Alvotech Reports Record Revenues and Adjusted EBITDA for the Second Quarter and First Six Months of 2024
Rhea-AI Summary
Alvotech (NASDAQ: ALVO) reported record financial results for Q2 and H1 2024, with total revenues reaching $236 million in H1, a ten-fold increase year-over-year. Product revenues grew 190% to $66 million, while license and other revenues surged to $170 million. The company achieved positive Adjusted EBITDA of $64 million in H1, compared to a loss of $147 million in the same period last year.
Key highlights include:
- U.S. order book for biosimilar Humira increased to 1.3 million units for 2024
- Successful launches of biosimilars in multiple markets
- Positive clinical results for AVT03, a proposed biosimilar to Prolia® and Xgeva®
- Expanded partnerships with STADA and Advanz Pharma
- Refinancing of debt obligations, improving overall debt profile
Positive
- Record total revenues of $236 million for H1 2024, a ten-fold increase year-over-year
- Product revenues grew 190% to $66 million in H1 2024
- License and other revenues increased to $170 million in H1 2024
- Positive Adjusted EBITDA of $64 million in H1 2024, compared to a loss of $147 million in H1 2023
- U.S. order book for biosimilar Humira increased to 1.3 million units for 2024
- Successful launches of biosimilars in multiple markets, including Europe, Canada, and Japan
- Positive clinical results for AVT03, a proposed biosimilar to Prolia® and Xgeva®
- Expanded partnerships with STADA and Advanz Pharma for commercialization of biosimilars
- Refinancing of debt obligations, reducing cost of capital and improving debt profile
Negative
- Cost of product revenue remains disproportionate relative to product revenue due to timing of new launches
- Reported net loss of $153.5 million for H1 2024, compared to $86.9 million in H1 2023
- Finance costs increased to $277.4 million in H1 2024, up from $64.3 million in H1 2023
- Income tax expense of $5.1 million in H1 2024, compared to a benefit of $49.9 million in H1 2023
News Market Reaction 1 Alert
On the day this news was published, ALVO gained 8.72%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Record Total Revenues of
$236 million for the first six months of 2024, an over ten-fold increase compared to same period in 2023
- Product revenues for the first six months were
$66 million , a190% increase from the same period last year, with Q2 product revenues contributing$53 million
- License and other revenues for the first six months increased to
$170 million , with Q2 license and other revenues contributing$145 million
- Adjusted EBITDA in the first six months was
$64 million , compared to negative ($147) million for the same period last year, with Q2 adjusted EBITDA contributing$102 million
- Achieved numerous development and performance milestones including the recent filing acceptance of EU marketing application for AVT06, biosimilar candidate to Eylea® (aflibercept)
- Alvotech will conduct a business update conference call and live webcast on Friday August 16, 2024, at 8:00 am ET (12:00 pm GMT)
REYKJAVIK, Iceland, Aug. 15, 2024 (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 unaudited financial results for the first six months of 2024 and provided a summary of recent corporate highlights.
“These are truly exciting times for Alvotech. In the first half of the year, Alvotech generated record results, with an over ten-fold increase in total revenues compared to the same period in 2023 and positive Adjusted EBITDA for the first time, both for the second quarter and the first half of the year. Product revenues are growing rapidly, as we launch multiple products globally, backed by exceptionally strong milestone revenues in the second quarter,” said Robert Wessman, Chairman and CEO of Alvotech. “Our order book for biosimilar Humira in the U.S. for 2024 has already grown from the initial 1 million units previously announced, to approximately 1.3 million units today. Revenues generated from these U.S. orders will be predominantly recognized in the second half of the year. Our recent launch of Stelara in Canada, Japan, and Europe highlights our global, multiproduct strategy. As we enter the second half of the year, we are already receiving replenishment orders in certain markets.”
Recent Highlights
Commercial and Development Milestones
Alvotech announced positive topline results from a confirmatory patient study for AVT03, a proposed biosimilar to Prolia® (denosumab) and Xgeva® (denosumab). Alvotech also announced positive top-line results from a pharmacokinetic (PK) study assessing the PK, safety, and tolerability of AVT03 compared to Xgeva in healthy adult participants. Previously, Alvotech announced positive top-line results from a separate PK study comparing AVT03 to Prolia.
