2021 First nine months results

2021 First Nine Months Results

Milano, 28th October 2021

First nine months 2021 highlights

• Q3 results continued to reflect the positive trends already seen in Q2, with rebound of revenue across SPC, strong contribution from Eligard(1) (all key markets now selling directly) and continued strong growth of Rare Diseases
• YTD Q3 net revenue of €1,156.2 million was +5.7% vs PY or +8.6% at CER; excluding Eligard® revenue of €59.4 million, growth in CER would be +3.2%, with good revenue momentum in recent months more than off-setting the full year impact of 2020 LOEs and impact of Covid-19 restrictions particularly on flu medicines in 1H
• Financial results are in line with expectations, with operating results reflecting planned increased investment behind Endo and Eligard® and return to higher level of activity in the field. Results also reflect higher financial charges (due to FX volatility) and non-recurring tax benefits of €26.2 million recognized in Q2:
• • EBITDA(2) €447.9 million or 38.7% of sales, +2.1%
  • Net Income €296.4 million or 25.6% of sales, +8.1%
  • Adjusted Net Income(3) €313.4 million or 27.1% of sales, -1.3%
  • Free cash flow(4) €352.9 million, an increase of € 69.6 million vs same period 2020
• Continued focus on ESG agenda results in MSCI rating improvement and inclusion in Euronext MIB ESG index
• Board approved interim 2021 dividend of € 0.53 per share, consistent with our dividend policy
• Approved a share buy-back program for a maximum of 1 million shares to service the stock option plans
• 1. Acquired under license from Tolmar International Ltd. in January 2021
  2. Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, and non-recurring items

2 (3) Net income excluding the amortization and write-downs of intangible assets (except software) and goodwill, and non-recurring items, net of tax effects

(4) Operating cash flow excluding financing items, milestones, dividends, purchases of treasury shares net of proceeds from exercise of stock options

Eligard® transition ahead of plan, with positive early signals from active promotion

• Revenue of €59.4 million* is ahead of expectations due to earlier switch to direct sales and Recordati promotion in several markets

• Recordati is MA Holder in all Mutual Recognition Procedure markets, with around 30 Marketing Authorisation Transfers completed before the end of September

• Eligard® is being promoted directly by our affiliates in 24 countries and indirectly by our partners in 6 additional countries with positive feedback from HCPs

• Encouraging signs of changes in the sales trend in early promotion markets with August in-market sales returning to growth in Spain and Germany and improvements in other markets including France and Italy

• The development of the new device by Tolmar is progressing, regulatory filing now expected in Q1 2022

as of September 30th

• On track to deliver just over €80 million revenue for FY 2021

Countries directly promoting Eligard®

Countries indirectly promoting Eligard® by our partners

3	* Recordati books net margin as Revenue until distribution transfer from Astellas in 2021

Signifor® & Signifor LAR® sales growth continues in Q3 2021 Isturisa® launch on track in US, EU and JP

Signifor® and Signifor® LAR commercialization on track

• YTD Q3 2021 reported Net Revenue of ~€58.5 million
• Growth of in-market sales at constant exchange rate estimated to be around 10% vs 2020*
• Continued new patient acquisition in all Regions across all approved indications
• Transfer of Marketing Authorization almost finalized in wave 2 markets

Isturisa® launch and new patient acquisition progressing as planned

• Isturisa® YTD Q3 2021 Net Revenue ~€32 million
• Robust patient uptake in US, France and other EU markets
• Reimbursement price agreed in Germany in line with expectation, discussion ongoing in other EU markets
• Launched in Japan on June 30th, 2021. Performing according to plan
• Strong support from top KOLs and patient organizations continues

• Recordati books only margins on sales of Signifor® and Signifor LAR® until transfer of market authorizations and distribution from Novartis; in market

4 sales performance estimated through net margin gross up for like for like comparison

Main products sales

(million Euro)	9M 2021		9M 2020		Change %
Zanidip® (lercanidipine)	107.2		106.1		1.0
Seloken®/Seloken® ZOK/Logimax®	73.0		77.7		(6.1)
(metoprolol/metoprolol+felodipine)
Eligard®(1)	59.4		-		n.m.
Urorec® (silodosin)	45.3		58.5		(22.6)
Livazo® (pitavastatin)	31.8		42.5		(25.0)
Zanipress® (lercanidipine+enalapril)	31.3		38.2		(18.1)
Other corporate products (2)	198.1		198.7		(0.3)
Drugs for rare diseases	279.4		232.4		20.2
of which Endo franchise(3)	90.5		53.8		68.2

	(1) Eligard® net revenue includes margins booked as net revenue until transfer of market authorizations and distribution
	(2) Includes the OTC corporate products for an amount of € 79.3 million in 2021 and € 78.4 million in 2020
5	(3) Endo franchise net revenue 2020 includes margins on sales of Signifor® and Signifor® LAR until transfer of market authorizations