Alvotech Reports Financial Results for Full Year 2022 and Provides Business Update
Alvotech reported a 114% increase in total revenue for the full year 2022, reaching $85.0 million compared to $39.7 million in 2021. The growth was driven by milestone and product revenue from the commercialization of AVT02, a biosimilar to Humira®, across 17 countries. The company advanced three biosimilar candidates into clinical development and submitted marketing applications for AVT04, a proposed biosimilar to Stelara®. Despite the revenue growth, Alvotech reported a net loss of $513.6 million. The FDA has set an action date of April 13, 2023, for AVT02's licensing application, and a reinspection of the Reykjavik manufacturing site is scheduled for March 6, 2023.
- Total revenue increased by 114% to $85.0 million in 2022.
- Successful commercialization of AVT02 in 17 countries.
- Three biosimilar candidates advanced into clinical development.
- Net loss of $513.6 million for 2022, up from $101.5 million in 2021.
- General and administrative expenses surged to $186.7 million, driven by non-cash share listing expenses.
- Full year 2022 total revenue, including other income, increased by
114% to$85.0 million , compared to$39.7 million in 2021, driven by both milestone revenue and product revenue from commercialization of AVT02, a biosimilar to Humira®, in 17 countries - Three biosimilar candidates, AVT03 (Prolia®/Xgeva®), AVT06 (Eylea®) and AVT05 (Simponi®/Simponi Aria®), advanced into clinical development in 2022
- Marketing applications for AVT04, a proposed biosimilar to Stelara®, were submitted in major markets including the U.S. and Europe
- U.S. Food and Drug Administration (FDA) confirmed a new goal date for AVT02 Biologics License Application (BLA) of April 13, 2023, and is expected to commence a reinspection of the Reykjavik manufacturing site on March 6, 2023
- Management will conduct a business update conference call and live webcast on Thursday, March 2, 2023, at 8:00 am ET (13:00 pm GMT)
REYKJAVIK, Iceland, March 01, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported financial results for full year 2022 and provided a summary of recent corporate highlights.
"Alvotech made significant progress in 2022. We were publicly listed, achieved a remarkable
Recent Highlights
In December 2022, Alvotech announced that the FDA has confirmed that the goal date for Alvotech’s original BLA for AVT02 as biosimilar to high-concentration Humira® is April 13, 2023, and that the FDA has completed its review of Alvotech’s BLA of AVT02 as an interchangeable to high-concentration Humira. Approval requires satisfactory outcome of an upcoming FDA reinspection of Alvotech’s facility in Reykjavik, Iceland, that is scheduled to start on March 6, 2023. In January 2023, Alvotech hosted a general Good Manufacturing Practice (GMP) inspection by EMA (European Medicines Agency) that resulted in a GMP recertification of the company’s manufacturing facility for European markets. This is the fourth successful inspection by EMA since 2018.
In January 2023, Alvotech announced that the FDA has accepted for review a BLA and the European Medicines Authority (EMA) has accepted for review a marketing authorization application for AVT04, a proposed biosimilar to Stelara® (ustekinumab). Three other biosimilar candidates, AVT03 (a proposed biosimilar for Prolia®/Xgeva®), AVT06 (a proposed biosimilar for Eylea®) and AVT05 (a proposed biosimilar for Simponi®/Simponi Aria®), advanced into clinical studies in 2022.
