RECORDATI: BEST IN CLASS VALUE CREATOR
February 2024
AGENDA
Recordati strategy and value proposition
Full Year 2023 preliminary results and FY 2024 guidance
- Appendix
2
UNIQUE AND DIVERSIFIED GLOBAL PLAYER IN RARE DISEASES AND EUROPEAN PARTNER OF CHOICE IN SPECIALTY PHARMA
RECORDATI IN NUMBERS - FY 2023
EMPLOYEES1MARKETS1> 4,300 | ~150 |
€ 2,082.3 | € 769.6 |
+12.4% vs PY | margin at 37% |
+14.0% LFL2 at CER |
€ 524.6 | ~ 1.96x EBITDA |
margin at 25.2% | |
ESG RECOGNITION
Specialty &
Primary Care
66% of Revenue
EBITDA margin 34.2%
Rare
Diseases
34% of Revenue
EBITDA margin 42.3%
1)FY 2022 figures | ||
2) | Pro-forma growth calculated excluding FY 2023 revenue of Avodart® and Combodart®/ Duodart®(SPC) and adding Q1 2022 revenue of EUSA Pharma (RRD) | |
3)Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, non-recurring items and non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory | 3 | |
according to IFRS 3 | ||
4) | Net income excluding amortization and write-downs of intangible assets (except software) and goodwill, non-recurring items, non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory (IFRS 3) and monetary net gains/losses from hyperinflation (IAS 29), net of | |
tax effects | ||
5) | Pro-forma considering the contribution of Avodart® and Combodart®/Duodart® for the last twelve months |
DELIVERING ANOTHER YEAR OF STRONG FINANCIAL RESULTS, WITH AVERAGE ROIC1 OF 15-20% OVER LAST DECADE
Group Revenue 2013-2025 - actual and guidance
million Euro | CAGR | > 2,4004 | ||||||||||||||||
+8.3% | 2,260 -2,320 | |||||||||||||||||
2,082 | ||||||||||||||||||
1,853 | ||||||||||||||||||
1,482 | 1,449 | 1,580 | ||||||||||||||||
1,288 | 1,352 | |||||||||||||||||
1,154 | ||||||||||||||||||
987 | 1,048 | |||||||||||||||||
942 | ||||||||||||||||||
RRD | ||||||||||||||||||
SPC2 | ||||||||||||||||||
2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 * | 2021 | 2022 | 2023 | 2024 | 2025 | ||||||
Actual vs Mid- | +2% | -1% | +5% | +6% | +6% | -1% | +3% | -7% | -1% | +6% | +4% | |||||||
point of guidance | ||||||||||||||||||
range% 3 | ||||||||||||||||||
*2020 figures impacted by LOE on silodosin and on pitavastatin (and COVID-19 pandemic) | ||||||||||||||||||
1) Return on invested capital avg. 2013-2023, source Bloomberg, Factset estimates and Company elaborations | 4 | |||||||||||||||||
2) Including Chemical Division | ||||||||||||||||||
3) Delta calculated on actual FY Revenues vs mid-point of Revenue guidance range given at the beginning of the year (February) |
4) On track to exceed the 2025 targets set in February 2023, with current portfolio alone (including sales of Avodart® and Combodart®/Duodart®) now expected to deliver Revenue in excess of € 2.4 billion in 2025, sustaining an EBITDA margin of +/- 37%
PROVEN AND SUSTAINABLE BUSINESS MODEL
Unique combination of resilient and cash flow generative branded Specialty & Primary Care business (RX, OTC) alongside a high growth global Rare disease business (US now Group's largest unit)
Best-in-class financial profile with consistent track record of growth at scale
Strong franchises with no material loss of exclusivity exposure
Disciplined R&D focused on targeted late stage rare disease programs
Proven M&A and integration capabilities to complement organic growth
World class management team with strong track record of delivering profitable growth, in line with plans
5
THREE DRIVERS OF GROWTH
1 | 2 | TARGETED | 3 |
ORGANIC | BD / M&A | ||
INNOVATION | |||
SPECIALTY | Branded portfolio of flagship RX / | Acquisition and licensing of | |||
& | OTC products,driven by focused | Line extensions on key OTC | European mature promotion- | ||
promotion and positive underlying | sensitive products and near | ||||
PRIMARY | brands | ||||
industry trends, with resilient | market opportunities with focus on | ||||
CARE | |||||
pricing | Cardio, Uro, Gastro | ||||
Acquisitions and partnerships with | |||||
RARE | Market penetration driven by | Targeted clinical opportunities | global/local scope focused on near | ||
increasing diagnosis rates and | which we believe we can turn into | market products, also exploring | |||
DISEASES | |||||
geographic expansion | commercial success | opportunities post proof of | |||
concept
6
THE EUROPEAN PARTNER OF CHOICE
Specialty & Primary Care
Strong organic growth ahead of relevant markets…
Pharmaceutical Revenue1 FY 2023 vs FY 2022
million Euro
+8.7% | ||||
+13.6% LFL2 at CER | ||||
1,313.6 | ||||
1,208.6 | + 3.8% | |||
365.2 | ||||
351.8 | ||||
Cardiovascular | 227.4 | 280.4 | + 23.3% | ||
Urology | |||||
203.2 | 219.3 | + 7.9% | |||
Gastrointestinal | |||||
Cough and Cold | 125.5 | 137.1 | + 9.3% | ||
Other | |||||
pharmaceuticals | 300.6 | 311.6 | + 3.7% | ||
FY 2022 | FY 2023 |
1)Excluding Chemicals € 54.0 million in FY 2023 and € 48.9 million in FY 2022
- Pro-formagrowth calculated excluding FY 2023 revenue of Avodart® and Combodart®/ Duodart®(SPC)
