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]

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in Citi’s 2024 Global Healthcare Conference in Miami, Florida on December 4, 2024, and in Evercore’s HealthCONx Conference in Coral Gables, Florida on December 5, 2024. Members of the management team will host one-on-one meetings at both conferences. Alvotech will also hold a fire-side chat at Evercore’s HealthCONx Conference on T ...

REYKJAVIK, Iceland, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies London Healthcare Conference, November 19-20, 2024. Members of the management team will host one-on-one meetings on both days. Alvotech will be presenting at the conference on Tuesday, November 19, 2024 at 9:00-9:25 am GMT. An audio webcast of the conference pr ...