Alvotech SA

Alvotech operates as a global biopharmaceutical company, which engages in developing and manufacturing biosimilar medicines through its subsidiaries. The firm's pipeline contains biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, and cancer. The company was founded on August 23, 2021 and is headquartered in Luxembourg.

Earnings data Q3 2022

Earnings data Q4 2022

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Earnings data Q4 2024

Alvotech reports robust Q1 earnings, eyes biosimilar market leadership

Alvotech's Q1 2024 earnings call highlighted strong financial performance, progress in commercializing biosimilars, and a positive outlook for revenue growth in 2024. The company's focus on interchangeability, exclusive agreements, and expanding its product pipeline positions it well for future success in the biosimilars market.

Alvotech reports stellar revenue growth and strategic financing moves

Alvotech's strong financial performance, focus on biosimilars, and strategic financing decisions underscore its growth trajectory. Challenges in maintaining margins and meeting EBITDA targets exist, but opportunities from new applications and revenue mix diversification are promising.

Alvotech reports robust Q3 earnings, eyes growth amid profitability challenges

Alvotech's Q3 2024 earnings call showcased strong financial performance, with total revenues reaching $339 million for the first 9 months.
The company reported positive operating profit and adjusted EBITDA for the second consecutive quarter, driven by product revenue growth and margin improvement.
Guidance for 2024 revenue remains at $400 million to $500 million, with a focus on operational execution and maximizing launches for continued success.

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Alvotech is a biotechnology company, which engages in the development and manufacture of biosimilar medicines. The firm is focusing on the development of its product candidates. It operates through the following geographical segments: Europe, North America, Asia, and Other. The company was founded by Róbert Vilhelm Wessman in 2013 and is headquartered in Luxembourg.

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an exclusive partnership agreement regarding the supply and commercialization of five biosimilar candidates in Europe.  Alvotech will be responsible for development and commercial supply and Advanz Pharma will be responsible for registration and commercialization in Europe.

Alvotech and Advanz Pharma extend strategic partnership to commercialize five proposed biosimilars in Europe

Alvotech (NASDAQ:ALVO ) Q1 2023 Earnings Conference Call May 19, 2023 8:00 AM ET Company Participants Benedikt Stefansson - Director of 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 Andrew Baum - Citigroup Thibault Boutherin - Morgan Stanley Ashish Verma - UBS Carl Byrnes - Northland Capital Markets Operator Welcome to the First Quarter 2023 Earnings Call for Alvotech. At this time, all participants are in a listen-only mode.

Alvotech (ALVO) Q1 2023 Earnings Call Transcript

REYKJAVIK, Iceland, May 19, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first three months of 2023 and provided a summary of recent corporate highlights.

Alvotech Reports Financial Results for First three Months of 2023 and Provides Business Update

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 Morgan Stanley Annual Sustainable Finance Summit on May 22, 2023.

Alvotech to Participate in Morgan Stanley Annual Sustainable Finance Summit

REYKJAVIK, Iceland, May 15, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the release of its second annual Equality Report covering 2022.

Alvotech Issues Annual Equality Report Covering 2022

NEW YORK , May 10, 2023 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Alvotech ("Alvotech" or the "Company") (NASDAQ: ALVO).  Such investors are advised to contact Robert S.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Alvotech - ALVO

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has entered into an exclusive agreement with Polifarma Ilac San. ve tic. A.S. (“Polifarma”) for the commercialization in Turkey of AVT06, a proposed biosimilar to Eylea® (aflibercept).

Alvotech enters into commercialization agreement with Polifarma for proposed biosimilar to Eylea® (aflibercept)

Viatris

Fuji Pharma Co., Ltd. is mainly a generics pharma company focused on the less volatile Japanese generics market, whose market structure is associated with less regulatory risks, competition, and generics profitability risks. Its generics focus is a positive thing in Japan since regulators want a greater generics to share in healthcare expenditure, and its products for women are low-penetration and received recent government support.

Fuji Pharma: High Scope For Growth In U.S. Foray, Biosimilars, And Women's Health Drugs

The Annual General Meeting of Alvotech S.A. will be held on Tuesday 6 June 2023, at 09.00 a.m. CEST at the premises of Arendt & Medernach S.A. at 41A, Avenue John F. Kennedy L-1855 Luxembourg, Grand Duchy of Luxembourg.

Alvotech S.A. Annual General Meeting to be held June 6, 2023

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of Alvotech's confirmatory patient study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). The objective of the clinical study is to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi® in adult patients with moderate to severe rheumatoid arthritis.

Alvotech Initiates Confirmatory Patient Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

NEW YORK--(BUSINESS WIRE)--WHY: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Alvotech (NASDAQ: ALVO, ALVOW) resulting from allegations that Alvotech may have issued materially misleading business information to the investing public. SO WHAT: If you purchased Alvotech securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. T.

ALVO, ALVOW INVESTOR NEWS: ROSEN, SKILLED INVESTOR COUNSEL, Encourages Alvotech Investors With Losses in Excess of $100K to Inquire About Securities Class Action Investigation – ALVOW

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, 2023, after U.S. markets close on Thursday, May 18, 2023.

