Core Insights - Teva Pharmaceutical Industries and partner Alvotech announced that the FDA has agreed to review their AVTO6 treatment for eye disorders, which is a biosimilar that could compete with Regeneron Pharmaceuticals' Eylea [1][3] - Eylea, which is used to treat conditions such as wet Age-related Macular Degeneration, had projected U.S. sales of $4.77 billion in 2024 [1] - Teva and Alvotech have been in a strategic partnership since August 2020, focusing on the U.S. biosimilar drug market and are developing a higher-dose version of the treatment to compete with Eylea HD [2][3] Market Reaction - Following the announcement, Teva's shares increased by approximately 3%, while Alvotech's shares decreased by 0.8% [2] - Regeneron Pharmaceuticals' shares rose by about 1.7% in response to the news [2]

Core Insights - Alvotech and Teva Pharmaceuticals announced that the FDA has accepted the Biologics License Application for AVT06, a proposed biosimilar to Eylea, with regulatory approval expected by Q4 2025 [1][2] - Eylea, a biologic for treating eye disorders, generated $4.77 billion in sales in the U.S. in 2024 [3] - Alvotech is also developing AVT29, another biosimilar candidate for Eylea HD, with Teva holding commercialization rights in the U.S. [2] Company Overview - Alvotech is focused on developing and manufacturing biosimilar medicines globally, aiming to be a leader in the biosimilar market with a fully integrated approach [7] - The company has two approved biosimilars for Humira and Stelara and a pipeline of nine additional candidates targeting various diseases [7] - Alvotech has established strategic partnerships for global reach, including collaborations with Teva, STADA, and others across multiple regions [7] Product Details - AVT06 and AVT29 are recombinant fusion proteins targeting vascular endothelial growth factors (VEGF) to inhibit neovascularization and vascular permeability [5] - A confirmatory clinical study showed that AVT06 met its primary endpoint, demonstrating therapeutic equivalence and comparable safety to Eylea [4]

Core Viewpoint - Alvotech and Teva Pharmaceuticals have announced that the FDA has accepted the Biologics License Applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria, marking a significant step towards providing U.S. patients access to this biosimilar treatment for inflammatory conditions [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 with a pipeline that includes nine disclosed candidates targeting various diseases [9]. - Teva Pharmaceuticals is a global pharmaceutical leader with a commitment to improving health outcomes through innovation and generics, employing approximately 37,000 people across 57 markets [10]. Strategic Partnership - Alvotech and Teva entered a strategic partnership in August 2020 for the exclusive commercialization of five biosimilar candidates, which has since expanded to nine products [3]. - Alvotech is responsible for development and manufacturing, while Teva handles commercialization in the U.S., leveraging its extensive sales and marketing infrastructure [3]. Regulatory Progress - The FDA review process for AVT05 is expected to be completed in the fourth quarter of 2025, with the applications being the first for a biosimilar candidate to golimumab [1]. - Alvotech has previously announced positive results from clinical studies comparing AVT05 to Simponi, indicating its efficacy and safety [2]. Market Developments - Two biosimilars developed under the Alvotech-Teva partnership have received FDA approval: SIMLANDI (adalimumab-ryvk) in February 2024 and SELARSDI (ustekinumab-aekn) in April 2024, with market entry planned for May 2024 and February 2025, respectively [4].

Company Performance - Alvotech (ALVO) has returned approximately 0.6% year-to-date, outperforming the average loss of 5.2% in the Medical sector [4] - The Zacks Consensus Estimate for Alvotech's full-year earnings has increased by 280% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [3] - Alvotech is currently ranked 2 (Buy) in the Zacks Rank, suggesting it is poised to outperform the broader market in the next one to three months [3] Industry Comparison - Alvotech belongs to the Medical - Biomedical and Genetics industry, which has seen an average loss of about 14.8% year-to-date, indicating that ALVO is performing better than its peers in this specific industry [5] - In contrast, Becton Dickinson (BDX), another stock in the Medical sector, has a year-to-date return of 3.9% and is also ranked 2 (Buy) [4][5] - The Medical - Dental Supplies industry, to which Becton Dickinson belongs, has moved up by 3.8% year-to-date, ranking 72 among 16 industries [6]

Group 1: Nasdaq Biotechnology Index Inclusion - Alvotech's stock will be added to the Nasdaq Biotechnology Index (NBI) as part of the annual reconstitution, effective December 23, 2024 [5] - The Nasdaq Biotechnology Index includes companies classified as Biotechnology or Pharmaceuticals, calculated under a modified capitalization-weighted methodology [1] Group 2: Company Overview - Alvotech is focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space with high-quality, cost-effective products [2] - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), marketed in multiple global markets [2] - Alvotech's development pipeline includes nine disclosed biosimilar candidates targeting various diseases, including autoimmune disorders and cancer [2] Group 3: 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 others across various regions [2] - Each partnership covers unique products and territories, leveraging local expertise in markets such as the U.S., Europe, Japan, and parts of Asia and South America [2]

Alvotech (ALVO) closed the last trading session at $11.80, gaining 0.6% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $16.50 indicates a 39.8% upside potential.The mean estimate comprises four short-term price targets with a standard deviation of $9.15. While the lowest estimate of $6 indicates a 49.2% decline from the current price level, the most optimistic analyst expects the ...

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Alvotech (ALVO) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.Alvotech is one of 1022 companies in the Medical group. The Medical group currently sits at #3 within the Zacks Sector Rank. The Zacks Sector Rank includes 16 differ ...

Group 1 - The pharmaceutical market is experiencing growth post-pandemic, with big pharma companies dominating the landscape [1] - Alvotech (NASDAQ: ALVO) is highlighted as a potential investment opportunity, focusing exclusively on biosimilars, which are essential in the current market [1] - The analysis emphasizes a preference for high-growth companies in sectors expected to expand significantly, with a focus on innovation and disruptive technologies [1] Group 2 - The article does not provide any specific financial data or performance metrics related to Alvotech or the broader pharmaceutical market [2][3]

Alvotech (NASDAQ:ALVO) Q3 2024 Earnings Conference Call November 14, 2024 8:00 AM ET Company Participants Benedikt Stefansson - Senior Director, Investor Relations and Global Communications Robert Wessman - Chairman and Chief Executive Officer Anil Okay - Chief Commercial Officer Joel Morales - Chief Financial Officer Ming Li - Chief Strategy Officer Conference Call Participants Balaji Prasad - Barclays Niall Alexander - Deutsche Bank Carl Byrnes - Northland Capital Markets Operator Good day, and thank you ...

Company Performance - Alvotech reported quarterly earnings of $0.19 per share, exceeding the Zacks Consensus Estimate of a loss of $0.15 per share, compared to a loss of $0.82 per share a year ago, representing an earnings surprise of 226.67% [1] - The company posted revenues of $102.99 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 5.63%, compared to year-ago revenues of $17.8 million [2] - Over the last four quarters, Alvotech has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2] Stock Outlook - Alvotech shares have increased by approximately 5.9% since the beginning of the year, while the S&P 500 has gained 25.5% [3] - The company's earnings outlook, including current consensus earnings expectations for upcoming quarters, will be crucial for investors [4] - The current consensus EPS estimate for the coming quarter is -$0.27 on revenues of $130.3 million, and -$0.67 on revenues of $245.9 million for the current fiscal year [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Alvotech belongs, is currently in the top 26% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Alvotech's stock performance [5]