco®
sales, which faced an additional 40.0% price cut in February 2015.
1 With the “Tiers-Payant” regulation, the patient now pays
upfront for a branded drug and is reimbursed only later on
Sales of Other primary care productsreached €2.5 million
in the second quarter 2015, down 8.4% year-on-year, mainly affected by
the 10.8% decline in Adrovance® sales over the
period. In the first half 2015, sales amounted to €5.5 million, down
4.4%.
In the second quarter 2015, Drug-related sales (active ingredients
and raw materials)1reached€5.5
million, up 64.5% year-on-year. In the first half 2015, sales amounted
to €12.1 million euros, up 64.2%. This performance was mainly explained
by Smecta®’s active ingredient sales recovery in South Korea
and the shift in Algeria’s commercial model, where Ipsen now supplies
Smecta®’s active ingredient to a local manufacturer and
records sales in the “Drug-related sales” line.
1 From January 2015 onwards, Drug-related sales (active
ingredients and raw materials) are recorded within Primary care sales
Sales by geographical area
Group sales by geographical area in the second quarters and first halves
2015 and 2014 were as follows:
|
|
| |
|
|
| | |
| | | 2nd Quarter | | | | First Half | |
|
|
|
| | | |
| |
(in million euros)
|
|
| 2015 |
|
| 2014 |
|
|
% Variation
|
|
|
% Variation at constant currency
| | | | 2015 |
|
| 2014 |
|
|
% Variation
|
|
|
% Variation at constant currency
| |
| | | |
|
| |
|
| |
|
| | | | | |
|
| |
|
| |
|
| | |
France
| | |
52,8
| | |
52,3
| | |
0,8%
| | |
0,8%
| | | |
106,9
| | |
106,7
| | |
0,2%
| | |
0,2%
| |
Germany
| | |
18,7
| | |
16,6
| | |
12,8%
| | |
-0,1%
| | | |
37,1
| | |
30,4
| | |
22,2%
| | |
8,9%
| |
Italy
| | |
15,8
| | |
14,6
| | |
8,2%
| | |
8,2%
| | | |
32,6
| | |
29,2
| | |
11,7%
| | |
11,7%
| |
United Kingdom
| | |
27,0
| | |
22,8
| | |
18,1%
| | |
18,1%
| | | |
53,5
| | |
47,1
| | |
13,5%
| | |
13,5%
| |
Spain
| | |
20,8
| | |
21,5
| | |
-3,3%
| | |
-3,3%
| | | |
42,0
| | |
43,7
| | |
-4,1%
| | |
-4,1%
| |
Major Western European countries | | | 135,0 | | | 127,9 | | | 5,6% | | | 3,8% | | | | 272,1 | | | 257,1 | | | 5,8% | | | 4,3% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
Eastern Europe
| | |
44,7
| | |
46,5
| | |
-3,8%
| | |
4,7%
| | | |
84,1
| | |
90,7
| | |
-7,3%
| | |
3,9%
| |
Others Europe
| | |
39,2
| | |
37,0
| | |
5,9%
| | |
6,1%
| | | |
76,6
| | |
74,4
| | |
3,0%
| | |
3,3%
| |
Other European Countries | | | 83,9 | | | 83,5 | | | 0,5% | | | 5,4% | | | | 160,7 | | | 165,0 | | | -2,7% | | | 3,6% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
North America | | | 37,6 | | | 17,2 | | | 119,0% | | | 76,5% | | | | 67,5 | | | 31,5 | | | 114,0% | | | 74,7% | |
Asia
| | |
57,1
| | |
51,9
| | |
10,0%
| | |
-10,9%
| | | |
116,8
| | |
92,2
| | |
26,6%
| | |
4,6%
| |
Other countries in the Rest of the world
| | |
50,2
| | |
52,3
| | |
-4,1%
| | |
-5,3%
| | | |
96,9
| | |
92,8
| | |
4,5%
| | |
1,9%
| |
Rest of the World | | | 107,3 | | | 104,2 | | | 2,9% | | | -8,4% | | | | 213,7 | | | 185,0 | | | 15,5% | | | 3,3% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
Group Sales |
|
| 363,8 |
|
| 332,7 |
|
| 9,3% |
|
| 4,5% | | | | 713,9 |
|
| 638,7 |
|
| 11,8% |
|
| 7,9% | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
|
In the second quarter 2015, sales generated in the Major Western
European countries reached €135.0 million, up 3.8% year-on-year. In
the first half 2015, sales generated in the Major Western European
countries amounted to €272.1 million, up 4.3%. Sales in the Major
Western European countries represented 38.1% of total Group sales in the
first half 2015, compared to 40.3% the previous year.
France – In the second quarter 2015, sales reached €52.8 million,
up 0.8% year-on-year. In the first half 2015, sales amounted to €106.9
million, up 0.2%, affected by Smecta® sales decline over the
period, penalized by the 7.5% price cut implemented in July 2014.
Moreover, sales of Tanakan® continued to erode. Sales of
specialty care products, up 6.0% over the period, were driven by the
sustained growth of Somatuline® and Dysport®,
offsetting the decrease in Decapeptyl® sales following the
3.0% price cut implemented as of 1st February 2015.
Consequently, the relative weight of France in the Group’s consolidated
sales has continued to decrease and now represents 15.0% of sales,
compared to 16.7% the previous year.
Germany –In the second quarter 2015, sales reached €27.0
million, up 18.1% year-on-year. In the first half 2015, sales reached
€53.5 million, up 13.5%, driven by the strong growth of Somatuline®
and NutropinAq®, offsetting the decline in Dysport®
sales. Over the period, sales in Germany represented 7.5% of total Group
sales, compared to 7.4% a year earlier.
Italy – In the second quarter 2015, sales reached €20.8 million,
down 3.3% year-on-year. In the first half 2015, sales reached €42.0
million, down 4.1%. The implementation of austerity measures targeting
hospital products still affects the performance of all specialty care
products. In the first half 2015, sales in Italy represented 5.9% of
consolidated Group sales, compared to 6.9% the previous year.
United Kingdom – In the second quarter 2015, sales reached €18.7
million, flat year-on-year. In the first half 2015, sales amounted to
€37.1 million, up 8.9%, supported by the strong growth of Somatuline®
and Decapeptyl®. In the first half 2015, sales in the United
Kingdom represented 5.2% of total Group sales, compared to 4.8% the
previous year.
Spain – In the second quarter 2015, sales reached €15.8 million,
up 8.2% year-on-year. In the first half 2015, sales amounted to €32.6
million, up 11.7%, driven by the double-digit growth of Somatuline®
and Decapeptyl®. In the first half 2015, Spain accounted for
4.6% of total Group sales, flat year-on-year.
In the second quarter 2015, sales generated in the Other European
countries reached €83.9 million, up 5.4% year-on-year. In the first
half 2015, sales amounted to €160.7 million, up 3.6%, supported by solid
performance in Czech Republic, Poland and Western Europe (excluding
Major Western European countries1), mainly driven by the
performance of Somatuline® in the Netherlands and in
Scandinavia. Nevertheless, sales were negatively impacted by the
contraction of activity in Ukraine as a result of the ongoing political
crisis. Over the period, sales in this region represented 22.5% of
consolidated Group sales, compared to 25.8% the previous year.
