Earnings Release • Feb 21, 2023
Earnings Release
Open in ViewerOpens in native device viewer
2022 Preliminary Full-Year Results and 2023-2025 Plan Update
Milano, February 21st 2023
Alberto Martinez Executive VP Specialty & Primary
Luigi La Corte Chief Financial Officer
Scott Pescatore Executive VP Rare Diseases
2022 preliminary full-year results
2023-2025 Financial projections
Luigi La Corte Chief Financial Officer
Rob Koremans Chief Executive Officer
Alberto Martinez Executive VP Specialty & Primary Care
Scott Pescatore Executive VP Rare Diseases
Rob Koremans Chief Executive Officer
Recordati today, strategy and value proposition
2023-2025 Financial projections
Luigi La Corte Chief Financial Officer
• Robust underlying performance across the business and cost discipline deliver another year of strong financial results:
• Free cash flow(4) of € 439.0 million, >90% of Adjusted Net Income; Net debt(5) of € 1,419.9 million, just over 2x EBITDA
• Reported results reflect IFRS3 PPA unwind related to EUSA Pharma acquisition of € 49.8 million and non-recurring expenses of € 48.9 million (related to EUSA and SPC rightsizing); IAS29 first time adoption (Turkey hyperinflation) results in Net Revenue uplift of around € 1 million and adverse impact on operating and net profits of € 7-9 million (at different levels of the P&L) and revaluation of Net Assets of around € 80 million (net of impairment of € 5 million)
7
1) Revenue excluding newly acquired rare oncology franchise (EUSA Pharma) and considering like for like sales treatment for Eligard® in 2022 vs 2021 (pre SOTC transition)
2) 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 (IFRS 3)
3) 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
| (million Euro) | FY 2022 | FY 2021 | Change % |
|---|---|---|---|
| (1) Zanidip® and Zanipress® (lercanidipine+enalapril) |
168.0 | 177.9 | (5.6) |
| Seloken®/Seloken® ZOK/Logimax® (metoprolol/metoprolol+felodipine) | 97.8 | 98.1 | (0.3) |
| Urorec® (silodosin) | 60.7 | 60.7 | - |
| Livazo® (pitavastatin) | 44.1 | 42.8 | 3.1 |
| (2) Eligard® |
104.1 | 85.3 | 22.1 |
| Other corporate products (3) | 313.5 | 286.1 | 9.6 |
| Drugs for rare diseases | 595.8 | 383.9 | 55.2 |
| o/w Endocrinology franchise(4) | 171.9 | 126.6 | 35.8 |
| o/w Oncology franchise | 136.0 | n.a. | n.a. |
1) of which Zanidip® € 130.5 million in FY 2022 and € 136.7 million in FY 2021
2) Eligard® net revenue includes margins booked as net revenue until transfer of market authorizations and distribution (mostly 2021)
3) Includes the OTC corporate products for an amount of € 124.7 million in FY 2022 and € 115.5 million in FY 2021
8 4) Endo franchise includes net revenue for Signifor® and Signifor® LAR of € 90.6 million and Isturisa® of € 81.3 million in FY 2022
| (million Euro) | FY 2022 | FY 2021 | Change % | Targets Feb 2022 |
|---|---|---|---|---|
| Revenue | 1,853.3 | 1,580.1 | 17.3 | 1,720 – 1,780 |
| Gross Profit | 1,286.6 | 1,152.3 | 11.6 | |
| as % of revenue | 69.4 | 72.9 | ||
| Adjusted Gross Profit(1) | 1,336.4 | 1,152.3 | 16.0 | |
| as % of revenue | 72.1 | 72.9 | ||
| SG&A Expenses | 572.2 | 480.9 | 19.0 | |
| as % of revenue | 30.9 | 30.4 | ||
| R&D Expenses | 220.1 | 166.1 | 32.5 | |
| as % of revenue | 11.9 | 10.5 | ||
| Other Income (Expense), net* | (57.0) | (15.1) | n.m. | |
| as % of revenue | (3.1) | (1.0) | ||
| Operating Income | 437.3 | 490.2 | (10.8) | |
| as % of revenue | 23.6 | 31.0 | ||
| Adjusted Operating Income(2) | 536.1 | 504.6 | 6.2 | |
| as % of revenue | 28.9 | 31.9 | ||
| Financial income/(Expenses), net | (35.9) | (26.8) | 33.7 | |
| as % of revenue | (1.9) | (1.7) | ||
| Net Income | 312.3 | 386.0 | (19.1) | |
| as % of revenue | 16.9 | 24.4 | ||
| Adjusted Net Income(3) | 473.3 | 424.6 | 11.5 | 450 – 470 |
| as % of revenue | 25.5 | 26.9 | ||
| EBITDA(4) | 672.8 | 602.3 | 11.7 | 630 – 660 |
| as % of revenue | 36.3 | 38.1 |
1) Gross profit adjusted from impact of non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory (IFRS 3)
2) Net income before income taxes, financial income and expenses, 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 (IFRS 3)
