Alvotech and JAMP Pharma also announced that they have obtained market authorization in Canada for AVT04. This is the first Stelara biosimilar to gain market authorization in Canada, and the time when the approved biosimilar developed the exclusive commercialization partnership between Alvotech and JAMP Pharma.
Alvotech and STADA Arzneimittel announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for AVT04. This is the first positive opinion issued through the EMA for a Stelara biosimilar. The marketing authorization, which awaits final approval from the European Commission, would be valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway.
Alvotech announced that the US Food and Drug Administration (FDA) accepted a new Biologics License Application (BLA) for AVT02, with a Biosimilar User Fee Act (BsUFA) target date of 24 February 2024. Approval is pending further FDA inspection. of the Alvotech facilities, which will take place from January 10 to 19, 2024.
Alvotech resubmitted the BLA for AVT04, which was also accepted by the FDA, with a BsUFA target date set for April 16, 2024. Approval of AVT04 is also subject to acceptable final results from the expected reinspection of FDA facilities in January 2024. an agreement agreement with Johnson
Alvotech has signed an exclusive licensing agreement with Kashiv Biosciences for the development and commercialization of AVT23, a biosimilar candidate for Xolair® (omalizumab). Under the terms of the agreement, Kashiv will expand and manufacture the AVT23, while Alvotech will leverage its global presence. Partnerships and market expertise for commercialization. The initiation of a confirmatory patient through Kashiv has been announced, which will compare AVT23 and Xolair in terms of efficacy, safety, tolerability and immunogenicity.
Financial effects for the first months of 2023
Liquidity and Resources: As of September 30, 2023, the Company had cash and money equivalents of $68. 3 million, excluding $25. 2 million of limited cash. Additionally, the Company had loans of $912. 1 million, adding $13. 6 million of existing loans, as of September 30, 2023. December 30, 2023. In the third quarter of 2023, gross revenues of $140 million were obtained from of the personal placement of convertible bonds, adding the subscription of Teva Pharmaceutical for 40 million dollars in a separate debt transaction.
Product Profit: Product Profit $29. 8 million for the nine months ended September 30, 2023, compared to $11. 1 million for the same nine months in 2022. Revenue for the nine months ended September 30, 2023 September 30, 2023 included benefits from AVT02 sales in select European countries and Canada.
Licenses and other revenue: Licenses and other revenue were $8. 2 million for the nine months ended September 30, 2023, compared to $48. 1 million for the same nine months of 2022. The $39. 9 million reduction is primarily due to the popularity of a studio investment. of $34. 7 million and a progression milestone in the same period last year, due to the finishing touch of the major AVT04 clinical program. The rest of the reduction is basically due to the timing of progression milestones and licensing agreements.
Product Cost of Revenue: Product Profit Charge $104. 4 million for the nine months ended September 30, 2023, compared to $35. 4 million for the same nine months of 2022, due to the successful launch of AVT02 in certain European countries and Canada. The cost of product gain for the quarter is disproportionate to product profit due to the timing of new releases and prices similar to higher production, resulting in prices higher than the benefits identified for the period. The Company expects this date to normalize with increased production resulting from the scaling and expansion of new or recent releases. The Company believes that the expected increase in sales volumes will result in further absorption of constant production prices. Prior to the recognition of the product profit charge, prices similar to those of pre-commercial production activities were identified as R&D expenses.
Expenditure on Research and Development (R
General and Administrative Expenses: General and administrative expenses were $58. 6 million for the nine months ended September 30, 2023, compared to $156. 5 million for the same nine months of 2022. The minimization in general and administrative expenses was basically due to a non-monetary expense. $83. 4 million. Percentage board prices, $21. 0 million of transaction prices recorded as a result of the business combination and $10. 6 million of non-recurring intellectual asset legal fees incurred in the nine months ended September 30, 2022. This minimization was partially offset through a net accrual of $9. 3 million in other management overhead due to additional pricing similar to operating as a public corporation. Finally, the Company recorded $9. 4 million in general and administrative expenses for percentage-based payments, resulting from the allocation of limited percentage sets (RSUs) in the nine-month era ending September 30, 2023.
Financial source of revenue: The financial source of revenue amounted to $46. 4 million for the nine months ended September 30, 2023, compared to $97. 3 million for the corresponding nine months of 2022. The upgrade is basically due to a reduction in the fair cost of derivatives. financial liabilities, due to a drop in the value of Alvotech’s common stock.