In the second quarter 2015, sales generated in North America
reached €37.6 million, up 76.5% year-on-year. In the first half 2015,
sales amounted to €67.5 million, up 74.7%, mainly driven by strong
Somatuline® growth of 87.8% associated with the launch in
neuroendocrine tumors, and by growing supply sales of Dysport® aesthetics,
and by the positive base effect resulting from Increlex®
supply interruption in the second half 2013. Sales in North America
represented 9.4% of consolidated Group sales, compared to 4.9% a year
earlier.
In the second quarter 2015, sales generated in the Rest of the World
reached €107.3 million, down 8.4% year-on-year, notably affected by the
performance of Decapeptyl® and Smecta® in China
and Algeria, and by the pharmaceutical market slowdown impacting Dysport®
in Brazil. In the first half 2015, sales amounted to €213.7 million, up
3.3%, benefitting from solid performance of Somatuline® and
Dysport® in Algeria, in Australia, in Mexico, and from the
anticipation of sales in Vietnam ahead of the import license renewal. In
the first half 2015, sales in the Rest of the World continued to
progress given the favorable exchange rate fluctuation, representing
29.9% of total consolidated Group sales, compared to 29.0% the previous
year.
1 France, Germany, Italy, United-Kingdom, Spain
|
|
| |
|
| |
|
| |
|
| |
|
| |
Comparison of consolidated incomes for the first halves 2015
and 2014 | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
|
(in millions of euros)
| | | 30 June 2015 | | | 30 June 2014 | | |
Change
|
|
|
|
|
|
| % sales |
|
|
|
|
| % sales |
|
|
|
Sales | | | 713.9 | | | 100.0% | | | 638.7 | | | 100.0% | | | 11.8% |
Other revenues
| | |
38.0
| | | 5.3% | | |
30.1
| | | 4.7% | | |
26.4%
|
Revenue | | | 751.9 | | | 105.3% | | | 668.8 | | | 104.7% | | | 12.4% |
Cost of goods sold
| | |
(168.3)
| | | -23.6% | | |
(155.8)
| | | -24.4% | | |
8.0%
|
Selling expenses
| | |
(259.9)
| | | -36.4% | | |
(211.4)
| | | -33.1% | | |
23.0%
|
Research and development expenses
| | |
(91.8)
| | | -12.9% | | |
(87.6)
| | | -13.7% | | |
4.8%
|
General and administrative expenses
| | |
(61.3)
| | | -8.6% | | |
(51.3)
| | | -8.0% | | |
19.5%
|
Other core operating income
| | |
1.9
| | | 0.3% | | |
4.0
| | | 0.6% | | |
-53.7%
|
Other core operating expenses
| | |
(4.8)
| | | -0.7% | | |
(4.7)
| | | -0.7% | | |
3.2%
|
Core operating income | | | 167.6 | | | 23.5% | | | 162.0 | | | 25.4% | | | 3.5% |
Other operating income
| | |
1.4
| | | 0.2% | | |
0.4
| | | 0.1% | | |
-
|
Other operating expenses
| | |
(8.0)
| | | -1.1% | | |
(3.4)
| | | -0.5% | | |
134.4%
|
Restructuring costs
| | |
(0.7)
| | | -0.1% | | |
(12.3)
| | | -1.9% | | |
-
|
Impairment losses
| | |
(57.0)
| | | -8.0% | | |
(0.4)
| | | -0.1% | | |
-
|
Operating income | | | 103.4 | | | 14.5% | | | 146.3 | | | 22.9% | | | -29.3% |
Investment income
| | |
0.6
| | | 0.1% | | |
0.8
| | | 0.1% | | |
-21.7%
|
Financing costs
| | |
(2.5)
| | | -0.4% | | |
(1.2)
| | | -0.2% | | |
104.8%
|
Net financing costs | | | (1.9) | | | -0.3% | | | (0.5) | | | -0.1% | | |
-
|
Other financial income and expense
| | |
5.1
| | | 0.7% | | |
(1.7)
| | | -0.3% | | |
-
|
Income taxes
| | |
(17.9)
| | | -2.5% | | |
(40.7)
| | | -6.4% | | |
-
|
Share of net profit (loss) from entities accounted for using the
equity method
| | |
1.5
| | | 0.2% | | |
1.2
| | | - | | |
-
|
Net profit (loss) from continuing operations | | | 90.2 | | | 12.6% | | | 104.7 | | | 16.4% | | | -13.9% |
Net profit (loss) from discontinued operations
| | |
0.3
| | | 0.0% | | |
(0.2)
| | | 0.0% | | |
-
|
Consolidated net profit | | | 90.5 | | | 12.7% | | | 104.5 | | | 16.4% | | | -13.4% |
- Attributable to shareholders of Ipsen S.A.
| | |
90.1
| | | | | |
104.0
| | | | | | |
- Attributable to non-controlling interests
|
|
|
0.3
|
|
|
|
|
|
0.4
|
|
|
|
|
|
|
Basic earnings per share - attributable to Ipsen S.A. shareholders
(in € per share)
| | |
1.10
| | | | | |
1.27
| | | | | | |
Core basic earnings per share - attributable to Ipsen S.A.
shareholders (in € per share) (*)
|
|
|
1.50
|
|
|
|
|
|
1.40
|
|
|
|
|
|
|
(*) The core consolidated net profit is detailled in Appendix 4.
| | | | | | | | | |
| | | | | | | | |
|
In the half-year period ended 30 June 2015, the Group's consolidated
sales reached €713.9 million, up 11.8% year-on-year and up 7.9%
excluding foreign exchange impact1.
Other revenues at 30 June 2015 totaled €38.0 million, up 26.4% over the
€30.1 million realized the prior year. The increase resulted primarily
from royalties received, of which €3.4 million stemmed from the
recognition of an upfront payment received by Ipsen as part of its sale
to Tonipharm of Ginkor Fort® licensing rights in the Group's
territories. The increase was also driven by royalties received from
Group partners, notably for Adenuric®. At 30 June 2015, these
royalties came to €14.9 million, versus €9.9 million a year earlier.
At 30 June 2015, the cost of goods sold amounted to €168.3 million,
representing 23.6% of sales, compared to a cost of goods sold totaling
€155.8 million, which represented 24.4% of sales for the period ended 30
June 2014. The improvement in the ratio was fuelled primarily by a more
favorable product-mix arising from higher sales volumes in specialty
care as well as productivity gains from the Group's production sites.
Selling expenses totaled €259.9 million, or 36.4% of sales at 30 June
2015. That performance represents a 23.0% rise over 30 June 2014, when
selling expenses reached €211.4 million, or 33.1% of sales. The increase
resulted primarily from the setup of an oncology sales force and the
marketing and medical investments necessary to promote Somatuline®
Depot® (lanreotide) 120 mg Injection in the United States in
the treatment of gastrointestinal and pancreatic neuroendocrine tumors
(GEP NETs). Somatuline® Depot® was approved for
this new indication by the US Food and Drug Administration (FDA) on 16
December 2014.
- Research and development expenses
At 30 June 2015, research and development expenses totaled €91.8
million, representing 12.9% of sales, compared with €87.6 million a year
earlier. The decrease of the Research and Development ratio is notably
related to the decision to stop the clinical trials of tasquinimod in
prostate cancer, as announced on 16 April 2015, as well as the end of
Somatuline® studies in neuroendocrine tumors.
