(MENAFN- GlobeNewsWire – Nasdaq) Revenue for the first nine months of 2022 increased to $59. 2 million, to $2. 0 million for the same era in 2021. Talks with the U. S. FDA U. S. advances on the two biological licensing programs for AVT02 (adalimumab); with the goal of launching in the United States, if approved, on July 1, 2023; Additional regulatory approvals granted in key markets Pipeline progress continues with the unveiling of marketing programs for Tellara’s® AVT04 biosimilar candidate in key markets, adding U. S. to the U. S. U. S. and EU at 8:00 a. m. ET (1:00 p. m. GMT)
REYKJAVIK, Iceland, Nov. 16, 2022 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO, or the “Company”), a global biotechnology company focused on developing and producing biosimilars for patients worldwide, announced unaudited monetary effects for the first nine months of 2022 and provided a summary of the company’s recent highlights.
“The filing of new regulatory applications, approvals and expanded advertising partnerships demonstrate the forged progress of our strategy and our continued commitment to our vision for the biosimilars market,” said Alvotech Founder and CEO Robert Wessman. “We are collaborating with the FDA for notable issues related to the prestige of production site inspection and pre-assembly our July 1, 2023 release date for our proposed biosimilar for Humira® in the U. S. In the USA, with the prospect of being the first interchangeable biosimilar of high concentration.
Pipeline and Partnership Highlights
Presentation of AVT02 change examination data at the 2022 American College of Rheumatology conference. We included replacement examination effects, demonstrating the bioequivalence of repeated adjustments between Humira and AVT02 treatment with unreplaced Humira®® treatment. in Alvotech’s interplaceable biologics license application, which was accepted for submission through the FDA in February 2022.
provided an update on the initial AVT02 biological license application: Alvotech won a September 2022 communication from the U. S. Food and Drug Administration. The U. S. Food and Drug Administration (FDA) noted some deficiencies similar to the March 2022 inspection of Alvotech’s production facility in Reykjavik, Iceland, and stated that an acceptable solution is required of the deficiency before the FDA can approve this BLA. Alvotech has complex discussions with the FDA on notable issues.
Expanded Exclusive Partnership with JAMP Pharma: Alvotech has expanded its exclusive partnership with JAMP Pharma covering the Canadian market to commercialize biosimilars developed and manufactured through Alvotech, adding two biosimilars applicants from Alvotech’s pipeline: AVT16, a biosimilar for an immune product, and AVT33, a biosimilar for an oncology product.
Submission of a marketing authorization application for the first biosimilar candidate in Japan: Alvotech’s marketing partner, Fuji Pharma Co. , Ltd. , has filed an application with the Japanese Ministry of Health, Labor and Welfare for marketing authorization of AVT04, a biosimilar of Stelara ® (ustekinumab), evolved the companies’ exclusive marketing partnership.
Increased access to adalimumab for patients in Switzerland: Alvotech and STADA announced the launch of Hukyndra® (adalimumab), a biosimilar from Humira® in Switzerland. Hukyndra® has already been introduced in several European markets. STADA launches in each country with adapted educational fabrics as well as committed patient programs.
Obtained approval for Ciptunec and Aralicip (adalimumab) in Australia: Alvotech’s marketing partner, Cipla Limited’s wholly-owned subsidiary, Cipla Limited Australia, received marketing authorization in Australia for Alvotech’s AVT02 (adalimumab) biosimilar for Humira, the so-called Ciptunec™™/Aralicip™™. ®
Approval received for Simlandi (adalimumab) in Saudi Arabia: Alvotech’s biosimilar AVT02 (adalimumab) in Humira® obtained marketing authorization in Saudi Arabia under the name Simlandi™ (adalimumab). Alvotech’s exclusive marketing partner in Saudi Arabia is YAS Holding LLC and its One Hundred Percent Bioventure Subsidiary.
Company Highlights
Appoints Sarah Tanksley Chief Quality Officer: Alvotech appointed Sarah Tanksley Chief Quality Officer effective October 14, 2022. Mrs. Tanksley has 20 years of experience at the U. S. National Institutes of Health (NIH). The U. S. Food and Drug Administration (FDA) is in the U. S. Department of Agriculture. U. S. Department of Health (FDA) and as an industry consultant.
Financial effects for the first months of 2022
Treasury
As of September 30, 2022, the Company had money and cash equivalents of $12. 8 million. In addition, the Company had loans of $518. 6 million, totaling $75. 0 million in existing loans, as of September 30, 2022.
Revenue $59. 2 million for the nine months ended September 30, 2022, compared to $2. 0 million for the same nine months of 2021. European countries and Canada, and $48. 1 million in licensing and other milestone bill revenue similar to the AVT04 main clinical program and the AVT05 clinical trial application.