9 4) 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 (IFRS 3)
| (million Euro) | FY 2022 | FY 2021 | Change |
|---|---|---|---|
| EBITDA(1) | 672.8 | 602.3 | 70.5 |
| Movements in working capital* | (61.4) | 20.0 | (81.4) |
| Changes in other assets & liabilities |
(16.8) | (15.5) | (1.3) |
| Interest received/(paid) | (18.2) | (18.0) | (0.2) |
| Income Tax Paid | (89.8) | (91.6) | 1.8 |
| Other | (24.9) | (5.6) | (19.3) |
| Cash flow from Operating activities | 461.7 | 491.6 | (29.9) |
| Capex (net of disposals) | (22.7) | (21.7) | (1.0) |
| Free cash flow(2) | 439.0 | 469.9 | (30.9) |
| Acquisition of subsidiaries(3) | (673.3) | - | (673.3) |
| Increase in intangible assets (net of disposals) |
(71.1) | (65.5) | (5.6) |
| Dividends paid |
(230.6) | (216.7) | (13.9) |
| Purchase of treasury shares (net of proceeds) |
(38.6) | (59.3) | 20.7 |
| financing cash flows(4) Other |
614.8 | (72.1) | 686.9 |
| Change in cash and cash equivalents |
40.2 | 56.3 | (16.1) |
1) 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 (IFRS 3)
2) Operating cash flow excluding financing items, milestones, dividends, purchases of treasury shares net of proceeds from exercise of stock options
3) Net of acquired cash and cash equivalents from EUSA Pharma for € 53.2 million
10 4) Opening of financial debts net of repayments and currency translation effect on cash and cash equivalents. 2022 amount also includes loan from EUSA Pharma, repaid for € 78.2 million
2023-2025 Financial projections
Rob Koremans Chief Executive Officer
• Diversified footprint with two equally important businesses:
• Effective capital allocation and financial discipline
• Strong track record executing on accretive and growth M&A and BD
SPC (68%) 1,257.5 Revenue EBITDA margin 33.2% RARE DISEASE (32%) 595.8 Revenue EBITDA margin 42.8%
• Very broad portfolio and diversified footprint minimizes exposure to single product market combination
• Fully vertical integrated platform from API to sale for key products, supporting margin
and protecting the supply chain • c.60% of volumes manufactured by
ROBUST SUPPLY CHAIN
Recordati plants
• Limited exposure to single reimbursement systems
1) cash R&D = R&D costs excl. amortisation
13
Moving into new geographies and disease areas, becoming a larger and more diversified organization
Resilient revenue post first generic entry, with no new material LOE expected in Plan Years
Revenue 2017 - 2022
Investment focused on lifecycle management and new indications
• Long term contracts on gas prices protecting 2022 and partially 2023
36.7% 43.0% 37.1% 33.9% 33.5% 29.1% 28.3% 39.3% 44.8% 43.9% 36.0% 29.3% 26.9% 29.3% 38.1% 37.0% 39.8% 39.1% 28.2% 28.4% 22.8% 36.3% 33.2% 36.9% 40.2% 22.2% 21.8% 25.6% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% 45.0% Recordati Swedish Orphan Biovitrum AB 2019 2020 20212022A Horizon Therapeutics Plc Ipsen SA Almirall SA UCB SA Lundbeck Peer 1 Peer 2 Peer 3 Peer 4 Peer 5 Peer 6 2019 2020 2021 2022A 2019 2020 20212022E 2019 2020 2021 2022E 2019 2020 2021 2022E 2019 2020 2021 2022E 2019 2020 2021 2022A
Source: 1) Company actual when available, Factset consensus for expected data as of Feb 7th 2023
50.0%
2023-2025 Financial projections
Rob Koremans Chief Executive Officer
24
The European partner of choice
Global player Focused on the Few
| SPC Near market |
• Go-to-partner for promotionally sensitive RX Established Brands, both regional and local, supported by competitive commercial capabilities |
|---|---|
| opportunities in core TAs and Specialist-driven |
• Near market opportunities in core areas of Cardiovascular, Urology and Gastro |
| Established Brands in other TA |
• Regional and local flagship brands in OTC in core countries and core areas |
| RRD Acquisition of Assets / |
• Worldwide deals |
| companies and partnerships for products after proof |
• Partner of choice for Biotech and Pharma companies looking for a regional partner |
| of concept | • Local deals in selected geographies ex-Europe and ex-US |
