- 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 billion1
and
Core Operating margin greater than 32.0% of net sales
PARIS–(BUSINESS WIRE)–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) 2071-928-000
France and continental
Europe: + 33 (0) 1 76 70 07 94
UK: 08-445-718-892
U.S.:
1-6315-107-495
Conference ID: 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
rates
3 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).
Contacts
Media
Christian Marcoux
Senior Vice President,
Global Communications
+33 (0)1 58 33 67 94
Christian.marcoux@ipsen.com
Fanny Allaire
Director, Ipsen France Hub,
Global Communications
+33 (0) 1 58 33 58 96
Fanny.allaire@ipsen.com
Financial
Community
Eugenia Litz
Vice President, Investor
Relations
+44 (0) 1753 627721
eugenia.litz@ipsen.com
Myriam Koutchinsky
Investor Relations Manager
+33 (0)1
58 33 51 04
myriam.koutchinsky@ipsen.com