Total Revenues in the first nine months of 2024 increased by $300 million compared to same period in 2023, to $339 million, with Q3 revenues contributing $103 millionProduct revenues in the first nine months of 2024 increased over four-fold compared to the same period last year, to $128 million, with Q3 product revenues contributing $62 millionLicense and other revenues for the first nine months of 2024 increased by $203 from the same period last year, to $211 million, with Q3 license and other revenues contributing $41 millionAdjusted EBITDA was $87 million in the first nine months of 2024, compared to negative ($225) million for the same period last year, with Q3 adjusted EBITDA contributi

REYKJAVIK, Iceland, Nov. 07, 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 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 Thursday, December 5, 2024 starting at 12:55 ET (17:55 GMT). A live audio webcast of Alvotech's fire-side chat at the Evercore He

REYKJAVIK, Iceland and LONDON, Nov. 04, 2024 (GLOBE NEWSWIRE) -- 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 European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech's proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. This is believed to be the first marketing authorization application filing announced globally f

REYKJAVIK, Iceland, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first nine months of the year ended September 30, 2024, after U.S. markets close on Wednesday, November 13, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Thursday November 14, 2024, at 8:00 am ET (13:00 GMT).   Live audio of the conference call will also be webcast and available to members of the news media, investors, and the general public. Access information is posted on Alvotech's

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 presentation will also be available to investors and the general public and can be accessed in the Investors Section of Alvotech's website under News and Events – Events and Presentations.

Approval of SELARSDI 130 mg/26 mL in a single-dose vial for intravenous infusion expands label to include treatment of adults with Crohn's disease and ulcerative colitisThe FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024SELARSDI's U.S. launch for all indications is expected in Q1 2025 REYKJAVIK, Iceland & PARSIPPANY, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) -- 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 SELARSDI (ustekinumab-aekn) in a

REYKJAVIK, Iceland, Oct. 10, 2024 (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 European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab). "EMA acceptance marks an important step towards making AVT03 available to patients and caregivers in Europe," said Joseph McClellan, Chief Scientific Officer of Alvotech. "Successful progression in the development of multiple biosimilar candidates demonstrates how Alvotech is able to leverage its end-to-end

Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio®Sales of Entyvio (vedolizumab) were about $5.4 billion globally in the last 12 months up to June 30, 2024Entyvio is indicated for the treatment of Ulcerative Colitis and Crohn's disease REYKJAVIK, Iceland, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab). The objective of the study is to

REYKJAVIK, Iceland, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announces its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. Members of the management team will hold an in-person fireside chat on September 5, 2024, starting at 5:35 pm EDT (21:35 GMT). A live audio webcast of the fireside chat will be available and can be accessed either during or after the event in the events section on Alvotech's investor website. A recording will also be archived and available for at least 90 days. About Alvotech Alvotec

Record Total Revenues of $236 million for the first six months of 2024, an over ten-fold increase compared to same period in 2023 Product revenues for the first six months were $66 million, a 190% increase from the same period last year, with Q2 product revenues contributing $53 million License and other revenues for the first six months increased to $170 million, with Q2 license and other revenues contributing $145 million Adjusted EBITDA in the first six months was $64 million, compared to negative ($147) million for the same period last year, with Q2 adjusted EBITDA contributing $102 million Achieved numerous development and perf

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REYKJAVIK, Iceland, Feb. 29, 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 Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer. Christina succeeds Sandra Casaca, who is leaving the company as a part of other organizational changes. Christina Siniscalchi has for over ten years served in senior quality positions for Alvogen and its manufacturing site in Norwich, NY, most recently as Alvogen's Chief Quality Officer. "We thank Sandra for her valuable contribution to Alvotech, as she successfully steered ou

Biodexa Pharmaceuticals PLC("Biodexa" or the "Company") Biodexa Appoints Ann Merchant to the Board of Directors CARDIFF, United Kingdom, Dec. 29, 2023 (GLOBE NEWSWIRE) – Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs including Type 1 diabetes and rare / orphan brain cancers, is pleased to announce the appointment of Ann Merchant to the Board of Directors of the Company as Non-executive Director with effect from 31 December 2023. Since 2018, Ann Merchant has served as Vice President for MorphoSys, and currently as Head of Global Supply Chain and Externa