The research tax credit reached €13.6 million, down versus the prior
year period mainly as a result of provisions reversed in 2014.
- General and administrative expenses
In the first half of 2015, general and administrative expenses totaled
€61.3 million, up 19.5% versus the prior-year period. The increase
resulted mainly from beefing up support functions in the United States
to support fast business growth, as well as the impact of the
outperformance on incentive plans.
- Other Core Operating Income and expenses
Other Core Operating Income amounted to €1.9 million at 30 June 2015,
compared with €4.0 million a year earlier, including revenue from the
sublease on Ipsen's headquarter, flat year-on-year, and the neutral
impact of cash flow hedges versus a gain at 30 June 2014.
Other core operating expenses reached €4.8 million at 30 June 2015,
compared with €4.7 million a year earlier, mainly including amortization
expense for intangible assets, excluding software, as well as the cost
of subleasing the Group's headquarter.
1 Sales growth excluding foreign exchange impact was
calculated by restating the first-half 2014 consolidated financial
statements with currency rates at 30 June 2015
Core Operating Income totaled €167.6 million, representing 23.5% of
sales in the first half of 2015. That result compares to €162.0 million,
or 25.4% of sales in the first half of 2014.
- Other operating income and expenses
In the first half of 2015, other non-core operating expenses totaled
€8.0 million, versus €3.4 million the prior-year period.
On 16 April 2015, Active Biotech and Ipsen announced the results of the
10TasQ10 clinical study. Preliminary efficacy and safety results did not
support a positive benefit-risk balance, prompting a decision by Ipsen
and Active Biotech to discontinue all clinical studies in prostate
cancer. As a result, Ipsen recognized the full €6.9 million committed
expenses related to tasquinimod clinical development studies at 30 June
2015.
At 30 June 2014, other non-core operating expenses stemmed primarily
from costs related to the transfer of operations of the Group's US-based
Ipsen Bioscience subsidiary from Milford to Cambridge.
In the first half of 2015, the Group recognized €0.7 million in
restructuring costs, versus €12.3 million in the prior-year period.
First-half 2014 restructuring costs included measures to adapt support
functions, continued efforts to restructure R&D activities and costs
related to transferring the operations of the Group's US-based Ipsen
Bioscience Inc. subsidiary from Milford to Cambridge.
At 30 June 2015, the Group recorded a €57.0 million loss to impair all
intangible assets related to the tasquinimod program, following a
decision to discontinue clinical studies in prostate cancer.
- Net financing costs and other financial income and expenses
At 30 June 2015, the Group had net financial income of €3.2 million,
compared with net financial expense of €2.2 million a year earlier. The
financial income resulted primarily from a final €4.9 million earnout
payment received in 2015 stemming from the sale of PregLem shares in
2010.
At 30 June 2015, the effective tax rate came to 16.8% of pre-tax profit
from continuing operations (excluding the share of profit (loss) from
associated companies and joint ventures), compared with an effective
rate of 28.2% at 30 June 2014.
The Group's effective tax rate benefited from the write-off of
tasquinimod-related intangible assets, which were fiscally deductible at
38%.
Consolidated net profit came to €90.5 million (€90.1 million
attributable to Ipsen S.A. shareholders), down 13.4% versus the €104.5
million (€104.0 million attributable to Ipsen S.A shareholders) recorded
at 30 June 2014.
At 30 June 2015, basic earnings attributable to the Group amounted to
€1.10 per share, down from basic EPS of €1.27 a year earlier.
Core earnings per share (see Appendix 4) for the period came to €1.50
per share, up 7.0% over €1.40 per share at 30 June 2014. The improvement
reflected strong business growth driven primarily by the launch of
Somatuline® in the treatment of neuroendocrine tumors.
Operating segments: Distribution of Core Operating Income by therapeutic
area
Segment information is presented according to the Group's two operating
segments, i.e. primary care and specialty care.
All costs allocated to these two segments are presented in key
performance indicators. Only research and development costs and
corporate overhead costs are not allocated to the two operating segments.
The Group uses Core Operating Income to measure its segment performance
and to allocate resources.
Sales, revenue and Core Operating Income are presented by therapeutic
area for the 2015 and 2014 half-year periods in the following table.
|
|
|
|
|
|
|
|
|
|
|
|
| |
| | | 30 June 2015 |
|
| 30 June 2014 |
|
|
Change
| |
(in millions of euros)
|
|
|
|
|
|
|
|
|
|
|
| % | |
Specialty Care | | | | | | | | | |
|
| | |
Sales
| | |
548.9
| | |
472.5
| | |
76.4
| | | 16.2% | |
Revenue
| | |
565.2
| | |
487.4
| | |
77.7
| | | 16.0% | |
Core Operating Income
| | |
239.0
| | |
220.3
| | |
18.7
| | | 8.5% | |
% of sales | | | 43.5% | | | 46.6% | | | | | | | |
Primary care (*) | | | | | | | | | | | | | |
Sales
| | |
165.0
| | |
166.1
| | |
(1.2)
| | | -0.7% | |
Revenue
| | |
186.7
| | |
181.3
| | |
5.4
| | | 3.0% | |
Core Operating Income
| | |
68.2
| | |
67.5
| | |
0.7
| | | 1.0% | |
% of sales | | | 41.3% | | | 40.6% | | | | | | | |
Total unallocated | | | | | | | | | | | | | |
Core Operating Income
| | |
(139.6)
| | |
(125.8)
| | |
(13.7)
| | | 10.9% | |
| | | | | | | | | | | | |
|
Group total | | | | | | | | | | | | | |
Sales
| | |
713.9
| | |
638.7
| | |
75.2
| | | 11.8% | |
Revenue
| | |
751.9
| | |
668.8
| | |
83.1
| | | 12.4% | |
Core Operating Income
| | |
167.6
| | |
162.0
| | |
5.6
| | | 3.5% | |
% of sales |
|
| 23.5% |
|
| 25.4% |
|
|
|
|
|
| |
(*) including drug related sales
| | | | | | | | | | | | | |
| | | | | | | | | | | | |
|
In specialty care, first-half 2015 sales amounted to €548.9
million, up 16.2% versus the prior-year period. The share of specialty
care products continued to increase, reaching 76.9% of total
consolidated sales at 30 June 2015, versus 74.0% a year earlier. Sales
of Decapeptyl® grew 5.4%, taking advantage of a favorable
exchange effect and held back by a slowdown in Europe's pharmaceutical
market. Somatuline® sales increased 35.2%, driven by the
launch of the new anti-tumor indication in the treatment of
neuroendocrine tumors (NETs) in the United States and Europe. Dysport®
sales rose 9.3% on the back of a robust performance in the aesthetics
activity. After factoring in the investment to launch Somatuline®
in neuroendocrine tumors in the United States, Core Operating Income for
specialty care amounted €239.0 million, representing 43.5% of sales in
the first half of 2015. That result compares to Core Operating Income in
the prior-year period of €220.3 million, representing 46.6% of sales.
In primary care, first-half 2015 sales came to €165.0 million,
down 0.7% over the prior-year period. In France, sales of primary care
products declined 7.7%, as a result of a price cut for Smecta®
in July 2014 and continued erosion of Tanakan® sales.
International sales increased 1.9% year-over year on the back of a
favorable foreign exchange impact, which offset lower sales in China and
Russia. First-half 2015 Core Operating Income for primary care totaled
€68.2 million, representing 41.3% of sales. That result compares to
primary care Core Operating Income in the prior-year period of €67.5
million, representing 40.6% of sales.