Product Cost
The cost of product earnings was $35. 4 million for the nine months ended September 30, 2022. These prices are basically the result of the successful launch of AVT02 in selected European countries and Canada for the nine months ending September 30, 2022. These prices included variable prices and constant production expenses related to the production of advertising, resulting in prices exceeding the profits identified for the period. The Company expects this to normalize as it scales and expands new and existing product launches, resulting in greater absorption of consistent production prices. Before the popularity of profit collection, these prices were recorded as study expenses and progression as a pre-advertising production activity.
Research and expenditure (R
R expenses
General and administrative expenses (G
General and administrative expenses were $156. 5 million for the nine months ended September 30, 2022, compared to $106. 3 million for the same nine months of 2021. The increase in general and administrative expenses is primarily due to the non-cash percentage of registration fees of $83. 4 million. and an accumulation of $16. 2 million in transaction prices recorded as a result of the business mix with Oaktree Acquisition Corp. II in June 2022 and the directory application procedure on Iceland’s Nasdaq Main Market. These expenses were partially offset through a minimum of $55. 4 million in long-term incentive plan expenses.
Financial products
Financial source of revenue $97. 3 million for the nine months ended September 30, 2022. This is basically due to a reduction in the fair cost of derivative monetary liabilities, as a result of a reduction in the value of Alvotech’s common stock.
Financial charges
Financial expenses were $69. 2 million for the nine months ended Sept. 30, 2022, compared to $157. 4 million for the same nine months of 2021. The reduction in finance expenses is basically due to the extinction of convertible bonds and shareholder loans for the year ended December 31, 2021. Derivative liabilities related to convertible bonds and loans resulted in finance fees of $72. 0 million recorded in the nine months ended September 30, 2021, due to fair value substitution. Interest expense of $31. 8 million was recorded on convertible shareholder loans for nine months ended September 30, 2021. Similar decreases to extinguished liabilities were partially offset by $7. 4 million recorded fees for the special put option and consent fees paid to bondholders, and a $6. 5 million loss on the revaluation of the bonds for the nine months ended September 30, 2022.
Exchange differences
The exchange differences resulted in a gain of $13. 6 million for the nine months ended September 30, 2022, compared to a gain of $3. 2 million for the same nine months of 2021. The accumulation is basically due to the exchange rate effect of monetary assets and liabilities denominated in Icelandic kroner.
Gain from extinction of monetary liabilities
Alvotech identified a monetary liability extinguishment gain of $17. 8 million in the nine months ended September 30, 2022, to a gain of $2. 6 million for the same nine months of 2021. The gain recognized in 2022 relates to the arrangement of loans between like-minded parties with shares, while the amount in 2021 relates to the very broad modification of the terms and conditions of convertible bonds and other similar concomitant operations.
Tax benefit
Income tax savings were $14. 8 million for the nine months ended Sept. 30, 2022, compared to $48. 0 million for the same nine months of 2021. The reduction is basically explained through a $15. 8 million reduction in the net operating loss tax credit, for which Alvotech expects to pay in full against long-term taxable profits, and a foreign exchange effect of $17. 3 million due to the weakening of the Icelandic krona against the U. S. dollar, which reduced the U. S. dollar price of deferred tax losses to be used on taxable profits. long-term.
Net loss Net loss of $193. 1 million, or ($1. 00) consistent with a percentage consistent on a fundamental, diluted basis, for the nine months ended September 30, 2022, compared to a net loss of $355. 3 million, or ($3. 48) consistent with a percentage consistent on a fundamental, diluted basis, for the same nine months of 2021.
Business Update Conference Call
Alvotech will host a convention call and webcast on industry updates on Wednesday, November 16 at 8:00 a. m. m. ET (1:00 p. m. GMT).
There will be a live webcast of the call on Alvotech’s online page in the Investors segment of the Company’s online page at News and Events – Events and Presentations, where you can also find a replay of the webcast, following the 90-day call. .
To participate in the convention call, log in advance to the link on Alvotech’s online investor relations page at News & Events – Events & Presentations, to download a local or toll-free phone number and your private PIN.
About AVT02 (adalimumab) AVT02 is a monoclonal antibody whose biosimilarity and interchangeability with Humira® (adalimumab), which inhibits tumor necrosis factor (TNF), is being evaluated in the EU, Norway, Iceland, Liechtenstein, United States. United Kingdom and Switzerland (Hukyndra®); Canada and Saudi Arabia (Simlandi®); and Australia (Ciptunec™ and Aralicip™). AVT02 instances are under review in several countries, including the United States.
About AVT04 (ustekinumab) AVT04 is a monoclonal antibody and biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, involved in inflammatory and immune responses. Abnormal regulation of these cytokines has been linked to immune-mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. AVT04 is a research product and has obtained regulatory approval in any country. Biosimilarity has been established through regulatory governance and is claimed.
