FULLTEXT DEL 1 AV 1
Kvartalsrapport Q1 2025
===== SIDA 1 ===== Q1 2025 Earnings and Business Update May 8, 2025 ===== SIDA 2 ===== Disclaimer 2 This presentation (“Presentation”) does not contain or constitute an offer to sell, a solicitation of an offer to buy, or a recommendation to purchase any security of Alvotech (the “Company”) to any person in the United States or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Any trademarks, servicemarks, trade names and copyrights of the Company and other companies contained in this Presentation are the property of their respective owners. Forward-Looking Statements This Presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or future financial or operating performance of the Company and may include, for example, the Company’s expectations regarding capitalization through equity or debt financing, Alvotech’s ability to maintain listing requirements, future growth, results of operations, performance, projections of future revenue and cash runway, competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, the re-inspection of the Company’s manufacturing site by the FDA, the expectation that the FDA’s facility inspection in March 2023 will also serve as the pre-license inspection for AVT04, potential approval, including for AVT02 and AVT04, by the FDA and other regulatory agencies, commercial launch of the Company’s products and product candidates, including AVT02 in the U.S., the timing and progress of the announcement of clinical study results, the commencement of patient studies, regulatory approvals and market launches, the Company’s partnerships, including with Teva and information about the market opportunity of the Company’s pipeline products. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by the Company and its management, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond the Company’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against the Company or others following the business combination between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (5) the Company’s estimates of expenses and profitability; (6) the Company’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (8) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (9) the ability of the Company or its partners to enroll and retain patients in clinical studies; (10) the ability of the Company or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of the Company’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) the Company’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of the Company’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) the Company’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) the Company’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding the Company’s products and product candidates; (17) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; and (18) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Company’s business, financial position, strategy and anticipated milestones; and (19) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that the Company may from time to time file or furnish with the SEC. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. This presentation also contains estimates and other statistical data made by independent parties and by the Company relating to market size and growth and other data about the Company’s industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of the future performance of the markets in which the Company operates are necessarily subject to a high degree of uncertainty and risk. Nothing in this Presentation should be regarded as a representation by any person that the forward- looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this Presentation. Non-IFRS Financial Measures This Presentation may include projections of certain financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”) including, but not limited to, Adjusted EBITDA and certain ratios and other metrics derived therefrom. These non-IFRS financial measures are not measures of financial performance in accordance with IFRS and may exclude items that are significant in understanding and assessing the Company’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to