Full Year 2023 Results
March 21, 2024
Disclaimer
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-lookingnon-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.
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Agenda
- Introduction
- Commercial Update
- Financial Update
- Q&A
ROBERT WESSMAN
Chairman and Chief Executive Officer
ANIL OKAY
Chief Commercial Officer
JOEL MORALES
Chief Financial Officer
MING LI
Chief Strategy Officer
BENEDIKT STEFÁNSSON
Director of IR and Global Communication
Robert Wessman
Chairman and
Chief Executive Officer
Focused Long Term Strategy
Strategy To Address
Global Healthcare Needs
BiosimilarsInfrastructure
Multi-ProductGlobal
PortfolioStrategy
Alvotech Overview
11 disclosed molecules in the portfolio and pipeline
In-house infrastructure able to develop and manufacture complex biologics
18 World-Class commercial partners covering >90 markets globally
Dual listed (NASDAQ: ALVO) in US and Iceland
5
2023; Building a Foundation for Growth
GAIN REGULATORY
APPROVALS
Simlandi® first approved high-concentration, interchangeable biosimilar to Humira® in U.S.1
Uzpruvo® (AVT04) first approved biosimilar to Stelara® in EU
Jamteki (AVT04) first approved biosimilar to Stelara® in Canada
AVT04 first approved biosimilar to Stelara® in Japan
AVT04 review complete for the U.S, expect approval in April 2024
COMPLIANCE
Established basis for successful US FDA Pre-License Inspection completed in Jan 2024
Hosted and supported numerous regulatory and partner inspections
EXPAND
COMMERCIAL
NETWORK
Expanded partnership with Teva for the U.S. market
Expanded partnership with Fuji Pharma in Japan
Partnership with Advanz Pharma covering 5 proposed biosimilars in Europe established
PIPELINE
PROGRESSION
AVT05, proposed biosimilar to Simponi® and Simponi Aria®, positive PK, Patient trial ongoing
AVT06, proposed biosimilar to Eylea®, met primary endpoint from a confirmatory patient study
AVT03, proposed biosimilar to Prolia® and Xgeva®, positive PK, Patient trial ongoing
AVT16, proposed biosimilar to Enyvio®, brought to scale-up phase
Secured partnership with Kashiv BioSciences for AVT23 (ADL018), proposed biosimilar to Xolair® for certain
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2024; A Look Ahead and Key Priorities
US LAUNCH OF | |||||||
SIMLANDI® | |||||||
Q2 | |||||||
First interchangeable, high | |||||||
concentration | |||||||
2024 | |||||||
biosimilar to Humira | |||||||
AVT16 CLINICAL
TRIAL INITIATION
Q3
Aim to be the first company
to bring a proposed
biosimilar to Entyvio® into patient trials
CA LAUNCH
OF JAMTEKI®
Q1
Aim to be the first biosimilar to Stelara, available in the Canadian Market
FILINGS FOR AT
LEAST 3
PROPOSED
BIOSIMILARS
Throughout '24
Major market filings for
at least 3 additional biosimilar candidates driving additional milestone revenue
JP LAUNCH
OF AVT04
(USTEKINUMAB)
Q2
Aim to be the first biosimilar to Stelara, available in the Japanese Market
AVT04 SUPPLY
INITIATION
FOR U.S.
Q4
Approval expected April '24
and Launch expected
February '25
EU LAUNCH OF
UZPRUVO®
Q3
Aim to be the first
biosimilar to Stelara,
available in the European Union
FURTHER
PARTNERSHIP
TRANSACTIONS
TBD
Partnering for any of
the remaining
unencumbered assets
in the portfolio
7
Anil Okay
Chief Commercial Officer
First High Concentration,
Interchangeable Biosimilar to Humira
Simlandi® approved by the U.S. FDA on February 23
Inclusive of high-concentration strengths
Interchangeable designation
Interchangeability for the high-concentration strengths
Exclusivity expected through April 2025 for approved presentations
~90% of the U.S. Humira market today comprises of high-concentration strengths
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Simlandi® Commercial Strategy for the U.S.
PRODUCT PROFILE
First and currently ONLY interchangeable, high-concentration, biosimilar to Humira®
Exclusivity for interchangeable designation for high- concentration strengths for 12 months post launch
12 months exclusivity for IC designation
PRICING | SUPPLY | ||||
Two-tier pricing | Alvotech facility | ||||
strategy to be | 100% dedicated to | ||||
employed | manufacturing in- | ||||
house portfolio |
Supply to partner commencing on plan
Imminent launch
DEVICE
Proprietary design
In partnership with Ypsomed, a leading developer and manufacturer of injection and infusion systems
Designed with the patient experience in mind
Supported by 2 design focused clinical studies
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Alvotech SA published this content on 20 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 March 2024 20:47:01 UTC.