About Alvotech Alvotech is a biotechnology company, founded through Robert Wessman, whose goal is to develop and produce biosimilar medicines for patients around the world. Alvotech seeks to be a global leader in the area of biosimilars by offering high-quality, cost-effective products and facilities enabled through fully incorporated technique and extensive in-house capabilities. Alvotech’s existing pipeline comprises 8 applicants for biosimilars for the treatment of autoimmune disorders, 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 including the United States, Europe, Japan, China and other Asian countries and major parts of South America, Africa and the Middle East. Alvotech’s trading components are Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (USA), STADA Arzneimittel AG (EU), Fuji Pharma Co. , Ltd (Japan), 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, Tutor 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. Except as otherwise provided herein, Alvotech is not responsible for the content of periodic filings, disclosures and other reports made to be obtained through its components. For more information, stop by Array None of the data on Alvotech’s online page deserves to be considered as part of this press release.
Forward-Looking Statements Certain statements 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 financial or operating performance and may include, for example, Alvotech’s expectations regarding long-term growth, effects of operations, functionality, long-term investments and other expenses, adding progression of infrastructure critical to global healthcare market position, competitive advantages, business customers and opportunities, adding continued product progression, long-term plans and intentions, effects, point of activities, functionality, goals or achievements or other long-term occasions, reinspection of Alvotech’s production site, prospective approval, addition of AVT02 and AVT04 through the FDA and other regulatory agencies and release of announcements from its product applicants, time of announcement of the effects of clinical examination, graduation of patient studies authorities, regulatory applications, market position approvals and releases, and the estimated total coupled addressable market position for Alvotech’s peline products. In some cases, you can identify forward-looking statements through words such as “possibly”, “deserve”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict” , “prospective” or “continuing”, or the negative terms of those terms or diversifications thereof or similar terminology. These forward-looking statements are subject to risks, uncertainties, and other aspects that may also cause actual effects to differ materially from those expressed or implied in such forward-looking statements. These forward-looking statements are based on estimates and assumptions that, while believed by Alvotech and its management to be conservative, are inherently uncertain and inherently related to hazards, variskills and contingencies, many of which are beyond Alvotech’s control. Alvotech. Factors that may also cause actual effects to differ materially from existing expectations include, but are not limited to: (1) the final results of any legal proceedings that could possibly be brought against Alvotech or others as a result of the combination between Alvotech Holdings S. A. , Oaktree Acquisition Corp. II and Alvotech; (2) the ability to raise really large additional funds, which might not be obtained on proper terms or at all; (3) the ability to maintain inventory exchange directory criteria or meet directory needs on the Nasdaq core market in Iceland; (4) adjustments in applicable legislation or regulations; (5) the option that Alvotech may be adversely affected by other economic, commercial and/or competitive reasons; (6) Estimates of Alvotech’s expenses and earning capacity; (7) Alvotech’s ability to develop, manufacture and market the products and product applicants in its portfolio; (8) movements by regulatory authorities, which could possibly initiate, schedule and progress clinical studies or long-term regulatory approvals or market positioning authorizations; (9) the ability of Alvotech or its partners to recruit and retain patients in clinical studies; (10) the ability of Alvotech or its partners to download regulatory approvals for planned clinical studies, test plans or sites; (11) the ability of Alvotech’s partners to conduct, supervise and monitor existing and prospective long-term clinical studies, which would potentially have an effect on progression programs and plans; (12) Alvotech’s ability to download and maintain regulatory approvals or authorizations for its products, adding the timing or likelihood of expansion into more market positions or geographies; (13) the good fortune of Alvotech’s existing and long-term collaborations, joint ventures, partnerships, or license agreements; (14) Alvotech’s ability, and that of its business partners, to execute its advertising strategy for approved products; (15) Alvotech’s ability to make a sufficient source of publicity for its approved products; (16) the final results of pending and long-term litigation related to Alvotech’s products and product applicants; (17) the potential impact of the ongoing COVID-19 pandemic on FDA review timelines, adding to its ability to conduct timely inspections of production sites; (18) have an effect on deteriorating macroeconomic conditions, the addition of emerging inflation and interest rates and general market position conditions, the war in Ukraine and global geopolitical tensions, as well as the pandemic of COVID -19 ongoing and evolving in the Company’s business, monetary condition, strategy and expected milestones; and (19) other dangers and uncertainties set forth in the sections entitled “Risk Factors” and “Caution Regarding Forward-Looking Statements” in documents that Alvotech may file from time to time with the SEC. There may be additional hazards that Alvotech is unaware of or that Alvotech believes are irrelevant and may also cause actual effects to differ from those contained in forward-looking statements. Nothing in this communication should be taken as a representation that the forward-looking statements set forth herein will be known or that any of the effects considered through 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 does not assume any legal responsibility to update such forward-looking statements or to notify the recipient of any matter of which it becomes aware that may be any matter referenced in this communication. Alvotech disclaims all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any user or entity as a result of anything contained or overlooked in this communication and such liability is expressly disclaimed. Recipient agrees not to seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, consultants or representatives liable for the provision of this communication, the data contained in this communication, or the omission of any data of this communication.
CONTACTS Alvotech Investor relations and global communication Benedikt Stefansson, alvotech. ir[at]alvotech. com
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