Financial expenses: Financial expenses amounted to $107. 8 million for the nine months ended September 30, 2023, compared to $69. 2 million for the corresponding nine months of 2022. The accumulation is basically due to interest charged on new loans and convertible bonds issued in the ninth month of 2022. 2023.
Foreign Exchange Differences: Foreign exchange differences resulted in a gain of $0. 9 million for the nine months ended September 30, 2023, compared to a gain of $13. 6 million for the corresponding nine months of 2022. The minimization is basically due to the effect of the exchange rate on monetary assets and liabilities denominated in Icelandic krona and euros.
Income Tax Revenue Source: The income tax revenue source amounted to $67. 1 million for the nine months ended September 30, 2023, compared to $14. 8 million for the corresponding nine months of 2022. The accrual is primarily due to deferred tax credits of $27. 9 million corresponding to an accrual of operating losses and a favorable foreign exchange effect of $27. 6 million due to the strengthening of the Icelandic krona against the U. S. dollar, extending the U. S. dollar value of the expected carry-forward tax losses. to be used as opposed to long-term taxable gains.
Loss for the consistent period: Net loss of $275. 2 million, or ($1. 21) consistent with percentage consistent on a fundamental and diluted basis, for the nine months ended September 30, 2023, compared to a net loss of $193. 1 million, or ($1. 00) consistent with consistent with percentage on a fundamental and diluted basis. on a fundamental, diluted basis, for the same nine months of 2022.
Activity Update Conference Call
Alvotech will host a telephone convention to provide an update on its activities and a webcast on Wednesday, November 29 at 8:00 a. m. m. ET (13:00 GMT).
A live webcast of the call will be held on Alvotech’s online page in the Investors segment of the Company’s online page (https://investors. alvotech. com) under “News & Events – Events & Presentations”, where you will also be able to locate a replay of the webcast, after the call for 90 days.
About AVT02 (adalimumab) AVT02 is a monoclonal antibody that has been approved as a biosimilar to Humira® (adalimumab) in several countries around the world, the 27 member states of the European Union, Norway, Lichtenstein, Iceland, the United Kingdom, Switzerland, Canada. , Australia, Egypt and Saudi Arabia. Lately it has been advertised in several European countries and Canada. Cases are also being tested in several countries around the world.
About AVT04 (ustekinumab) AVT04 is a monoclonal antibody and a biosimilar to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses [1]. AVT04 has obtained marketing authorization in Japan and Canada and has been proposed for approval through the Authority European Medicines Council. Cases are also being tested in several countries around the world.
About AVT23 (omalizumab) AVT23 is a proposed biosimilar to Xolair® (omalizumab). Omalizumab is a humanized monoclonal antibody that targets loose IgE, thereby reducing the amount of loose IgE needed to trigger the allergic cascade [2]. AVT23 is an investigational compound and has not obtained regulatory approval in any country. Biosimilarity has not been established through regulatory governance and is not asserted.
[1] https://www. janssenlabels. com/package-insert/product-monograph/prescribe-information/STELARA-pi. pdf[2] https://www. ema. europa. eu/en/documents/product -information/xolair-epar-product-information_fr. pdf
Humira is a registered trademark of AbbVie Inc. Stelara is a registered trademark of Johnson
About Alvotech Alvotech is a biotechnology company founded by Robert Wessman and focused solely on the progression and production of biosimilar medicines for patients worldwide. Alvotech seeks to become a global leader in biosimilars by offering high-quality, cost-effective products and services, made possible through fully incorporated technology and extensive in-house capabilities. Alvotech’s current portfolio comprises eight biosimilar applicants for the treatment of autoimmune diseases, ocular disorders, osteoporosis, respiratory diseases and cancer. Alvotech has formed a network of strategic business partnerships to deliver global success and leverage local expertise in markets such as the United States, Europe, Japan, China and other Asian countries and major parts of South America, Africa and the Middle East. Alvotech’s commercial components are Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (USA), STADA Arzneimittel AG (EU), Fuji Pharma Co. , Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia). and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co. , Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co. , Ltd. (Thailand, Vietnam, Philippines and South Korea). Each business component covers a unique set of products and territories. Unless otherwise indicated, Alvotech disclaims all responsibility for the content of periodic documents, disclosures and other reports made through its components. For more information, visit www. alvotech. com. None of the data on Alvotech’s online page will be considered part of this press release.
