Alvotech(ALVO) - 2023 Q4 - Annual Report

PART I Key Information The company faces significant financial, developmental, and operational risks, including a history of losses and material control weaknesses Risk Factors The company's viability is challenged by substantial debt, recurring losses, regulatory hurdles, and identified material weaknesses in financial controls - The company has a limited operating history, has incurred significant losses since its 2013 inception, and anticipates continued significant losses in the immediate future; the accumulated deficit was $2,205.8 million as of December 31, 2023[21] - Alvotech has substantial indebtedness, totaling $960.2 million as of December 31, 2023, which could adversely affect business operations and financial returns[35] - Recurring losses and the need for additional funding raise substantial doubt about the company's ability to continue as a going concern, as noted in the independent auditor's report[20][29] - Material weaknesses have been identified in internal control over financial reporting, which could affect the reliability of financial statements if not remediated[20][280] - The company is dependent on partners like Teva, STADA, and Advanz for the commercialization of its products in major markets[20][130] Information on the Company Alvotech is a vertically integrated biotech firm specializing in biosimilar development and manufacturing through a global partnership network History and Development of the Company Founded in Iceland in 2013, the company focuses on a fully integrated platform for biosimilar development and manufacturing - Alvotech hf. was founded in 2013 in Reykjavik, Iceland, to focus on developing and manufacturing biosimilars for the global market[362] Capital Expenditures (USD in millions) | Year | Amount | | :--- | :--- | | 2023 | $33.2 | | 2022 | $37.9 | | 2021 | $20.5 | Business Overview The company's strategy centers on its integrated platform, diverse biosimilar pipeline, and strategic commercial partnerships for global distribution - Alvotech's strategy is to leverage its integrated platform to develop high-quality biosimilars and commercialize them through a global network of partners in over 90 markets[390] Key Product Pipeline Status | Product | Reference Product | Status | | :--- | :--- | :--- | | AVT02 | Humira (adalimumab) | Approved in >50 markets, including U.S. (interchangeable), EEA, UK, Canada; Launched in >20 markets | | AVT04 | Stelara (ustekinumab) | Approved in Japan, Canada, EEA; Launched in Canada; U.S. FDA review expected by April 16, 2024 | | AVT06 | Eylea (aflibercept) | Confirmatory clinical study showed positive topline results in Jan 2024 | | AVT03 | Prolia/Xgeva (denosumab) | Positive top-line results from PK study announced Jan 2024; Confirmatory patient study ongoing | | AVT05 | Simponi/Simponi Aria (golimumab) | Positive topline results from PK study announced Nov 2023; Efficacy study results expected in 2024 | | AVT23 | Xolair (omalizumab) | In-licensed from Kashiv; Confirmatory clinical efficacy study is ongoing | - The company has established key strategic commercial partnerships for global reach, including with Teva for the U.S, STADA and Advanz for Europe, Fuji Pharma for Japan, and JAMP Pharma for Canada[390][419][428][435][437][441] - Alvotech and AbbVie entered into settlement and license agreements in March/April 2022, resolving all IP disputes regarding AVT02 and allowing for a U.S. launch on July 1, 2023, in exchange for royalties[447][449] Organizational Structure Alvotech is a Luxembourg-based parent with wholly-owned subsidiaries in key locations and a joint venture in China - The company's main operating subsidiary is Alvotech hf. in Iceland; other key subsidiaries are located in Germany, Switzerland, the UK, and the USA[549] - Alvotech has a 50% stake in a joint venture with CCHN in China, but is currently in discussions to sell its interest back to the partner[549][446] Property, Plants and Equipment The company owns its primary R&D and manufacturing facility in Iceland, which is undergoing a major expansion, and leases other global offices - The main manufacturing and R&D facility in Reykjavik, Iceland, is owned by the company and is being expanded to double its size to 280,000 square feet, with completion expected in 2024[552] - The company leases additional facilities globally, including an R&D center in Zurich, Switzerland; cell line development and analytical sites in Jülich and Hannover, Germany; and