Alvotech to Report First Quarter 2023 Financial Results and Recent Business Highlights on May 18, 2023 and Host Conference Call on May 19, 2023 at 8:00 am ET

NEW YORK--(BUSINESS WIRE)-- #A--Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Alvotech (“Alvotech” or the “Company”) (NASDAQ: ALVO) on behalf of Alvotech stockholders. Our investigation concerns whether Alvotech has violated the federal securities laws and/or engaged in other unlawful business practices. Click here to participate in the action.

ALVOTECH ALERT: Bragar Eagel & Squire, P.C. is Investigating Alvotech on Behalf of Alvotech Stockholders and Encourages Investors to Contact the Firm

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced changes to the company's Quality unit.  Sandra Casaca has been appointed Chief Quality Officer of Alvotech and Sarah Tanksley will be joining the Board of Directors of Alvotech hf., the operating entity for Alvotech's manufacturing site in Iceland.

Sarah Tanksley Joins Board of Directors for Alvotech hf. and Sandra Casaca Appointed Chief Quality Officer

LOS ANGELES--(BUSINESS WIRE)---- $ALVO #ALVO--The Schall Law Firm Announces it is Investigating Claims Against Alvotech and Encourages Investors with Losses to Contact the Firm

INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Alvotech and Encourages Investors with Losses to Contact the Firm

BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Alvotech (“Alvotech” or the “Company”) (NASDAQ: ALVO) investors concerning the Company's possible violations of federal securities laws. On April 13, 2023, Alvotech disclosed that it received communication from the U.S. Food and Drug Administration (“FDA”) regarding the FDA's March 2022 inspection of Alvotech's manufacturing facility in Reykjavik, Iceland.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Alvotech (ALVO) on Behalf of Investors

LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Alvotech (“Alvotech” or the “Company”) (NASDAQ: ALVO) investors concerning the Company's possible violations of the federal securities laws.

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Alvotech (ALVO) on Behalf of Investors

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces an investigation of Alvotech (“Alvotech” or the “Company”) (NASDAQ: ALVO) on behalf of investors concerning the Company's possible violations of federal securities laws. If you are a shareholder who suffered a loss, click here to participate. On April 13, 2023, Alvotech disclosed that it received communication from the U.S.

The Law Offices of Frank R. Cruz Announces Investigation of Alvotech (ALVO) on Behalf of Investors

Alvotech's shares decline as it receives a complete response letter for biosimilar candidate, AVT02, treating autoimmune disorders.

Alvotech (ALVO) Declines on CRL for Humira's Biosimilar Candidate

TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its partner Alvotech (NASDAQ: ALVO) for the Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab).

Complete Response Letter Received for AVT02 Biologics License Application

REYKJAVIK, Iceland, April 14, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech's Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA's reinspection of the company's Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved. No other deficiencies in the application were noted by the FDA. Alvotech provided the FDA comprehensive responses to the inspection observations on April 3, 2023, and is awaiting communication from the agency assessing those responses.

Alvotech Provides Regulatory Update on AVT02 Biologics License Application

REYKJAVIK, Iceland, March 28, 2023 (GLOBE NEWSWIRE) -- Alvotech (Nasdaq: ALVO) (the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced an update to the Company's Corporate Sustainability framework, including the release of key environmental, social and governance (“ESG”) indicators for 2022.

Alvotech Provides Update on Corporate Sustainability Framework

REYKJAVIK, Iceland, March 17, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the presentation of two posters related to its clinical studies in support of biosimilarity and clinical comparability of Alvotech's ATV04 (ustekinumab) and the reference product Stelara® at the 2023 American Academy of Dermatology (AAD) Annual Meeting, March 17-21 in New Orleans.

Alvotech to Present Clinical Study Data for AVT04, a Proposed Biosimilar to Stelara®, at 2023 American Academy of Dermatology (AAD) Annual Meeting

Alvotech has a current portfolio of eight products and product candidates targeting autoimmune disease, eye disorders, respiratory disease, and cancer. The company has successfully launched its biosimilar candidate AVT02 in 16 European countries and Canada, which is expected to normalize its cost of product revenue in the future.

Alvotech: Biosimilar Specialist Targeting Lucrative Markets

Alvotech (NASDAQ:ALVO ) Q4 2022 Results Conference Call March 2, 2023 8:00 AM ET Company Participants Benedikt Stefansson - Director of Investor Relations Robert Wessman - Chairman and CEO Anil Okay - Chief Commercial Officer Hafrun Fridriksdottir - Chief Operating Officer Joel Morales - Chief Financial Officer Conference Call Participants Thibault Boutherin - Morgan Stanley Niall Alexander - Deutsche Bank Andrew Baum - Citi Benedikt Stefansson Thank you, and good morning or afternoon to everyone joining this call today. Yesterday evening, the company issued a press release that can be found on our website, investors.alvotech.com, under News and Events in the Events and Presentations section.

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