Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2025, after U.S. markets close on Wednesday, May 7, 2025. Alvotech will also conduct a conference call with analysts to present the financial results and recent business highlights on Thursday May 8, 2025, at 8:00 am EDT (12:00 noon GMT, 14:00 CET). Live audio of the confer ...

REYKJAVIK, Iceland, May 02, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2025, after U.S. markets close on Wednesday, May 7, 2025. Alvotech will also conduct a conference call with analysts to present the financial results and recent business highlights on Thursday, May 8, 2025, at 8:00 am EDT ...

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Financial Performance - In 2024, the company achieved revenues of $492 million, representing a growth of over 400% compared to the previous year [20][70] - Adjusted EBITDA for 2024 was approximately $108 million, a significant improvement from a loss of $300 million in 2023 [20][69] - Product revenues exceeded milestone revenues for the first time, totaling just over $273 million, an increase of 460% year-on-year [20][66] - Product gross margins improved from negative in Q1 to 45% in Q4, driven by scale, process improvements, and a better product mix [22][67] Business Lines and Market Performance - The company has ten products in advanced development and 18 molecules have passed cell line development, targeting a total addressable market of over $185 billion [12][13] - The launch of AVT02 in the U.S. and AVT04 in Europe were highlighted as significant achievements, with AVT02 capturing about 12% of the total U.S. demand for Humira by the end of 2024 [16][34] - The company expects to launch several new biosimilars in 2025, including AVT03 and AVT06, with anticipated approvals in Q4 2024 [24][78] Strategic Direction and Industry Competition - Alvotech aims to leverage its R&D capabilities and expand its pipeline, with a goal of reaching $1.5 billion in revenues and a 40% to 45% EBITDA margin by 2028 [25][90] - The acquisition of Xbrane's R&D operations in Sweden is expected to enhance the company's development capabilities and attract talent [28][61] - The company is positioned to be first to market with several biosimilars, including those for Cimzia and high-dose Eylea, which are expected to launch in 2028 [30][88] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the growth of biosimilars, particularly in the U.S. market, where they expect significant market share conversion in 2025 [35][36] - The company anticipates a strong performance in 2025, projecting revenues between $570 million and $670 million, representing a 25% year-on-year growth [74][75] - Management highlighted the importance of maintaining a strong supply chain and quality focus to capitalize on market opportunities [40][41] Other Important Information - The company raised over $300 million in capital in 2024, simplifying its capital structure and removing all 2025 maturities [19][72] - Alvotech closed the year with $1.069 billion in debt and $51 million in cash, with plans to achieve free cash flow positive status in 2025 [72][73] Q&A Session Summary Question: Thoughts on Stelara pricing and potential private label deals - Management indicated that it is too early to comment on U.S. pricing for Stelara due to its recent launch, but they are optimistic about market position [100][102] - In Europe, established pricing trends were noted, with expectations of some price pressure as competition increases [101][102] Question: Cadence of milestone revenues and future expectations - Management expressed confidence in achieving milestone revenues in 2025 due to signed contracts and progress in R&D [99][103] - They expect about 75% of milestone revenues to be recognized in the second half of 2025, driven by approvals and launches [104][105]

Full Year 2024 Earnings and Business Update March 27, 2025 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 p ...