net income, cash flows from operations or other measures of profitability, liquidity or performance under IFRS. You should be aware that the Company’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. The Company believes these non- IFRS measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. The Company believes that the use of these non-IFRS financial measures provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other similar companies, many of which present similar non-IFRS financial measures to investors. These non-IFRS financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-IFRS financial measures. Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from these projected measures, together with some of the excluded information not being ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable IFRS financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable IFRS measures is included and no reconciliation of the forward-looking non-IFRS financial measures is included. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results. ===== SIDA 3 ===== Agenda RÓBERT WESSMAN Chairman and Chief Executive Officer ANIL OKAY Chief Commercial Officer JOEL MORALES Chief Financial Officer BALAJI PRASAD Chief Strategy Officer BENEDIKT STEFÁNSSON VP of IR and Global Communication 1 2 3 4 OVERVIEW COMMERCIAL UPDATE FINANCIAL UPDATE Q&A ===== SIDA 4 ===== Róbert Wessman Chairman and Chief Executive Officer ===== SIDA 5 ===== 5 2025 Revised Outlook ‖ Adjusted EBITDA $200-280m ‖ CAPEX & Intangibles 2 $60-70m ‖ Taxes 1 ~20% ‖ Debt Service Payments 3 $55-60m 2025 Outlook ‖ Revenues $600-700m Product Revenue $340-410m Milestone Revenues $260-290m 1) Post utilization of NOLs; $1.579m as of March 31, 2025 2) CAPEX includes capitalized intangibles, including co-development arrangements. 3) Debt Service Payments includes net interest and principal payments. AVT04 US launch in Q1 Three additional biosimilar launches Ongoing significant contributions from milestone revenues ‖ Product Margin 38-41% ‖ Gross Margin 65-66% ===== SIDA 6 ===== CIMZIA® – Unique biologic in the immunology space High-barrier asset with stable sales and first-to-market opportunity Only anti-TNF indicated for women of childbearing age during pregnancy and breastfeeding Expect to be the first biosimilar development to enter the clinical stage1 Synergy with Alvotech immunology basket 64% 63% 61% 19% 20% 21% 17% 17% 19% $2.3 Bn $2.3 Bn $2.3 Bn 2022 2023 2024 STABLE WW MARKET SALES1 WW MARKET VOLUME GROWS AT 11%2 38% 38% 38% 38% 38% 38% 24% 24% 24% 3.4 Mn 3.7 Mn 3.8 Mn 2022 2023 2024 US EU RoW US EU RoW 1Based on public info and GlobalData CI tool 2Reported Cimzia® sales. Source GlobalData 3MIDAS IQVIA ===== SIDA 7 ===== Forward Momentum Continues 7 STRONG FINANCIAL PERFORMANCE GROWING IN US AND EX- US MARKETS NEAR-TERM LAUNCHES AND PIPELINE GROWTH Triple digit % increases in total revenues and product revenues compared to same quarter last year Fourth consecutive quarter of positive adjusted EBIDTA and operating profits Positive cash flow from operations and expecting to be internally funded and free cash flow positive in 2025 Marketing applications for three biosimilar candidates under review in major markets and for fourth biosimilar in the UK, with filing in Europe pending Six biosimilars on the market by 2026, contributing to diversification of product revenues Moving 6 new biosimilar candidates into process development in 2025 Stelara® biosimilar SELARSDI launched in U.S. on February 21 after successful 2024 launches in Europe, Canada and Japan SELARSDI approved by FDA for interchangeability with all presentations of Stelara® as of April 30, 2025 Expecting continuing growth in both U.S. and ex-US markets for both Humira® and Stelara® biosimilars ===== SIDA 8 ===== Anil Okay Chief Commercial Officer ===== SIDA 9 ===== Most Valuable R&D Pipeline of Biosimilars Developers 9 BIOSIMILAR CANDIDATE REFERENCE BIOLOGIC THERAPEUTIC AREA EARLY PHASE PRE- CLINICAL CLINICAL TRIAL(S) FILING1 APPROVAL LAUNCHPK STUDY PATIENT TRIAL AVT02 adalimumab HUMIRA® Immunology AVT04 ustekinumab STELARA® Immunology AVT03 denosumab PROLIA®/ XGEVA® Bone Disease AVT05 