1Q23 Business Results

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Celltrion

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2023

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#1HEALTHCARE CELLTRION 2023.05 Celltrion Healthcare 2023.1Q Earnings Presentation#2Contents OO HEALTHCARE CELLTRION Section 01. 1Q23 Business Results Section 02. Key Products Section 03. Plan & Vision Appendix#31Q23 Business Results Key Products Plan & Vision Appendix Revenue: Increased by 21% due to the stable prescription of all products, especially with the highly profitable products such as RemsimaⓇSC and YuflymaⓇ Operating Profit: Achieved solid operating profit through the sales of high-margin products and cost improvement in RemsimaⓇ although the SG&A has increased after the direct sales began in the US Net Profit: NP has improved both QoQ and YoY as a result of increased non-operating income by the weak KRW 1Q23 Business Results (KRW bn) '22.1Q '22.4Q '23.1Q % YoY %QoQ Revenue 415.7 541.1 503.6 21.1% -6.9% Gross Profit 104.2 163.6 153.2 47.0% -6.4% (%) 25.1% 30.2% 30.4% 5.3%p 0.2%p SG&A 59.2 126.3 102.2 72.6% -19.1% (%) 14.2% 23.3% 20.3% 6.1%p -3.0%p Personnel expenses 12.5 26.3 18.1 44.8% -31.2% Research expenses 5.0 11.6 4.6 -8.0% -60.3% Advertising expenses 2.9 10.5 10.2 251.7% -2.9% Commissions 13.4 24.6 30.1 124.6% 22.4% Transportation expenses 7.4 13.7 13.9 87.8% 1.5% Operating Profit 45.0 37.3 51.0 13.3% 36.7% (%) 10.8% 6.9% 10.1% -0.7%p 3.2%p EBIT 61.3 (112.1) 120.1 95.9% TP Net Profit 43.6 (73.1) 54.1 24.1% TP Investor Relations 2023 3#41Q23 Business Results 1Q23 Business Results Key Products By Product (Unit: KRW bn) By Region (Unit: KRW bn) 541.1 541.1 503.6 12% 503.6 7% 6% 5% 21% 415.7 3% 4% 415.7 21% 3% 5% 15% 13% 9% 19% 6% 9% 10% 41% 13% 34% 15% 33% 43% 45% 47% 39% '22.1Q '22.4Q '23.1Q RemsimaⓇ / Inflectra™ TruximaⓇ Herzuma® RemsimaⓇSC Yuflyma Chemical Others Note: Others included VegzelmaⓇ, Regkirona TM, Covid-19 kit and etc. 45% 38% 38% '22.1Q '22.4Q '23.1Q Europe N. America Growth market Plan & Vision Appendix Investor Relations 2023 4#51Q23 Business Results 1Q23 경영실적 주요 제품 주요 사업 현황 Appendix Balance Sheet Cash Flow (KRW bn) '22 '1Q23 Change (KRW bn) '22 '1Q23 Cash at beginning of year 254.9 458.0 Total Assets 4,454.6 4,666.8 212.2 Operating 200.6 30.5 Cash and Cash 458.0 362.7 -95.3 Operating profit 228.9 51.0 Equivalents Working capital 6.5 2.6 Short Term 73.1 71.3 -1.8 Others -34.8 -23.1 Financial Assets Investing 177.4 3.6 Trade and Other Receivables 897.0 1,035.1 138.1 Short term financial assets 190.7 3.8 Others -13.3 -0.2 Inventories 2,352.9 2,545.7 192.8 Financing -174.9 -129.4 Borrowing and redemption -43.4 -80.6 Total Liabilities 2,392.8 2,638.7 245.9 Share buyback -91.0 -47.9 Cash Dividend -39.9 Total Equity 2,061.8 2,028.1 -33.7 Share issue 3.5 0.2 Others -4.1 -1.1 Debt-to-Equity Ratio 116.1% 130.1% 14.0%p Cash at the end of year 458.0 362.7 Investor Relations 2023 5#6Remsima® & Inflectra™M RemsimaⓇ, the