In February 2023, Alvotech announced the completion of a private share placement for aggregate gross proceeds of approximately
Financial Results for Full Year 2022
Cash position and sources of liquidity
As of December 31, 2022, the Company had cash and cash equivalents of
Revenue
Revenue, including other income, was
Cost of product revenue
Cost of product revenues was
Research and development (R&D) expenses
R&D expenses were
General and administrative (G&A) expenses
G&A expenses were
Finance income
Finance income was
Finance costs
Finance costs were
Exchange rate differences
Exchange rate differences resulted in a gain of
Loss / Gain on extinguishment of financial liabilities
Alvotech recognized a loss on extinguishment of financial liabilities of
Income tax benefit
Income tax benefit was
Net Loss
Net loss was
Business Update Conference Call
Alvotech will conduct a business update conference call and live webcast on Thursday, March 2, 2023, at 8:00 am ET (1:00 pm GMT). A live webcast of the call will be available on Alvotech’s website in the Investors Section of the Company’s website under News and Events – Events and Presentations, where you will also be able to find a replay of the webcast, following the call for 90 days. In order to participate in the conference call, please register in advance using the link on Alvotech’s Investor Relations website under News and Events – Events and Presentations, to obtain a local or toll-free phone number and your personal pin.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU/EEA, UK, Switzerland), 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, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial or operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding capitalization through equity or debt financing, future growth, results of operations, performance, including cost of product revenue, future capital and other expenditures, competitive advantages, partnerships, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, the re-inspection of Alvotech’s manufacturing site, the potential approval, including for AVT02 and AVT04 by the FDA, the EMA and other regulatory agencies and commercial launch of its product candidates, the timing of the announcement of clinical study results, the commencement of patient studies, regulatory applications, and completion of regulatory review, regulatory approvals and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against Alvotech or others following the business combination between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (9) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (10) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (11) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (12) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (13) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (14) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (15) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (16) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Company’s business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise 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 information contained in this communication, or the omission of any information from this communication.
CONTACTS
Alvotech Investor Relations and Global Communication
Benedikt Stefansson, Director
alvotech.ir[at]alvotech.com
Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss for the years ended 31 December 2022, 2021 and 2020 | ||||||
2022 | 2021 | 2020 | ||||
USD in thousands | ||||||
Product revenue ..................................................................................................... | 24,836 | - | - | |||
License and other revenue ..................................................................................... | 58,193 | 36,772 | 66,616 | |||
Other income .......................................................................................................... | 1,988 | 2,912 | 2,833 | |||
Cost of product revenue ........................................................................................ | (64,095) | - | - | |||
Research and development expenses .................................................................... | (180,622) | (191,006) | (148,072) | |||
General and administrative expenses ................................................................... | (186,742) | (84,134) | (58,914) | |||
Operating loss | (346,442) | (235,456) | (137,537) | |||
Share of net loss of joint venture .......................................................................... | (2,590) | (2,418) | (1,505) | |||
Finance income ....................................................................................................... | 2,549 | 51,568 | 5,608 | |||
Finance costs ........................................................................................................... | (188,419) | (117,361) | (161,551) | |||
Exchange rate difference ....................................................................................... | 10,566 | 2,681 | 3,215 | |||
(Loss) / gain on extinguishment of financial liabilities ....................................... | (27,311) | 151,788 | - | |||
Non-operating (loss) / profit | (205,205) | 86,258 | (154,233) | |||
Loss before taxes | (551,647) | (149,198) | (291,770) | |||
Income tax benefit ................................................................................................. | 38,067 | 47,694 | 121,726 | |||
Loss for the year | (513,580) | (101,504) | (170,044) | |||
Other comprehensive income / (loss) | ||||||
Item that will be reclassified to profit or loss in subsequent periods: | ||||||
Exchange rate differences on translation of foreign operations ........................ | (6,111) | (305) | 5,954 | |||
Total comprehensive loss | (519,691) | (101,809) | (164,090) | |||
Loss per share | ||||||
Basic and diluted loss for the period per share .................................................... | (2.60) | (0.92) | (1.82) |
Consolidated Statements of Financial Position as of 31 December 2022 and 2021 | |||||||
USD in thousands | 31 December 2022 | 31 December 2021 | |||||
Non-current assets | |||||||
