Ipsen delivers strong results for the first half of 2019 with robust double-digit sales growth and improved Core Operating margin and upgrades its guidance for full year 2019

PARIS--(BUSINESS WIRE)-- Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, today announced financial results for the first half of 2019.

Extract of audited consolidated results for H1 2019 and 2018

David Meek, Chief Executive Officer of Ipsen, stated: “In the first half of 2019, the strong operational execution of our growth strategy led to robust double-digit sales growth, continued Core Operating margin expansion and an upgrade in our sales guidance for full year 2019. The value of our pipeline was further strengthened by the closing of the Clementia acquisition and promising interim Phase 2 data for Onivyde in first-line pancreatic cancer. Going forward, we will continue to advance our strategic priorities to deliver sustained top-line, bottom-line and pipeline growth.”

Upgraded Full Year 2019 guidance

• Group sales growth greater than +14.0% at constant currency and consolidation scope¹ (versus initial guidance of greater than +13.0%)
  • Impact of currencies estimated at +1.5% based on the current level of exchange rates
  • Impact of consolidation scope reflecting the consolidation under the equity method for joint arrangements related to the Schwabe partnership estimated at -1.0%
• Core Operating margin at around 30.0% of net sales, including the impact of Clementia but excluding potential incremental investments in pipeline expansion initiatives

¹ Subsidiaries involved in the partnership between Ipsen and Schwabe Group are consolidated in accordance with the equity method starting 1 January, 2019. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

Q2 2019 Pipeline highlights

• 17 April: Completion of the Clementia Pharmaceuticals acquisition
• 24 June: U.S. FDA approval of the Somatuline New Delivery System
• 5 July: Presentation at ESMO-GI of promising interim data from the Phase 1/2 study of the investigational use of Onivyde^® in combination with 5-fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) in study patients with previously untreated metastatic pancreatic ductal adenocarcinoma cancer (PDAC)

H1 2019 Financial highlights

• Group sales growth of 15.5% as reported and 14.3% at constant exchange rates and consolidation scope¹, driven by the strong performance of Specialty Care across all major products and geographies.
• Core Operating margin at 31.5% of net sales, up 1.2 points and Core Operating Income growth of 20.1% after higher R&D investments including Clementia

IFRS operating margin at 25.8% of net sales, up 0.5 points and IFRS Operating Income growth of 17.8%.

Refinancing update

• Full refinancing following the acquisition of Clementia Pharmaceuticals to increase debt capacity for future business development, extend the maturity horizon and diversify sources of financing.
• 24 May: Signature of a new 5-year revolving credit facility (RCF) of €1.5 billion with two possible one-year extensions to replace existing bank facilities with specific indicators linked to CSR (Corporate Social Responsibility).
• 23 July: Closing of a $300 million dual-tranche issuance of notes with 7- and 10-year maturities on the U.S. market (U.S. Private Placement - USPP) from a group of long-term U.S. investors.

First issuance in the private placement market and in the U.S. debt market for the company, illustrating the high level of confidence of investors in Ipsen and in the quality of its credit profile.

The transaction in this press release is not an offer for sale of the securities in the United States. No public offering of the securities will be made in the United States. The securities have not been registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be sold in the United States absent registration or an exemption from registration under the Securities Act.

¹ Subsidiaries involved in the partnership between Ipsen and Schwabe Group are consolidated in accordance with the equity method starting 1 January, 2019. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

Review of the first half 2019 results

Note: Unless stated otherwise, all variations of year-on-year sales are stated at constant exchange rates and consolidation scope. Subsidiaries involved in the partnership between Ipsen and Schwabe Group are consolidated in accordance with the equity method starting 1 January, 2019. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

Group sales reached €1,229.6 million, up 14.3% year-on-year.

Specialty Care sales reached €1,100.0 million, up 16.9%, driven by the growth in Oncology of +20.7% from the continuous growth of Cabometyx^® and Onivyde^® as well as Somatuline^® and Decapeptyl^® across all geographies.

Consumer Healthcare sales reached €129.6 million, down 3.7%, mainly from the competitive environment for Smecta^® in China.

Core Operating Income was €387.5 million, up 20.1%, driven by the growth of Specialty Care sales, a sound management of Selling expenses and an increased investment in Research and Development (including Clementia costs from Q2 2019).

Core Operating margin reached 31.5% of sales, up 1.2 points versus the first half of 2018 despite the dilutive impact of Clementia expenses.

Core consolidated net profit was €283.0 million, compared to €237.1 million in 2018, up 19.3%, after increased financing costs mainly linked to the Clementia acquisition.

Core earnings per share fully diluted grew by 18.5% to reach €3.38, compared to €2.86 in 2018.

IFRS Operating Income was €317.8 million after amortization of intangible assets and higher Other operating expenses, mainly related to Clementia integration costs and costs arising from the Group’s transformation programs. Operating Income margin of 25.8% is up 0.5 points compared to the first half of 2018.

IFRS Consolidated net profit was €220.6 million versus €197.3 million in 2018, up 11.8% impacted by the Onivyde^® revised contingent earn-out and milestones accounting following the recent publication of positive results related to the ongoing developments on Onivyde^®.

IFRS Fully diluted EPS (Earnings per share) was €2.64 versus €2.38 in 2018, up 10.9%.

Free Cash Flow reached €101.0 million, down by €63.5 million versus 2018, mainly driven by a lower Operating Cash Flow combined with higher Other operating expenses and Restructuring costs.

Closing net debt reached €1,499.5 million at the end of June 2019, versus €438.0 million at the end of June 2018, notably after the impact of Clementia’s acquisition for €986 million and of IFRS16 – Leases standard implemented starting 1 January 2019 for €188 million.

The company’s auditors performed a limited review of the accounts.

The interim financial report, with regard to regulated information, is available on the Group’s website, under the Regulated Information tab in the Investor Relations section.

Conference call

Ipsen will hold a conference call Thursday, 25 July 2019 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately five to ten minutes prior to its start. No reservation is required to participate in the conference call.

Standard International: +44 (0) 2071-928-000
France and continental Europe: + 33 (0) 1 76 70 07 94
UK: 08-445-718-892
United States: 1-6315-107-495

Conference ID: 3574629

A recording will be available for seven days on Ipsen’s website.

About Ipsen

Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. Its commitment to Oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.2billion in 2018, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.

Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties 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).

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