most prescribed Infliximab drug in Europe, marked 10th anniversary after its first launch; M/S has risen by the dual formulation strategy with RemsimaⓇSC ✓ Inflectra™ has constantly grown in the US market after being listed as the preferred drug by major US payers Market share of RemsimaⓇ in Europe and Japan 57% 59% 57% 56% 55% 55% 54% 53% 53% 52% 52% 49% 26% 21% 21% 22% 19% 16% 12% 10% 8% 7% 6% 5% Market share of Inflectra™ in the US 12% 9% 6% '18 '19 17.3Q 18.1Q 3Q 19.1Q 3Q 20.1Q 3Q 21.1Q 3Q 22.1Q 3Q 4Q Note: market share is based on volume Source: IQVIA Europe Japan '20 23% 33% 32% '21 122 Inflectra™ ■■■A Biosimilar ■■■B Biosimilar Note: market share is based on volume Source: Symphony Health '23.1Q Investor Relations 2023 6 1Q23 Business Results Key Products Plan & Vision Appendix#7RemsimaⓇSC (1/2) ✓ Both RemsimaⓇ and RemsimaⓇSC's market share has increased in the entire European market M/S trend of CTHC's Infliximab products in Europe 33% 33% 33% 32% 30% 29% 25% 25% 25% 24% 24% 24% 0% 90 Top 5 Countries with the Highest M/S of RemsimaⓇSC 38% 37% 37% 35% 35% Germany 32% 34% Finland 25% 12% 20% 19% France 21% 17% 16% 15% 15% 15% 10% 14% Czech Republic 18% 44% 8% 12% 5% 4% 3% 2% 90 1% Belgium 12% 58% 0% 20.1Q 2Q 3Q 4Q 21.1Q 2Q 3Q 4Q 22.1Q 2Q 3Q 4Q RemsimaⓇ RemsimaⓇ SC Inflectra™ Note: The market share is based on the combined volume of 16 European countries RemsimaⓇSC has been launched Source: IQVIA, Market Data, etc. 29% 47% 0% 10% 20% 30% 40% 50% 60% 70% RemsimaⓇSC ■RemsimaⓇ & Inflectra™ Investor Relations 2023 7 1Q23 Business Results Key Products Plan & Vision Appendix#8RemsimaⓇSC (2/2) ✓ Prescriptions of RemsimaⓇSC has increased based on the accumulation of annual real-world data which shows positive response from the patients PK levels of RemsimaⓇSC switching patients Achievement of Clinical Remission in CD&UC 20 15 Serum infliximab levels, µg/dl 10 un = H H 0 Baseline 3m 6m 12m PBO 0.04 0.00 VDZ SC 108 mg Q2W* 0.16 0.68 VDZ IV 300 mg Q4W* 047 0.63 VDZ IV 300 mg Q8W* 0.61 055 IFX IV 3.5 mg/kg Q8W N/A IFX IV 5 mg/kg Q8W 0.38 0.49 0.35 IFX IV 10 mg/kg Q8W 0.81 0.59 RemsimaⓇ 120 mg Q2W 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 g 1Q23 Business Results Key Products Plan & Vision Appendix 091 0.82 0.9 1.0 Investor Relations 2023 8 Note: Measured every 3 months after the switching. PK level of Infliximab has been maintained high and stable. Source: Philip J Smith et al. Efficacy and Safety of Elective Switching From Intravenous to Subcutaneous Infliximab (Ct-P13): A Multi-Centre Cohort Study, Journal of Crohn's and Colitis, 2022; jac053, https://doi.org/10.1093/ecco-jcc/jjac053 Note: Higher scores correspond to a higher ranking for achieving clinical remission. Source: L Peyrin-Biroulet, et al. P445, Network meta-analysis to evaluate the comparative efficacy of intravenous and subcutaneous infliximab and vedolizumab in the maintenance treatment of adult patients with Crohn's Disease and Ulcerative Colitis. J Crohns Colitis. 