Property, plant and equipment ....................................................................................... | 220,594 | 78,530 | |||||
Right-of-use assets ........................................................................................................... | 47,501 | 126,801 | |||||
Goodwill ........................................................................................................................... | 11,643 | 12,367 | |||||
Other intangible assets .................................................................................................... | 25,652 | 21,509 | |||||
Contract assets ................................................................................................................. | 3,286 | 1,479 | |||||
Investments in joint venture ........................................................................................... | 48,568 | 55,307 | |||||
Other long-term assets .................................................................................................... | 5,780 | 1,663 | |||||
Restricted cash ................................................................................................................. | 25,187 | 10,087 | |||||
Deferred tax assets .......................................................................................................... | 209,496 | 170,418 | |||||
Total non-current assets | 597,707 | 478,161 | |||||
Current assets | |||||||
Inventories ....................................................................................................................... | 71,470 | 39,058 | |||||
Trade receivables ............................................................................................................. | 32,972 | 29,396 | |||||
Contract assets ................................................................................................................. | 25,370 | 17,959 | |||||
Other current assets ........................................................................................................ | 32,949 | 14,736 | |||||
Receivables from related parties ..................................................................................... | 1,548 | 1,111 | |||||
Cash and cash equivalents .............................................................................................. | 66,427 | 17,556 | |||||
Total current assets | 230,736 | 119,816 | |||||
Total assets | 828,443 | 597,977 |
Consolidated Statements of Financial Position as of 31 December 2022 and 2021 | |||
USD in thousands | 31 December 2022 | 31 December 2021 | |
Equity | |||
Share capital ..................................................................................................................... | 2,126 | 135 | |
Share premium ................................................................................................................. | 1,058,432 | 1,000,118 | |
Other reserves .................................................................................................................. | 30,582 | - | |
Translation reserve .......................................................................................................... | (1,442) | 4,669 | |
Accumulated deficit ......................................................................................................... | (1,654,114) | (1,140,534) | |
Total equity | (564,416) | (135,612) | |
Non-current liabilities | |||
Borrowings ....................................................................................................................... | 744,654 | 398,140 | |
Derivative financial liabilities .......................................................................................... | 380,232 | - | |
Other long-term liability to related party ....................................................................... | 7,440 | 7,440 | |
Lease liabilities ................................................................................................................. | 35,369 | 114,845 | |
Long-term incentive plan ................................................................................................ | 544 | 56,334 | |
Contract liabilities ............................................................................................................ | 57,017 | 44,844 | |
Deferred tax liability ........................................................................................................ | 309 | 150 | |
Total non-current liabilities | 1,225,565 | 621,753 | |
Current liabilities | |||
Trade and other payables ................................................................................................ | 49,188 | 28,587 | |
Lease liabilities ................................................................................................................. | 5,163 | 7,295 | |
Current maturities of borrowings .................................................................................. | 19,916 | 2,771 | |
Liabilities to related parties ............................................................................................. | 1,131 | 638 | |
Contract liabilities ............................................................................................................ | 36,915 | 29,692 | |
Taxes payable ................................................................................................................... | 934 | 841 | |
Other current liabilities ................................................................................................... | 54,047 | 42,012 | |
Total current liabilities | 167,294 | 111,836 | |
Total liabilities | 1,392,859 | 733,589 | |
Total equity and liabilities | 828,443 | 597,977 |
Consolidated Statements of Cash Flows for the years ended 31 December 2022, 2021 and 2020 | |||||
2022 | 2021 | 2020 | |||
USD in thousands | |||||
Cash flows from operating activities | |||||
Loss for the year ..................................................................................................... | (513,580) | (101,504) | (170,044) | ||
Adjustments for non-cash items: | |||||
Gain on extinguishment of SARs liability ............................................................ | (4,803) | - | - | ||
