Alvotech Reports First Half 2022 Financial Results

Alvotech (NASDAQ: ALVO), has reported financial results for the first half of 2022 and provided a summary of recent corporate highlights. The company also filed the interim financial statements with the Icelandic stock exchange for the first six months of 2022, in accordance with the Nasdaq First North rulebook.

As of June 30, 2022, the Company had $128.4 million in cash and cash equivalents. In addition, the Company had borrowings of $559.0 million, including $120.8 million of current portion of borrowings, as of June 30, 2022.

Revenue was $40.1 million for the six months ended June 30, 2022, compared to $2.0 million for the same six months of 2021. Revenue in the first six months ended June 30, 2022 consisted of $3.9 million of product revenue from the sales of AVT02 in select European countries and Canada, and $36.2 million of license and other revenue from the completion of the milestone related to the AVT04 main clinical program during the six months ended June 30, 2022.

Cost of product revenue was $17.8 million for the six months ended June 30, 2022. These costs were a result of the successful launch of AVT02 in select European countries and Canada during the six months ended June 30, 2022.

Research and Development (R&D) Expenses were $86.9 million for the six months ended June 30, 2022, compared to $90.4 million for the same six months of 2021. This decrease was primarily due to pre-commercial manufacturing costs that were previously recognized as research and development and are now recognized as cost of product revenue in conjunction with the Company’s first commercial launch.

General and Administrative (G&A) Expenses were $139.1 million for the six months ended June 30, 2022, compared to $86.4 million for the same six months of 2021. This increase was primarily due to the $83.4 million non-cash share listing expense and $21.0 million of transaction costs recognized as a result of the Business Combination. These expenses were offset by a $55.7 million decrease in expenses related to the long-term incentive plan.

Net loss was $184.5 million, or ($1.02) per share on a basic and diluted basis, for the six months ended June 30, 2022 as compared to net loss of $273.7 million, or ($2.77) on a basic and diluted basis, for the same six months of 2021.

Fur further information visit Alvotech's Newsroom.

Completed merger with Oaktree Acquisition Corp. II (OACB): Transaction included a fully committed and upsized $175 million PIPE raised through top-tier investors at $10.00 per share.

Listed on Nasdaq Stock Market in U.S.: Ordinary shares and warrants began trading under ticker symbols “ALVO” and “ALVOW”, respectively. Largest debut by an Icelandic company on a U.S. stock exchange.

Listed on First North Market in Iceland: First dual-listed Icelandic company on both a United States and Icelandic stock market.

Expanded and diversified Board of Directors: Four new members enhance independence and diversity of Board of Directors.

Announced plan to list on Icelandic Main Market: Board of Directors approved a plan to move share listing in Iceland from the First North Growth Market to the Nasdaq Main Market.

Launched ESG reporting portal: Provides further transparency to stakeholders with reporting on Environmental, Social and Governance indicators.

Received approval for AVT02 in Canada: Health Canada granted marketing authorization for AVT02 paving way for marketing in Canada.

Exclusive global licensing agreement with BiosanaPharma: Entered into an exclusive global licensing agreement with BiosanaPharma to co-develop AVT23, a proposed biosimilar to Xolair® (omalizumab).

Expanded partnership for Japanese market: Granted Fuji Pharma exclusive commercial rights to an undisclosed biosimilar currently in early phase development by Alvotech. The agreement brings the total number of proposed biosimilars with respect to which the company is partnering to six.

FDA Accepted BLA for AVT02 including biosimilarity and interchangeability: Alvotech is the only known company that has a high-concentration biosimilar candidate to Humira® that has completed a switching study, to support a proposed interchangeable designation for the high concentration adalimumab; goal date in December 2022

Resolved U.S. Patent and Trade Secret Disputes with AbbVie: Alvotech executed a U.S. settlement agreement with AbbVie that grants Alvotech non-exclusive rights to market AVT02 (100mg/mL), its high-concentration, citrate-free biosimilar candidate for Humira® (adalimumab) in the United States. The settlement grants Alvotech a license entry date in the United States of July 1, 2023.

Announced positive results from a PK similarity study for AVT04: Results demonstrate bioequivalence of AVT04 (ustekinumab) to the reference product, Stelara®.

Announced positive results from a clinical patient study for AVT04: Results demonstrate therapeutic equivalence between AVT04 (ustekinumab) and the reference product, Stelara®. Alvotech is the 2nd company to report positive topline results from a patient study for a proposed biosimilar to Stelara®.

Launched AVT02 with JAMP Pharma in Canada: Exclusive Canadian partner JAMP Pharma launched AVT02 (adalimumab) under tradename Simlandi™.

Launched AVT02 with STADA in Europe: Exclusive European partner STADA launched AVT02 (adalimumab) under tradename Hukyndra® in European markets.

Initiated patient study for AVT06: Confirmatory clinical study in patients for AVT06 (aflibercept), a biosimilar candidate to Eylea®.

Initiated Pharmacokinetics study for AVT03: Pharmacokinetic, safety and tolerability study in healthy subjects for AVT03 (denosumab), a biosimilar candidate to Prolia® and Xgeva®.

Initiated Patient Study for AVT03: Confirmatory clinical study in patients for AVT03 (denosumab), a biosimilar candidate for Prolia® and Xgeva®

About AVT02 (adalimumab)

AVT02 is a monoclonal antibody that is being evaluated for biosimilarity and interchangeability to Humira® (adalimumab), which inhibits tumor necrosis factor (TNF). AVT02 has been approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada. AVT02 dossiers are under review in multiple countries, including in the United States.

About AVT04 (ustekinumab)

AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). AVT04 was developed using an Sp2/0 host cell line and is manufactured using a continuous perfusion process. The Sp2/0 host cell line allows for more efficient sialyation of the molecule as compared to Chinese hamster ovary (CHO) cells and is the same type of host cell line used to produce Stelara®. Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. Abnormal regulation of these cytokines has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

About AVT03 (denosumab)

AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® and Xgeva® (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed.

About AVT06 (aflibercept)

AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability. AVT06 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

About AVT23 (omalizumab)

AVT23 is a proposed biosimilar to Xolair (omalizumab). Omalizumab is an antibody that targets free IgE; it is used to improve the control of severe persistent allergic asthma, for chronic (long-term) spontaneous urticaria (itchy rash) in patients with elevated IgE who do not respond to treatment with antihistamines and to treat nasal polyps in people 18 years of age and older when medicines to treat nasal polyps called nasal corticosteroids have not worked well enough. Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.