Effort recognized by main leading ESG indices and ratings in 2022
2022 preliminary full-year results
Recordati today, strategy and value proposition
2023-2025 Financial projections
Alberto Martinez Executive VP Specialty & Primary Care
A story of growth, international expansion and business diversification
Net Revenue, including Chemical Division
across Europe, CIS, Turkey and Tunisia; with exports to RoW via licensors (9% of sales)
in Rx (77%) and OTC (23%) promoted to specialists, GPs and pharmacies by ~1,500 salespersons
and maintaining originator brands through their life cycle across multiple Therapy Areas resulting into a large portfolio of Established Brands with negligible new Loss of Exclusivity risk
Subsidiaries and direct selling organizations
Countries where Recordati products are sold (under license or export)
SPC Core Therapy Areas (>70% of 2022 Sales) set to accelerate growth driven by ageing population and increasing consumer demand
billion Euro
"Lipid regulators, which have been declining steadily since leading product expiries a decade ago, are expected to return to growth…"
"It is possible that new brand growth will be lower while older established brands may grow more after they have demonstrated value in the market and negotiated market access"
"Medicine spending in the top five European markets is expected to increase by \$59Bn over the next five years, up from \$53Bn in the past five years"
Significant Brand equity in today's portfolio with category leading Brands
Simplify & Focus: strategy to secure another chapter of profitable growth
35
Fully integrated Regional Pharma Organization, having significant scope and scale with cost effective and competitive commercial capabilities in every market Go to partner for promotionally sensitive Established Brands and new near market opportunities in our core areas of Cardiovascular disease, Urology and Gastro Focus on local and Regional flagship Brands in OTC to drive organic and inorganic profitable growth balancing digital innovation and clinical advocacy Focus our resources on organic growth, optimizing our business model for Established Brands and maximizing every new launch opportunity
1) 2021 Eligard: Recordati booked net margin as Revenue until distribution transfer from Astellas in 2021 2) Procto-Glyvenol residual Rx sales included in Growth Brands
Eligard Evolution Index Jan 2020 - Nov 2022 (1)
million Euro
1) Evolution index calculated based on LEU (Local Currency Euro) on market where IQVIA data is available 2) 2021 Eligard: Recordati booked net margin as Revenue until distribution transfer from Astellas in 2021
Revenue trend 2021 - 2025
Recordati SPC Evolution Index gains 10 points in 2 years and outperforms the market by +5%
• Optimise our Established Brands portfolio to ensure profitable stabilization after LoE, while accelerating with our Growth Brands in core areas of Cardiovascular, Urology and Gastro and in both Rx and OTC
CUSTOMER FOCUS
• A shift to Specialty Care, while retaining presence in key Primary Care markets, especially Southern Europe
FOOTPRINT
• Headcount reduction of ~350 FTE's 2021-23 in Primary care, with savings partly reinvested in enhancing Commercial Excellence capabilities and relaunching Growth Brands
COMPETITIVENESS
• Enhancing customer engagement in both Rx and OTC through evolving omnichannel approach supported by better market insights, targeting and segmentation
2022 preliminary full-year results
Recordati today, strategy and value proposition
2023-2025 Financial projections
Scott Pescatore Executive VP Rare Diseases
With significant headroom and market potential
WITH LIMITED COMPETITION
EXPEDITED DEVELOPMENT
PATHWAY
BENEFITS
+7.000 more than 7,000 designated rare diseases…
~85% …of which 85% are life threatening…
…with only approximately 570 approved drugs 570 to date
Source: OECD April 2021, EU Health Policy Forum; : Evaluate Pharma April 2022, Evaluate Ltd, Orphan Drug Report 2022
Acquisition
A global presence, Focused on the Few
A portfolio of Orphan and Ultra-Orphan