a U.S. regulatory affairs office in Virginia[555][556][557] Operating and Financial Review and Prospects Financial performance shows growing revenue but continued operating losses, with liquidity dependent on financing and partner payments Operating Results The company's net loss increased to $551.7 million in 2023, driven by higher R&D and finance costs despite nearly doubled product revenue Consolidated Results of Operations (USD in thousands) | Metric | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Product revenue | 48,699 | 24,836 | — | | License and other revenue | 42,735 | 58,193 | 36,772 | | Operating loss | (354,860) | (346,442) | (235,456) | | Loss for the year | (551,731) | (513,580) | (101,504) | - Product revenue grew 96% YoY to $48.7 million in 2023, driven by increased sales volume of AVT02 in Europe[586] - R&D expenses increased by 16.7% to $210.8 million in 2023, primarily due to a contract termination charge and increased clinical development spending[591][592] - General & Administrative expenses decreased by 59.0% to $76.6 million in 2023, mainly due to the absence of one-time share listing expenses from 2022[593] - Finance costs increased by 41.8% to $267.2 million in 2023, driven by higher interest on debt and a change in the fair value of derivative liabilities[597] Adjusted EBITDA Reconciliation (USD in thousands) | Metric | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Loss for the year | (551,731) | (513,580) | (101,504) | | Adjustments | 260,754 | 308,402 | (79,213) | | Adjusted EBITDA | (290,977) | (205,178) | (180,717) | Liquidity and Capital Resources The company's liquidity is strained by operating losses, with a material uncertainty regarding its ability to continue as a going concern - As of December 31, 2023, the company had cash and cash equivalents of $11.2 million and an accumulated deficit of $2,205.8 million[630] Cash Flow Summary (USD in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Cash used in operating activities | (312,185) | (312,389) | | Cash used in investing activities | (46,340) | (63,537) | | Cash generated from financing activities | 301,319 | 424,910 | - In February 2024, the company raised gross proceeds of approximately $166 million through a sale of Ordinary Shares[637][656] - Management has determined that there is a material uncertainty that may cast significant doubt about the company's ability to continue as a going concern[657][848] - Total outstanding borrowings as of December 31, 2023, amounted to $960.2 million, including Senior Bonds, Convertible Bonds, and loans from Alvogen[646] Critical Accounting Estimates Key estimates involve revenue recognition from complex licensing deals, valuation of derivatives, and assessing deferred tax assets - Revenue recognition for out-licensing contracts is critical, requiring estimation of variable consideration and allocation of the transaction price to performance obligations[663][664][665] - The valuation of derivative financial liabilities, such as warrants and conversion features, is a key estimate determined using option-pricing models[666] - Valuation of deferred tax assets requires significant judgment regarding the probability of future taxable profits being available for utilization[668][669] Directors, Senior Management and Employees The company is led by founder Robert Wessman, with an eight-member board and a workforce of 1,026 primarily focused on R&D and operations Directors and Senior Management Leadership includes founder Robert Wessman as Executive Chairman and CEO, with an eight-member board of which three are independent - Robert Wessman is the founder and serves as Executive Chairman and Chief Executive Officer[673] - The Board of Directors is composed of eight members; three directors are independent under Nasdaq standards[707][680][682][685] Compensation Executive compensation includes salary, bonuses, and equity awards, with independent directors receiving fees and restricted stock units 2023 Executive Compensation (USD in thousands) | Key employees | Salaries and benefits | Pension contribution | Other long-term benefits | | :--- | :--- | :--- | :--- | | Robert Wessman CEO | 1,491 | 26 | — | | Other Leadership Team Members | 5,020 | 346 | 9,456 | | Total | 6,511 | 372 | 9,456 | 2023 Director Compensation (USD in thousands) | Director | Board fees | Other long-term benefits | | :--- | :--- | :--- | | Richard Davies | 156 | 104 | | Ann Merchant | 113 | 104 | | Linda McGoldrick | 81 | 104 | | Lisa Graver | 71 | 104 | | Total Paid | 421 | 416 | - The company adopted the Alvotech Management Incentive Plan in 2022, authorizing the grant of shares, RSUs, and options, with an initial share reserve of 5.79% of share capital[701][702] Board Practices The eight-member board has five standing committees, including a fully independent Audit and Risk Committee, and oversees risk management - The board has five standing committees: Audit and Risk, Compensation, Nominating and Corporate Governance, Strategy, and Corporate Sustainability[709] - The Audit and Risk Committee consists of three independent directors: Dr. McGoldrick (Chair), Ms. Merchant, and Mr. Davies[710] Employees As of year-end 2023, the company had 1,026 employees and contractors, with 87% dedicated to R&D, quality, and technical operations Employee Headcount by Function | Function | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Manufacturing | 575 | 512 | 360 | | Administrative | 131 | 129 | 104 | | Research and development | 320 | 306 | 268 | | Total | 1,026 | 947 | 732 | Employee Headcount by Geography | Geography | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Iceland | 839 | 745 | 557 | | European Union | 74 | 79 | 94 | | United States | 14 | 28 | 23 | | Elsewhere | 99 | 95 | 58 | | Total | 1,026 | 947 | 732 | Major Shareholders and Related Party Transactions Ownership is highly concentrated with two shareholders holding over 71%, and the company engages in significant related party transactions Major Shareholders Ownership is highly concentrated, with Aztiq and Alvogen collectively owning approximately 71.6% of ordinary shares Beneficial Ownership of Major Shareholders (as of Feb 15, 2024) | Shareholder | Number of Shares | Percentage | | :--- | :--- | :--- | | Aztiq Pharma Partners S.à r.l. | 101,165,374 | 37.91% | | Alvogen Lux Holdings S.à r.l. | 90,005,334 | 33.73% | - The two largest shareholders, Alvogen and Aztiq, collectively own approximately 71.6% of the company's Ordinary Shares, giving them significant influence over shareholder approvals[350] Related Party Transactions The company engages in numerous transactions with related parties, including facility leases and financing arrangements, overseen by the Audit and Risk Committee - The Board has adopted a written policy for the review and approval of related person transactions, overseen by the Audit and Risk Committee[729] - The company has significant lease agreements with related parties for its facilities in Iceland, including a 15-year lease for its new 140,000 sq ft facility expansion[731] - In July 2023, an affiliate of major shareholder Aztiq acquired $30.0 million in Tranche A convertible bonds as part of a larger private placement[734] Financial Information The company does not anticipate paying dividends and is not currently party to any material legal proceedings - The company does not anticipate paying any cash dividends in the foreseeable future, intending to retain all available funds to support business development and expansion[736] - The company is not currently a party to any legal proceedings that management believes are likely to have a material adverse effect on the business[740] Additional Information This section covers material contracts, tax considerations for investors, and highlights potential PFIC and CFC risks for U.S. shareholders Material Contracts Key contracts include amended Senior Bonds with a 12% coupon and 2022 Convertible Bonds with a $10.00 per share conversion price - On November 16, 2022, the company amended and upsized its Senior Bonds, issuing $70.0 million in new bonds with a coupon rate of 12.00% per annum[750][751] - In December 2022, the company issued convertible bonds maturing in December 2025, convertible into Ordinary Shares at a price of $10.00 per share[755] Taxation This details Luxembourg and U.S. tax considerations, including significant risks for U.S. holders related to potential PFIC or CFC classification - Non-resident holders of shares are generally not liable for Luxembourg income tax on dividends or capital gains, with certain exceptions[760] - There is a risk that Alvotech could be treated as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes, which would result in adverse tax consequences for U.S. Holders[354][355][778] - Because the company's corporate structure includes a U.S. subsidiary, its non-U.S. subsidiaries will be treated as Controlled Foreign Corporations (CFCs), which may have tax implications for certain