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 ...

Group 1 - Alvotech (NASDAQ: ALVO) was previously rated as a "Buy" with shares trading at $12, ending 2024 at approximately $13.5, but has seen a significant decline since mid-February [2] - The investing group Haggerston BioHealth provides insights for both novice and experienced biotech investors, including catalysts, buy and sell ratings, product sales forecasts, and detailed financial analyses [2] - The analyst, Edmund Ingham, has over 5 years of experience in biotech, healthcare, and pharma, having compiled detailed reports on over 1,000 companies [2]

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]

Financial Performance & Outlook - Total revenues reached $492 million, exceeding the latest guidance, compared to $93 million in 2023, a 427% increase[25,59] - Product revenues were $273 million, surpassing $49 million in 2023, a 462% increase[25,59] - Adjusted EBITDA was $108 million, a significant turnaround from a loss of $291 million in 2023[25,59] - The company anticipates revenues between $570 million and $670 million in 2025, with product revenue contributing $340 million to $410 million and milestone revenues between $230 million and $260 million[67] - The company projects an adjusted EBITDA between $180 million and $260 million in 2025[67] - Alvotech targets approximately $1.5 billion in revenue by 2028[70,77] - Alvotech targets an EBITDA margin of 40-45% by 2028[73,77] Commercial & R&D Updates - SIMLANDI units shipped to the US across both branded and private label channels in 2024 reached 1.3 million, with 60% of those units shipped in Q4 2024[35] - The company has biosimilar approval in 63 markets and has launched in 29 markets[37] - By the end of 2025, investments will enable a total annual capacity of 15 million finished units[42]

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]

[Executive Summary and 2024 Highlights](index=1&type=section&id=Executive%20Summary%20and%202024%20Highlights) [Company Overview and Strategic Achievements](index=1&type=section&id=Company%20Overview%20and%20Strategic%20Achievements) Alvotech reported record financial results for full year 2024, achieving positive EBITDA for the first time, driven by substantial investments in R&D and manufacturing - Alvotech achieved record revenue from product sales and development milestones, along with **positive EBITDA for the first time** in its history, demonstrating strong R&D and manufacturing capabilities[3](index=3&type=chunk) - The company successfully diversified revenue across products and geographies, with **product margins improving quarter-over-quarter** due to higher utilization, greater scale, and process efficiencies[3](index=3&type=chunk) - Alvotech completed a record year in development, filing **three new biosimilar submissions** in major global markets, and is poised for rapid pipeline expansion with **18 additional cell lines developed**[3](index=3&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) Alvotech announced several key business developments and regulatory milestones from December 2024 to March 2025, including stock index inclusion, multiple BLA/MAA acceptances for biosimilar candidates (AVT05, AVT06, AVT03, AVT23), the launch of SELARSDI™ (AVT04) in the U.S., the acquisition of Xbrane's R&D operations, and a key executive appointment - Total Revenues in 2024 reached **$492 million**, representing a **427% increase** over prior year[6](index=6&type=chunk) - Product Revenues in 2024 reached **$273 million**, representing a **462% increase** over prior year[6](index=6&type=chunk) - Adjusted EBITDA in 2024 was **$108.3 million** compared to **negative $291 million in 2023**[6](index=6&type=chunk) [December 2024 Highlights](index=1&type=section&id=December%202024%20Highlights) - Alvotech's stock was added to the **Nasdaq Biotechnology Index (NASDAQ:NBI)**[4](index=4&type=chunk) [January 2025 Highlights](index=1&type=section&id=January%202025%20Highlights) - U.S. Biologics License Applications (BLAs) for **AVT05** (biosimilar to Simponi and Simponi Aria) were accepted, following EMA acceptance in November 2024[5](index=5&type=chunk) [February 2025 Highlights](index=1&type=section&id=February%202025%20Highlights) - U.S. Biologics License Application for **AVT06** (biosimilar to Eylea) LD was accepted, following EMA acceptance in August 2024[6](index=6&type=chunk)[7](index=7&type=chunk) - Launch of **SELARSDI™ (ustekinumab-aekn)**, a biosimilar to Stelara, in the U.S. market, determined interchangeable with Stelara after April 30, 2025[8](index=8&type=chunk) [March 2025 Highlights](index=2&type=section&id=March%202025%20Highlights) - U.S. Biologics License Application for **AVT03** (biosimilar to Prolia