Exhibit 99.1
Cautionary Note Regarding Forward Looking Statements
This Exhibit contains “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 its ability to satisfy conditions precedent to close the transaction and draw down the Term Loans under the Loan Agreement, to comply with the covenants of the Loan Agreement and to exercise its rights under the Loan Agreement, the expected use of proceeds from the Loan Agreement, potential future financings or strategic transactions, 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, market launches, and partnership and distribution agreements. 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 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, distribution 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 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 (17) 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 Exhibit 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 Exhibit.
Company Overview
We are a vertically integrated biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Our purpose is to improve the health and quality of life of patients around the world by improving access to proven treatments for various diseases. Since our inception, we have built our company with key characteristics we believe will help us capture the substantial global market opportunity in biosimilars: a leadership team that has brought numerous successful biologics and biosimilars to market around the world; a purpose-built biosimilars research and development and manufacturing platform; commercial partnerships in global markets; and a diverse, expanding portfolio and pipeline addressing many of the biggest disease areas and health challenges globally.
We have built a portfolio and pipeline comprising two approved products and nine product candidates covering a variety of therapeutic areas, including immunology, ophthalmology, bone disease and cancer.
· | Our lead program, AVT02, a high concentration formulation biosimilar to Humira, has received regulatory approval in over 50 markets and has been launched in over 20 markets globally, including in select European countries under the trade name Hukyndra and in Canada under the trade name SIMLANDI. In the first quarter of 2024, the FDA approved our biologics license application (“BLA”) supporting interchangeability for AVT02 in the United States for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. We launched AVT02 under the trade name SIMLANDI in the United States in the second quarter of 2024. Additionally, in the second quarter of 2024, we entered into a strategic partnership agreement with Quallent Pharmaceuticals (“Quallent”), a subsidiary of the Cigna group, to distribute AVT02 under Quallent’s private label in the United States, and we entered into an agreement with STADA to extend its commercial rights to AVT02 to the Commonwealth of Independent States (CIS) countries. |
· | For AVT04, a proposed biosimilar to Stelara (ustekinumab), our commercialization partner Fuji Pharma received regulatory approval in Japan in the third quarter of 2023 and our commercialization partner JAMP Pharma received regulatory approval in Canada in the fourth quarter of 2023. Our commercialization partner STADA received approval for the European Economic Area (the “EEA”) in January 2024. AVT04 was launched under the trade name Jamteki in Canada on March 1, 2024, and we expect it to be launched in Japan in the second quarter of 2024 and in select European markets starting in the third quarter of 2024. In the second quarter of 2024, the FDA approved AVT04 for marketing in the United States as a biosimilar to Stelara under the tradename Selarsdi, which is expected to be launched in February 2025. Additionally, in the second quarter of 2024, we entered into an agreement with STADA to extend its commercial rights to AVT04 to the Commonwealth of Independent States (CIS) countries |
· | We are in advanced stages of development for AVT03, a biosimilar candidate to Prolia / Xgeva (denosumab), AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab), and AVT06, a biosimilar candidate to Eylea (aflibercept). We expect to file marketing applications and BLAs for these biosimilar candidates in 2024. In the second quarter of 2024, we signed a commercial partnership agreement with Dr. Reddy’s Laboratories Ltd. for the commercialization of AVT03 with exclusive rights for the United States and semi-exclusive rights for Europe and United Kingdom. In addition, in the second quarter of 2024, we entered into an agreement with STADA to extend the partnership to cover AVT03 pursuant to which STADA will become marketing authorization holder, upon approval of AVT03, and 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. We also regained commercial rights from STADA to AVT06 pursuant to this agreement. |
· | We are also developing through an in-license agreement with Kashiv Biosciences LLC, AVT23, a biosimilar candidate to Xolair (omalizumab). The agreement covers all 27 countries of the European Union, the UK, Australia, Canada, and New Zealand. | |
· | Our pre-clinical programs include AVT16, a biosimilar candidate to Entyvio (vedolizumab), AVT33, a biosimilar candidate to Keytruda (pembrolizumab), and three undisclosed programs. |
Recent Developments
Financial Updates
Sale of shares
On February 26, 2024, we announced that we had accepted an offer from investors to sell 10,127,132 of our ordinary shares at a $16.41 per share, for gross proceeds of approximately $166 million. The shares were delivered to the investors from the shares held in treasury by our subsidiary, Alvotech Manco ehf., through the Nasdaq Iceland Main Market.
