|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
![]() |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
2025-03-26 23:36:12 CET 2025-03-26 23:36:22 CET REGULATED INFORMATION Alvotech S.A. - Annual Financial ReportAlvotech Reports Record Results for 2024 and Provides Business Update
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 2024 and provided a summary of recent pipeline and corporate highlights. Management will conduct a business update conference call and live webcast on March 27, 2024, at 8:00 am ET (12:00 pm GMT). “Our 2024 results demonstrate Alvotech’s best-in-class and end-to-end manufacturing and R&D capabilities, made possible by the substantial investments in infrastructure and development over the past decade,” said Robert Wessman, Chairman and CEO of Alvotech. “We reached record revenue from both products sales and development milestones, as well as positive EBITDA for the first time in our history. More importantly, we accomplished these results while completing a record year in development, filing three submissions in major global markets that pave the way for near term growth. Our earlier stage pipeline offers further operating leverage.” Joel Morales, Chief Financial Officer, added: “We met our financial guidance for the year while successfully diversifying our revenue across both products and geographies. Additionally, our product margins improved quarter by quarter, driven by higher utilization, greater scale, and process efficiencies – highlighting the strength and potential of our end-to-end platform. This past year was transformational for Alvotech, and I couldn’t be more pleased with our operations and performance.” Joseph McClellan, Chief Scientific Officer, commented: “Our success in development stems equally from experience, state-of-the-art infrastructure, and process. Seamless integration of R&D with in-house manufacturing and quality enables us to accelerate development without compromising standards. Looking ahead, we are poised for rapid pipeline expansion, having completed the development of 18 additional cell lines, beyond our already substantial disclosed portfolio. With the recent addition of XBrane’s R&D operations, we are not only enhancing our capabilities but also reinforcing our position as a global leader in biosimilar development – enabling us to run multiple development projects with greater speed, scale, and efficiency than ever before.” Recent Business Highlights Since Our Last Earnings Release December 2024 January 2025 February 2025 Alvotech and Teva also announced the launch of SELARSDI™ (ustekinumab-aekn) in the U.S., a biosimilar to Stelara®. FDA has determined that SELARSDI will be interchangeable with the reference biologic Stelara® following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025. SELARSDI is the second biosimilar developed by Alvotech to launch in the U.S. market. March 2025 Alvotech, Kashiv and Advanz also announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab). Xolair is a biologic indicated for treatment of severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Alvotech also announced the acquisition of Xbrane’s R&D operations near Stockholm, Sweden and of a biosimilar candidate referencing Cimzia® (certolizumab pegol). The acquisition, subject to approvals from the relevant authorities and XBrane’s shareholders, increases the company’s pipeline and R&D capabilities to drive future development. Alvotech also announced its intentions to explore the possibility of a listing of Swedish Depository Receipts (SDR), equity share equivalents, on the Nasdaq Stokholm stock market, in the future. Uri Hillel was appointed Chief Quality Officer (CQO) for Alvotech on March 8, 2025. Uri joins Alvotech from Teva, where he was Vice President, Quality R&D and Complex Biologics Manufacturing Supply Operations (CBMSO). Earlier in his career, Uri served as the Global Head of Quality Compliance, where he established Teva's Management Controls, including the Quality Management System (QMS), Audit function, Inspection readiness, Quality Metrics and Market Action Committee. Uri holds a Bachelor of Pharmacy degree from the University of Jerusalem in Israel Summary of the Financial Results for 2024 Full Year Cash position and sources of liquidity: As of December 31, 2024, the Company had cash and cash equivalents of $51.4 million. In addition, the Company had borrowings of $1,068.6 million, including $32.7 million of current portion of borrowings. Product Revenue: Product revenue was $273.5 million for the year ended December 31, 2024, compared to $48.7 million for the same period in the prior year. Revenue for the year ended 31 December 2024, consisted of product revenue from sales of AVT02 in select European countries and Canada, launch of AVT02 in the U.S., and the launches of AVT04 in Canada, Japan and select European markets. License and Other Revenue: License and other revenue was $216.2 million for the year ended December 31, 2024, compared to $42.7 million for the same period in the prior year. The license and other revenue of $216.2 million was primarily attributable to the achievement of key research and development milestones during 2024: $6.6 million for the approval of AVT04 in Europe, $16.8 million for the CTA submission for AVT16, a total of $34.4 million for the MAA submissions with the EMA for AVT03, AVT05, and AVT06, $39.1 million for the CES completion of AVT03, and $56.4 million for the CES completion of AVT05. This also included the following performance milestones reached during 2024: $6.9 million for the achievement of sales target of AVT02 in Europe and Canada, $15.4 million for the product launches of AVT04 in Europe and Japan, $18.8 million for the product launch of AVT02 in the U.S., and a net milestone revenue of $20.4 million for the execution of out-license contracts during the year ended 31 December 2024. Cost of product revenue: Cost of product revenue was $185.3 million for the year ended December 31, 2024, compared to $160.9 million for the same period