golimumab SIMPONI®/ SIMPONI ARIA® Immunology AVT06 aflibercept EYLEA® Ophthalmology AVT232 omalizumab XOLAIR® Respiratory AVT16/803 vedolizumab ENTYVIO® Immunology AVT29 aflibercept EYLEA® HD Ophthalmology AVT33 pembrolizumab KEYTRUDA® Oncology AVT19 dupilumab DUPIXENT® Immunology AVT28 ixekizumab TALTZ® Immunology AVT41 guselkumab TREMFYA® Immunology AVT48 canakinumab ILARIS® Immunology AVT65 ofatumumab KESIMPTA® Immunology 1Filing status reflects filing acceptance in at least one major market 2AVT23 rights licensed from Kashiv BioSciences for EU, UK, Australia, Canada, and New Zealand , 3Represent vial and PFS presentations of Entyvio, respecitvely 31 MARKETS 27 MARKETS 64 MARKETS 48 MARKETS 74 MARKETS 70 MARKETS ONGOING ONGOING ONGOING HUMIRA is a registered trademark of AbbVie Inc.; STELARA, SIMPONI, SIMPONI ARIA and TREMFYA are registered trademarks of Johnson & Johnson Inc.; XOLAIR, ILARIS and KESIMPTA are a registered trademarks of Novartis AG; PROLIA AND XGEVA are registered trademarks of Amgen, Inc.; EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.; ENTYVIO is a registered trademark of Millennium Pharmaceuticals, Inc.; KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp; DUPIXENT is a trademark and brand of Sanofi Biotechnology; TALTZ is a registered trademark of Eli Lilly and Company In addition to these named programs, Alvotech has developed 15 cell lines, providing a range of opportunities Launched Launching in 2025 Late-stage development Early-stage development 37 MARKETS 37 MARKETS 37 MARKETS 1 MARKETPOSITIVE RESULTS ===== SIDA 10 ===== Commercialization Update 10 Biosimilar to Stelara® SELARSDI® approved in the U.S. as interchangeable biosimilar to Stelara®, for all presentations First U.S. formulary inclusion for SELARSDI® (ESI) and private label deals announced, robust order book. UZPRUVO® with highest or second highest market share for Stelara® biosimilars in each market launched Expecting double digit market share of overall Stelara® market in Europe at year end 2025 Biosimilar to Humira® All major PBMs have announced that they will exclude Humira® from formulary this year Expecting >50% of the U.S. Humira® market to convert to biosimilars before the end of 2025 SIMLANDI® fastest growing Humira® biosimilar in the Canadian market High single digit market share for HUKYNDRA® in over 15 European markets ===== SIDA 11 ===== Late Stage Pipeline Update Established anti-TNF with significant market in immunology disease Only one other company has completed a clinical trial for biosimilar candidate to the reference biologic Partnership with Teva in the U.S. and Advanz Pharma in Europe. Expected approval in Q4 2024 and launch in Europe and U.S. ASAP after approval AVT05 AVT03 Leading biologic in osteoporosis and bone disease Partnership with Dr. Reddy’s Laboratories for the U.S., Dr. Reddy’s and STADA in European market Expected approval in Q4 2024 with anticipated launch in Europe in Q4 2024 and in U.S. ASAP after approval AVT23 Important biologic in respiratory disease, growing market with limited competition Licensed from Kashiv BioSciences. Partnered with Advanz in EU, UK, Australia, Canada and New Zealand Expected UK approval in Q4 with launch in 2026 and filing in Europe later this year 11 Leading biologic for retinal diseases Alvotech has developed both vial and pre-filled syringe presentations Partnership with Teva in the U.S. and Advanz Pharma, STADA and Biogaran in Europe Expected approval in Q3 in US and Q4 in Europe with launch ASAP after approval AVT06 SIMPONI and SIMPONI ARIA registered trademarks of Johnson & Johnson Inc.; XOLAIR is a registered trademarks of Novartis AG; PROLIA AND XGEVA are registered trademarks of Amgen, Inc.; EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc. ===== SIDA 12 ===== Joel Morales Chief Financial Officer ===== SIDA 13 ===== 13 Top and Bottom-line Growth Demonstrating Operating Leverage Product revenues growth driven by: › US launch of biosimilars to HUMIRA® in Q2’24 and STELARA® in Q1’25 › EU/ROW launch of biosimilar to STELARA® in Q3’24 › Increased EU sales for of biosimilars to HUMIRA® License revenues driven by new launches and performance basted milestones from