- 5 new chemical entities advancing in
pipeline
- 9 significant regulatory submissions
planned from 2019 to 2022
- 2022 financial outlook of Group Net
Sales around €3.2 billion1and Core Operating margin greater than
32.0% of net sales
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven
biopharmaceutical group, today will host an Investor Day in Paris
to present a comprehensive corporate update, with a focus on its
advancing R&D pipeline.
David Meek, Chief Executive Officer of Ipsen stated: “The
business momentum of Ipsen is strong, delivering industry-leading
top-line growth and investing to build an innovative and
sustainable pipeline. The execution of our R&D strategy over
the last two years through accelerating key internal programs and
externally sourcing innovation has significantly strengthened the
focus and value of our pipeline.
“Ipsen currently has five new chemical entities in clinical
development, nine significant regulatory submissions planned from
2019 to 2022 and several mid-to-late-stage program readouts in the
coming months. We remain committed to executing on our top-line,
bottom-line and pipeline growth strategy to create and deliver
long-term value to patients and shareholders.”
In Rare Diseases, palovarotene is a late-stage and
largely de-risked drug candidate for the treatment of rare and
extremely disabling bone disorders with no current treatment
options. Palovarotene has Orphan Drug, Fast Track, Breakthrough
Therapy and Rare Pediatric Disease designations and is supported by
robust clinical data. The company expects to submit an NDA to the
FDA in the second half of 2019 for the first indication of
fibrodysplasia ossificans progressiva (FOP).
In Neuroscience, Ipsen is pursuing two new therapeutic
indications to maximize the potential of Dysport®. The Company is
also leveraging its research and development expertise building
upon its neurotoxin franchise to advance its proprietary
next-generation neurotoxin program with a fast-acting neurotoxin to
enter Phase 2 clinical development in the second half of 2019 and a
long-acting neurotoxin in preclinical development.
In Oncology, there are numerous ongoing mid-to-late-stage
programs to broaden the scope of Cabometyx® (cabozantinib) and
Onivyde® (irinotecan liposomal). The Phase 3 CheckMate 9ER trial in
combination with nivolumab has the potential to strengthen
Cabometyx®’s presence in the first-line renal cell cancer market,
with top-line results expected in the first half of 2020. In
addition, the Phase 3 trial in combination with atezolizumab for
first-line hepatocellular carcinoma has the potential to expand the
use of Cabometyx® earlier in the treatment paradigm and to serve as
the registrational trial to enter China.
Regarding Onivyde®, the interim analysis of the Phase 2
combination trial for the treatment of first-line metastatic
pancreatic cancer indicates encouraging results on the disease
control rate and has been accepted as an oral presentation by the
ESMO World Congress on Gastrointestinal Cancer in July 2019. There
is also an ongoing Phase 2 trial for second-line small cell lung
cancer with top-line results expected in the second half of
2019.
In earlier-stage Oncology development, Ipsen is advancing its
innovative Systemic Radiation Therapy program with satoreotide (IPN
1070 and IPN 1072) which is expected to move into a Phase 2/3 trial
in neuroendocrine tumors by the first quarter of 2020 and IPN 1087
which is currently in Phase 1 development for pancreatic cancer.
Both are platform technologies with the possibility to expand to
additional solid tumors and to provide precision targeted treatment
to patients.
_______________1 Assuming current level of exchange rates
Ipsen will also execute on its external innovation and business
development model in its key therapeutic areas, building on its
strong balance sheet and cash flow generation to acquire assets and
invest in R&D pipeline for long term shareholders’ value.
Along with an R&D pipeline update, Ipsen will also provide
updates on its corporate strategy, commercial highlights of its key
Specialty Care products, and new objectives on its capital
allocation strategy and mid-term financial outlook.
2022 Financial
outlook
Ipsen provides its 2022 financial outlook to reflect the strong
momentum of its Specialty Care business and the impact from the
acquisition of Clementia closed in April 2019:
- Group Net Sales around €3.2
billion2
- Core Operating margin greater than
32.0% of net sales
This outlook includes only the existing commercial portfolio of
products under current approved indications and assumes the
approval and launch of palovarotene in FOP indications3 only. It
assumes the earliest possible entry of somatostatin analog (SSA)
generics based on market intelligence. It does not include the
potential short-term, low single-digit Core Operating margin
dilution of business development transactions to further accelerate
building an innovative and sustainable pipeline.
Webcast and Conference
call
Ipsen will host an audio and video webcast and conference call
of the Investor Day on Tuesday 14 May 2019 at 1:00 p.m. (CEST,
BST+1) available at www.ipsen.com. Participants should dial in to
the call approximately 5 to 10 minutes prior to its start. No
reservation is required to participate in the conference call.
Standard International: +44 (0) 2071-928-000France and
continental Europe: + 33 (0) 1 76 70 07 94UK: 08-445-718-892U.S.:
1-6315-107-495
Conference ID: 8463129
A recording will be available for 7 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 €2.2 billion 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.
_______________2 Assuming current level of exchange rates3
Including both flare-up and chronic indications for FOP
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 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).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190513005766/en/
MediaChristian MarcouxSenior Vice President,
Global Communications+33 (0)1 58 33 67
94Christian.marcoux@ipsen.com
Fanny AllaireDirector, Ipsen France Hub,
Global Communications+33 (0) 1 58 33 58
96Fanny.allaire@ipsen.comFinancial
CommunityEugenia LitzVice President, Investor
Relations+44 (0) 1753 627721eugenia.litz@ipsen.com
Myriam KoutchinskyInvestor Relations Manager+33 (0)1 58
33 51 04myriam.koutchinsky@ipsen.com
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