Unallocated Core Operating Income came to (€139.6) million,
compared with (€125.8) million in the first half of 2014. The expenses
consisted mainly of the Group's research and developments costs, which
totaled (€90.6) million in 2015, versus (€86.1) million in 2014, and, to
a lesser extent, unallocated general and administrative expenses.
Cash flow and financing
The consolidated cash flow statement at 30 June 2015 shows that the
Group's operating activities generated net cash flow of €36.2 million,
compared with €54.7 million a year earlier.
|
|
| |
|
| | |
Analysis of the consolidated cash flow statement | | | | | | | |
| | |
|
|
|
| |
(in millions of euros)
| | | 30 June 2015 | | | 30 June 2014 | |
|
|
|
|
|
|
| |
Cash flow from operating activities before changes in working
capital requirement
| | |
143.0
| | |
128.0
| |
(Increase) / decrease in working capital requirement for operations
| | |
(106.8)
| | |
(73.3)
| |
Net cash flow from operating activities | | | 36.2 | | | 54.7 | |
Net investments in financial and tangible and intangible assets
| | |
(53.0)
| | |
(24.0)
| |
Other cash flow from investments
| | |
(4.9)
| | |
(8.0)
| |
Net cash provided (used) by investment activities | | | (57.8) | | | (32.0) | |
Net cash provided (used) by financing activities |
|
| (74.4) |
|
| (20.5) | |
CHANGES IN CASH AND CASH EQUIVALENTS (a) |
|
| (96.1) |
|
| 2.2 | |
Opening cash and cash equivalents (b)
| | | 180.1 | | | 125.4 | |
Impact of exchange rate fluctuations (c)
|
|
|
3.8
|
|
|
1.4
| |
| | | | | | |
|
At 30 June 2014, closing cash and cash equivalents included €80.0
million drawn down from the Group's syndicated credit line.
- Net cash flow from operating activities
In the first half of 2015, cash flow from operating activities before
changes in working capital requirement amounted to €143.0 million, up
from the €128.0 million generated in the prior-year period.
Working capital requirement for operating activities increased by €106.8
million in the first half of 2015, compared with growth of €73.3 million
in the prior-year period. The increase stemmed from the following items:
-
In the first half of 2015, inventories decreased by €0.6 million,
compared to a decline of €4.9 million in the first half of 2014.
-
In the first half of 2015, trade receivables grew by €60.2 million,
compared with an increase of €46.8 million in the prior-year period.
The growth resulted primarily from higher sales and the seasonal
nature of trade receivables collection, notably in Italy, which was
partially offset by tighter management of payment delays in Russia,
Spain and Portugal.
-
Trade payables in the first half of 2015 decreased by €12.4 million,
compared to an increase of €0.2 million in the prior year period. The
decline comes mainly from the seasonal nature of expenditures, as well
as the pace of settlements, in particular the commissions paid
annually to distributors.
-
In the first half of 2015, the change in other operating assets and
liabilities constituted a use of funds amounting to €40.4 million,
compared with the €34.3 million use of funds recorded in the
prior-year period. As in the first half of 2014, the Group recorded no
new deferred income from its partnerships at 30 June 2015.
-
In the first half of 2015, the change in net tax liability remained a
favorable source of funds totaling €5.6 million, versus a source of
funds amounting to €2.6 million in the prior-year period.
- Net cash flow used by investment activities
In the first half of 2015, net cash used by investment activities came
to €57.8 million in net use of funds, compared with a €32.0 million net
use of funds in the prior year period.
Investments in tangible and intangible assets, net of disposals, totaled
€21.7 million, versus €24.0 million at 30 June 2014. The cash outflow
mainly included:
-
€16.4 million in acquisitions of property, plant and equipment,
compared with €20.9 million in the first half of 2014. Those
acquisitions consisted primarily of capital expenditures needed to
maintain the Group's production equipment and R&D activities;
-
€5.4 million in investments in intangible assets, versus €3.3 million
in the first half of 2014, mainly in the area of information
technology, as well as an additional payment as part of the
partnership with Lexicon.
The investment outflow in the first half of 2015 also included the
purchase of a €6.0 million option to acquire Canbex Therapeutics.
The acquisition of OctreoPharm Sciences during the first half of 2015
led to an outflow of €31.3 million. In the first half of 2014, cash flow
used by other investment activities included €3.6 million reflecting the
change in consolidation method for the Swiss company, Linnea.
- Net cash provided (used) by financing activities
In the first half of 2015, net cash provided (used) by financing
activities amounted to a net use of funds of €74.4 million, compared to
a net use of funds of €20.5 million in the prior-year period.
The change in the first half of 2015 resulted mainly from the payment of
€70.0 million in dividends, as well as the €3.9 million repurchase of
treasury shares.
In the first half of 2014, the dividend payout totaled €65.7 million and
€33.4 million in treasure shares were repurchased. The 2014 movement
also included the Group's €80.0 million drawdown of the credit line.
- Analysis of Group cash flow
The Group must respect the following covenant ratios at the end of each
half-year period:
-
Net debt to equity: less than 1
-
Net debt to EBITDA: less than 3.5 with the ratio assessed on a rolling
12-month basis.
The Group met all its covenant ratios at 30 June 2015.
Reconciliation of cash and cash equivalents and net cash and
cash equivalents | |
|
|
|
|
|
|
| |
(in millions of euros)
|
|
| 30 June 2015 |
|
| 30 June 2014 | |
Closing cash and cash equivalents
|
|
|
87.8
|
|
|
129.0
| |
Credit lines and bank loans
| | |
-
|
|
|
(80.0)
| |
Other financial liabilities
| | |
(10.4)
| | |
(10.9)
| |
Non-current liabilities | | | (10.4) | | | (90.9) | |
Credit lines and bank loans
| | |
(4.0)
| | |
(4.0)
| |
Financial liabilities (excluding derivative instruments) (**)
| | |
(2.6)
| | |
(3.6)
| |
Current liabilities |
|
| (6.6) |
|
| (7.6) | |
Debt |
|
| (17.0) |
|
| (98.5) | |
Net cash and cash equivalents (*) |
|
| 70.8 |
|
| 30.4 | |
| | | | | | |
|
(*) Net cash and cash equivalents: Cash and cash equivalents,
less bank overdrafts, bank loans and other financial liabilities and
excluding derivative financial instruments.
