Core Insights - Alvotech reported strong financial results for Q1 2025, with significant increases in product revenue and adjusted EBITDA, indicating robust growth and operational efficiency [2][7][17]. Financial Performance - Total revenues for Q1 2025 reached $132.8 million, a 260% increase from $36.9 million in Q1 2024 [7]. - Product revenue was $109.9 million, representing a 786% increase compared to $12.4 million in the same period last year [7]. - Adjusted EBITDA for Q1 2025 was $20.5 million, a significant recovery from a negative $38.4 million in Q1 2024 [7]. - The company had cash and cash equivalents of $39.5 million as of March 31, 2025, with total borrowings of $1,096.7 million [6]. Business Developments - Alvotech launched SELARSDI™, a biosimilar to Stelara®, in the U.S., and received interchangeability status effective April 30, 2025 [3]. - The company announced the acceptance of U.S. Biologics License Applications (BLAs) for AVT05 and AVT06, proposed biosimilars to Simponi® and Eylea®, respectively [3]. - Alvotech acquired Xbrane's R&D operations in Sweden and all rights to a biosimilar candidate referencing Cimzia® [5]. Pipeline Expansion - The company is focused on launching four new biosimilars as key near-term priorities and is expanding its development pipeline [2]. - Alvotech's acquisition of Xbrane is expected to enhance its R&D capabilities and strengthen its position in the biosimilar market [2]. Cost Management - Cost of product revenue increased to $65.4 million in Q1 2025 from $20.0 million in Q1 2024, driven by higher sales [10]. - Research and development expenses decreased to $38.2 million in Q1 2025 from $49.9 million in Q1 2024, reflecting a shift towards commercialization [11]. Profitability - Operating profit for Q1 2025 was $10.6 million, a turnaround from an operating loss of $48.4 million in the same period last year [13]. - Reported net profit was $109.7 million, or $0.39 per share, compared to a net loss of $218.7 million, or ($0.89) per share, in Q1 2024 [17].

Total Revenues in the first quarter of 2025 reached $132.8 million, compared to $36.9 million in the same period last year, representing a 260% increase Product Revenues in the first in the first quarter of 2025 reached $109.9 million, compared to $12.4 million in the same period last year, representing a 786% increase Adjusted EBITDA in the first quarter of 2025 was $20.5 million compared to negative $38.4 million in 2023 Full year guidance increased to $600-$700 million in top line revenue and $200-280 mi ...

Core Viewpoint - Alvotech anticipates that potential U.S. tariffs on imported pharmaceuticals will have minimal impact on its product revenues in 2025, estimating the effect of a 10% tariff to be less than 1% of total expected revenues [1][2]. Group 1: Tariff Impact - Alvotech manufactures its biosimilars in Iceland, which currently faces a minimum tariff of 10% on goods imported to the U.S. [1][2] - The estimated impact of a 10% tariff on Alvotech's sales to the U.S. in the second half of 2025 would be less than 1% of expected product revenues [2]. - Customers are responsible for all costs of transport and import duties to the U.S., meaning Alvotech will not bear these costs [1][2]. Group 2: Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space [3]. - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), and a pipeline of nine disclosed biosimilar candidates targeting various diseases [3]. - Alvotech has established strategic commercial partnerships across multiple regions, including the U.S., Europe, Japan, and parts of Asia and South America [3].

Core Viewpoint - Alvotech anticipates that potential U.S. tariffs on imported pharmaceuticals will have minimal impact on its product revenues in 2025, estimating the effect of a 10% tariff to be less than 1% of expected total product revenues [1][2]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space by providing high-quality, cost-effective products [3]. - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), and a pipeline of nine disclosed biosimilar candidates targeting various diseases [3]. - Alvotech has established strategic commercial partnerships across multiple regions, including the U.S., Europe, Japan, and parts of South America, Africa, and the Middle East [3]. Tariff Impact Analysis - The company manufactures its biosimilars in Iceland, which currently faces a minimum tariff of 10% on goods imported to the U.S. [1][2]. - According to the company's estimates, the impact of a 10% tariff on U.S. sales in the second half of the year would be less than 1% of expected product revenues in 2025, with costs not borne by Alvotech due to contractual terms [2]. - Looking beyond 2025, the anticipated impact of tariffs is expected to remain a low single-digit percentage of total product revenues, considering future product launches and increased sales [2].