2023;17(Suppl 1): 1574-1576#9TruximaⓇ ✓ Started direct sales in the EU since 2H22, revenue has recovered by the active bid participation ✓ Maintained stable M/S in the US markets with optimal price strategy M/S of TruximaⓇ in Europe 40% 39% 38% 37% 36% 36% 31% 29% 24% 22% 18.2Q 4Q 19.2Q 4Q 20.2Q 4Q 21.2Q 4Q 22.2Q MabtheraⓇ TruximaⓇ C Biosimilar Note: The market share is based on volume Source: IQVIA M/S of TruximaⓇ in the US 37% 30% 20.1Q 2Q 3Q 4Q 21.1Q 2Q 3Q 4Q 22.1Q 2Q 3Q 4Q 23.1Q TruximaⓇ D Biosimilar 32% 29% 4Q 44 20.1Q 2Q 3Q 4Q 21.1Q 2Q 3Q 4Q 22.1Q 2Q 3Q 4Q 23.1Q TruximaⓇ D Biosimilar 출처 : Symphony Health Investor Relations 2023 9 1Q23 Business Results Key Products Plan & Vision Appendix#10HerzumaⓇ ✓ Started direct sales since 2H22 in Europe, recovered the revenue by winning bids in Türkiye and Hungary ✓ M/S in Japan exceeded the original's and continues to increase; Continuous winning from the tender in LATAM M/S of HerzumaⓇ in Europe 4% 0% 18% 19% 16% 15% 13% 13% 13% M/S of HerzumaⓇ in Japan 23% 14% 19.08 approval of 3-weekly regimen 12% 25% 50% 51% 53% 54% 55% 57% 46% 44% 39% 35% 59% 2% 0% 18.1Q 2Q 3Q 4Q 19.1Q 2Q 3Q 4Q 20.1Q 2Q Herzuma® 3Q 4Q 21.1Q 2Q 3Q 4Q 22.1Q 2Q -HerceptinⓇ 3Q 4Q 19.2Q 3Q 4Q 20.1Q 2Q 3Q 4Q 21.1Q 2Q 3Q 4Q 22.1Q 2Q 3Q 4Q HerzumaⓇ Herceptin® F Biosimilar ............G Biosimilar E Biosimilar Note: The market share is based on volume Source: IQVIA Note: The market share is based on volume Source: IQVIA Investor Relations 2023 10 1Q23 Business Results Key Products Plan & Vision Appendix#11YuflymaⓇ ✓ Prescription of the product has been increased due to its competitive product advantage with diverse strength and device options provided in the EU ✓ Will be launched in the US market in 2H23; currently in the process of discussion with the stakeholders including PBM and GPO etc. Global market size of Adalimumab 80% Global Adalimumab Market Size $34.6bn Competitive Edge of YuflymaⓇ ✓ 85% of the market taken by high-concentration in the US High Concentration ✓ Improving patient convenience by reducing administration time A global interchangeability 13% 7% phase 3 clinical trial ongoing Interchange- ability Yuflyma adalimumab Strength Variation EMA approved for 40mg/0.4ml & 80mg/0.8ml ✓ EMA application for 20mg/0.2ml submitted FDA application for 40mg/0.4ml submitted US ■ Europe ROW Note: Market size is as of 2022 Source: IQVIA Citrate & Latex-Free: Reducing pain & allergic reactions following injection Reduce Injection Device Variation Pain Over 90% prescribed Al type in the US The only BS having 80mg/0.8ml Al type Investor Relations 2023 11 1Q23 Business Results Key Products Plan & Vision Appendix#12VegzelmaⓇ ✓ In Europe, actively participated in the tender based on its price advantage and the synergy with existing oncology products ✓ Launched in April 2023, it has registered with Medicare and is currently in the process of discussion with PBMs in the US The global market size of Bevacizumab 41% 