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.

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.

Alvotech (ALVO) Q4 2022 Earnings Call Transcript

REYKJAVIK, ICELAND (March 1, 2023) — Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported financial results for full year 2022 and provided a summary of recent corporate highlights.

Alvotech Reports Financial Results for Full Year 2022 and Provides Business Update

REYKJAVIK, Iceland, Feb. 28, 2023 (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 full year 2022, after U.S. markets close on Wednesday, March 1, 2023.

Alvotech Announces Webcast of 2022 Full Year Financial Results at 8:00 am ET on March 2, 2023

AbbVie

Amgen

Bristol-Myers

Coherus BioSciences

Cigna

CVS Health

Fresenius Medical Care

GlaxoSmithKline

Johnson & Johnson

Merck

Novo Nordisk

Novartis

Organon & Co

Pfizer

Regeneron Pharmaceuticals

Roche Holding AG

Sanofi

Teva Pharmaceutical

Viatris

It's among the prohibitively expensive biologic pharmaceuticals being replaced by cheaper “biosimilar” copycats. Relief is on the way for patients who need Humira, a product made by AbbVie.

Competition Coming For AbbVie's Blockbuster Humira

Alvotech (Nasdaq: ALVO) and Landsbankinn hf. have updated their market making agreement, which has been in effect since Alvotech's shares were admitted to trading in Iceland on June 23, 2022. The updated agreement goes into effect at the start of trading on the Nasdaq Iceland market on February 15, 2023 and applies to ALVO shares trading on the Nasdaq Iceland exchange.

Updated market making agreement with Landsbankinn for Alvotech shares trading on the Nasdaq Iceland market

REYKJAVIK, Iceland, Feb. 10, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the completion of the equity transaction announced on January 23, 2023 (the “Private Share Placement”) with the transfer to the counterparties of a total of 11,834,061 treasury shares previously held by Alvotech's subsidiary Alvotech Manco ehf. The net cash proceeds of the Private Share Placement are expected to be used for general corporate purposes and to reduce reliance on other funding sources for the foreseeable future, including the Standby Equity Purchase Agreement facility with YA II PN, Ltd (“Yorkville”).

Settlement of Alvotech Private Share Placement Completed

REYKJAVIK, Iceland and BAD VILBEL, Germany, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and global pharmaceutical company STADA Arzneimittel (STADA) today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech's proposed biosimilar to Stelara® (ustekinumab). The companies anticipate that the EMA could recommend approving a marketing authorization for AVT04 as soon as in the second half of 2023.

EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)

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 Advanz Pharma, for the commercialization of AVT23, a proposed biosimilar to Xolair® (omalizumab).  The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand.

Alvotech enters into commercialization agreement with Advanz Pharma for proposed biosimilar to Xolair® (omalizumab)

REYKJAVIK, Iceland, Feb. 06, 2023 (GLOBE NEWSWIRE) -- 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 Advanz Pharma, for the commercialization of AVT23, a proposed biosimilar to Xolair® (omalizumab). The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand.

Alvotech Enters Into Commercialization Agreement With Advanz Pharma for Proposed Biosimilar to Xolair® (Omalizumab)

Alvotech (NASDAQ: ALVO) and Bioventure, a wholly owned subsidiary of GlobalOne Healthcare Holding LLC (“GHH”), the healthcare division of Yas Holding LLC, today announced that the Saudi Food & Drug Authority (“SFDA”) has approved the manufacturing and distribution of AVT02, a biosimilar for Humira® (adalimumab), which is commonly indicated for the treatment of rheumatoid arthritis and several other inflammatory diseases. The biosimilar will be marketed as Simlandi™ in Saudi Arabia.

Alvotech and Bioventure Announce Approval of AVT02 (adalimumab) as Simlandi in Saudi Arabia

REYKJAVIK, Iceland, Jan. 23, 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 completion of a private placement of approximately $137 million, at current exchange rates, of its ordinary shares, par value $0.01 per share, (the “Shares”) at a purchase price of $11.57 per Share at current exchange rates. The Shares are expected be delivered from previously issued treasury shares held by Alvotech's subsidiary, Alvotech Manco ehf.

Alvotech Completes $137 Million Private Share Placement

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Japanese pharmaceutical company Fuji Pharma Co., Ltd. (“Fuji”, Tokyo Stock Exchange: 4554) have decided to expand their existing exclusive commercialization partnership covering Japan, by adding a new undisclosed biosimilar candidate.

Alvotech and Fuji Pharma Expand Partnership Adding a New Biosimilar Candidate

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). The study will assess the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult subjects.

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

REYKJAVIK, Iceland & PARSIPPANY, N.J.--( BUSINESS WIRE )--Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech's proposed biosimilar to Stelara® (ustekinumab), which is prescribed to treat a variety of inflammatory conditions. The companies anticipate that the FDA's review will be completed in second half of 2023.

Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)

REYKJAVIK, Iceland, Dec. 22, 2022 (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 FDA has granted a new Biosimilar User Fee Amendment (BsUFA) goal date of April 13, 2023, for Alvotech's original Biologics License Application (BLA) for AVT02 as biosimilar to Humira®. Approval of the application requires satisfactory outcome of a reinspection of Alvotech's facility in Reykjavik, Iceland. Alvotech is working with the FDA to schedule a reinspection in the first quarter of 2023.

Update on U.S. Regulatory Status of AVT02, Alvotech's Proposed High-Concentration, Interchangeable Biosimilar to Humira®

Reference is made to the announcement issued earlier today about the completion of a private placement of subordinated convertible bonds. The aggregate principal amount is approximately US$70 million, instead of US$59.7 million. Please see correction below.

Correction to Total Amount in Announcement About Private Placement Published 2022-12-16 09:00 GMT to headline field

Correction to Total Amount in Announcement About Private Placement Published 2022-12-16 09:00 GMT

REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.

Alvotech Completes $59.7 Million Private Placement

The Icelandic biotech company has a deal to expand the reach of its Humira biosimilar in Eastern Europe.

Why Shares of Alvotech Jumped This Week

REYKJAVIK, Iceland, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced that trading in its shares will move from the Nasdaq Iceland First North Growth market (“First North”) to the Nasdaq Iceland Main Market (“Main Market”), starting today December 8, 2022. The “ALVO” stock market symbol for Alvotech remains unchanged and trade on the Nasdaq U.S. stock exchange is not affected.  A Main Market listing in Iceland can increase a company's visibility and, subject to meeting certain conditions, may result in inclusion in Icelandic and international indexes.

Alvotech Shares Start Trading on Nasdaq Iceland Main Market

REYKJAVIK, Iceland and BAD VILBEL, Germany, Dec. 07, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and STADA are contributing to the availability of high-quality biologic treatments in Europe by rolling out their Hukyndra high-concentration, low-volume, citrate-free formulation of adalimumab in several European countries.

Alvotech and STADA Broaden Access to Hukyndra® adalimumab biosimilar in Europe

Nasdaq Iceland has approved Alvotech S.A's (“Alvotech”) request for admission to trading of its shares on the Nasdaq Iceland Main Market (“Main Market”). Alvotech's shares will be admitted to trading on the Main Market following the passporting of Alvotech's prospectus to Iceland. Alvotech's shares will be delisted from the Nasdaq Iceland First North Market after market closing, on the day preceding the first day of trading of the shares on the Main Market.

Nasdaq Iceland Approves the Request for Trading of Alvotech's Shares on the Main Market

Hafrun Fridriksdottir, previously Executive VP and Head of Global R&D at Teva, will become Chief Operating Officer

News for Alvotech SA Stock (ALVO)