Financial Performance - The company incurred significant losses of $231.9 million, $551.7 million, and $513.6 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $2,437.7 million as of December 31, 2024[31]. - The company’s ability to generate cash flow to meet significant debt service obligations is uncertain, which could adversely affect its financial condition[42]. - As of December 31, 2024, the company had cash and cash equivalents of $51.4 million, indicating a stable financial position despite uncertainties[46]. - The company had outstanding indebtedness of $1,068.6 million, consisting of $990.7 million under the Secured Loan Facility and $77.8 million in bank loans[51]. - The company may need to raise substantial additional funding, which could lead to shareholder dilution and restrict operations[45]. - The company may require significant additional funding to obtain regulatory approval and successfully commercialize product candidates, which could lead to dilution of existing shareholders' equity[47]. - The company faces risks related to its substantial indebtedness, which could limit its ability to obtain additional financing and increase vulnerability to adverse economic conditions[52]. Regulatory Challenges - The company faces risks related to regulatory approval processes, which are lengthy and uncertain, potentially impacting the commercialization of product candidates[30]. - The lengthy regulatory approval processes may significantly delay the commercialization of product candidates, impacting the company's ability to generate revenue[80]. - The company faces risks related to the development of biosimilar product candidates, including the need to demonstrate biosimilarity to regulatory authorities[92]. - The transition period following Brexit has created uncertainty that may affect the company's ability to achieve regulatory approval in the UK[84]. - The UK is now considered a third country to the EU, which complicates the regulatory landscape for the company[86]. - The MHRA has introduced new procedures to prioritize access to new medicines, which may impact the company's marketing authorization applications[89]. - The company may incur significant additional expenses due to changes in the regulatory framework in the UK and EEA[90]. - Regulatory approvals may impose limitations on marketing conditions and require additional data generation, potentially increasing costs and delaying commercialization[131]. - The company must maintain various regulatory approvals, and failure to do so could disrupt operations and lead to enforcement actions[161]. - The company faces significant regulatory challenges that could restrict business activities and impact drug development and revenue generation capabilities[163]. Research and Development - The company anticipates significant increases in research and development expenses as it advances product candidates through clinical studies[45]. - Clinical drug development is lengthy and expensive, with potential delays due to public health emergencies or geopolitical events[102]. - The company may incur additional costs or impair its ability to achieve regulatory approval if it fails to complete necessary clinical studies[105]. - Changes in manufacturing processes may require additional studies to demonstrate comparability, potentially delaying regulatory approval[106]. - The company relies on participant recruitment for clinical trials, and any withdrawal could delay the development or approval of product candidates[115]. Manufacturing and Supply Chain - The company acquired the Reykjavik manufacturing and research facility for $48.8 million, which is secured by a first priority mortgage[70]. - Manufacturing of product candidates is dependent on third-party CMOs, and any failure to provide sufficient quantities or quality could adversely affect the company's operations[145]. - The manufacturing process is susceptible to variability without well-controlled master and working cell banks, which are essential for consistent high-quality biologic medicine production[98]. - Compromised cell banks could prevent the company from producing usable products, impacting its ability to meet market demand[99]. - The company is subject to risks from natural disasters affecting its manufacturing facility in Reykjavik, Iceland, which could disrupt operations[158]. - Regulatory compliance and quality assurance are critical, and any failure by third-party manufacturers to comply with cGMP regulations could lead to significant delays in product approval[146]. Competition and Market Dynamics - The company is exposed to competition from other biosimilars and reference products, which could limit market penetration and revenue potential[176]. - The company faces intense competition from established pharmaceutical companies with greater resources, which may hinder its ability to commercialize products successfully[182]. - Competitors may develop improved versions of reference products, potentially reducing the market for the company's biosimilar candidates[178]. - The company may face price competition from other biosimilars, which could adversely affect market share and revenue[204]. - The uncertainty of third-party coverage and reimbursement could limit the company's ability to market products and generate revenue[194]. - The company expects pricing pressures due to managed healthcare trends and legislative changes[198]. Intellectual Property and Legal Risks - The company may face claims of patent infringement from third parties, which could lead to substantial legal expenses and potential damages[207]. - There is uncertainty regarding the identification and interpretation of relevant patents, which may adversely affect the company's ability to develop and market its products[216]. - The company has not completed a freedom-to-operate analysis for products in its future biosimilar pipeline, leaving potential risks from unexpired patents[208]. - Patent litigation could result in significant costs and distract management from core business operations, potentially harming the company's financial condition[213]. - The company may be subject to claims from non-practicing entities, which could lead to costly litigation and impact its market operations[210]. - The issuance of "submarine" patents could delay the company's ability to introduce biosimilar candidates into the market[215]. - The company may incur substantial expenses defending against patent infringement claims, which could hinder its research and development efforts[220]. Strategic Partnerships and Collaborations - The company has entered into collaboration agreements with Teva and STADA for the development and commercialization of AVT02 and AVT04 in the U.S. and Europe, respectively[190]. - The company does not have direct sales capabilities and relies on partners for commercialization, which could adversely affect revenue if partners do not perform adequately[153]. - Collaborations with third parties for product development may be terminated, impacting the company's ability to commercialize its product candidates[151].