(**) Financial liabilities exclude €0.5 million in derivative
instruments at 30 June 2015, compared with no derivative instruments at
30 June 2014.
APPENDIX 1
|
|
| |
|
| | |
Consolidated income statement | | | | | | | |
| | | | | | |
|
(in millions of euros)
|
|
| 30 June 2015 |
|
| 30 June 2014 | |
Sales | | | 713.9 | | | 638.7 | |
Other revenues
| | |
38.0
| | |
30.1
| |
Revenue | | | 751.9 | | | 668.8 | |
Cost of goods sold
| | |
(168.3)
| | |
(155.8)
| |
Selling expenses
| | |
(259.9)
| | |
(211.4)
| |
Research and development expenses
| | |
(91.8)
| | |
(87.6)
| |
General and administrative expenses
| | |
(61.3)
| | |
(51.3)
| |
Other core operating income
| | |
1.9
| | |
4.0
| |
Other core operating expenses
| | |
(4.8)
| | |
(4.7)
| |
Core operating income | | | 167.6 | | | 162.0 | |
Other operating income
| | |
1.4
| | |
0.4
| |
Other operating expenses
| | |
(8.0)
| | |
(3.4)
| |
Restructuring costs
| | |
(0.7)
| | |
(12.3)
| |
Impairment losses
| | |
(57.0)
| | |
(0.4)
| |
Operating income | | | 103.4 | | | 146.3 | |
Investment income
| | |
0.6
| | |
0.8
| |
Financing costs
| | |
(2.5)
| | |
(1.2)
| |
Net financing costs | | | (1.9) | | | (0.5) | |
Other financial income and expense
| | |
5.1
| | |
(1.7)
| |
Income taxes
| | |
(17.9)
| | |
(40.7)
| |
Share of net profit (loss) from entities accounted for using the
equity method
| | |
1.5
| | |
1.2
| |
Net profit (loss) from continuing operations | | | 90.2 | | | 104.7 | |
Net profit (loss) from discontinued operations
| | |
0.3
| | |
(0.2)
| |
Consolidated net profit | | | 90.5 | | | 104.5 | |
- Attributable to shareholders of Ipsen S.A.
| | |
90.1
| | |
104.0
| |
- Attributable to non-controlling interests
| | |
0.3
| | |
0.4
| |
|
|
|
|
|
|
| |
|
|
|
|
|
|
| |
Basic earnings per share, continuing operations (in euro)
| | |
1.09
| | |
1.27
| |
Diluted earnings per share, continuing operations (in euro)
| | |
1.09
| | |
1.27
| |
| | | | | | |
|
Basic earnings per share, discontinued operations (in euro)
| | |
0.00
| | |
(0.00)
| |
Diluted earnings per share, discontinued operations (in euro)
| | |
0.00
| | |
(0.00)
| |
| | | | | | |
|
Basic earnings per share (in euro)
| | |
1.10
| | |
1.27
| |
Diluted earnings per share (in euro)
|
|
|
1.09
|
|
|
1.26
| |
| | | | | | |
|
APPENDIX 2
Consolidated balance sheet before allocation of net profit | |
|
|
|
|
|
|
| |
(in millions of euros)
| | | 30 June 2015 |
|
| 31 December 2014 | |
|
|
|
|
|
|
| |
ASSETS | | | | | | | |
Goodwill
| | |
336.8
| | |
324.4
| |
Other intangible assets
| | |
105.8
| | |
160.9
| |
Property, plant & equipment
| | |
336.9
| | |
309.6
| |
Equity investments
| | |
53.3
| | |
15.0
| |
Investments in companies accounted for using the equity method
| | |
15.4
| | |
13.7
| |
Non-current financial assets
| | |
-
| | |
4.2
| |
Deferred tax assets
| | |
225.6
| | |
204.6
| |
Other non-current assets
| | |
14.5
| | |
9.3
| |
Total non-current assets | | | 1,088.2 | | | 1,041.7 | |
Inventories
| | |
107.8
| | |
105.5
| |
Trade receivables
| | |
318.0
| | |
243.5
| |
Current tax assets
| | |
63.2
| | |
65.9
| |
Current financial assets
| | |
6.1
| | |
0.1
| |
Other current assets
| | |
84.6
| | |
67.8
| |
Cash and cash equivalents
| | |
92.9
| | |
186.3
| |
Assets of disposal group classified as held for sale
| | |
-
| | |
2.6
| |
Total current assets | | | 672.6 | | | 671.6 | |
TOTAL ASSETS |
|
| 1,760.8 |
|
| 1,713.3 | |
|
|
|
|
|
|
| |
1. EQUITY AND LIABILITIES | | | | | | | |
Share capital
| | |
83.1
| | |
82.9
| |
Additional paid-in capital and consolidated reserves
| | |
902.4
| | |
801.7
| |
Net profit (loss) for the period
| | |
90.1
| | |
153.5
| |
Exchange differences
| | |
56.3
| | |
27.1
| |
Equity attributable to Ipsen S.A. shareholders | | | 1,132.0 | | | 1,065.2 | |
Equity attributable to non-controlling interests
| | |
2.6
| | |
2.7
| |
Total shareholders' equity | | | 1,134.6 | | | 1,067.9 | |
Retirement benefit obligation
| | |
57.1
| | |
59.6
| |
Non-current provisions
| | |
43.5
| | |
42.1
| |
Other non-current financial liabilities
| | |
10.4
| | |
12.1
| |
Deferred tax liabilities
| | |
10.0
| | |
5.6
| |
Other non-current liabilities
| | |
131.0
| | |
115.8
| |
Total non-current liabilities | | | 251.9 | | | 235.2 | |
Current provisions
| | |
6.0
| | |
26.0
| |
Current bank loans
| | |
4.0
| | |
4.0
| |
Current financial liabilities
| | |
3.1
| | |
4.0
| |
Trade payables
| | |
172.5
| | |
179.8
| |
Current tax liabilities
| | |
7.1
| | |
4.1
| |
Other current liabilities
| | |
176.6
| | |
186.1
| |
Bank overdrafts
| | |
5.1
| | |
6.1
| |
Total current liabilities | | | 374.3 | | | 410.2 | |
TOTAL EQUITY & LIABILITIES |
|
| 1,760.8 |
|
| 1,713.3 | |
| | | | | | |
|
APPENDIX 3
Consolidated statement of cash flow |
|
| |
|
| | |
| | |
|
|
|
| |
(in millions of euros)
| | | 30 June 2015 |
|
| 30 June 2014 | |
|
|
| Total |
|
| Total | |
Consolidated net profit | | | 90.5 | | | 104.5 | |
Share of profit (loss) from companies accounted for using the equity
method before impairment losses
| | |
(0.8)
| | |
0.4
| |
Profit (loss) before share from companies accounted for using the
equity method | | | 89.6 | | | 104.9 | |
Non-cash and non-operating items | | | | | | | |
- Depreciation, amortization, provisions
| | |
5.8
| | |
15.7
| |
- Impairment losses included in operating income and net financial
income
| | |
57.0
| | |
0.4
| |
- Change in fair value of financial derivatives
| | |
2.6
| | |
(0.2)
| |
- Net gains or losses on disposals of non-current assets
| | |
0.0
| | |
1.3
| |
- Foreign exchange differences
| | |
(4.7)
| | |
(3.5)
| |
- Change in deferred taxes
| | |
(9.3)
| | |
7.1
| |
- Share-based payment expense
| | |
1.9
| | |
2.3
| |
- (Gain) or loss on sales of treasury shares
| | |
0.1
| | |
0.0
| |
Cash flow from operating activities before changes in working
capital requirement | | | 143.0 | | | 128.0 | |
- (Increase)/decrease in inventories
| | |
0.6
| | |
4.9
| |
- (Increase)/decrease in trade receivables
| | |
(60.2)
| | |
(46.8)
| |
- Increase/(decrease) in trade payables
| | |
(12.4)
| | |
0.2
| |
- Net change in income tax liability
| | |
5.6
| | |
2.6
| |
- Net change in other operating assets and liabilities
| | |
(40.4)
| | |
(34.3)
| |
Change in working capital requirement related to operating
activities | | |
(106.8)
| | | (73.3) | |
NET CASH PROVIDED (USED) BY OPERATING ACTIVITIES | | | 36.2 | | | 54.7 | |
Acquisition of property, plant & equipment
| | |
(16.4)
| | |
(20.9)
| |
Acquisition of intangible assets
| | |
(5.4)
| | |
(3.3)
| |
Proceeds from disposal of intangible assets and property, plant &
equipment
| | |
0.0
| | |
0.1
| |
Payments to post-employment benefit plans
| | |
(0.5)
| | |
(0.4)
| |
Acquisition of shares in non-consolidated companies
| | |
(31.3)
| | |
-
| |
Impact of changes in the consolidation scope
| | |
-
| | |
(3.6)
| |
Other cash flow related to investment activities
| | |
(5.3)
| | |
(2.0)
| |
Deposits paid
| | |
0.4
| | |
0.0
| |
Change in working capital related to operating activities
| | |
0.4
| | |
(1.9)
| |
NET CASH PROVIDED (USED) BY INVESTMENT ACTIVITIES | | | (57.8) | | | (32.0) | |
Additional long-term borrowings
| | |
1.1
| | |
82.2
| |
Repayment of long-term borrowings
| | |
(3.7)
| | |
(3.4)
| |
Capital increase
| | |
2.3
| | |
0.6
| |
Treasury shares
| | |
(2.0)
| | |
(33.4)
| |
Dividends paid by Ipsen S.A.