products sold to hospitals and specialists and a promising pipeline of low-risk development projects
Primary focus on rare Metabolic, Endocrine and Oncologic diseases
Global footprint with access to North America, EU, Japan, Australia/NZ, Latin America and South Korea
Plans on track for further geographic expansion (China)
Driving growth through patient and physician awareness
Subsidiaries and direct presence of orphan drug representatives
32% of Revenue - 38% of EBITDA (1)
1) FY 2022 percentages of Group Revenue and EBITDA
A diversified portfolio with a strong foundation in Metabolic disorders and strong growth drivers in Endocrinology and rare / niche Oncology
Driving growth through our experience in rare diseases
million Euro
• Oncology: €250m - €300 million (including Qarziba US)
2022 preliminary full-year results
Recordati today, strategy and value proposition
Chief Executive Officer
| Group Evolution |
• Continuation of successful strategic approach • Organic revenue growth complemented with accretive M&A and BD • Invest behind both businesses, with Rare Diseases 35% - 40% of revenue by 2025 • No material exposure to new LOEs in planning period |
|---|---|
| Revenue | • Pricing and reimbursement environment broadly in line with current • Organic growth of both businesses driven by volume, with potential step up post 2028 from new indications • YoY pricing expected to be net positive, slightly below 2022 level • Bolt-on acquisitions and new licenses included in the plan (2025 only) • FX headwinds of just over -1% per annum |
| Margin and Profitability |
• Short term inflationary pressure on Gross profit margin offset by operating leverage and efficiencies in SG&A • Slight increase in cash R&D cost (roughly +1% of sales), related to lifecycle management projects • Target EBITDA margin of +/- 36% • Financing cost reflecting increase in benchmark rates (Euribor); tax rate around 22-23% • Non-recurring costs <€10 million in 2023, mainly from EUSA, PPA unwind (COGS) in line with 2022 level (in 2023-2024) |
| Cash Flow and Capital allocation |
• Continued strong cash generation at around 90-100% of adj. net income on average • c.40% cash flow to be reinvested in the business to drive future growth • c.60% of cash flow paid out via dividends |
| Net Debt | • Bolt on M&A and milestones from recent deals funded through operating cash flow, with Net Debt planned to stay at around 1.7x – 2.0x EBITDA (depending on timing and structure of deals) • Potential for temporary increases up to close to 3x leverage for really high-quality opportunities of scale |
Revenue EBITDA (1) margin on sales Adjusted Net Income (2) margin on sales FY 2022 Actual FY 2023 Target FY 2025 Target (incl. BD & M&A) CAGR 2022-2025 1,853.3 672.8 36.3% 473.3 25.5% 2,250 – 2,350 810 – 850 +/- 36% 550 – 580 +/- 24–25% 1,970 – 2,030 700 – 730 +/- 36% 470 – 490 +/- 24% +7.5% +7.3% +6.1% million Euro
1) 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 (IFRS 3) 2) 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
| Diversified business with strong organic growth |
Sustain high level of profitability |
Pursue affordable pipeline opportunities |
Maintain clear capital allocation policy |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| business segments | Strong underling volume growth over the period of current portfolio across both |
Maintain sector leading operating and bottom-line margin as % of revenue |
Invest behind new capabilities and low risk lifecycle management opportunities (new indications) to accelerate future growth |
60% | Progressive dividend pay-out at roughly 60% of cash flow |
|||||
| SPC Mid single digit growth at CER |
RRD Double digit growth at CER |
EBITDA Margin at +/- 36% |
(1) Cash R&D spend between 7-8% of revenue |
40% | Accretive & growth bolt-on M&A and BD |
|||||
| Strong cash flow generation & robust balance sheet | ||||||||||
| Free cash flow conversion 90-100% of Adjusted Net Income |
Net Debt / EBITDA 1.7x – 2x by 2025 Subject to timing and structure of deals |
Max of close to 3x for larger scale, high quality opportunities |
