Ipsen to Host an Investor Day to Highlight Its Innovative R&D Pipeline and Provide Financial Outlook for 2022

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    • 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
      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

    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

    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

    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
    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


    Christian Marcoux
    Senior Vice President,
    Global Communications
    +33 (0)1 58 33 67 94

    Fanny Allaire
    Director, Ipsen France Hub,
    Global Communications
    +33 (0) 1 58 33 58 96


    Eugenia Litz
    Vice President, Investor
    +44 (0) 1753 627721

    Myriam Koutchinsky
    Investor Relations Manager
    +33 (0)1
    58 33 51 04