and Xgeva) was accepted, following EMA acceptance in October 2024[9](index=9&type=chunk) - UK MHRA accepted a marketing application for **AVT23** (biosimilar to Xolair)[10](index=10&type=chunk) - Acquisition of **Xbrane's R&D operations** and a biosimilar candidate referencing Cimzia (certolizumab pegol), enhancing pipeline and R&D capabilities[11](index=11&type=chunk) - **Uri Hillel** was appointed Chief Quality Officer (CQO) for Alvotech[12](index=12&type=chunk) [Financial Performance for Full Year 2024](index=2&type=section&id=Financial%20Performance%20for%20Full%20Year%202024) [Overview of Financial Results](index=2&type=section&id=Overview%20of%20Financial%20Results) As of December 31, 2024, Alvotech reported cash and cash equivalents of $51.4 million and total borrowings of $1,068.6 million Cash Position and Borrowings (as of December 31, 2024) | Metric | Amount (USD millions) | | :----------------------- | :-------------------- | | Cash and cash equivalents | 51.4 | | Total borrowings | 1,068.6 | | Current portion of borrowings | 32.7 | [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Alvotech experienced substantial revenue growth in 2024, with product revenue increasing by 462% and license and other revenue by 406% [Product Revenue](index=2&type=section&id=Product%20Revenue) Product Revenue (YoY Change) | Year | Product Revenue (USD millions) | YoY Change | | :--- | :----------------------------- | :--------- | | 2024 | 273.5 | +462% | | 2023 | 48.7 | | - Revenue growth was attributed to sales of **AVT02** in Europe, Canada, and the U.S., and launches of **AVT04** in Canada, Japan, and select European markets[14](index=14&type=chunk) [License and Other Revenue](index=2&type=section&id=License%20and%20Other%20Revenue) License and Other Revenue (YoY Change) | Year | License and Other Revenue (USD millions) | YoY Change | | :--- | :------------------------------------- | :--------- | | 2024 | 216.2 | +406% | | 2023 | 42.7 | | - Primarily driven by R&D milestones: **$6.6M for AVT04 Europe approval**, **$16.8M for AVT16 CTA submission**, **$34.4M for EMA MAA submissions (AVT03, AVT05, AVT06)**, **$39.1M for AVT03 CES completion**, and **$56.4M for AVT05 CES completion**[15](index=15&type=chunk) - Also included performance milestones: **$6.9M for AVT02 sales target**, **$15.4M for AVT04 launches**, **$18.8M for AVT02 U.S. launch**, and **$20.4M net for out-license contracts**[15](index=15&type=chunk) [Cost and Expense Analysis](index=2&type=section&id=Cost%20and%20Expense%20Analysis) While the cost of product revenue increased due to higher sales volumes, Alvotech successfully reduced R&D and G&A expenses in 2024 through program advancements, cost rationalization, and lower share-based payments [Cost of Product Revenue](index=2&type=section&id=Cost%20of%20Product%20Revenue) Cost of Product Revenue (YoY Change) | Year | Cost of Product Revenue (USD millions) | YoY Change | | :--- | :----------------------------------- | :--------- | | 2024 | 185.3 | +15.2% | | 2023 | 160.9 | | - Increase driven by **higher sale volumes** from new product launches, partially offset by lower production-related charges and reduced costs for FDA inspection readiness[16](index=16&type=chunk) [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) R&D Expenses (YoY Change) | Year | R&D Expenses (USD millions) | YoY Change | | :--- | :-------------------------- | :--------- | | 2024 | 171.3 | -18.7% | | 2023 | 210.8 | | - Decrease primarily due to a **one-time charge in 2023 ($18.5M)** for AVT23 co-development termination, reduced costs for commercialized programs (AVT02, AVT04) and programs with substantially completed clinical phases (AVT03, AVT05, AVT06), and lower headcount/other R&D expenses[17](index=17&type=chunk) - Partially offset by a **$20.0 million increase in direct program expenses**, mainly for AVT16 advancing through its clinical phase[17](index=17&type=chunk) [General and Administrative (G&A) Expenses](index=3&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) G&A Expenses (YoY Change) | Year | G&A Expenses (USD millions) | YoY Change | | :--- | :-------------------------- | :--------- | | 2024 | 65.7 | -14.3% | | 2023 | 76.6 | | - Decrease mainly from **$4.5 million lower third-party services**, reduced insurance premiums and headcount, and a **$6.0 million decrease in share-based payment expenses**[18](index=18&type=chunk) [Profitability and Other Income/Loss](index=3&type=section&id=Profitability%20and%20Other%20Income%2FLoss) Alvotech significantly improved its operating profit in 2024, moving from a substantial loss to a positive figure, driven by revenue growth and expense management [Operating Profit](index=3&type=section&id=Operating%20Profit) Operating Profit (YoY