REYKJAVIK, Iceland, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Sarah Tanksley will join its corporate leadership team as Chief Quality Officer, effective October 14. Ms. Tanksley succeeds Reem Malki, who is stepping down for personal reasons. "Sarah has been actively working with Alvotech as a consultant and we are very pleased that she will join our team in this new capacity," said Mark Levick, Chief Executive Officer of Alvotech. "Her familiarity with our operation facilitates a smooth transition and we are excited to benefit furt

Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-2) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification:

Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-1) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification:

Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-3) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification:

Submission status for ALVOTECH USA INC's drug SIMLANDI (SUPPL-3) with active ingredient ADALIMUMAB-RYVK has changed to 'Approval' on 08/26/2024. Application Category: BLA, Application Number: 761299, Application Classification:

Submission status for ALVOTECH USA INC's drug SIMLANDI (SUPPL-6) with active ingredient ADALIMUMAB-RYVK has changed to 'Approval' on 08/26/2024. Application Category: BLA, Application Number: 761299, Application Classification:

Submission status for ALVOTECH USA INC's drug SELARSDI (ORIG-1) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 04/16/2024. Application Category: BLA, Application Number: 761343, Application Classification:

Submission status for ALVOTECH USA INC's drug SIMLANDI (ORIG-1) with active ingredient ADALIMUMAB-RYVK has changed to 'Approval' on 02/23/2024. Application Category: BLA, Application Number: 761299, Application Classification:

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Total Revenues in the first nine months of 2024 increased by $300 million compared to same period in 2023, to $339 million, with Q3 revenues contributing $103 millionProduct revenues in the first nine months of 2024 increased over four-fold compared to the same period last year, to $128 million, with Q3 product revenues contributing $62 millionLicense and other revenues for the first nine months of 2024 increased by $203 from the same period last year, to $211 million, with Q3 license and other revenues contributing $41 millionAdjusted EBITDA was $87 million in the first nine months of 2024, compared to negative ($225) million for the same period last year, with Q3 adjusted EBITDA contributi

REYKJAVIK, Iceland, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first nine months of the year ended September 30, 2024, after U.S. markets close on Wednesday, November 13, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Thursday November 14, 2024, at 8:00 am ET (13:00 GMT).   Live audio of the conference call will also be webcast and available to members of the news media, investors, and the general public. Access information is posted on Alvotech's

Record Total Revenues of $236 million for the first six months of 2024, an over ten-fold increase compared to same period in 2023 Product revenues for the first six months were $66 million, a 190% increase from the same period last year, with Q2 product revenues contributing $53 million License and other revenues for the first six months increased to $170 million, with Q2 license and other revenues contributing $145 million Adjusted EBITDA in the first six months was $64 million, compared to negative ($147) million for the same period last year, with Q2 adjusted EBITDA contributing $102 million Achieved numerous development and perf

REYKJAVIK, Iceland, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first half of the year ended June 30, 2024, after U.S. markets close on Thursday, August 15, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Friday August 16, 2024, at 8:00 am EDT (12 noon GMT).   Live audio of the conference call will also be webcast and available to members of the news media, investors, and the general public.  Information on how to access the webcast or particip

Total revenues in Q1 2024 increased to $37 million compared to $16 million in the same period last year. Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year. Alvotech signed new commercialization agreements for its high concentration interchangeable biosimilar to Humira® in the U.S. and for its proposed biosimilar to Prolia® and Xgeva® in the U.S. and Europe. Alvotech raises topline revenue guidance to $400-$500 million and tightens guidance for bottom line range for 2024 to $100-$150 million. Management will conduct a business update conference call and live webcast on Wednesday May 22, 2024, at 8:00 am ET (12:00 pm GMT). REYKJAVIK, Ic

REYKJAVIK, Iceland, May 13, 2024 (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 quarter ended March 31, 2024, after U.S. markets close on Tuesday, May 21, 2024. Alvotech will also conduct a conference call with analysts to present the first quarter 2024 financial results and recent business highlights on Wednesday May 22, 2024, at 8:00 am EDT (12 noon GMT). Live audio of the conference call will be webcast and available to members of the news media, investors, and the general public. Information o

REYKJAVIK, Iceland, March 22, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO) (the "Company"), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, has increased the Company´s share capital by an amount of one hundred and thirty thousand (USD 130,000) by issuing thirteen million (13,000,000) ordinary shares. The Company's subsidiary, Alvotech Manco ehf. (the "subsidiary"), has subscribed to all of the newly issued shares for a price of USD 15.98 per share. The shares held by the subsidiary are treated as treasury shares without voting rights or dividend entitlement. Following the above-mentioned transactions, the subsidia