| | |
(70.0)
| | |
(65.5)
| |
Dividends paid by subsidiaries to non-controlling interests
| | |
(0.5)
| | |
(0.2)
| |
Change in working capital related to operating activities
| | |
(1.6)
| | |
(0.7)
| |
NET CASH PROVIDED (USED) BY FINANCING ACTIVITIES | | | (74.4) | | | (20.5) | |
CHANGE IN CASH AND CASH EQUIVALENTS | | | (96.1) | | | 2.2 | |
Opening cash and cash equivalents | | | 180.1 | | | 125.4 | |
Impact of exchange rate fluctuations
| | |
3.8
| | |
1.4
| |
Closing cash and cash equivalents |
|
| 87.8 |
|
| 129.0 | |
| | | | | | |
|
APPENDIX 4 | |
Core consolidated net profit for the first-half of 2015, versus
the prior-year period | |
|
|
|
| |
(in millions of euros)
|
|
|
30 June 2015
|
|
|
Non-core items
|
|
|
30 June 2015 Core
|
|
|
30 June 2014
|
|
|
Non-core items
|
|
|
30 June 2014 Core
| |
Core operating income | | | 167.6 |
|
| - |
|
| 167.6 |
|
| 162.0 |
|
| - |
|
| 162.0 | |
Other operating income
| | |
1.4
| | |
(1.4)
| | |
-
| | |
0.4
| | |
(0.4)
| | |
-
| |
Other operating expenses
| | |
(8.0)
| | |
8.0
| | |
-
| | |
(3.4)
| | |
3.4
| | |
-
| |
Restructuring costs
| | |
(0.7)
| | |
0.7
| | |
-
| | |
(12.3)
| | |
12.3
| | |
-
| |
Impairment losses
| | |
(57.0)
| | |
57.0
| | |
-
| | |
(0.4)
| | |
0.4
| | |
-
| |
Operating income | | | 103.4 | | | 64.2 | | | 167.6 | | | 146.3 | | | 15.7 | | | 162.0 | |
Investment income
| | |
0.6
| | |
-
| | |
0.6
| | |
0.8
| | |
-
| | |
0.8
| |
Financing costs
| | |
(2.5)
| | |
-
| | |
(2.5)
| | |
(1.2)
| | |
-
| | |
(1.2)
| |
Net financing costs | | | (1.9) | | | - | | | (1.9) | | | (0.5) | | | - | | | (0.5) | |
Other financial income and expense
| | |
5.1
| | |
(4.9)
| | |
0.2
| | |
(1.7)
| | |
-
| | |
(1.7)
| |
Income taxes
| | |
(17.9)
| | |
(25.3)
| | |
(43.2)
| | |
(40.7)
| | |
(4.7)
| | |
(45.3)
| |
Share of net profit (loss) from entities accounted for using the
equity method
| | |
1.5
| | |
-
| | |
1.5
| | |
1.2
| | |
-
| | |
1.2
| |
Net profit (loss) from continuing operations | | | 90.2 | | | 34.0 | | | 124.2 | | | 104.7 | | | 11.0 | | | 115.7 | |
Net profit (loss) from discontinued operations
| | |
0.3
| | |
(0.3)
| | |
-
| | |
(0.2)
| | |
0.2
| | |
-
| |
Consolidated net profit | | | 90.5 | | | 33.7 | | | 124.2 | | | 104.5 | | | 11.3 | | | 115.7 | |
- Attributable to shareholders of Ipsen S.A.
| | |
90.1
| | |
33.7
| | |
123.9
| | |
104.0
| | |
11.3
| | |
115.3
| |
- Attributable to non-controlling interests
|
|
|
0.3
|
|
|
-
|
|
|
0.3
|
|
|
0.4
|
|
|
-
|
|
|
0.4
| |
Diluted earnings per share - attributable to Ipsen S.A. shareholders
(in € per share)
|
|
|
1.09
|
|
|
|
|
|
1.50
|
|
|
1.26
|
|
|
|
|
|
1.40
| |
| | | | | | | | | | | | | | | | | | |
|
Core Operating Income is the key performance indicator for understanding
and measuring the performance of the Group's activities. Items not
included in Core Operating Income are not tabbed as "exceptional" or
"extraordinary" but correspond to unusual, abnormal or infrequent items
of disclosure targeted in paragraph 28 of the IASB Framework.
Similarly, Core consolidated net profit corresponds to net profit
adjusted for non-core items as defined above and unusual events
affecting financial income (expense) items, net of taxes, or the taxes
themselves.
GOVERNMENT MEASURES
In the current context of financial and economic crisis, the governments
of many countries in which the Group operates continue to introduce new
measures to reduce public health expenses, some of which have affected
the Group sales and profitability in the first half 2015. In addition,
certain measures introduced in 2014 have continued to affect the Group's
accounts year-on-year.
Measures impacting the first half 2015
In the Major Western European countries:
-
In France, the price of Smecta® was cut by 7.5% as of 1st
July 2014, following a first price cut of the same magnitude as of 1st
January 2014. Morever, all Decapeptyl®’s formulations were
impacted by a 3.1% price decrease in February 2015;
-
In Spain, Dysport® was included in the reference price
system as the product has been on the market for more than 10 years;
In the Other European countries:
-
In the United States, Somatuline® prices increased on June
30th, 2015 (Somatuline® 120mg: +1.6%, Somatuline®
60mg /90mg: + 3.0%);
-
In Belgium, requirement for pharmaceutical companies to implement
modulated price decreases on their product portfolio was cancelled.
Dysport® was subject to a mandatory price cut of 2.4% in
January 2015 because the product had been reimbursed for more than 15
years;
-
In the Netherlands, as of 1st April 2015, prices of Ipsen’s
specialty care products (excluding Hexvix®) were increased
following an International Reference Pricing review;
-
In Poland, Ipsen’s affiliate received positive assessment results from
National HTA agency on Hexvix® reimbursement application.
