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 ...

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, 2024 Entyvio is indicated for the treatment of Ulcerative Colitis and Crohn’s disease Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation o ...

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 ei ...

iQoncept Investment Overview - Recap on Alvotech My last coverage of Alvotech (NASDAQ:ALVO) for Seeking Alpha was back in April, a few weeks before the biosimilar medicine specialist announced its Q1 2024 earnings. I gave its stock a "Buy" rating, concluding that: if you are an investor looking to gain exposure to the biosimilar industry today, Alvotech represents one of your better options, in my view. It is cheaper to own a chunk of Alvotech than most other generic drug manufacturer's I can think of - Te ...

Alvotech (NASDAQ:ALVO) Q2 2024 Earnings Conference Call August 16, 2024 8:00 AM ET Company Participants Benedikt Stefansson - Senior Director, Investor Relations and Global Communications Robert Wessman - Founder, Chairman and Chief Executive Officer Anil Okay - Chief Commercial Officer Joel Morales - Chief Financial Officer Conference Call Participants Carl Byrnes - Northland Capital Markets Kirsty Ross Stewart - Citi Operator Good day, and thank you for standing by. Welcome to the Alvotech’s Q2 2024 Earni ...

Q2 2024 Earnings AUGUST 16, 2024 Disclaimer This presentation ("Presentation") does not contain or constitute an offer to sell, a solicitation of an offer to buy, or a recommendation to purchase any security of Alvotech (the "Company") to any person in the United States or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Any trademarks, servicemarks, trade names and copyrights of the Company and other companies contained in this Presentation are the property of their respectiv ...

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

Financial Performance - Product revenue for the six months ended June 30, 2024, was $65.9 million, a significant increase from $22.7 million for the same period in 2023[7]. - License and other revenue rose to $169.7 million for the six months ended June 30, 2024, compared to a loss of $2.5 million in the same period of 2023, driven by multiple R&D milestones[8]. - Operating profit for the six months ended June 30, 2024, was $43,447 thousand, a turnaround from an operating loss of $189,101 thousand in the prior year[28]. - The Group's revenue for the six months ended 30 June 2024 was $235.6 million, a significant increase from $20.3 million in the same period of 2023[53]. - Product revenue recognized in 2024 was $65.9 million, compared to $22.7 million in 2023, while license revenue surged to $68.1 million from $7.6 million[53]. - The total comprehensive loss for the six months ended June 30, 2024, was $153.4 million, reflecting the company's ongoing operational challenges[44]. Expenses and Losses - Research and development expenses decreased slightly to $97.5 million for the six months ended June 30, 2024, from $99.6 million in the same period of 2023[11]. - General and administrative expenses were reduced to $29.6 million for the six months ended June 30, 2024, down from $41.9 million in the same period of 2023[12]. - The net loss for the six months ended June 30, 2024, was $153.5 million, or $(0.61) per share, compared to a net loss of $86.6 million, or $(0.39) per share, for the same period in 2023[12]. - The company reported a loss for the period of $(153,504) thousand for the first half of 2024, compared to a loss of $(86,854) thousand in the same period of 2023[28]. - For the six months ended June 30, 2024, the company reported a net loss of $153.5 million, compared to a net loss of $86.9 million for the same period in 2023, reflecting an increase in losses of approximately 76.7%[44]. Cash and Borrowings - As of June 30, 2024, Alvotech had $10.9 million in cash and cash equivalents and borrowings of $1,055.9 million, including $999.0 million in current borrowings[7]. - The company entered into a $965 million Facility in June 2024 to improve capital costs and address upcoming debt maturities[17]. - The Group's total outstanding borrowings increased to $1,055,913 million as of June 30, 2024, compared to $960,159 million at the end of 2023, reflecting a 10% increase[83]. - Cash used in operating activities was $(126,000) thousand for the six months ended June 30, 2024, slightly improved from $(128,002) thousand in the same period of 2023[37]. - The company had cash and cash equivalents of $10.9 million as of June 30, 2024, with current assets less current liabilities amounting to ($917.3) million[44]. Assets and Equity - Total assets increased to $1,068,478 thousand as of June 30, 2024, up from $950,090 thousand at the end of 2023, reflecting a growth of approximately 12.4%[31]. - The total equity position improved to $(605,922) thousand as of June 30, 2024, compared to $(932,493) thousand at the end of 2023, indicating a reduction in accumulated deficit[34]. - The accumulated deficit reached $2,359.3 million, up from $2,205.8 million as of December 31, 2023, indicating ongoing financial challenges[44]. Share Issuance and Financing - Alvotech issued approximately 22.1 million new shares on July 1, 2024, corresponding to approximately $221.1 million from the conversion of 2022 Convertible Bonds[20]. - The company recognized a capital contribution of $144.6 million during the first half of 2024, contributing to its equity position[44]. - The Group issued approximately 22.1 million new shares from the conversion of 2022 Convertible Bonds, corresponding to an aggregate value of approximately $221.1 million[50]. Regulatory Approvals and Collaborations - Alvotech's AVT04 biosimilar to Stelara received FDA approval in April 2024, with commercialization expected to start on or after February 21, 2025[13]. - The company announced a collaboration with Dr. Reddy's Laboratories for the commercialization of AVT03, a biosimilar candidate to Prolia and Xgeva, with exclusive rights in the U.S.[45]. - The FDA also approved SIMLANDI, an interchangeable biosimilar to Humira, which had U.S. sales of nearly $12.2 billion in 2023[49]. Inventory and Costs - The Group's inventory balance increased to $96,574 million as of June 30, 2024, up from $74,433 million at the end of 2023, representing a 30% increase[77]. - The Group recognized $32.0 million in cost of inventory within cost of goods sold during H1 2024, compared to $16.5 million in H1 2023, indicating a 94% increase[76]. Financial Ratios and Tax - The effective tax rate for the six months ended 30 June 2024 was (3.5)%, compared to 36.5% in the same period of 2023, reflecting a tax charge and a tax benefit, respectively[60]. - The weighted-average interest rate of outstanding borrowings was 12.80% for H1 2024, slightly up from 12.73% for the twelve months ended 31 December 2023[82].

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 aud ...

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 au ...