Nasdaq Nordic · interim-report
Kvartalsrapport Q1 2023
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Omsättning
- performance of the Company and may include, for example, the Company’s expectations regarding capitalization through equity o r 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 incl uding 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,
- Q1 2023 Adjustment Entries | Cost of Product Revenue − $1m charge related to long-term incentive plan (non-cash) | R&D
- Entries Adjusted | Product Revenue 16 - 16 0 - 0 | License and Other Revenue - 0 0 - 0 0
- Product Revenue 16 - 16 0 - 0 | License and Other Revenue - 0 0 - 0 0 | Other Income 0 (0) - 0 (0) -
- Other Income 0 (0) - 0 (0) - | Cost of Product Revenue (39) 1 (38) (2) - (2) | R&D (51) 19 (32) (47) (8) (55)
EBITDA
- Non-IFRS Financial Measures | This Presentation may include projections of certain financial measures not presented in accordance with International Financ ial 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 e xclude items that are significant in understanding and assessing the Company’s financial results. Therefore,
- Loss Per Share (in $) (1.24) (0.33) (0.43) (0.39) | EBITDA: | Operating Loss (96) 26 (71) (72) 5 (67)
- D&A 5 - 5 5 (0) 5 | EBITDA (91) 26 (66) (67) 5 (63)
Periodens resultat
- derived therefrom. These non-IFRS financial measures are not measures of financial performance in accordance with IFRS and may e xclude 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
Fulltext
===== SIDA 1 ===== ===== SIDA 2 ===== This presentation (“Presentation”) does not contain or constitute an offer to sell, a solicitation of an offer to buy, or a r ecommendation 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 resp ective 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 o r 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 incl uding 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 Tev a 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 res ults 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, b ut 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, tim ing 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 co nduct, 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 co mmercial 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 regardin g 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 o f 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 Financ ial 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 e xclude 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 pr esent 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. Consequ ently, 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 ===== ===== SIDA 4 ===== ===== SIDA 5 ===== ===== SIDA 6 ===== ===== SIDA 7 ===== ===== SIDA 8 ===== ===== SIDA 9 ===== ===== SIDA 10 ===== • • • • • • • • • ===== SIDA 11 ===== ===== SIDA 12 ===== ===== SIDA 13 ===== Q1 2023 Adjustment Entries Cost of Product Revenue − $1m charge related to long-term incentive plan (non-cash) R&D − $19m of one-time, Biosana accounts receivables reserve pertaining to the termination of AVT-23 (non-cash) − $1m charge related to long-term incentive plan (non-cash) − ($1m) IP litigation costs attributable to programs - reclassified from G&A G&A − $1m of one-time costs in connection with the Iceland main board listing − $1m IP litigation costs attributable to programs - reclassified to R&D − $4m charge related to long-term incentive plan (non-cash) Finance Cost − $179m fair value adjustment on derivatives (non-cash) Exchange Rate Differences − Impact of exchange rate fluctuations (non-cash) Income Tax − Tax impact of discrete adjustments in jurisdictions where tax benefits are available Q1 2022 Adjustment Entries R&D − ($8m) IP litigation costs attributable to programs - reclassified from G&A G&A − $2m charge related to long-term incentive plan (non-cash) − $8m of IP litigation costs directly attributable to programs - reclassified to R&D − $3m of transaction costs incurred in connection with the OACB merger Exchange Rate Differences − Impact of exchange rate fluctuations (non-cash) Income Tax − Tax impact of discrete adjustments in jurisdictions where tax benefits are available Q1 2023 Q1 2022 $ millions Reported Adjustment Entries Adjusted Reported Adjustment Entries Adjusted Product Revenue 16 - 16 0 - 0 License and Other Revenue - 0 0 - 0 0 Other Income 0 (0) - 0 (0) - Cost of Product Revenue (39) 1 (38) (2) - (2) R&D (51) 19 (32) (47) (8) (55) G&A (22) 6 (17) (24) 13 (11) Operating Loss (96) 26 (71) (72) 5 (67) Share of Net Loss of JV (1) - (1) (1) - (1) Finance Income 1 - 1 0 - 0 Finance Costs (208) 179 (29) (20) - (20) Exchange Rate Diffrences (2) 2 - (2) 2 - (Loss) Gain on exting. of fin. liab. - - - - - - Loss Before Taxes (306) 207 (99) (95) 7 (88) Income Tax Benefit 29 (4) 25 18 (1) 17 Loss For The Period (276) 202 (74) (77) 6 (71) Loss Per Share (in $) (1.24) (0.33) (0.43) (0.39) EBITDA: Operating Loss (96) 26 (71) (72) 5 (67) D&A 5 - 5 5 (0) 5 EBITDA (91) 26 (66) (67) 5 (63)