The price is under negotiation with the Ministry of Health. Somatuline®,
Decapeptyl® and Dysport® prices will be reviewed
based on the lowest price in Europe. Prices are expected to be
published in January 2016;
In the Rest of the World:
-
In Brazil, Dysport® therapeutics and Somatuline®
prices increased by ~5% in April 2015 due to inflation;
-
In Algeria, in the context of continuous and sharp oil price drop, the
authorities are looking at drastically reducing importation cost. This
applies to import of Pharmaceuticals, which stands roughly for 3Bn€ in
the state budget. For Ipsen Primary Care portfolio, this also
coincides with the price reduction usually assorted to the 5-year Free
Sales Certificat renewal. On the Specialty Care segment, this resulted
in a 5% price reduction for Somatuline® and of almost 20%
for Decapeptyl®, as authorities were systematically
benchmarking prices versus that prevailing in neighboring countries
and other European countries;
Furthermore, and in the context of the financial and economic crisis,
governments of many countries in which the Group operates continue to
introduce new measures to reduce public health expenses, some of which
will affect the Group sales and profitability beyond 2015.
Measures impacting beyond 2015
In the Major Western European countries:
-
In France, the government presented the new Social Security Finance
Bill (PLFSS), which sets forth expenditure targets in the healthcare
sector for 2015. The target growth of healthcare expenditure has been
set at 2.1% year-on-year, down from 2.4% in 2014. This is expected to
result in €3.2 billion savings. Moreover, the two Smecta®
price cuts will fully impact countries that reference French prices
(incl. European Union, sub-Saharan Africa) starting in 2015;
-
In Belgium, Somatuline® will be impacted by a 17% price
decrease as the product has been reimbursed for between 12 and 15
years;
In the Rest of the World:
-
In Algeria, part of the 2015 cost containment measures undertaken by
the Authorities aim at reducing importation cost. For pharmaceuticals,
a new importation quota is currently being implemented to target
imported products with at least one generic that is locally
manufactured;
-
In China, the government announced in May that it will remove price
caps for most medicines and allow the market to play a bigger role in
determining costs.The new reform may not cause a large hike in prices
as it will be mainly controlled by bidding price at hospital level.
For pharmaceutical treatments sold through retail channels, a more
flexible drug pricing mechanism is likely to impact pharmaceutical
firms - in particular foreign brands - who could benefit from
increased pricing flexibility that could raise their incentive for
innovation.
MAJOR DEVELOPMENTS
During the first half 2015, major developments included:
-
On 10 January 2014 – Ipsen announced topline results for two
double-blind phase III studies of Dysport®
(abobotulinumtoxinA) in Pediatric Lower Limb (PLL) spasticity in
children with cerebral palsy and in Adult Lower Limb (ALL) spasticity
in patients who had experienced a stroke or traumatic brain injury. In
the PLL phase III study, conducted in children with hemiparetic or
diplegic cerebral palsy, treatment with Dysport® showed a
statistically significant response versus placebo in the improvement
of muscle tone, as measured by the Modified Ashworth Scale (MAS;
primary endpoint), and a statistically significant overall benefit
versus placebo, as measured by the Physician Global Assessment (PGA;
first secondary endpoint). In the ALL phase III study, conducted in
hemiparetic patients who had experienced a stroke or traumatic brain
injury, treatment with Dysport® at the dose of 1500U showed
a statistically significant response versus placebo in the improvement
of muscle tone, as measured by the Modified Ashworth Scale (MAS;
primary endpoint). An overall benefit (measured by the Physician
Global Assessment (PGA); first secondary endpoint) versus placebo was
observed but did not reach statistical significance according to the
pre-specified statistical analysis.
-
On 23 February 2015 – Ipsen Canbex Therapeutics Ltd (Canbex) announced
that Canbex has granted Ipsen an option giving Ipsen the exclusive
right to purchase 100% of Canbex shares upon completion of the Phase
IIa study of Canbex’s lead candidate for the treatment of spasticity
in people with multiple sclerosis (MS), known as VSN16R. Canbex is a
spin-off of University College London (UCL) that raised a Series A
financing of GBP 2.3 million in 2013 from MS Ventures (the corporate
venture arm of Merck Serono, Merck KGaA), the Wellcome Trust and UCL
Business Plc. Under the financial terms of the agreement, Ipsen has
paid an option fee of €6 million to Canbex. If Ipsen elects to
exercise its option to acquire Canbex at the end of the proof of
concept Phase IIa study, Canbex’s shareholders will be eligible to
receive a total of up to an additional €90 million , comprising an
acquisition payment, and additional milestone payments contingent upon
launch subsequent to achievement of clinical and regulatory success.
In addition, Canbex shareholders will be eligible to receive royalties
on world-wide annual net sales of VSN16R.
-
On 2 March 2015 – Ipsen announced that Dominique Laymand has been
appointed Senior Vice President, Chief Ethics and Compliance Officer
for the Ipsen group, effective as of 16th of March. She will report
directly to Marc de Garidel, Chairman and CEO of Ipsen. Dominique
Laymand will be a member of the Chairman’s Committee.
-
On 1 April 2015 – Ipsen announced the inauguration of its new R&D
center, Ipsen Bioscience, in Cambridge (MA, USA), a recognized hub in
the USA for biomedical research & innovation. Ipsen's strategic
decision to invest in the Ipsen Bioscience facility in Cambridge is an
important element of the company’s open innovation strategy and its
goal of broadening its partnerships with the American biotechnology,
medical and scientific communities.
-
On 16 April 2015 – Active Biotech and Ipsen announced top line results
of the 10TASQ10 study. While the study showed that tasquinimod reduced
the risk of radiographic cancer progression or death compared to
placebo (rPFS, HR=0.69, CI 95%: 0.60 – 0.80) in patients with
metastatic castration resistant prostate cancer (mCRPC) who have not
received chemotherapy, tasquinimod did not extend overall survival
(OS, HR=1.09, CI 95%: 0.94 – 1.28). Efficacy results together with
preliminary safety data do not support positive benefit risk balance
in this population. Therefore the companies have decided to
discontinue all studies in prostate cancer. Full results will be
presented at an upcoming scientific conference.
-
On 19 May 2015 – Ipsen announced the signature of an agreement to
acquire OctreoPharm Sciences (referred to as OctreoPharm), a private
German life sciences company focusing on the development of innovative
radioactive labeled compounds for molecular imaging diagnostics and
therapeutic applications. Ipsen plans to maintain the company location
and staff to ensure successful transition of know-how and expertise.
Ipsen expects to complete its acquisition once closing conditions have
been cleared. Under the terms of the agreement, which is subject to
closing conditions, OctreoPharm’s shareholders are eligible to receive
up to a total of approximately €50 million for the purchase of 100% of
the company’s shares in the form of an upfront payment and downstream
payments contingent upon clinical and regulatory milestones.
-
on 2 June 2015 – Ipsen confirmed its eligibility for the PEA-PME
scheme, in accordance with the French decree n° 2014-283 of 4 March
2014. The Group complies with the thresholds set by the legislator for
eligibility to the PEA-PME scheme, namely having less than 5 000
employees and total revenue below €1 500 million or total assets below
€2 000 million. As a consequence, investment in company shares can be
made through PEA-PME accounts, benefiting from the same tax advantages
as the traditional Equity Savings Plan (PEA).