U.S. Holders[357] Quantitative and Qualitative Disclosures About Market Risk The company is exposed to foreign currency, interest rate, credit, and inflation risks, with currency fluctuations being most significant - The company is exposed to foreign exchange risk, with significant assets and liabilities in EUR, GBP, ISK, and CHF; a 10% fluctuation of the ISK against the USD can have a significant impact[796] - Interest rate risk is primarily related to cash holdings, as the majority of the company's borrowings are at fixed interest rates[797] - Credit risk from trade receivables is considered low due to the high credit quality of the company's large multinational collaboration partners[798] PART II Controls and Procedures Management concluded that disclosure controls were not effective as of year-end 2023 due to identified material weaknesses in internal control Disclosure Controls and Procedures Management concluded that disclosure controls and procedures were not effective as of December 31, 2023, due to material weaknesses - The CEO and CFO have concluded that as of December 31, 2023, the company's disclosure controls and procedures were not effective due to identified material weaknesses[804] Management's Annual Report on Internal Control Over Financial Reporting Management concluded internal controls were not effective due to insufficient staffing, inconsistent control operation, and inadequate segregation of duties - Management concluded that internal control over financial reporting was not effective as of December 31, 2023[807] - Identified material weaknesses include: 1) insufficient number of trained professionals in internal control; 2) inconsistent operation and documentation of controls; and 3) ineffective controls over segregation of duties and IT general controls[808] - Remediation activities underway include hiring qualified individuals, enhancing governance, redesigning controls, and implementing a new ERP system[810][811] Corporate Governance and Other Matters As a foreign private issuer, the company follows home country governance practices and has implemented a cybersecurity risk management program Principal Accountant Fees and Services Total fees paid to the independent auditor, Deloitte ehf., were $3.34 million in 2023 and $3.29 million in 2022 Principal Accountant Fees (USD in thousands) | Fee Type | 2023 | 2022 | | :--- | :--- | :--- | | Audit Fees | 2,876 | 2,615 | | Audit-Related Fees | 365 | 656 | | Tax Fees | 97 | 20 | | Total | 3,339 | 3,291 | Corporate Governance As a foreign private issuer, Alvotech follows Luxembourg governance practices in lieu of certain Nasdaq rules on board independence and shareholder approval - The company is a foreign private issuer and follows home country governance practices in lieu of certain Nasdaq rules[824] - Exemptions include not requiring a majority-independent board and not requiring shareholder approval for certain security issuances[824][825] Cybersecurity The company has a cybersecurity program overseen by the Audit and Risk Committee and did not identify any material threats in 2023 - The company's cybersecurity risk management program is designed to identify, mitigate, and manage threats, with oversight from the Audit and Risk Committee[828][831] - A Cybersecurity and Risks Council, including the CIO and Director of Cybersecurity, is responsible for managing cyber risk exposure[831] - In 2023, no identified cybersecurity threats were deemed reasonably likely to materially affect the company's business, results of operations, or financial condition[830] PART III Financial Statements The audited financial statements are presented fairly, but the auditor's report highlights substantial doubt about the company's ability to continue as a going concern - The independent auditor's report includes a "Going concern" paragraph, noting that the company's recurring losses from operations raise substantial doubt about its ability to continue as a going concern[848] Consolidated Statement of Financial Position (USD in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Total Assets | 950,090 | 828,443 | | Total Liabilities | 1,882,583 | 1,392,859 | | Total Equity | (932,493) | (564,416) | Consolidated Statement of Profit or Loss (USD in thousands) | | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Total Revenue & Other Income | 93,382 | 85,017 | 39,684 | | Operating Loss | (354,860) | (346,442) | (235,456) | | Loss for the year | (551,731) | (513,580) | (101,504) |