Alvotech and STADA strengthened their existing strategic alliance, to include AVT03. Upon approval, STADA will assume semi-exclusive commercial rights in Europe, including Switzerland and the UK, as well as exclusive commercial rights in selected countries in Central Asia and the Middle East. Alvotech and STADA also agreed to extend STADA’s commercial rights for biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab) to Commonwealth of Independent States (CIS) countries in Central Asia.
Alvotech and Advanz Pharma expanded their partnership with an agreement regarding the supply and commercialization of Alvotech’s proposed biosimilar to Eylea® (aflibercept). Alvotech is currently developing AVT06, a proposed biosimilar to Eylea® low dose (2 mg) and AVT29, a biosimilar candidate for Eylea® high dose (8 mg). Advanz Pharma has exclusive commercialization rights for AVT06 and AVT29 in Europe, except for Germany and France where the rights are semi-exclusive. Alvotech and Advanz Pharma also announced that the European Medicines Authority had accepted the EU/EEA marketing application for AVT06. The process to obtain marketing authorization could be completed in the third quarter of 2025.
STADA and Alvotech announced the launch of Uzpruvo® (ustekinumab), known as AVT04, the first approved biosimilar to Stelara® in Europe, across a majority of European countries. The pioneering launch came immediately upon expiry of exclusivity rights for Stelara. Previously, AVT04 had been launched in Canada and Japan.
Corporate Milestones
Alvotech announced that holders of the majority of subordinated convertible bonds, originally issued by Alvotech in 2022, with maturity on December 20, 2025, (the “Convertible Bonds”) elected to convert the principal and accrued interest into ordinary shares of Alvotech at the fixed conversion price of US
On July 11, 2024, Alvotech announced the closing of a senior first lien term loan facility of
As per the terms of the Facility, upon closing Alvotech settled its existing debt obligations. Holders of the Convertible Bonds that did not exercise their right to conversion obtained repayment in July 2022. As a result, Alvotech does not have any convertible bonds outstanding. Outstanding debt is limited to the Facility, mortgage debt and equipment financing. All outstanding debt has maturity in June 2029 or at a later date.
Summary of the Financial Results for First Six Months of 2024
Cash position and sources of liquidity: As of June 30, 2024, the Company had cash and cash equivalents of
Product Revenue: Product revenue was
License and Other Revenue: License and other revenue was
Cost of product revenue: Cost of product revenue was
Research and development (R&D) expenses: R&D expenses were
General and administrative (G&A) expenses: G&A expenses were
Operating profit: Operating profit was
Finance income: Finance income was
Finance costs: Finance costs were
Exchange rate differences: Exchange rate differences resulted in a gain of
Income tax benefit: Income tax expense was
Loss for the Period: Reported net loss was
Business Update Conference Call
Alvotech will conduct a business update conference call and live webcast on Friday, August 16, at 8:00 am EDT (12:00 pm GMT). Registration for the conference call and access to the live webcast is found on https://investors.alvotech.com/events/event-details/q2-2024-earnings, where you will also be able to find a replay of the webcast, following the call for 90 days.
About AVT02 (adalimumab)
AVT02 is a monoclonal antibody and has been approved as a biosimilar to Humira® (adalimumab) in over 50 countries globally, including the U.S., Europe, Canada, Australia, Egypt, Saudi Arabia and South Africa. It is currently marketed in the U.S. as SIMLANDI and under private label, in Europe as HUKYNDRA, in Canada as SIMLANDI and in Australia as ADALACIP. Dossiers are also under review in multiple countries globally.
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 [2]. 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 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 been launched in Canada as JAMTEKI, in the EEA as UZPRUVO, and in Japan as USTEKINUMAB BS (F). It has been approved in the U.S. as SELARSDI. Dossiers are also under review in multiple countries globally.