Forward-Looking Statements Certain statements contained in this release may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements sometimes relate to long-term events or Alvotech’s long-term operational monetary functionality and could include, for example, Alvotech’s expectations related to competitive advantages, business customers and opportunities, including current product progression. Developing. plans and intentions, effects, point of activities, functionality, objectives or achievements or other long-term events, regulatory filings, reviews and intermovements, adding resubmission of BLAs for AVT02 and AVT04, possible re-inspection of Alvotech production facilities, responses acceptable to FDA Inspection results and resolution of other deficiencies are submitted after inspection of Alvotech’s production site, potential approval and publication of advertisements by applicants for its products, the time of regulatory approval, the addition of AVT04 and market position statements. In some cases, you can identify forward-looking statements by terms such as “possibly”, “would”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”. “forward-looking”, “target” or “continue”, or the negative terminology of those terms or their diversifications or similar terminology. These forward-looking statements are subject to risks, uncertainties and other matters that may also cause actual effects to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based on estimates and assumptions that, while considered conservative by Alvotech and its management, are inherently doubtful and are inherently subject to hazards, variations and unforeseen events, many of which are beyond the control of Alvotech. They may also cause actual effects to differ materially from existing expectations including, but not limited to: (1) the ultimate results of any legal proceedings that would possibly be brought against Alvotech or others as a result of the business combination . corporations between Alvotech Holdings S. A. and Oaktree Acquisition Corp. II and Alvotech; (2) the ability to raise significant additional funds that may not be available under the right conditions or at all; (3) the ability to maintain stock exchange board standards; (4) adjustments in applicable legislation or regulations; (5) the possibility that Alvotech may have adverse effects through other economic, commercial and/or competitive aspects; (6) Alvotech’s earnings and expense estimates; (7) Alvotech’s ability to develop, manufacture and advertise the products and product applicants in its portfolio; (8) moves by regulatory authorities, which would likely have effects on the initiation, timing and progress of clinical studies or long-term regulatory approvals or market positioning authorizations; (9) the ability of Alvotech or its partners to respond to inspection findings and deficiencies to the satisfaction of regulators; (10) the ability of Alvotech or its partners to recruit and retain patients in clinical studies; (11) the ability of Alvotech or its partners to obtain regulatory approval for planned clinical studies, designs or examination sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and future long-term clinical studies, which would potentially have an effect on timelines and progression plans; (13) Alvotech’s ability to discharge and maintain regulatory approval or clearances for its products, including the timing or likelihood of expansion into other market positions or geographies; (14) the good fortune of Alvotech’s existing and long-term collaborations, joint ventures, partnerships or licensing agreements; (15) the ability of Alvotech and its business partners to execute their advertising strategy for approved products; (16) Alvotech’s ability to manufacture a sufficient advertising source for its approved products; (17) the final results of pending and long-standing litigation relating to Alvotech’s products and product applicants; (18) the potential impact of the ongoing COVID-19 pandemic on FDA review schedules, including its ability to conduct timely inspections of production sites; (19) the effect of deteriorating macroeconomic conditions, adding inflation and emerging interest rates and general market position conditions, the war in Ukraine and global geopolitical tensions, as well as the ongoing COVID -19 pandemic and evolving in the Company’s monetary operations. condition, strategy and planned milestones. ; and (20) other dangers and concerns set forth in the sections titled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may file with or provide from time to time to the SEC. There may be other dangers that Alvotech is not aware of or that Alvotech considers insignificant and that could also cause actual effects to differ from those contained in the forward-looking statements. Nothing in this communication should be construed as a representation by any user that the forward-looking statements set forth herein will be achieved or that any of the intended effects of such forward-looking statements will be achieved. You deserve not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech assumes no legal responsibility to update such forward-looking statements or to inform the recipient of any matter of which any of them is aware that may also have an effect on any matter discussed in this communication. Alvotech assumes no liability for any loss or damage (whether foreseeable or otherwise) suffered or incurred by any user or entity as a result of anything contained in or overlooked in this communication and such liability is expressly disclaimed. Recipient agrees not to sue or hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors or representatives liable in any respect for the provision of this communication, the data contained in this communication or the omission of any data in this communication.
CONTACTS
Alvotech Global Investor Relations & Communications Benedikt Stefansson alvotech. ir@alvotech. com
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