Ipsen : delivers sales growth in the first nine months of 2020 despite the impact of COVID-19 and confirms its 2020 full year guidance

Paris (France), 22 October 2020 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, today announced sales for the third quarter of 2020.

• Q3 2020 Group sales growth of +2.2%[1] at constant exchange rates and decrease of -1.8% as reported, driven by Specialty Care sales growth of 5.1%1 despite the continuing negative COVID-19 impact. Positive Q3 performance results in YTD sales growth of +2.8%1 at constant exchange rates and +1.5% as reported.
• Confirmation of 2020 full year guidance, with Group sales growth greater than +2.0% at constant currency and Core Operating margin greater than 30.0% of net sales.
• Key Q3 pipeline progress:
  • Cabometyx^® (cabozantinib): Presentation at the ESMO 2020 Virtual Congress of the Phase III CheckMate -9ER trial in patients with previously untreated advanced renal cell carcinoma, in which Cabometyx in combination with nivolumab met all key efficacy endpoints of overall survival, progression-free survival and objective response rate. The results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 expression subgroups.
  • Palovarotene: Presentation at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting of detailed data from the Phase III MOVE trial investigating palovarotene as a chronic and episodic treatment for patients with fibrodysplasia ossificans progressiva (FOP).
• Appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020, with responsibility for business development and alliance management.

David Loew, Chief Executive Officer of Ipsen stated: 'The Group delivered a resilient performance in the third quarter, despite the continued impact of the pandemic, and I am pleased to confirm our 2020 full year financial objectives. Our pipeline achieved notable progress with incremental positive data on Cabometyx and palovarotene, supporting our intention to bring these important therapies to patients. I look forward to sharing my long-term vision for Ipsen and the outcomes of a comprehensive strategic review at our Capital Markets Day on December 1^st.'

COVID-19 impact

In the third quarter of 2020, the business recovered gradually from the impact of COVID-19. While the Specialty Care portfolio comprised of differentiated products for critical conditions remained relatively resilient, Somatuline, Decapeptyl and Onivyde sales were negatively impacted by lower patient diagnoses and missed treatments due to the ongoing impact of the pandemic and the challenging hospital environment. In neuroscience, the aesthetics market showed a stronger recovery, while the therapeutics market rebounded more slowly with the gradual re-opening of injection centers. Consumer Healthcare sales, notably Smecta, continued to be negatively impacted across geographies.

The Group continued to realize cost savings in the third quarter, resulting from digital sales detailing, lower travel throughout the Group and the conversion to virtual conference and medical meetings.

2020 Guidance confirmed

The Group confirms the following financial targets for the current year:

• Group sales growth greater than +2.0% at constant currency, with an expected negative impact of 1.5% from currencies based on the level of exchange rates at the end of September.
• Core Operating margin greater than 30.0% of net sales

Recent pipeline highlights

• Positive results of the Phase III CheckMate -9ER trial presented at the ESMO Congress, in which Cabometyx^® in combination with Bristol Myers Squibb's Opdivo^® (nivolumab) demonstrated significant improvements across all efficacy endpoints, including superior overall survival (OS), a doubling of median progression-free survival (PFS) and superior objective response rate (ORR) versus sunitinib, with a favorable safety profile in previously untreated advanced renal cell carcinoma (RCC). Key efficacy results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 expression subgroups. The regulatory filing has been submitted and validated by the EMA, thus beginning the centralized review process.
• At the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting, Ipsen presented post hoc analyses from the Phase III MOVE trial investigating palovarotene as a chronic and episodic treatment for fibrodysplasia ossificans progressiva (FOP) in both pediatric and adult patients, with palovarotene demonstrating a 62% reduction in mean annualized new heterotopic ossification (HO) volume relative to untreated patients from a longitudinal Natural History Study (NHS).
• The Phase II CLARINET FORTE study results showed that increasing the dose frequency of Somatuline^® from monthly to bi-monthly achieved a progression-free survival of 8.3 months in patients with progressive midgut neuroendocrine tumors (NETs) and 5.6 months in patients with progressive pancreatic NETs. These results showed no new safety signals associated with this increased dose regimen, potentially delaying the need for additional, more toxic second-line therapies.

Third quarter 2020 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 2020 Group sales grew 2.2%¹ to €633.3 million.

Sales of Specialty Care products reached €580.5 million, up 5.1% year-on-year.

Somatuline sales reached €272.9 million, up 7.1% year-on-year, driven by volume growth in North America, the U.K. and Germany and despite delays in patient diagnoses and treatment due to COVID-19. In the U.S., the performance of Somatuline in Q3 was also negatively impacted by end-user buying patterns.

Decapeptyl sales reached €94.5 million, down 2.8% year-on-year, mainly due to lower sales in China and in some European countries as a result of the impact of COVID-19.

Cabometyx sales reached €76.8 million, growing 20.9% year-on-year, driven by good performance in Major Western European countries, Russia and Brazil.

Onivyde sales reached €27.5 million, up 11% year-on-year, driven by volume growth in the U.S.

Dysport sales reached €87.4 million, down 1.4% year-on-year, impacted by COVID-19 despite a gradual recovery of the therapeutics market and better dynamics in the aesthetics market.

Consumer Healthcare product sales reached €52.8 million, down 21.9%¹, with a decrease in Smecta sales of 38% impacted by COVID-19, implementation of hospital central procurement in China and lower performance in France.

Conference call

Ipsen will hold a conference call Thursday, 22 October 2020 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately 15 minutes prior to its start.

Participants can register for the call on the link below:

http://emea.directeventreg.com/registration/3185126

Conference ID: 3185126

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

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[1]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.