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

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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 & PARSIPPANY, N.J.--(BUSINESS WIRE)--Alvotech (NASDAQ: ALVO) 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 approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn's disease,.

Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

Johnson & Johnson

Alvotech said on Thursday it has reached settlement agreements with Johnson & Johnson for launching the biosimilar of the pharmaceutical giant's blockbuster psoriasis drug Stelara in Japan, Canada and the European Economic Area.

Alvotech settles with J&J to launch Stelara biosimilar in Europe, Canada

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT04, a biosimilar to Stelara® (ustekinumab). Regulatory approval for AVT04 in these markets has already been granted. Market applications for AVT04 are currently pending in additional global markets, including in the U.S.

Alvotech Announces Expected Global Market Entry Dates for AVT04 Biosimilar to Stelara® (ustekinumab)

REYKJAVIK, Iceland, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab.

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®

The FDA concludes the reinspection of Alvotech's (ALVO) facility in Iceland. The company believes that it may receive approval for biosimilar candidates, AVT02 and AVT04, in the United States.

Alvotech (ALVO) Up on BLA Update for Two Biosimilar Candidates

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech's facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form 483 with one observation. Alvotech expects to provide the FDA with a response in the following days.

Alvotech Provides Update on Status of Biologics License Applications for AVT02 and AVT04

REYKJAVIK, Iceland, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech's facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form 483 with one observation. Alvotech expects to provide the FDA with a response in the following days.

Alvotech Provides Update on Status of Biologics License Applications for AVT02 and AVT04

Partners STADA and Alvotech today announced that the European Commission issued a marketing authorization for Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab). The centralized marketing authorization for Europe's first ustekinumab biosimilar is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway.

STADA and Alvotech Secure Approval for Uzpruvo, Europe's First Ustekinumab Biosimilar to Stelara

BAD VILBEL, Germany and REYKJAVIK, Iceland, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Partners STADA and Alvotech today announced that the European Commission issued a marketing authorization for Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab). The centralized marketing authorization for Europe's first ustekinumab biosimilar is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway.

STADA and Alvotech secure approval for Uzpruvo, Europe's first ustekinumab biosimilar to Stelara

The confirmatory clinical, safety and efficacy study for AVT06, biosimilar candidate to Eylea® (aflibercept) met its primary endpoint in patients with neovascular (wet) Age-related Macular Degeneration (AMD)

Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea® (aflibercept)

From a technical perspective, Alvotech (ALVO) is looking like an interesting pick, as it just reached a key level of support. ALVO's 50-day simple moving average crossed above its 200-day simple moving average, which is known as a "golden cross" in the trading world.

Alvotech (ALVO)'s Technical Outlook is Bright After Key Golden Cross

Alvotech (NASDAQ:ALVO ) Q3 2023 Earnings Conference Call November 29, 2023 8:00 AM ET Company Participants Benedikt Stefansson - Senior Director of IR and Global Communications Robert Wessman - Chairman and CEO Anil Okay - Chief Commercial Officer Joel Morales - CFO Conference Call Participants Mikaela Franceschina - Barclays Niall Alexander - Deutsche Bank Thibault Boutherin - Morgan Stanley Operator Welcome to Alvotech's Earnings Call for the First Nine Months of 2023. At this time, all participants are in a listen-only mode.

Alvotech (ALVO) Q3 2023 Earnings Call Transcript

The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary endpoint The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary endpoint

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

REYKJAVIK, Iceland, Nov. 28, 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 nine months of 2023 and provided a summary of recent corporate highlights.

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

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 nine months of 2023 and provided a summary of recent corporate highlights.

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

REYKJAVIK, ICELAND, Nov. 21, 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 the first nine months of 2023, after U.S. markets close on Tuesday, November 28, 2023.

Alvotech to Report Financial Results for the First Nine Months of 2023 on November 28, 2023, and Host Business Update Conference Call on November 29, 2023, at 8:00 am ET

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group (“JAMP Pharma”), a Canadian owned pharmaceutical organization headquartered in the Greater Montreal area, announced today that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® (ustekinumab) developed by Alvotech. AVT04 will be marketed under the brand name JamtekiTM.

Alvotech and JAMP Pharma Announce Receipt of Marketing Authorization for Jamteki (AVT04), the First Biosimilar of Stelara® (ustekinumab)

Pr Jamte ki TM is the second biosimilar developed under th is partnership that receives market ing authorization in Ca nada.

Alvotech and JAMP Pharma Announce Receipt of Marketing Authorization for Jamteki™ (AVT04), the First Biosimilar of Stelara® (ustekinumab)

BAD VILBEL, Germany and REYKJAVIK, Iceland, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Partners STADA and Alvotech today announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion for Uzpruvo (AVT04), a biosimilar candidate to Stelara® (ustekinumab).

STADA and Alvotech receive positive CHMP opinion for Europe's first ustekinumab biosimilar to Stelara

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 taking place in London on November 14-16, 2023.

Alvotech to Present at the Jefferies 2023 London Healthcare Conference

REYKJAVIK, Iceland, Oct. 12, 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 US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech's Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara® (ustekinumab).

Alvotech Provides Update on Status of U.S. Biologics License Application for AVT04

Alvotech (Nasdaq: ALVO) and Íslandsbanki hf. (“Islandsbanki”) have entered into a market making agreement. According to the market making agreement, Islandsbanki places bids and offers for ALVO shares trading on the Nasdaq Iceland Main Market (the “Exchange”) for a minimum amount with a fixed spread between the bid and offer price.

Alvotech and Islandsbanki enter into Market Making Agreement for Shares Trading on Nasdaq Iceland

PISCATAWAY, N.J. & REYKJAVIK, Iceland--(BUSINESS WIRE)--Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company, and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that they have entered into an exclusive licensing agreement for ADL018 (also called AVT23), a proposed biosimilar to Xolair® (omalizumab), which is in clinical development. The agreement covers a.

Kashiv BioSciences Enters into Exclusive Licensing Agreement with Alvotech for Development & Commercialization of a Proposed Biosimilar to Xolair® (omalizumab)

REYKJAVIK, Iceland and PISCATAWAY, N.J., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company, today announced that they have entered into an exclusive licensing agreement for AVT23 (also called ADL018), a proposed biosimilar to Xolair® (omalizumab), which is currently in clinical development.

Alvotech Enters into Exclusive Licensing Agreement with Kashiv BioSciences for Development and Commercialization of a Proposed Biosimilar to Xolair® (omalizumab)

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. (“Fuji”), has received marketing approval for AVT04 (ustekinumab), a biosimilar to Stelara®, from the Japanese Ministry of Health, Labor and Welfare. Based on publicly available information, AVT04 is the first biosimilar to Stelara to be approved for sale in global markets. Global sales of Stelara reached over $10 billion for the twelve months preceding June 30, 2023, according to the manufacturer's public filings, making it one of the world's highest grossing biologics.

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