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Alvotech Announces Marketing Approval in Japan of Three New Biosimilars
Globenewswire· 2025-09-19 11:45
Core Viewpoint - Alvotech has received marketing approval for three new biosimilars in Japan, expanding its product offerings and addressing the growing demand for cost-effective biologic medicines [1][2][5] Group 1: New Product Approvals - Fuji Pharma has received marketing approval for three biosimilars: AVT03 (biosimilar to Ranmark®), AVT05 (biosimilar to Simponi®), and AVT06 (biosimilar to Eylea®) [1][2][3][4] - AVT05 is noted as the first golimumab biosimilar approved for sale in major markets globally [1] - AVT03 is approved for treating bone lesions due to multiple myeloma or metastases of solid tumors [2] - AVT05 is approved for treating Rheumatoid Arthritis in patients who have not responded sufficiently to conventional treatments [3] - AVT06 is approved for treating Age-related Macular Degeneration and other eye conditions [4] Group 2: Strategic Partnerships and Market Expansion - The partnership with Fuji Pharma was established in November 2018, and they successfully launched the first biosimilar to Stelara® in May 2024 [5] - Alvotech has licensed commercial rights in Japan to Fuji Pharma for two additional biosimilar candidates currently under development [5] Group 3: Company Overview - Alvotech is focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space [7] - The company has a pipeline that includes eight disclosed biosimilar candidates targeting various diseases, including autoimmune disorders and cancer [7] - Alvotech has formed strategic commercial partnerships to enhance its global reach, including collaborations with companies in the US, Europe, Japan, and other regions [7]
Alvotech Gears Up to Report Q2 Earnings: Here's What to Expect
ZACKS· 2025-07-30 15:16
Core Viewpoint - Alvotech (ALVO) is set to announce its Q2 2025 earnings results, with expectations of a loss per share of 26 cents and total revenues of $115.4 million [1][5]. Group 1: Revenue Segments - Alvotech recognizes revenues from two segments: Product revenue and License and other revenue [2]. - Product revenue comes from the sale of two approved biosimilars, Simlandi and Selarsdi, which are biosimilars to AbbVie's Humira and JNJ's Stelara, respectively [3]. Group 2: Market Performance - Investors are particularly interested in the sales figures for Simlandi and Selarsdi, which were launched in the U.S. in 2024 and Q1 2025, respectively, but have yet to gain significant market traction [4]. - Year-to-date, ALVO's shares have decreased by 26.5%, contrasting with the industry's growth of 0.6% [4]. Group 3: Pipeline Developments - Alvotech's pipeline includes AVT05, AVT06, and AVT03, with multiple regulatory filings currently under review in the U.S. and EU [5]. - AVT05 is being developed as a proposed biosimilar to JNJ's Simponi, with regulatory decisions expected by the end of the year [7]. - AVT06 is a proposed biosimilar to Bayer and Regeneron's Eylea, with decisions anticipated by the end of 2025 [8]. - AVT03 is a biosimilar candidate to Amgen's Prolia and Xgeva, with the FDA accepting a regulatory filing for review in March 2025 [9]. Group 4: Partnership Expansions - Alvotech and Dr. Reddy's Laboratories have expanded their partnership to co-develop a biosimilar candidate to Merck's Keytruda [10]. Group 5: Earnings Surprise History - Alvotech has a strong earnings surprise history, having beaten estimates in the last three quarters with an average surprise of 244.18% [11]. - In the last reported quarter, the company achieved an earnings surprise of 305.88% [12]. Group 6: Earnings Predictions - Alvotech currently has an Earnings ESP of 0.00%, indicating no predictive advantage for an earnings beat this time [14].
Alvotech Reports Results for the First Quarter of 2025 and Provides Business Update
Globenewswire· 2025-05-07 20:45
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].
Alvotech(ALVO) - 2024 Q4 - Earnings Call Transcript
2025-03-27 16:09
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]
Alvotech(ALVO) - 2024 Q4 - Earnings Call Presentation
2025-03-27 13:07
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]