Total Revenues in 2023 were $93.4 million, up 10% from previous yearProduct Revenues in 2023 were $48.7 million, compared to $24.8 million in 2022, with Q4 2023 product revenues of $18.9 million, up by 37% from the same period last yearAlvotech's Simlandi™ biosimilar to Humira® (adalimumab) was approved in the U.S. as the first high-concentration biosimilar with interchangeable statusSales of Alvotech's Jamteki™ biosimilar to Stelara® (ustekinumab) started in Canada with launches expected in Japan in Q2 and Europe in Q3Positive top-line results were announced from a confirmatory efficacy study for Alvotech's proposed biosimilar to Eylea® (aflibercept) and PK studies for proposed biosimilars

REYKJAVIK, Iceland, March 05, 2024 (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 full year 2023, after U.S. markets close on Wednesday, March 20, 2024. Following the release, Alvotech will conduct a conference call for analysts on Thursday, March 21, 2024, at 8:00 am ET (12 noon GMT). Live audio of the conference call will be webcast and available to members of the news media, investors and the general public. Information on how to access the webcast or participate by conference call is posted on Alvotech'

Product revenue for the nine months of 2023 increased to $29.8 million, compared to $11.1 million for the same period in 2022Marketing authorization was received for AVT04 in Canada and Japan, the first for a biosimilar to Stelara® (ustekinumab)The European Medicines Agency proposed market authorization for AVT04 in the 30 member states of the European Economic Area, pending a final decision by the European Commission Approvability of AVT02 and AVT04 in the U.S. now pending satisfactory US Food and Drug Administration (FDA) inspection of Alvotech's facility in Iceland, currently expected on January 10 – 19, 2024Management will conduct a business update conference call and live webcast on Wed

Barclays analyst Balaji Prasad maintains Alvotech (NASDAQ:ALVO) with a Overweight and lowers the price target from $22 to $18.

 STADA and Alvotech have launched Uzpruvo®, the first approved biosimilar to Stelara® in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry. The pioneering launch comes immediately upon expiry of exclusivity rights linked to the European reference molecule patent, offering patients, physicians and payers expanded access at the earliest possible opportunity to a life-altering medicine used in certain indications within gastroenterology1, dermatology and rheumatology. Launches in further European countries are scheduled over the coming months, following national price app

Positive topline results demonstrate clinical similarity between AVT03 and the reference biologic, Prolia® (denosumab) Two additional studies comparing the pharmacokinetics, safety, and tolerability of AVT03 to Prolia and Xgeva, respectively, have also met their primary endpoint Alvotech expects to file marketing applications for AVT03 later this year for major global markets REYKJAVIK, Iceland, July 02, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory patient study for AVT03, a proposed biosimilar to Prolia® (den

Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced certain preliminary, unaudited key financial information for the second quarter and six months ended June 30, 2024, as follows:   Strong preliminary revenue growth with total revenues for the second quarter between $196 - $201 million. Preliminary total revenues for the first six months are $233 - $238 million, an approximately 10-fold increase compared to total revenues for the same period in 2023. Preliminary product revenues, from global sales of Alvotech's biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab), for th

Advanz Pharma secures rights to commercialize Alvotech's biosimilar candidate for Eylea® in Europe Advanz Pharma will leverage its existing specialty and hospital capabilities in Europe to ensure successful market registration, commercialization, and patient access

- SEC Filing

Under the terms of the agreement, Alvotech will be responsible for development and manufacturing at its state-of-the-art facility in Reykjavik, Iceland. STADA will become marketing authorization holder, upon approval of AVT03, and will assume semi-exclusive commercial rights in Europe, including Switzerland and the UK, as well as exclusive commercial rights in selected countries in Central Asia and the Middle East.

Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the successful arrangement of a strategic refinancing transaction. The financing, led by GoldenTree Asset Management, with participation from other institutional investors (collectively, the "Lenders"), will enable Alvotech (the "Company") to improve cost of capital, address upcoming debt maturities in 2025 and enhance its financial flexibility by adding incremental cash to the balance sheet.   With the transaction, Alvotech obtains financing from experienced healthcare investors who share the Company's confidence in its expected ne