Share listing expense .............................................................................................. | 83,411 | - | - | ||
Long-term incentive plan expense ........................................................................ | 5,492 | 17,955 | 18,053 | ||
Depreciation and amortization ............................................................................. | 20,409 | 18,196 | 16,419 | ||
Impairment of property, plant and equipment .................................................... | - | 2,092 | 2,142 | ||
Impairment of other intangible assets .................................................................. | 2,755 | 3,993 | - | ||
Share of net loss of joint venture .......................................................................... | 2,590 | 2,418 | 1,505 | ||
Finance income ....................................................................................................... | (2,549) | (51,568) | (5,608) | ||
Finance costs ........................................................................................................... | 188,419 | 117,361 | 161,551 | ||
Loss/(Gain) on extinguishment of financial liabilities ........................................ | 27,311 | (151,788) | - | ||
Share based payments ............................................................................................ | 10,317 | - | - | ||
Exchange rate difference ....................................................................................... | (10,566) | (2,681) | (3,215) | ||
Income tax benefit / (expense) ............................................................................. | (38,067) | (47,694) | (121,726) | ||
Operating cash flow before movement in working capital | (228,861) | (193,220) | (100,923) | ||
Increase in inventories ........................................................................................... | (32,412) | (29,412) | (3,255) | ||
(Increase) / decrease in trade receivables ............................................................ | (3,576) | (28,813) | 21,771 | ||
Increase / (decrease) in liabilities with related parties ......................................... | 56 | (453) | 1,674 | ||
(Increase) / (increase) in contract assets ............................................................... | (9,218) | 15,286 | (11,667) | ||
Increase in other assets .......................................................................................... | (17,194) | (4,363) | (7,383) | ||
Increase in trade and other payables ..................................................................... | 16,442 | 14,318 | 227 | ||
Increase in contract liabilities ................................................................................ | 19,396 | 21,470 | 24,019 | ||
(Decrease) / increase in other liabilities ................................................................ | (21,384) | 5,160 | 7,134 | ||
Cash used in operations | (276,751) | (200,027) | (68,403) | ||
Interest received ..................................................................................................... | 568 | 16 | 212 | ||
Interest paid ............................................................................................................ | (35,372) | (28,004) | (5,664) | ||
Income tax paid ...................................................................................................... | (834) | (155) | (440) | ||
Net cash used in operating activities | (312,389) | (228,170) | (74,295) |
Cash flows from investing activities | |||||
Acquisition of property, plant and equipment ..................................................... | (37,880) | (20,462) | (7,485) | ||
Disposal of property, plant and equipment ......................................................... | 379 | - | 79 | ||
Acquisition of intangible assets ............................................................................. | (11,122) | (20,171) | (4,497) | ||
Restricted cash in connection with the amended bond agreement .................... | (14,914) | - | (5,000) | ||
Net cash used in investing activities | (63,537) | (40,633) | (16,903) | ||
Cash flows from financing activities | |||||
Repayments of borrowings .................................................................................... | (34,714) | (37,496) | (2,896) | ||
Repayments of principal portion of lease liabilities ............................................. | (11,147) | (7,350) | (6,087) | ||
Proceeds from new borrowings ............................................................................ | 193,678 | 113,821 | 30,000 | ||
Proceeds on issue of equity shares ........................................................................ | - | 185,856 | 34,385 | ||
Extinguishment financing fees .............................................................................. | (12,102) | - | - | ||
Gross proceeds from the PIPE Financing ........................................................... | 174,930 | - | - | ||
Gross PIPE Financing fees paid ........................................................................... | (5,562) | - | - | ||
Proceeds from the Capital Reorganization .......................................................... | 9,827 | - | - | ||
Proceeds from loans from related parties ............................................................ | 160,000 | - | - | ||
Repayment of loans from related parties ............................................................. | (50,000) | - | - | ||
Net cash generated from financing activities | 424,910 | 254,831 | 55,402 | ||
Increase / (decrease) in cash and cash equivalents ............................................. | 48,984 | (13,972) | (35,796) | ||
Cash and cash equivalents at the beginning of the year ...................................... | 17,556 | 31,689 | 67,403 | ||
Effect of movements in exchange rates on cash held ......................................... | (113) | (161) | 82 | ||
Cash and cash equivalents at the end of the year ..................................... | 66,427 | 17,556 | 31,689 |
FAQ
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