Change) | Year | Operating Profit (USD millions) | YoY Change | | :--- | :------------------------------ | :--------- | | 2024 | 69.6 | +$424.5M | | 2023 | (354.9) | | - Increase primarily due to **sharp rise in total revenues** from product commercialization expansion and milestone recognition, coupled with **decreased operating expenses** from scaling and rationalizing operations[19](index=19&type=chunk) [Share of Net Loss of Joint Venture and Loss on Sale](index=3&type=section&id=Share%20of%20Net%20Loss%20of%20Joint%20Venture%20and%20Loss%20on%20Sale) - Company sold its share in a joint venture for **$18.0 million (gross proceeds)**, resulting in a **net loss of $3.0 million in 2024**[20](index=20&type=chunk) [Finance Income](index=3&type=section&id=Finance%20Income) Finance Income (YoY Change) | Year | Finance Income (USD millions) | YoY Change | | :--- | :---------------------------- | :--------- | | 2024 | 80.1 | +$75.3M | | 2023 | 4.8 | | - Primarily attributable to the **change in fair value of derivatives**, driven by bondholders exercising conversion rights into ordinary shares[21](index=21&type=chunk) [Finance Costs](index=3&type=section&id=Finance%20Costs) Finance Costs (YoY Change) | Year | Finance Costs (USD millions) | YoY Change | | :--- | :--------------------------- | :--------- | | 2024 | 303.2 | +13.5% | | 2023 | 267.2 | | - Comprised of **$130.5 million** reflecting the fair value of Predecessors Earn Out shares (negatively impacted by share price increase) and **$147.4 million** in interest charges on outstanding debts[22](index=22&type=chunk) [Loss on Extinguishment of Financial Liabilities](index=3&type=section&id=Loss%20on%20Extinguishment%20of%20Financial%20Liabilities) - A **loss of $69.0 million** was recorded due to the refinancing of existing debt obligations, including the conversion of 2022 Convertible Bonds and Aztiq Convertible Bonds into ordinary shares[23](index=23&type=chunk) - The company entered into a **$965.0 million Senior Loan Facility** in June 2024, maturing in July 2029, which required settling existing debt[23](index=23&type=chunk) [Income Tax (Expense) / Benefit](index=3&type=section&id=Income%20Tax%20(Expense)%20%2F%20Benefit) Income Tax (Expense) / Benefit (YoY Change) | Year | Income Tax (Expense) / Benefit (USD millions) | YoY Change | | :--- | :------------------------------------------ | :--------- | | 2024 | (14.3) (expense) | -$113.6M | | 2023 | 99.3 (benefit) | | - Shift from tax benefit to expense driven by a **$94.9 million increase in deferred tax expense** due to positive operating results and a **$16.8 million increase in foreign currency impact** from weakening Icelandic krona[24](index=24&type=chunk) [Loss for the Year](index=3&type=section&id=Loss%20for%20the%20Year) Net Loss and EPS (YoY Change) | Year | Net Loss (USD millions) | EPS (USD) | YoY Change (Net Loss) | | :--- | :---------------------- | :-------- | :-------------------- | | 2024 | (231.9) | (0.87) | +$319.9M | | 2023 | (551.8) | (2.42) | | - Net loss heavily impacted by **fair value costs associated with derivative liabilities** and the **refinancing of existing debt obligations**[26](index=26&type=chunk) [Product Pipeline and Company Information](index=4&type=section&id=Product%20Pipeline%20and%20Company%20Information) [Business Update Conference Call](index=4&type=section&id=Business%20Update%20Conference%20Call) Alvotech will host a business update conference call and live webcast on March 27, 2025, at 8:00 am ET, with registration and replay available on their investor relations website - A business update conference call and live webcast is scheduled for **Thursday, March 27, 2025, at 8:00 am ET (12:00 noon GMT)**[27](index=27&type=chunk) [Product Candidate Descriptions](index=4&type=section&id=Product%20Candidate%20Descriptions) Alvotech provides detailed descriptions of its key biosimilar candidates, including their reference biologics, mechanisms of action, and current regulatory/commercial status [AVT02 (adalimumab)](index=4&type=section&id=AVT02%20(adalimumab)) - A biosimilar to **Humira (adalimumab)**, approved in over **50 countries globally**, including the U.S., Europe, and Canada[28](index=28&type=chunk) - Marketed as **SIMLANDI** in the U.S. and Canada, **HUKYNDRA** in Europe, and **ADALACIP** in Australia[28](index=28&type=chunk) [AVT04 (ustekinumab)](index=4&type=section&id=AVT04%20(ustekinumab)) - A biosimilar to **Stelara (ustekinumab)**, launched in Canada as **JAMTEKI**, in the EEA as **UZPRUVO**, in Japan as **USTEKINUMAB BS (F)**, and in the U.S. as **SELARSDI (ustekinumab-aekn)**[29](index=29&type=chunk) - Binds to **IL-12 and IL-23 cytokines** involved in inflammatory and immune responses[29](index=29&type=chunk) [AVT03 (denosumab)](index=4&type=section&id=AVT03%20(denosumab)) - A biosimilar candidate to **Prolia and Xgeva (denosumab)**, targeting the RANK ligand to reduce osteoclast numbers and bone resorption[30](index=30&type=chunk) - Currently an **investigational product**, not yet received regulatory approval[30](index=30&type=chunk) [AVT06/AVT29 (aflibercept)](index=4&type=section&id=AVT06%2FAVT29%20(aflibercept)) - A biosimilar candidate to **Eylea (aflibercept) 2 mg and 8 mg dose**, inhibiting vascular endothelial growth factors (VEGF)[31](index=31&type=chunk) - Currently an **investigational product**, not yet received regulatory approval[31](index=31&type=chunk) [AVT16 (vedolizumab)](index=4&type=section&id=AVT16%20(vedolizumab)) - A biosimilar candidate to **Entyvio (vedolizumab)**, targeting the alpha-4-beta-7 protein to reduce inflammation in the gastrointestinal tract[32](index=32&type=chunk) - Currently an **investigational product**, not yet received regulatory approval[32](index=32&type=chunk) [AVT23 (omalizumab)](index=4&type=section&id=AVT23%20(omalizumab)) - A proposed biosimilar to **Xolair (omalizumab)**, targeting free immunoglobulin E (IgE) for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps[33](index=33&type=chunk) - Currently an **investigational product**, not yet received regulatory approval[33](index=33&type=chunk) [Company Profile and Partnerships](index=5&type=section&id=Company%20Profile%20and%20Partnerships) Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the space through an integrated approach and broad in-house capabilities - Alvotech is a biotech company focused solely on the development and manufacture of biosimilar medicines, aiming to be a global leader by delivering high quality, cost-effective products[36](index=36&type=chunk) - The company has launched **two biosimilars** and has a current development pipeline of **nine disclosed biosimilar candidates** targeting autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer[36](index=36&type=chunk) - Alvotech has established a network of strategic commercial partnerships for global reach, including **Teva Pharmaceuticals (US)**, **STADA Arzneimittel AG (EU)**, **Fuji Pharma Co., Ltd (Japan)**, and many others across various regions[36](index=36&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section outlines the inherent risks and uncertainties associated with Alvotech's forward-looking statements, including those related to funding, regulatory approvals, commercialization, litigation, and macroeconomic conditions - Forward-looking statements are subject to risks, uncertainties, and other factors that could cause actual results to differ materially, including the ability to raise funding, maintain stock exchange listings, changes in regulations, and competitive factors[38](index=38&type=chunk) - Risks also include the ability to develop, manufacture, and commercialize products, actions of regulatory authorities, success of collaborations, and the impact of macroeconomic conditions[38](index=38&type=chunk)[39](index=39&type=chunk) [Unaudited Condensed Consolidated Interim Financial Statements](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) [Statements of Profit or Loss and Other Comprehensive Income or Loss](index=6&type=section&id=Statements%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income%20or%20Loss) The statement of profit or loss shows a significant improvement in operating profit for 2024, reaching $69.6 million compared to a loss of $354.9 million in 2023 Key Profit or Loss Figures (USD thousands) | Metric | 2024 | 2023 | | :------------------------------------ | :------- | :------- | | Product revenue | 273,472 | 48,699 | | License and other revenue | 216,210 | 42,735 | | Cost of product revenue | (185,309) | (160,856) | | Research and development expenses | (171,312) | (210,827) | | General and administrative expenses | (65,713) | (76,559) | | Operating profit / (loss) | 69,644 | (354,860) | | Finance income | 80,145 | 4,823 | | Finance costs | (303,165) | (267,157) | | Loss on extinguishment of financial liabilities | (69,378) | — | | Income tax (expense) / benefit | (14,301) | 99,318 | | Loss for the year | (231,864) | (551,731) | | Loss per share | (0.87) | (2.42) | [Statements of Financial Position](index=7&type=section&id=Statements%20of%20Financial%20Position) As of December 31, 2024, total assets increased to $1,221.4 million from $950.1 million in 2023, driven by increases in property, plant and equipment, and current assets like inventories and trade receivables Key Financial Position Figures (USD thousands) | Metric | 31 December 2024 | 31 December 2023 | | :-------------------------- | :--------------- | :--------------- | | Total non-current assets | 