New term loan credit agreement
On June 7, 2024, we entered into a secured term loan credit agreement (the “Loan Agreement”), by and among us, as borrower, GLAS USA LLC, as administrative agent, GLAS Americas LLC, as collateral agent, and the lenders party thereto, which provides for a term loan in an aggregate principal amount of $965.0 million (the “Term Loan”). The Term Loan is scheduled to mature on the fifth anniversary of the closing date.
Commercial Updates
Agreement with Quallent
In April 2024, we and our partner Teva announced a long-term agreement with Quallent Pharmaceuticals LLC (“Quallent”) to distribute AVT02 in the United States. Under a partnership agreement, we will manufacture AVT02 and Quallent will – distribute the product under its own private label.
Agreement with Dr. Reddy
In May 2024, we announced that we had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03. We will be responsible for development and manufacturing of the product. Dr. Reddy’s will be responsible for registration and commercialization of the product in the applicable markets. The license and supply agreement includes an upfront payment to us, with additional payments upon certain regulatory and commercialization milestones as well as sales-based payments, if AVT03 is approved. Dr. Reddy’s commercialization rights are exclusive for the United States, and semi-exclusive for the European Economic Area (excluding Iceland), the United Kingdom and Switzerland.
Agreement with STADA
In June 2024, we announced that we had entered into an agreement with STADA to amend and strengthen our strategic partnership. Under the terms of the agreement, we will be responsible for development and manufacturing AVT03 in Reykjavik, Iceland, and STADA will become marketing authorization holder, upon approval of AVT03, and 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.
In parallel with the commercial agreement for AVT03, we agreed to extend STADA’s commercial rights to AVT02 and AVT04 to Commonwealth of Independent States (CIS) countries in Central Asia, and we regained commercial rights from STADA to AVT06.
Financial Results for First Three Months of 2024
The following discussion and analysis of Alvotech’s financial condition and results of operations should be read in conjunction with Alvotech’s unaudited condensed consolidated interim financial statements and related notes and other financial information that are included elsewhere in this filing, as well as our audited consolidated financial statements and the related notes for the year ended 31 December 2023 and other financial information included in the Company’s annual report on the Form 20-F filed on 20 March 2024. The following discussion is based on Alvotech’s financial information prepared in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Some of the information contained in this discussion and analysis, including information with respect to Alvotech’s plans and strategy for its business and related financing, includes forward-looking statements that involve risks and uncertainties. Alvotech’s actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. All amounts discussed are in U.S. dollars, unless otherwise indicated.
Cash position and sources of liquidity: As of March 31, 2024, the Company had cash and cash equivalents of $64.8 million, excluding $25.0 million of restricted cash. In addition, the Company
had borrowings of $978.1 million, including $37.6 million of current portion of borrowings, as of March 31, 2024.
Product Revenue: Product revenue was $12.4 million for the three months ended March 31, 2024, compared to $15.7 million for the same three months of 2023. Revenue for the three months ended March 31, 2024, consisted of product revenue from sales of AVT02 in select European countries and Canada, launch of AVT02 in the U.S and launch of AVT04 in Canada.
License and Other Revenue: License and other revenue was $24.4 million for the three months ended March 31, 2024. No license and other revenue were recognized during the first three months ended March 31, 2023. The license and other revenue of $24.4 million was primarily attributable to the recognition of a $6.5 million research and development milestone due to the approval of AVT04 in Europe and $16.8 million relative to research and development milestone due to the CTA submission for the AVT16 clinical program.
Cost of product revenue: Cost of product revenue was $20.0 million for the three months ended March 31, 2024, compared to $39.1 million for the same three months of 2023, as a result of sales in the period, including the launch of AVT04 in Canada, tempered by lower production-related charges and other costs associated with FDA inspection readiness. Cost of product revenue for the period is disproportionate relative to product revenue due to the timing of new launches and elevated production-related charges, resulting in higher costs than revenues recognized for the period. The Company expects this relationship to continue normalizing with increased production from the scaling and expansion of new or recent launches. The Company estimates that the anticipated increase in sales volumes will result in a greater absorption of fixed manufacturing costs.
Research and development (R&D) expenses: R&D expenses were $49.9 million for the three months ended March 31, 2024, compared to $50.9 million for the same three months of 2023. The slight 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 three months of 2023, and a $17.8 million increase in direct program expenses mainly from five biosimilar candidates, AVT03, AVT05, AVT06, AVT16 and AVT23 that are in clinical phase.
General and administrative (G&A) expenses: G&A expenses were $15.5 million for the three months ended March 31, 2024, compared to $22.2 million for the same three months of 2023. The decrease in G&A expenses was primarily attributable to $3.7 million in lower 3rd party services, lower insurance premiums and less headcount, coupled with a $1.9 million decrease in expenses for share-based payments.