About AVT06/AVT29 (aflibercept)
AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept) 2 mg and 8 mg dose, which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06/AVT29 are investigational products and have not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
Sources
[1] EMA Uzpruvo product information
[2] Prolia product information
[3] Eylea product information
Use of trademarks
Humira is a registered trademark of AbbVie Inc. Stelara is a registered trademark of Johnson & Johnson Inc. Prolia and Xgeva are registered trademarks of Amgen Inc. Stelara is a registered trademark of Johnson & Johnson Inc. Eylea is a registered trademark of Regeneron Pharmaceuticals Inc. and Bayer AG.
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 has launched two biosimilars. The current development pipeline includes nine disclosed 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), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), 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.
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Alvotech 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 operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, 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”, “aim” 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 ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (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 respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) 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; (13) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, 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.
ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com
| Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income or Loss | ||
| USD in thousands, except for per share amounts | Six months ended 30 June 2024 | Six months ended 30 June 2023 |
| Product revenue | 65,912 | 22,715 |
| License and other revenue | 169,678 | (2,460) |
| Other income | 57 | 45 |
| Cost of product revenue | (65,167) | (67,909) |
| Research and development expenses | (97,479) | (99,582) |
| General and administrative expenses | (29,554) | (41,910) |
| Operating profit / (loss) | 43,447 | (189,101) |
| Share of net loss of joint venture | — | (2,706) |
| Loss on sale of investment in joint venture | (2,970) | — |
| Finance income | 80,823 | 122,480 |
| Finance costs | (277,414) | (64,300) |
| Exchange rate differences | 7,742 | (3,081) |
| Non-operating (loss) / profit | (191,819) | 52,393 |
| Loss before taxes | (148,372) | (136,708) |
| Income tax (expense) / benefit | (5,132) | 49,854 |
| Loss for the period | (153,504) | (86,854) |
| Other comprehensive income / (loss) | ||
| Item that will be reclassified to profit or loss in subsequent periods: | ||
| Exchange rate differences on translation of foreign operations | 121 | (1,523) |
| Total comprehensive loss | (153,383) | (88,377) |
| Loss per share | ||
| Basic and diluted loss for the year per share | (0.61) | (0.39) |
| Unaudited Condensed Consolidated Interim Statements of Financial Position USD in thousands | ||
Non-current assets | 30 June 2024 | 31 December 2023 |
| Property, plant and equipment | 239,535 | 236,779 |
| Right-of-use assets | 138,110 | 119,802 |
| Goodwill | 11,692 | 12,058 |
| Other intangible assets | 19,901 | 19,076 |
| Contract assets | 33,457 | 10,856 |
| Investment in joint venture | — | 18,494 |
| Other long-term assets | 8,952 | 2,244 |
| Restricted cash | 25,000 | 26,132 |
| Deferred tax assets | 306,638 | 309,807 |
| Total non-current assets | 783,285 | 755,248 |
| Current assets | ||
| Inventories | 96,574 | 74,433 |
| Trade receivables | 93,521 | 41,292 |
| Contract assets | 39,771 | 35,193 |
| Other current assets | 44,337 | 31,871 |
| Receivables from related parties | 46 | 896 |
| Cash and cash equivalents | 10,944 | 11,157 |
| Total current assets | 285,193 | 194,842 |
| Total assets | 1,068,478 | 950,090 |
| Unaudited Condensed Consolidated Interim Statements of Financial Position USD in thousands | ||
| Equity | 30 June 2024 | 31 December 2023 |
| Share capital | 2,602 | 2,279 |
| Share premium | 1,716,605 | 1,229,690 |
