Ipsen reports solid sales growth in first quarter 2020 with limited COVID-19 impact

• Continued momentum with Q1 2020 Group sales growth of 9.6% as reported, or 8.7%¹ at constant exchange rates

• Limited Q1 2020 financial impact from COVID-19 given resilient Specialty Care product portfolio comprised mostly of highly-differentiated treatments for critical conditions. Levels of inventory are adequate and no supply chain issues are anticipated. Limited disruption to ongoing clinical trials

• 2020 Guidance remains suspended as announced in March given the uncertainty around the duration and scale of the COVID-19 pandemic

• Significant progress for palovarotene with clearance to re-initiate dosing in fibrodysplasia ossificans progressiva (FOP) patients 14 years of age and older, and complete response submitted to the FDA’s questions related to the partial clinical hold on patients under 14 years of age in palovarotene trials

• Focus on near-term priorities: executing on COVID-19 business continuity plan, identifying a new CEO and determining the regulatory pathway for palovarotene for FOP

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

Aymeric Le Chatelier, Chief Executive Officer and Chief Financial Officer of Ipsen stated: “Thanks to the resilient Specialty Care product portfolio, the Group delivered solid sales growth in the first quarter with limited impact from COVID-19. Our priorities in these unprecedented times are to ensure the safety of our employees as well as driving business continuity so patients can maintain access to important medicines. Our 2020 guidance remains suspended until we have more visibility.
“During the first quarter, we received authorization to re-initiate dosing of palovarotene in patients with FOP and are now focused on working with the FDA and other agencies on defining a regulatory path forward with the objective of bringing palovarotene to FOP patients as quickly as possible.
“Thanks to the continued commitment and dedication of our people around the world, we are mobilized to face the COVID-19 pandemic. Together, we will continue to advance and strengthen our pipeline and drive growth and sustainability to fulfill our mission of improving patients’ lives.”

First quarter sales

First quarter 2020 unaudited IFRS consolidated sales

Continuing its growth trajectory, Ipsen achieved solid Group sales growth of 9.6% as reported, or 8.7%¹ at constant exchange rates in the first quarter of 2020.

• Specialty Care sales growth of 12.5%¹, reflecting continued strong double-digit growth of Somatuline® (lanreotide) and the continued growth of Cabometyx® (cabozantinib) and Decapeptyl® (triptorelin).
• Consumer Healthcare sales down by 21.9%, mainly related to China with the negative impact of the implementation of hospital central procurement and COVID-19.

COVID-19 update

In the first quarter of 2020, the business remained strong with COVID-19 having a limited impact on sales due to increased stocking in the Oncology portfolio in some European countries toward the end of first quarter. This offsets a lower demand in China in February and March which had a significant impact on the Consumer Healthcare portfolio.
Ipsen continues to operate all of its manufacturing sites and is closely monitoring the situation. There is an adequate level of inventory with no supply chain issues anticipated to continue providing medicines to patients. There is also limited impact to date on clinical trials, with minimal disruption to investigational drug supply for ongoing patients, despite a general slowdown in the recruitment of new patients as well as new site activations in ongoing trials across Europe and the U.S.
Ipsen remains focused on ensuring that patients continue to have access to their treatments and on addressing the impact of this pandemic in their communities. Most Ipsen employees around the world, excluding mainly those at the manufacturing and distribution sites, are working from home today, and the commercial organization continues to support healthcare providers virtually.
In the second quarter of 2020, the situation in China should improve as business begins to resume. However, despite Ipsen’s sustainable and resilient Oncology portfolio comprised mostly of highly-differentiated long-acting treatments for critical conditions, there is expected to be some impact from delayed diagnoses and lower new patient gains. It is also anticipated that there will be more of a negative impact on Dysport sales and revenues in both the therapeutics and aesthetics markets with delayed injections.

2020 Guidance

As announced in March 25th, the 2020 guidance remains suspended due to the lack of visibility on all the consequences of the global COVID-19 pandemic despite a resilient Oncology portfolio. It is not possible at this stage to quantify the impact on the Group’s financial statements. Further updates will be provided as the situation evolves.

Palovarotene update

In the last few months, Ipsen made significant progress on advancing palovarotene, a top priority for the company. On 26 March 2020, clearance was received from the U.S. Food and Drug Administration (FDA) and other regulatory authorities to re-initiate palovarotene dosing in patients 14 years of age and older in the fibrodysplasia ossificans progressiva (FOP) clinical program. It was also decided to terminate the Phase 2 MO-Ped trial in patients with multiple osteochondromas (MO) in order to analyze the accumulated data and to better inform on the efficacy, safety and future of palovarotene in MO. A Complete Response was recently submitted to address the FDA’s questions related to the partial clinical hold on patients under 14 years of age in palovarotene trials.

Positive topline results from pivotal Phase 3 CheckMate -9ER trial

CheckMate -9ER, a pivotal Phase 3 trial evaluating Cabometyx in combination with Opdivo (nivolumab) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met its primary endpoint of progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).
The safety profiles of Cabometyx and Opdivo observed in the trial reflect the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line RCC.
Detailed results of CheckMate -9ER will be submitted for presentation at an upcoming medical conference.

2020 Near-term priorities

Ipsen remains focused on the following near-term priorities:

• COVID-19: Ipsen will effectively manage the developing situation of COVID-19 by ensuring the safety of all employees and business continuity for patients as well as preparing for business recovery including protecting profitability and cash flow generation.
• CEO search: The board of directors is progressing with its search for a new CEO with no delay expected due to COVID-19.
• Palovarotene program: Ipsen intends to engage with the FDA and other regulatory authorities on the appropriate patient population eligible for treatment and a potential regulatory path forward for palovarotene in FOP.

2020 Annual Shareholders’ Meeting and proposed distribution of €1.00 per share confirmed
The Annual Shareholders’ Meeting will be held on 29 May 2020 behind closed doors, without the physical attendance of shareholders. It will be broadcast via a link provided on Ipsen’s website. Ipsen will request its shareholders to cast their votes remotely and submit their questions in advance.
Furthermore, the company confirms the proposed distribution of €1.00 per share for the 2019 financial year to be paid on 5 June 2020. The ex-dividend date is set for 3 June 2020.
Conference call details                                                           
Ipsen will hold a conference call on Wednesday, 22 April 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/7159233
A recording will be available for seven days on Ipsen’s website.

1. At constant exchange rates. 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.

Attachment

• Q1-2020-Sales-announcement