Core Viewpoint - The FDA has approved Teva Pharmaceutical Industries Ltd. and Alvotech's Selarsdi as an interchangeable biosimilar to Johnson & Johnson's Stelara, expanding treatment options for various inflammatory conditions [1][2]. Group 1: Product Approval and Details - Selarsdi is approved for multiple indications, including adult and pediatric psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis, effective from April 30, 2025 [1]. - The approved presentations of Selarsdi include 45 mg/0.5 mL and 90 mg/mL in prefilled syringes, 45 mg/0.5 mL in vials, and 130 mg/26 mL for intravenous infusion [3]. Group 2: Strategic Partnerships and Market Position - Teva and Alvotech entered a strategic partnership in August 2020 to exclusively commercialize five biosimilar candidates, which was later extended to include additional products [4]. - Teva's recent launches of Selarsdi and another biosimilar, along with a robust pipeline, position the company for strong leadership in the biosimilars market [2]. Group 3: Financial Impact and Stock Performance - Following the news of the approval, TEVA stock increased by 2.10% to $16.53, while ALVO stock rose by 0.67% to $8.22 [5]. Group 4: Future Developments - The FDA has accepted Biologics License Applications for three additional biosimilar candidates developed by Alvotech in partnership with Teva, with goal dates for approval in Q4 2025 [6].

Core Insights - Teva Pharmaceuticals and Alvotech announced FDA approval for SELARSDI™ (ustekinumab-aekn) as interchangeable with Stelara® (ustekinumab), effective April 30, 2025, for various conditions including psoriatic arthritis and Crohn's disease [1][7][8] Company Developments - The approval of SELARSDI is seen as a significant advancement for patient access to affordable treatment options, aligning with Teva's strategy to lead in the biosimilars market [2][4] - Teva has launched two biosimilars, SELARSDI and EPYSQLI, and has a robust pipeline of additional biosimilars expected to launch in the coming years [2][4] - Alvotech is expanding its portfolio with two approved biosimilars in the U.S. and three additional biosimilar candidates under FDA review, indicating a strong growth trajectory [2][6] Product Information - SELARSDI is available in multiple presentations, including 45 mg/0.5 mL and 90 mg/mL for subcutaneous injection, and 130 mg/26 mL for intravenous infusion [2][7] - The biosimilar targets the p40 protein, crucial for treating immune-mediated diseases, and is produced using the same cell line and process as Stelara® [3][7] Strategic Partnerships - Teva and Alvotech have a strategic partnership for the exclusive commercialization of biosimilars, which has been extended to include additional products and presentations [4][5] - The partnership allows Teva to leverage its extensive sales and marketing infrastructure while Alvotech manages development and manufacturing [4][5] Market Context - The approval of SELARSDI and other biosimilars is part of a broader trend towards increasing access to biologic treatments, which is essential for lowering healthcare costs [2][4] - The FDA's approval of SELARSDI as interchangeable with Stelara® is expected to enhance competition in the biologics market, benefiting patients and healthcare providers [2][4]

Core Viewpoint - Alvotech is set to release its financial results for Q1 2025 on May 7, 2025, and will hold a conference call on May 8, 2025, to discuss these results and recent business highlights [1]. Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines globally, aiming to be a leader in the biosimilar market by providing high-quality, cost-effective products [3]. - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), which are marketed in multiple global markets [3]. - Alvotech's development pipeline includes nine disclosed biosimilar candidates targeting various conditions such as autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [3]. - The company has established a network of strategic commercial partnerships across the United States, Europe, Japan, China, and other regions, enhancing its global reach [3]. Investor Relations - Information regarding the webcast and conference call participation is available on Alvotech's investor website, with the webcast being archived for 90 days post-event [2]. - The company encourages engagement through its investor portal and social media platforms [4].

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]