- IQVIA December YTD Evolution Index on promoted and reminder products
…driven by commercial excellence
- Fully integrated regional player with direct presence in 30+ countries, having significant scope and scale with cost effective and competitive commercial capabilities in every market, resulting into market outperformance with promoted portfolio (103% Evolution Index)3
- Go to partner for promotionally sensitive Established Brands and new near market opportunities in core areas of Cardiovascular, Urology and Gastroenterology, with ~1,500 salespeople
- Focus on local and Regional flagship Brands in OTC to drive organic and inorganic profitable growth balancing digital innovation and clinical advocacy
- Portfolio expected to grow organically mid-singledigit at CER, driven by several growth drivers in RX and OTC4 with a stable core of mature brands and negligible LOE risk
7
4) RX 47% and OTC 16% of FY 2023 revenue
A GLOBAL RARE DISEASES BUSINESS
Rare Diseases
Double-digit growth driven by Endo and Onco…
Revenue FY 2023 vs FY 2022 | |
million Euro | +20.0% |
+14.9% LFL2 at CER |
…and by patient and physician awareness
- One of the few truly global rare diseases businesses, with direct presence in key geographies: North America, EU, Japan, Australia/NZ, China, Latin America, South Korea
595.8 | |
(634.2)2 | |
38.4 | |
Oncology | 136.0 |
Endocrinology 1 |
714.7 + 15.2%
2200.9
+ 41.0%
• | Portfolio of >20 Orphan and Ultra-orphan products across three |
therapeutic areas: Metabolic, Endocrinology and Oncology | |
• | Plans on track for further geographic expansion (LATAM and rest |
of Asia) |
Metabolic | 171.9 |
287.9
242.3
271.6
- 5.7%
• Expect to continue delivering double-digitgrowth at CER, driven |
by Endocrinology, Oncology and increased international presence |
• Exciting pipeline opportunities to enhance growth beyond 2025, |
with Isturisa label extension into Cushing Syndrome and |
dinutuximab beta in neuroblastoma in US, REC 0559 in |
Neurotrophic Keratitis (Ph2) and pasireotide in Post Bariatric |
Hypoglycemia (Ph2) |
FY 2022 | FY 2023 |
1) | Of which Signifor® and Signifor® LAR of € 102.9 million and Isturisa® of € 139.5 million | 8 |
2) | Pro-forma growth calculated adding Q1 2022 revenue of EUSA Pharma (RRD) of €38.4 million |
RARE ENDO AND ONCO PORTFOLIO POSITIONED FOR STRONG
GROWTH IN MID-LONG TERM
ENDOCRINOLOGY
Revenue | ~500-550 |
million Euro | |
300-340 | |
242
172
127
2021 | 2022 | 2023 | 2025 | Peak sales | |
(excl. PBH) |
ONCOLOGY | ||||||
Revenue | ||||||
million Euro | ~250-300 | |||||
220-250 | ||||||
201 | ||||||
174 | ||||||
152 | 1 | 136 | ||||
38 | 1 | |||||
2021 | 2022 | 2023 | 2025 | Peak sales |
Key drivers
- Isturisa2 increased patient uptake, leveraging long-term efficacy / safety data and maximizing treatment adherence, with also US label extension to Cushing Syndrome
- Signifor LAR second line medical treatment in Acromegaly
- Potential Peak sales: Isturisa on track to exceed €400 million and
Signifor/Signifor LAR €100-150 million (excluding PBH) - Pasireotide ph. II opportunity in Chronic condition in post-bariatric surgical patients (PBH); potential additional peak sales of >€150 million3
- Qarziba improved further penetration in EMEA / LAC and ambition to enter the US market in Relapsed / Refractory High-RiskNeuroblastoma patients
- Improving iMCD diagnosis for Sylvant, ensuring long-term retention
- Potential Peak sales: ~€250-300 million, including Qarziba in US
- Potential new indications opportunities under evaluation for both Qarziba and Sylvant
1) | EUSA Pharma results consolidated as of Q2 2022 in Recordati financials | 9 |
2) | Approved in Europe and internationally for Cushing Syndrome, in US for Cushing Disease only | |
3) PBH peak sales estimates non-risk adjusted |
UPCOMING R&D PIPELINE MILESTONES
PROGRAM | EXPECTED TIMELINE |
ONGOING
PROGRAMS
ADDITIONAL
OPPORTUNITIES
Osilodrostat | • | Cushing Syndrome US | FDA meeting end of Q2 2024 | |
( | ) | |||
Pasireotide | • | Post-Bariatric Hypoglycaemia (PBH) | Phase 2 enrollment completion by end 2024 / early 2025 | |
Dinutuximab beta | • | High Risk relapsed/refractory Neuroblastoma | Further interactions with FDA in H1 2024 | |
( | ) | in US | ||
REC 0559 / | • | Moderate/severe Neurotrophic Keratitis | Phase 2 trial top-line data readout in mid-2024 | |
MT8* | ||||
Dinutuximab beta | • | Ewing sarcoma | Under evaluation | |
( | ) | |||
Siltuximab | • | Cytokine response syndrome (CAR-T patients) | Under evaluation | |
( | ) | |||
Legend | ||
ENDO | ONCO | META |
Filing dates planning estimates, subject to study read outs and regulatory feedback | 10 |
* In-licensed from MimeTech | |
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Recordati Industria Chimica e Farmaceutica S.p.A. published this content on 01 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 March 2024 14:17:07 UTC.