On October 24, 2019 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported sales for the third quarter of 2019 (Press release, Ipsen, OCT 24, 2019, View Source [SID1234542454]).

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Financial highlights

Q3 2019 Group sales growth of +16.0% as reported and +14.5%1 at constant exchange rates and consolidation scope, driven by Specialty Care sales growth of 16.5%1, reflecting strong double-digit momentum of Somatuline (lanreotide) and the continued growth from Cabometyx (cabozantinib) and Decapeptyl (triptorelin)
YTD Group sales growth of +15.7% as reported and +14.3%1 at constant exchange rates and consolidation scope fueled by strong Specialty Care sales growth of 16.8%1
Full Year 2019 guidance confirmed with Group sales growth greater than +14.0% at constant currency and consolidation scope1 and Core Operating margin at around 30.0% of net sales
Recent pipeline highlights

Positive interim Phase 1/2 clinical data evaluating Onivyde (liposomal irinotecan) as first-line treatment for metastatic pancreatic cancer presented at ESMO (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer
Positive interim data from seamless Phase 2/3 clinical trial evaluating Onivyde as a second-line treatment for small cell lung cancer (SCLC) presented at the IASLC 2019 World Conference on Lung Cancer
FDA approval of Dysport (abobotulinumtoxinA) for the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy (CP)
In-licensing of BLU-782 from Blueprint Medicines, a highly selective ALK2 inhibitor in Phase 1 development for the treatment of fibrodysplasia ossificans progressiva (FOP)
Palovarotene regulatory submission to the FDA for the episodic treatment of FOP now expected in Q1 2020 as a result of the processing of additional supportive data.
Key figures

Unaudited IFRS consolidated sales

Third Quarter

Nine Months

(in million euros)

2019

2018

%

Variation

%

Variation

at constant

currency and

consolidation

scope1

2019

2018

%

Variation

%

Variation at

constant currency

and consolidation

scope 1

Specialty Care

574.2

484.1

18.6%

16.5%

1,674.1

1,404.2

19.2%

16.8%

Consumer Healthcare2

70.6

71.9

-1.8%

0.1%

200.2

216.2

-7.4%

-2.4%

Group sales

644.7

555.9

16.0%

14.5%

1,874.3

1,620.4

15.7%

14.3%

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.

David Meek, Chief Executive Officer of Ipsen stated: "In the third quarter, we continued to execute on our objectives with a strong performance of our Specialty Care business, including double-digit growth of Somatuline in both the U.S. and Europe. With our excellent performance year-to-date, we are increasingly confident in our ability to achieve our 2019 financial guidance.

"We remain focused on the successful execution of the palovarotene program to bring the first therapeutic treatment to FOP patients as expeditiously as possible. We also continue to deliver on our external innovation strategy. The recent in-licensing of BLU-782 reinforces our leadership in FOP with a different and potentially complementary mechanism of action to palovarotene, expands our portfolio approach in this complex ultra-rare bone disorder and leverages our clinical and commercial capabilities. Advancing our pipeline remains a key focus going forward to deliver on our growth strategy and to bring additional value to patients and shareholders."

Third quarter 2019 sales highlights

Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts (currency effects established by recalculating net sales for the relevant period at the exchange rates from the previous period)

Q3 2019 Group sales grew 14.5%1 to €644.7 million.

Sales of Specialty Care products reached €574.2 million, up 16.5% year-on-year.

Somatuline sales reached €264.0 million, up 18.8%, year-on-year, driven by 20.0% growth in North America, double-digit growth in key European countries and good performance in Japan.

Decapeptyl sales reached €98.9 million, up 10.5% year-on-year, driven by volume and market share gains in Europe and double-digit growth in China.

Cabometyx sales reached €64.5 million, growing 66.3% year-on-year, driven by the good performance in all launched European countries and additional launches in Asia and Oceania.

Onivyde sales reached €26.1 million, down 7.3% year-on-year, impacted by limited shipments to Ipsen’s ex-U.S. partner in the third quarter.

Dysport sales reached €97.4 million, up 8.8% year-on-year, driven by the solid performance in the U.S. in the therapeutics and aesthetics markets, as well as growth from Galderma in Europe.

Consumer Healthcare product sales totaled €70.6 million, stable at +0.1%1, driven by Smecta growth of 2.5% year-on-year, from the good performance in France and in China despite the new hospital competitive pricing environment, and Forlax growth of 9.7% year-on-year. Tanakan sales reached €8.8 million, down 10.0% year-on-year, due to competitive pressure in emerging countries and a market slowdown in France.

Confirmation of Full Year 2019 guidance

Group sales growth greater than +14.0% at constant currency and consolidation scope1
Impact of currencies estimated at +2.0% 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
Conference call

Ipsen will hold a conference call Thursday, 24 October 2019 at 2:30 p.m. (Paris time, GMT+2). 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
U.S.: 1-6315-107-495
Conference ID: 5649858

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