| (million Euro) | FY 2022 | FY 2021 | Change % |
|---|---|---|---|
| Italy | 272.7 | 258.2 | 5.6 |
| U.S.A. | 260.5 | 176.9 | 47.2 |
| France | 169.1 | 151.7 | 11.5 |
| Germany | 167.6 | 152.9 | 9.6 |
| Spain | 142.6 | 120.0 | 18.8 |
| Portugal | 53.5 | 45.4 | 17.7 |
| Turkey | 74.3 | 70.3 | 5.7 |
| Russia, other CIS countries and Ukraine | 131.7 | 99.6 | 32.2 |
| Other CEE countries | 128.8 | 112.0 | 15.0 |
| Other W. Europe countries | 136.7 | 104.4 | 31.0 |
| North Africa | 37.7 | 35.9 | 4.9 |
| Other international sales | 229.2 | 204.2 | 12.3 |
| TOTAL PHARMACEUTICALS | 1,804.4 | 1,531.6 | 17.8 |
| CHEMICALS | 48.9 | 48.5 | 2.6 |
| (In local currency, millions) | FY 2022 | FY 2021 | Change % |
|---|---|---|---|
| U.S.A. (USD) | 274.3 | 209.2 | 31.1% |
| Turkey (TRY) | 1,295.5 | 690.3 | 87.7% |
| Russia (RUB)(1) | 7,330.1 | 6,338.8 | 15.6% |
1) Net revenue in local currency in Russia exclude sales of products for rare diseases
| (million Euro) | 31 DEC 2022 | 31 DEC 2021 | Change |
|---|---|---|---|
| Cash and cash equivalents | 284.7 | 244.5 | 40.2 |
| Short-term debts to banks and other lenders | (83.4) | (8.7) | (74.8) |
| due within one year(1) Loans and leases – |
(289.0) | (221.5) | (67.5) |
| due after one year(1) Loans and leases – |
(1,332.2) | (750.8) | (581.3) |
| NET FINANCIAL POSITION (2) | (1,419.9) | (736.5) | (683.4) |
1) Includes the fair value measurement of the relative currency risk hedging instruments (cash flow hedge)
2) Cash and cash equivalents, less bank debts and loans, which include the measurement at fair value of hedging derivatives
| (million Euro) | FY 2022 | FY 2021 | Change % |
|---|---|---|---|
| Net income | 312.3 | 386.0 | (19.1) |
| Income taxes | 89.1 | 77.4 | |
| Financial (income)/expenses, net | 35.9 | 26.8 | |
| (2) o/w net FX losses |
5.8 | 5.8 | |
| o/w net monetary (gains)/losses from application of IAS 29 (Turkey) |
(4.5) | - | |
| Non-recurring expenses | 48.9 | 14.4 | |
| Non-cash charges from PPA inventory uplift |
49.8 | - | |
| Adjusted Operating Income(3) | 536.1 | 504.6 | 6.2 |
| Depreciation, amortization and write downs | 136.7 | 97.6 | |
| o/w EUSA Pharma | 19.7 | - | |
| o/w write downs of assets | 10.9 | - | |
| EBITDA(1) | 672.8 | 602.3 | 11.7 |
| (million Euro) | FY 2022 | FY 2021 | Change % |
|---|---|---|---|
| Net income | 312.3 | 386.0 | (19.1) |
| Amortization and write-downs of intangible assets (exc. software) |
107.4 | 70.7 | |
| o/w EUSA Pharma | 18.5 | - | |
| Non-cash charges from PPA inventory uplift | 48.9 | - | |
| Non-recurring expenses | 49.8 | 14.4 | |
| Net monetary (gains)/losses (IAS 29 Turkey) | (4.5) | - | |
| Tax effects | (40.6) | (18.7) | |
| Non-recurring tax items | - | (27.8) | |
| Adjusted Net income(4) | 473.3 | 424.6 | 11.5 |
1) 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 (IFRS 3) 2) FX losses and FX driven consolidation adjustments
59 3) Net income before income taxes, financial income and expenses, 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 (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
Statements contained in this presentation, other than historical facts, are "forward-looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, on current best estimates, and on assumptions believed to be reasonable. This information, these estimates and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company's control. Hence, actual results may differ materially from those expressed or implied by such forward-looking statements.
All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company's activities and are not intended to indicate the advisability of administering any product in any particular instance.
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases. Consolidated revenue for 2021 was €1,580.1 million, operating income was €490.2 million and net income was €386.0 million.
Recordati S.p.A. Via M. Civitali 1 20148 Milano, Italy
Federica De Medici +39 02 48787146 [email protected]
Website: www.recordati.com
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.