| Other reserves | 35,627 | 42,911 |
| Translation reserve | (1,407) | (1,528) |
| Accumulated deficit | (2,359,349) | (2,205,845) |
| Total equity | (605,922) | (932,493) |
| Non-current liabilities | ||
| Borrowings | 56,877 | 922,134 |
| Derivative financial liabilities | 201,670 | 520,553 |
| Lease liabilities | 121,873 | 105,632 |
| Contract liabilities | 90,120 | 73,261 |
| Deferred tax liability | 1,394 | 53 |
| Total non-current liabilities | 471,934 | 1,621,633 |
| Current liabilities | ||
| Trade and other payables | 58,566 | 80,563 |
| Lease liabilities | 10,644 | 9,683 |
| Current maturities of borrowings | 999,036 | 38,025 |
| Derivative financial liabilities | 39,714 | — |
| Liabilities to related parties | 26,528 | 9,851 |
| Contract liabilities | 4,484 | 59,183 |
| Taxes payable | 1,031 | 925 |
| Other current liabilities | 62,463 | 62,720 |
| Total current liabilities | 1,202,466 | 260,950 |
| Total liabilities | 1,674,400 | 1,882,583 |
| Total equity and liabilities | 1,068,478 | 950,090 |
| Unaudited Condensed Consolidated Interim Statements of Cash Flows USD in thousands | ||
Cash flows from operating activities | Six months ended 30 June 2024 | Six months ended 30 June 2023 |
| Loss for the period | (153,504) | (86,854) |
| Adjustments for non-cash items: | ||
| Depreciation and amortization | 14,748 | 10,934 |
| Change in allowance for receivables | — | 18,500 |
| Change in inventory reserves | (6,936) | — |
| Loss on disposal of property, plant and equipment | — | 323 |
| Loss on sale of investment in joint venture | 2,970 | — |
| Share of net loss of joint venture | — | 2,706 |
| Finance income | (80,823) | (122,480) |
| Finance costs | 277,414 | 64,300 |
| Share-based payments | 5,294 | 11,911 |
| Exchange rate difference | (7,742) | 3,081 |
| Income tax expense / (benefit) | 5,132 | (49,854) |
| Operating cash flow before movement in working capital | 56,553 | (147,433) |
| Increase in inventories | (15,205) | (7,896) |
| (Increase) / decrease in trade receivables | (52,229) | 16,665 |
| Increase / (decrease) in liabilities with related parties | 16,769 | (102) |
| (Increase) / decrease in contract assets | (27,179) | 1,215 |
| Decrease in other assets | 369 | 3,711 |
| Decrease in trade and other payables | (21,758) | (6,182) |
| (Decrease) / increase in contract liabilities | (35,881) | 37,679 |
| (Decrease) / increase in other liabilities | (6,056) | 4,395 |
| Cash used in operations | (84,617) | (97,948) |
| Interest received | 26 | 25 |
| Interest paid | (41,037) | (29,427) |
| Income tax paid | (372) | (652) |
| Net cash used in operating activities | (126,000) | (128,002) |
| Cash flows from investing activities | ||
| Acquisition of property, plant and equipment | (10,271) | (22,594) |
| Disposal of property, plant and equipment | — | 133 |
| Acquisition of intangible assets | (1,430) | (2,764) |
| Restricted cash in connection with amended bond agreement | 1,132 | — |
| Net cash used in investing activities | (10,569) | (25,225) |
| Cash flows from financing activities | ||
| Repayments of borrowings | (75,059) | (84,507) |
| Repayments of principal portion of lease liabilities | (4,815) | (3,700) |
| Proceeds from new borrowings | 67,500 | 93,561 |
| Gross proceeds from equity offering | 150,451 | 136,877 |
| Fees from equity offering | (5,812) | (4,141) |
| Proceeds from warrants | 4,841 | 6,365 |
| Options exercised | 76 | — |
| Net cash generated from financing activities | 137,182 | 144,455 |
| Increase / (decrease) in cash and cash equivalents | 613 | (8,772) |
| Cash and cash equivalents at the beginning of the year | 11,157 | 66,427 |
| Effect of movements in exchange rates on cash held | (826) | 2,811 |
| Cash and cash equivalents at the end of the period | 10,944 | 60,466 |
FAQ
What were Alvotech's (ALVO) total revenues for the first half of 2024?
How much did Alvotech's (ALVO) product revenues grow in H1 2024?
What was Alvotech's (ALVO) Adjusted EBITDA for the first half of 2024?
How many units of biosimilar Humira does Alvotech (ALVO) expect to sell in the U.S. in 2024?
What recent clinical milestone did Alvotech (ALVO) achieve for AVT03?