Core Insights - Alvotech has appointed Dr. Balaji V. Prasad as Chief Strategy Officer, bringing 25 years of experience in the pharmaceutical industry, particularly in specialty pharma and healthcare sectors [1][2][3] Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space by delivering high-quality, cost-effective products [4] - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), marketed in multiple global markets [4] - Alvotech's development pipeline includes nine disclosed biosimilar candidates targeting various conditions such as autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [4] Strategic Partnerships - Alvotech has established a network of strategic commercial partnerships to enhance its global reach, including collaborations with Teva Pharmaceuticals, STADA Arzneimittel AG, and several others across various regions [4]

Total Revenues in 2024 reached $492 million, representing a 427% increase over prior yearProduct Revenues in 2024 reached $273 million, representing a 462% increase over prior yearAdjusted EBITDA in 2024 was $108.3 million compared to negative $291 million in 2023Submissions in major global markets were made in 2024 for three new proposed biosimilars. All applications have been subsequently accepted by the relevant regulatory authorities. Alvotech will conduct a business update conference call and live webc ...

Core Insights - Alvotech reported record financial results for 2024, achieving total revenues of $492 million, a 427% increase from the previous year, and positive EBITDA for the first time in its history [6][25] - The company successfully diversified its revenue streams and improved product margins, driven by higher utilization and process efficiencies [2][6] - Alvotech's development pipeline is expanding rapidly, with three new biosimilar submissions accepted in major global markets, indicating strong near-term growth potential [4][6] Financial Performance - Total revenues for 2024 reached $492 million, with product revenues of $273 million, representing a 462% increase year-over-year [6][13] - Adjusted EBITDA was $108.3 million compared to a negative $291 million in 2023, marking a significant turnaround [6][25] - The company reported a net loss of $231.9 million, an improvement from a net loss of $551.8 million in the previous year [25][40] Product Development and Pipeline - Alvotech filed three Biologics License Applications (BLAs) for proposed biosimilars AVT05, AVT06, and AVT03 in the U.S. and Europe, marking significant milestones in its development efforts [4][8][10] - The company completed the development of 18 additional cell lines, enhancing its R&D capabilities and pipeline [2][10] - Alvotech launched SELARSDI™ (ustekinumab-aekn) in the U.S., which is interchangeable with the reference biologic Stelara [6][7] Strategic Developments - Alvotech was added to the Nasdaq Biotechnology Index, reflecting its growth and market presence [3] - The acquisition of Xbrane's R&D operations is expected to bolster Alvotech's capabilities in biosimilar development [10] - The company is exploring the possibility of listing Swedish Depository Receipts (SDR) on the Nasdaq Stockholm stock market [10] Management Commentary - The CEO highlighted the company's best-in-class manufacturing and R&D capabilities, attributing success to substantial investments made over the past decade [2] - The CFO noted that the company met its financial guidance while diversifying revenue across products and geographies [2] - The Chief Scientific Officer emphasized the seamless integration of R&D with in-house manufacturing, which accelerates development without compromising quality [2]

Core Insights - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab), which is used for treating severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps [1][4] - Global sales of Xolair in 2024 were approximately USD $4.4 billion, indicating a significant market opportunity for AVT23 [1] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes nine disclosed biosimilar candidates [7] - Kashiv Biosciences is a fully integrated biopharmaceutical company dedicated to developing high-quality, cost-effective therapies, reflecting a commitment to innovation and improving access to biosimilars [3] - Advanz Pharma focuses on specialty, hospital, and rare disease medications, emphasizing the expansion of treatment options for patients [4] Strategic Partnerships - Alvotech and Advanz Pharma entered a commercialization agreement for AVT23 in February 2023, which was later expanded to include five additional biosimilar candidates [4] - Alvotech and Kashiv announced a licensing agreement for AVT23 in October 2023, further solidifying their collaboration in the biosimilar market [4]