recent launches › Successful US in-market launch of biosimilar to STELARA® › Performance milestone achieved for biosimilar to STELARA® in EU Positive Product Margin driven by new launches and manufacturing efficiencies › Manufacturing at higher scale and improved production processes resulting in lower unit costs Positive Gross Margin driven by product revenue contribution Positive EBITDA driven by increased Gross Profit and lower OPEX Adjusted Results Change Q1 2025 USD % USD Millions Product Revenue $110 $12 $97 784% Licensing and Other Revenue $23 $24 ($2) -6% Total Revenue $133 $37 $96 260% Gross Profit $68 $17 $51 N/A Product Margin 41% -62% Gross Margin 51% 45% EBITDA $21 ($38) $59 N/A EBITDA Margin 15% -104% Q1 2024 ===== SIDA 14 ===== Cash & Liquidity 14 CASH AND LIQUIDITY SHARES OUTSTANDING Positive cash flows from operating activities Cash and cash equivalents of $39 million as of 31 March Total borrowings of $1,097 million, as of 31 March Based on current operating plans, the Company expects to be free cash flow positive in 2025 301.9 million shares outstanding as of 31 March Includes 39.6 million of earnout shares, of which 19.2 million not currently vested Excludes shares to be issued for certain programs and arrangements that are not yet settled as of 31 March ===== SIDA 15 ===== Appendix ===== SIDA 16 ===== 16 Reported to Adjusted Reconciliation Q1 2025 Adjustment Entries Cost of Product Revenue ⁻ $0.5m charge related to long-term incentive plan R&D ₋ $0.3m charge related to long-term incentive plan (non-cash) ₋ ($1.9m) IP litigation costs attributable to programs - reclassified from G&A G&A ₋ $0.5m charge related to long-term incentive plan (non-cash) ₋ $1.9m IP litigation costs attributable to programs - reclassified to R&D ₋ $0.3m one-time transaction cost Finance Income ₋ ($125.6m) fair value adjustment on derivatives (non-cash) Exchange Rate Differences ₋ $7.9m impact of exchange rate fluctuations (non-cash) Income Tax ₋ ($1.9m) tax impact of discrete adj. in jurisdictions where tax benefits are available Q1 2024 Adjustment Entries Cost of Product Revenue ₋ ($0.2m) charge related to long-term incentive plan R&D ₋ $0.8m charge related to long-term incentive plan (non-cash) ₋ ($0.2m) IP litigation costs attributable to programs - reclassified from G&A G&A ₋ $2.2m charge related to long-term incentive plan (non-cash) ₋ $0.2m IP litigation costs attributable to programs - reclassified to R&D Finance Costs ₋ $140.9m fair value adjustment on derivatives (non-cash) Exchange Rate Differences ₋ ($6.5m) impact of exchange rate fluctuations (non-cash) Income Tax ₋ $0.7m tax impact of discrete adj. in jurisdictions where tax benefits are available ===== SIDA 17 ===== 17 Financial Guidance Summary $ millions 2023A 2024A 2025 Guidance 2025 Revised “Target 2028” Product Revenue (1) 49 274 340 – 410 340 – 410 80 – 85% of total revenue Milestone Revenue (1) 45 218 230 – 260 260 – 290 15 – 20% of total revenue (Cumulative ~$1.0b from ’25E - ’28E) Total Alvotech Revenue $93 $492 $570 – $670 $600 – $700 ~$1.5b COGS (156) (184) (210) - (240) (210) - (240) 30 – 40% of revenues R&D (190) (172) (155) - (150) (165) - (160) 15 – 20% of revenues G&A (63) (58) (60) - (55) (60) - (55) ~5% of revenues Adjusted EBITDA ($291) $108 $180 – $260 $200 – $280 40 – 45% Margin CapEx (2) $43m $65 $60 – $70 $60 – $70 $20-$25 (Cumulative ~$190m from ’25E - ’28E) Taxes (3) N/A N/A 20% 20% 20% 1. Revenues represent risk adjusted revenues 2. CAPEX includes capitalized intangibles, including co-development arrangements. 3. Post utilization of NOLs; 31-Mar 2025 NOL balance of $1.579m ===== SIDA 18 ===== Capital Structure as of 31 March 2025 18 Note: This table is intended to reflect a list of instruments that could have potential future dilutive effects and is not reflective of the IFRS diluted share count that is used in calculating Diluted EPS. 1 Using the Company's average stock price of $11.35 and calculated in accordance with the Warrant Agreement dated September 21, 2020. ===== SIDA 19 ===== Additional information investors.alvotech.com investors.alvotech.com alvotech.com alvotech.com alvotech.is alvotech.is alvotech.ir@alvotech.com alvotech.ir@alvotech.com