24% Global Bevacizumab Market Size $5.7bn 24% 11% US ■ Europe ■ Japan ROW Note: Market size is as of 2022 Source: IQVIA Europe US Launched in October 2022 Obtained the tender with price and the portfolio advantages - Received orders from Finland, Italy, and Belgium - More participation in a tender of other EU countries Launched in April 2023 - Listed in Medicare - Negotiating with the number of payers to be registered in the list 1Q23 Business Results Investor Relations 2023 12 Key Products Plan & Vision Appendix#13Expanding Global Direct Sales ✓ Switched to complete direct sales in Europe in 2022 ✓ Appointed the leading professionals to accommodate the successful product launch and extend the prescription in the US Expanding direct sales network Celltrion USA N. America US, Canada 1% Europe Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Romania, UK Asia Hong Kong, Japan, Malaysia, Philippine Singapore, Taiwan, Thailand LATAM Argentina, Brazil, Chile, Columbia, Mexico, Peru Oceania Australia, New Zealand 30% 90% 2016 2022 Switched to complete direct sales in the EU 2023(E) Start direct sales in the US Note: 1) AS of 1Q23 2) Direct sales % relative to the market size CEO Joon Serk Seo CCO Thomas Nusbickel 1Q23 Business Results Kdy Products Plan & Vision Appendix Sales Eric Gibbs Market Access Francine Dumhart Commercial Operation John Verniero Investor Relations 2023 13#14Business Growth with Portfolio Enhancement ✓ More than one follow-up product will be launched every year in time for the expiration of original patents ✓ Portfolio will be enhanced through the pipelines and its experience of biosimilar commercialization CTHC's target market size in EU & the US (Unit: USD bn) CTHC's revenue & portfolio outlook 20.6 ~122 +161% ---------- Note: The market size is as of 3Q22MAT Source: IQVIA 53.7 +70% 91.3 '23(E) '24(E)~ (Unit: KRW bn, ea) 12 1,628 1,805 1,972 Revenue 1,101 7 6 No. of Portfolio 4 3 '19 '20 20 '21 '22 '26(E) EU US 2023(E) Vegzelma bevacizumab Yuflyma adalimumab CT-P43 CT-P39 CT-P41 CT-P42 CT-P47 bStelara bXolair bProlia bEylea bActemra 2024(E) Remsima SUBCUTANEOUS 2025(E) 2026(E) Infliximab CT-P41 CT-P39 CT-P47 bProlia bXolair bActemra CT-P43 CT-P42 bStelara bEylea Note: Launching plan could be subjective to the approval Investor Relations 2023 14 1Q23 Business Results Key Products Plan & Vision Appendix#15Main Portfolio Remsima Infliximab INFLECTRA EL ME EU US 2013 2016 Truxima Rituximab INFLECTRA 2017 INFL XMAS Product Name Reference Drug Herzuma Trastuzumab 2018 Remsima Infliximab SUBCUTANEOUS 2019 2020 Truxima Rituximab Indications (Herzum (Herzuma Trastuzumab Regkirona 2021 regdanvimab EU Yuflyma adalimumab 2022 Vegzelma bevacizumab Launching Timeline 2023 Vegzelma bevacizumab Yuflyma adalimumab US Remsima Infliximab INFLECTRA NFL MAS RemicadeⓇ (Infliximab) Rheumatoid Arthritis (RA), Ulcerative Colitis (UC), Crohn's disease (CD), etc. Sep 2013 Nov 2016 Truxima Rituximab Ⓡ (Rituximab) Rituxan (MabTheraⓇ) Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), etc. Apr 2017 Nov 2019 (Herzuma® Trastuzumab HerceptinⓇ (Trastuzumab) HER2-Positive Metastatic Breast Cancer, Early Breast Cancer(EBC), etc. May 2018 Mar 2020 Remsima® SUBCUTANEOUS Infliximab (Infliximab) Rheumatoid Arthritis (RA), Ulcerative Colitis (UC), Crohn's disease (CD), etc. Feb 2020 1H24(E) Yuflyma adalimumab HumiraⓇ (Adalimumab) Rheumatoid Arthritis (RA), Ulcerative Colitis (UC), Crohn's disease (CD), etc. Aug 2021 2H23(E) Vegzelma bevacizumab AvastinⓇ (Bevacizumab) Metastatic Colorectal Cancer (MCC), Non-Small Cell Lung Cancer(NSNLC), etc. Oct 2022 Apr 2023 Note: Inflectra TM logo belongs to Pfizer Investor Relations 2023 15 1Q23 Business Results Key Products Plan & Vision Appendix#16Pipeline Product Name Reference Drug Manufacturer Indication Global Market Size ($bn) US CT-P43 StelaraⓇ (Ustekinumab) Johnson Autoimmune Disease 17.7 & Johnson EU Completed Global Phase 3 Clinical Trials (Sep 2022) CT-P39 XolairⓇ (Omalizumab) Completed Global Phase 3 Asthma, Genentech 3.8 Clinical Trials Chronic Idiopathic Urticaria Application Submitted (Apr 2023) (Apr 2023) CT-P42 EyleaⓇ (Aflibercept) Bayer Aged Macular Degeneration 9.6 & Regeneron CT-P41 ProliaⓇ (Denosumab) Amgen Osteoporosis Completed Global Phase 3 Clinical Trials (Apr 2023) 6.2 In Global Phase 3 Clinical Trials CT-P47 Actemra® (Tocilizumab) Roche Autoimmune Disease 2.8 In Global Phase 3 Clinical Trials CT-P53 OcrevusⓇ (Ocrelizumab) Roche Multiple Sclerosis 6.7 Note: 1) Global market size is as of 2022, 2) Launching plan could be subjective to the approval Source: IQVIA, Regeneron (Eylea) Application Submitted for Global Phase 3 Clinical Trials Investor Relations 2023 16 1Q23 Business Results Key Products Plan & Vision Appendix#17Summary in Income Statement 1Q23 Business Results Key Products Plan & Vision Appendix (KRW bn) 1Q21 2Q21 3Q21 4Q21 1Q22 2Q22 3Q22 4Q22 1Q23 '21 '22 Revenue 356.3 433.3 409.1 605.8 415.7 519.0 496.4 541.1 503.6 1,804.5 1,972.2 Cost of Sales 274.0 306.2 334.4 459.4 311.5 378.1 343.3 377.5 350.4 1,374.0 1,410.4 Gross Profit 82.3 127.1 74.7 146.4 104.2 140.9 153.1 163.6 153.2 430.5 561.8 SG&A 50.8 50.9 52.7 76.7 59.2 66.8 80.6 126.3 102.2 231.1 332.9 Operating Income 31.5 76.2 22.0 69.7 45.0 74.1 72.5 37.3 51.0 199.4 228.9 Non-operating Income 3.5 11.6 30.5 (46.7) 16.3 21.1 112.7 (149.4) 69.1 (1.1) 0.7 Financial Income 5.5 4.6 2.2 0.8 4.3 3.4 22.8 (11.8) 11.2 13.1 18.7 Financial Expenses 12.5 3.5 18.5 (2.8) 5.0 13.9 17.2 23.3 5.7 31.7 59.4 Other Income 27.0 15.6 51.8 (22.6) 30.9 38.8 114.0 (80.7) 79.4 71.8 103.0 Other Expenses 16.4 4.9 5.0 26.9 13.7 7.1 6.7 33.4 15.7 53.2 60.9 Profit before Taxes 35.0 87.8 52.5 23.0 61.3 95.2 185.2 (112.1) 120.1 198.3 229.6 Tax Expense (Benefit) 3.5 24.1 11.9 6.2 17.7 56.1 47.6 (39.0) 66.0 45.7 82.4 Net Profit (Loss) 31.5 63.7 40.6 16.8 43.6 39.1 137.6 (73.1) 54.1 152.6 147.2 Investor Relations 2023 17#18Thank You

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