766,380 | 755,248 | | Total current assets | 455,020 | 194,842 | | Total assets | 1,221,400 | 950,090 | | Total equity | (412,771) | (932,493) | | Total non-current liabilities | 1,440,775 | 1,621,633 | | Total current liabilities | 193,396 | 260,950 | | Total liabilities | 1,634,171 | 1,882,583 | | Total equity and liabilities | 1,221,400 | 950,090 | - Derivative financial liabilities significantly decreased from **$520.6 million in 2023 to $210.2 million in 2024**[43](index=43&type=chunk) - Cash and cash equivalents increased from **$11.2 million in 2023 to $51.4 million in 2024**[42](index=42&type=chunk) [Statements of Cash Flows](index=8&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities decreased to $236.8 million in 2024 from $312.2 million in 2023, reflecting improved operational efficiency Key Cash Flow Figures (USD thousands) | Metric | 2024 | 2023 | 2022 | | :------------------------------------ | :------- | :------- | :------- | | Net cash used in operating activities | (236,843) | (312,185) | (312,389) | | Net cash generated from (used in) investing activities | (18,868) | (46,340) | (63,537) | | Net cash generated from financing activities | 297,306 | 301,319 | 424,910 | | Increase / (decrease) in cash and cash equivalents | 41,595 | (57,206) | 48,984 | | Cash and cash equivalents at the end of the period | 51,428 | 11,157 | 66,427 | - Proceeds from new borrowings amounted to **$896.3 million in 2024**, contributing significantly to financing activities[46](index=46&type=chunk) - Gross proceeds from equity offering were **$150.5 million in 2024**[46](index=46&type=chunk)

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 [5][12][24] - The company successfully diversified its revenue streams and improved product margins through higher utilization and process efficiencies [2][5] - Alvotech's development pipeline is expanding rapidly, with three new biosimilar submissions accepted in major global markets [4][5][8] Financial Performance - Total revenues for 2024 reached $492 million, a 427% increase compared to the prior year [5][12] - Product revenues amounted to $273 million, representing a 462% increase year-over-year [5][13] - Adjusted EBITDA was $108.3 million, a significant improvement from a negative $291 million in 2023 [5][24] - Operating profit was $69.6 million, compared to a loss of $354.9 million in the previous year [5][18] - Reported net loss for the year was $231.9 million, or ($0.87) per share, an improvement from a net loss of $551.8 million, or ($2.42) per share, in 2023 [5][24] Business Developments - Alvotech's stock was added to the Nasdaq Biotechnology Index, meeting various eligibility requirements [3] - The company announced the acceptance of U.S. Biologics License Applications for multiple proposed biosimilars, including AVT05 and AVT06 [4][5][8] - Alvotech launched SELARSDI™, a biosimilar to Stelara®, in the U.S., which will be interchangeable with the reference biologic following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025 [7] - The acquisition of Xbrane's R&D operations enhances Alvotech's capabilities and pipeline [10] Research and Development - Alvotech completed the development of 18 additional cell lines, expanding its R&D capabilities [2] - The company has a pipeline of nine disclosed biosimilar candidates targeting various diseases, including autoimmune disorders and cancer [35] Cash Position and Liquidity - As of December 31, 2024, Alvotech had cash and cash equivalents of $51.4 million and total borrowings of $1,068.6 million [12][40]

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 Viewpoint - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair, which is significant for increasing patient access to biologic treatments for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps [1][2][4]. 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 targeting various diseases [7]. - Kashiv Biosciences is a fully integrated biopharmaceutical company dedicated to developing high-quality, cost-effective therapies, reflecting a commitment to innovation and global access to biosimilars [3]. - Advanz Pharma is a UK-based pharmaceutical company focused on specialty, hospital, and rare disease medications, emphasizing the expansion of treatment options for patients [4]. Product Information - AVT23 is an investigational biosimilar to Xolair (omalizumab), which targets free immunoglobulin E (IgE) and is indicated for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps [5]. - Global sales of Xolair were approximately USD 4.4 billion in 2024, highlighting the market potential for AVT23 [1]. 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, indicating a collaborative approach to bringing biosimilars to market [4].