in the prior year. This is the result of increased sale volumes during 2024, including the launches of AVT02 in the U.S., AVT04 in Canada, Japan and select European countries, tempered by lower production-related charges and lower costs associated with FDA inspection readiness. Research and development (R&D) expenses: R&D expenses were $171.3 million for the year ended December 31, 2024, compared to $210.8 million for the same period in the prior year. The decrease was primarily driven by a one-time charge of $18.5 million relating to the termination of the co-development agreement with Biosana for AVT23 recognized during the year 2023, a decrease of $6.3 million primarily related to programs which reached commercialization (i.e., AVT02 and AVT04 programs), a decrease of $25.0 million related to programs for which the clinical phase is substantially completed (i.e. AVT03, AVT05, and AVT06), and overall lower headcount and other R&D expenses for $8.2 million, partially offset by a $20.0 million increase in direct program expenses mainly due to AVT16 that is advancing through clinical phase. General and administrative (G&A) expenses: G&A expenses were $65.7 million for the year ended December 31, 2024, compared to $76.6 million for the same period in the prior year. The decrease in G&A expenses was primarily attributable to $4.5 million in lower third-party services, lower insurance premiums and headcount, coupled with a $6.0 million decrease in expenses for share-based payments. Operating profit: Operating profit was $69.6 million for the year ended December 31, 2024, compared to ($354.9) million for the same period in the prior year. The increase of $424.5 million was primarily attributable to the sharp increase in total revenues due to a combination of expansion of our product commercialization and milestones recognition for advancing our product through our pipeline and achieving contractual sales targets. This is coupled with a decrease in operating expenses driven by continuing efforts by the Company to scale and rationalize operations. Share of net loss of joint venture and loss on sale of interest in joint venture: In June 2024, the Company sold its share in the joint venture for gross proceeds of $18.0 million (less $1.3 million in transaction costs). The sale resulted in a net loss of $3.0 million during the year ended December 31, 2024. Finance income: Finance income was $80.1 million for the year ended December 31, 2024, compared to $4.8 million for the same period in the prior year. Finance income for the year ended December 31, 2024 was primarily attributable to the change in fair value of our derivatives [primarily driven by the Tranche A Conversion Feature of the 2022 Convertible bonds impacted by the bond holders exercising their right to conversion into ordinary shares on the last scheduled conversion date prior to maturity, which was July 1, 2024]. Finance income for the year ended December 31, 2023, was mainly attributable to interest recognized from bank accounts. Finance costs: Finance costs were $303.2 million for the year ended December 31, 2024, compared to $267.2 million for the same period in the prior year. Finance costs for the year ended December 31, 2024, were primarily comprised of a $130.5 million finance costs reflecting the fair value of the Predecessors Earn Out shares, which was negatively impacted by the increase in the Company's share price during the year, and by interest charges on outstanding debts of $147.4 million. Loss on extinguishment of financial liabilities: On June 7, 2024, the Company entered into a $965.0 million Senior Loan Facility, maturing in July 2029 that was funded in July 2024. Upon the closing of the Senior Loan Facility, the Company was required to settle its existing debt obligations. In parallel, the Company announced that all holders of the Tranche A and some holders of the Tranche B of the 2022 Convertible Bonds exercised their right to conversion into ordinary shares at the fixed conversion price of $10.00 per share on the last scheduled conversion date prior to maturity, which is July 1, 2024. Similarly, some holders of the Aztiq Convertible Bonds decided to exercise similar conversion right into ordinary shares at the same conversion price. A loss on extinguishment of financial liabilities of $69.0 million related to the refinancing of existing debt obligations, including the conversion of the 2022 Convertible Bonds and Aztiq Convertible Bonds, was recorded during the year ended December 31, 2024. Income tax (expense) / benefit: Income tax expense was $14.3 million for the year ended December 31, 2024, compared to a benefit of $99.3 million for the same period in the prior year. The shift from a tax benefit to a charge is driven by a $94.9 million increase in deferred tax expense corresponding to positive operating results reported for the year ended December 31, 2024 and a $16.8 million increase in foreign currency impact due to the weakening of the Icelandic krona against the U.S. Dollar, decreasing the U.S. Dollar value of Icelandic tax loss carry-forwards that the Company expects to utilize against future taxable profits. Loss for the Year: Reported net loss was $231.9 million, or ($0.87) per share on a basic and diluted basis, for the year ended December 31, 2024, compared to a reported net loss of $551.8 million, or ($2.42) per share on a basic and diluted basis, for the same period in the prior year. As mentioned above, the net loss for the period is heavily impacted by the fair value costs associated with our derivative liabilities and the impact of the refinancing of the existing debt obligations. Business Update Conference Call About AVT02 (adalimumab) About AVT04 (ustekinumab) About AVT03 About AVT06/AVT29 About AVT16 About AVT23 Sources Use of trademarks About Alvotech Please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Alvotech Forward Looking Statements ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Attachments ![]() |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|