-
On 3 June 2015 – Ipsen announced it has granted Natixis a mandate to
purchase 500 000 shares, or about 0.60% of the share capital. This
mandate begins on 3 June 2015 and will end on 31 December 2015. The
purchased shares will be cancelled, mainly to compensate for the
dilution resulting from the issuance of new shares within the free
share plans. These operations are part of the authorizations granted
by the Combined Shareholder’s meeting held on 27 May 2015.
-
On 2 July 2015 - Ipsen hosted its Investor Day. The Group’s management
provided a comprehensive review of its 2020 strategy and its 2020
outlook including organic sales ranging between €1.8bn and €2bn and
Core Operating Margin of above 26%
-
On 16 July 2015 – Ipsen announced that the U.S. Food and Drug
Administration (FDA) has approved its supplemental Biologics License
Application (sBLA) for Dysport® (abobotulinumtoxinA) for
the treatment of upper limb spasticity in adult patients after the
submission of the dossier in September 2014. Dysport® is
now approved for the treatment of upper limb spasticity in adult
patients, to decrease the severity of increased muscle tone in elbow
flexors, wrist flexors and finger flexors. Clinical improvement may be
expected one week after administration of Dysport®. A
majority of patients in clinical studies were retreated between 12 and
16 weeks; some patients had a duration of response as long as 20
weeks. In Europe, regulatory procedures are in progress for
strengthening the existing upper limb spasticity label indication of
Dysport® to include key medical data such as muscle dose
recommendations, treatment intervals, efficacy data and safety updates.
APPENDIX
RISK FACTORS
The Group operates in an environment which is undergoing rapid change
and exposes its operations to a number of risks, some of which are
outside its control. The risks and uncertainties set out below are not
exhaustive and the reader is advised to refer to the Group’s 2013
Registration Document available on its website (www.ipsen.com).
-
The Group is faced with uncertainty in relation to the prices set for
all its products, in so far as medication prices have come under
severe pressure over the last few years as a result of various
factors, including the tendency for governments and payers to reduce
prices or reimbursement rates for certain drugs marketed by the Group
in the countries in which it operates, or even to remove those drugs
from lists of reimbursable drugs.
-
The Group depends on third parties to develop and market some of its
products, which generates or may generate substantial royalties for
the Group, but these third parties could behave in ways that cause
damage to the Group’s business. The Group cannot be certain that its
partners will fulfill 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.
-
Actual results may depart significantly from the objectives given that
a new product can appear to be promising at a development stage, or
after clinical trials, but never be launched on the market, or be
launched on the market but fail to sell, notably for regulatory or
competitive reasons.
-
The Research and Development process typically lasts between eight and
twelve years from the date of discovery to a product being brought to
market. This process involves several stages; at each stage, there is
a substantial risk that the Group could fail to achieve its objectives
and be forced to abandon its efforts in respect of products in which
it has invested significant amounts. Thus, in order to develop viable
products from a commercial point of view, the Group must demonstrate,
by means of pre-clinical and clinical trials, that the molecules in
question are effective and are not harmful to humans. The Group cannot
be certain that favorable results obtained during pre-clinical trials
will subsequently be confirmed during clinical trials, or that the
results of clinical trials will be sufficient to demonstrate the
safety and efficacy of the product in question such that the required
marketing approvals can be obtained.
-
The Group must deal with or may have to deal with competition (i) from
generic products, particularly in relation to Group products which are
not protected by patents, such as Forlax® and Smecta®
(ii), products which, although they are not strictly identical to the
Group’s products or which have not demonstrated their bioequivalence,
may obtain a marketing authorization for indications similar to those
of the Group’s products pursuant to the bibliographic reference
regulatory procedure (well established medicinal use) before the
patents protecting its products expire. Such a situation could result
in the Group losing market share which could affect its current level
of growth in sales or profitability.
-
Third parties might claim the benefit of intellectual property rights
with respect to the Group’s inventions. The Group provides the third
parties with which it collaborates (including universities and other
public or private entities) with information and data in various forms
relating to the research, development, manufacturing and marketing of
its products. Despite the precautions taken by the Group with regard
to these entities, in particular of a contractual nature, they (or
certain of their members or affiliates) could claim ownership of
intellectual property rights arising from the trials carried out by
their employees or any other intellectual property right relating to
the Group’s products or molecules in development.
-
The Group’s strategy includes acquiring companies or assets which may
enable or facilitate access to new markets, research projects or
geographical regions or enable the Group to realize synergies with its
existing businesses. Should the growth prospects or earnings potential
of such assets as well as valuation assumptions change materially from
initial assumptions, the Group might be under the obligation to adjust
the values of these assets in its balance sheet, thereby negatively
impacting its results and financial situation.
-
The marketing of certain products by the Group has been and could be
affected by supply shortages and other disruptions. Such difficulties
may be of both a regulatory nature (the need to correct certain
technical problems in order to bring production sites into compliance
with applicable regulations) and a technical nature (difficulties in
obtaining supplies of satisfactory quality or difficulties in
manufacturing active ingredients or drugs complying with their
technical specifications on a sufficiently reliable and uniform
basis). This situation may result in inventory shortages and/or in a
significant reduction in the sales of one or more products. More
specifically, in their US Hopkinton facility, Lonza, our supplier of
IGF-1 (Increlex® drug substance), is experiencing
manufacturing issues with Increlex®. Supply interruption
occurred in mid-June 2013 in the US and in Q3 2013 in Europe and the
rest of the world. On December 18th 2013, Ipsen announced
that Lonza had successfully re-manufactured the active ingredient of
Increlex® and that the European Medicines Agency (EMA) had
been informed that Ipsen was preparing for the resupply of Increlex®
in the European Union. Consultations with the National competent
authorities have allowed a resupply in Europe early 2014. In the
United States, Ipsen has released one batch of Increlex®’s
active ingredient on 2 June 2014. Ipsen anticipates that additional
lots will be released in the coming months, as the company continues
to work closely with the FDA to make additional Increlex®
lots available as soon as possible.
-
In certain countries exposed to significant public deficits, and where
the Group sells its drugs directly to public hospitals, the Group
could face discount or lengthened payment terms or difficulties in
recovering its receivables in full. The Group closely monitors the
evolution of the situation in Southern Europe where hospital payment
terms are especially long. More generally, the Group may also be
unable to purchase sufficient credit insurance to protect itself
adequately against the risk of payment default from certain customers
worldwide. Such situations could negatively impact the Group’s
activities, financial situation and results.
-
In the normal course of business, the Group is or may be involved in
legal or administrative proceedings. Financial claims are or may be
brought against the Group in connection with some of these proceedings.
-
The cash pooling arrangements for foreign subsidiaries outside the
euro zone expose the Group to financial foreign exchange risk. The
variation of these exchange rates may impact significantly the Group’s
results.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150730006770/en/
Contacts:
For further information:
Media
Didier
Véron
Senior Vice-President, Public Affairs
and
Communication
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33
50 58
E-mail: didier.veron@ipsen.com
or
Brigitte
Le Guennec
Corporate External Communication Manager
Tel.:
+33 (0)1 58 33 51 17
Fax: +33 (0)1 58 33 50 58
E-mail: brigitte.le.guennec@ipsen.com
or
Financial
Community
Stéphane Durant des Aulnois
Vice-President,
Investor Relations
Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58
33 50 63
E-mail: stephane.durant.des.aulnois@ipsen.com
Source: Ipsen
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