Finance income: Finance income was $0.8 million for the three months ended March 31, 2024, compared to $1.2 million for the same three months of 2023. This was primarily attributable to interests received on bank accounts resulting from lower cash balances versus the same period in the prior year.
Finance costs: Finance costs were $184.1 million for the three months ended March 31, 2024, compared to $207.6 million for the same three months of 2023. The decrease was primarily attributable to lower fair value of derivative liabilities from $179.1 million for the three months
ended March 31, 2023, to $140.9 million for the three months ended March 31, 2024, partially offset by an increase in interest charged on additional borrowings and convertible bonds issued during 2023.
Exchange rate differences: Exchange rate differences resulted in a gain of $6.5 million for the three months ended March 31, 2024, compared to a loss of $1.7 million for the same three months of 2023. The increase was primarily driven by the movements in the exchange rate of foreign currencies, predominantly Icelandic krona and euros.
Income tax benefit: Income tax benefit was $6.4 million for the three months ended March 31, 2024, compared to $29.4 million for the same three months of 2023. The decrease was mainly driven by a decrease in operating losses and an unfavorable foreign currency translation effect during the three months ended March 31, 2024 due to the weakening of the Icelandic krona against the U.S. dollar.
Loss for the Period: Reported net loss was $218.7 million, or ($0.89) per share on a basic and diluted basis, for the three months ended March 31, 2024, compared to a reported net loss of $276.2 million, or ($1.24) per share on a basic and diluted basis, for the same three months of 2023. As mentioned above, the net loss for the period is heavily impacted by the fair value costs associated with our derivative liabilities.
Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income or Loss | ||||
Three months ended March 31, 2024 | Three months ended March 31, 2023 | |||
USD in thousands, except for per share amounts | ||||
Product revenue | 12,430 | 15,864 | ||
License and other revenue | 24,422 | - | ||
Other income | 42 | 19 | ||
Cost of product revenue | (19,957) | (39,095) | ||
Research and development expenses | (49,868) | (50,864) | ||
General and administrative expenses | (15,488) | (22,198) | ||
Operating loss | (48,419) | (96,274) | ||
Share of net loss of joint venture | - | (1,164) | ||
Finance income | 783 | 1,226 | ||
Finance costs | (184,063) | (207,600) | ||
Exchange rate differences | 6,532 | (1,748) | ||
Non-operating loss | (176,748) | (209,286) | ||
Loss before taxes | (225,167) | (305,560) | ||
Income tax benefit | 6,438 | 29,380 | ||
Loss for the period | (218,729) | (276,180) | ||
Other comprehensive loss | ||||
Item that will be reclassified to profit or loss in subsequent periods: | ||||
Exchange rate differences on translation of foreign operations | (820) | 648 | ||
Total comprehensive loss | (219,549) | (275,532) | ||
Loss per share | ||||
Basic and diluted loss for the year per share | (0.89) | (1.24) |
Unaudited Condensed Consolidated Interim Statement of Financial Position | ||||
USD in thousands | 31 March 2024 | 31 December 2023 | ||
Non-current assets | ||||
Property, plant and equipment | 235,394 | 236,779 | ||
Right-of-use assets | 127,440 | 119,802 | ||
Goodwill | 11,779 | 12,058 | ||
Other intangible assets | 19,370 | 19,076 | ||
Contract assets | 10,356 | 10,856 | ||
Investment in joint venture | 18,494 | 18,494 | ||
Other long-term assets | 2,285 | 2,244 | ||
Restricted cash | 25,000 | 26,132 | ||
Deferred tax assets | 318,223 | 309,807 | ||
Total non-current assets | 768,341 | 755,248 | ||
Current assets | ||||
Inventories | 92,236 | 74,433 | ||
Trade receivables | 41,252 | 41,292 | ||
Contract assets | 30,059 | 35,193 | ||
Other current assets | 62,900 | 31,871 | ||
Receivables from related parties | 1,038 | 896 | ||
Cash and cash equivalents | 64,811 | 11,157 | ||
Total current assets | 292,296 | 194,842 | ||
Total assets | 1,060,637 | 950,090 |
Unaudited Condensed Consolidated Interim Statement of Financial Position | ||||
USD in thousands | 31 March 2024 | 31 December 2023 | ||
Equity | ||||
Share capital | 2,604 | 2,279 | ||
Share premium | 1,726,610 | 1,229,690 | ||
Other reserves | 38,883 | 42,911 | ||
Translation reserve | (2,348) | (1,528) | ||
Accumulated deficit | (2,424,574) | (2,205,845) | ||
Total equity | (658,825) | (932,493) | ||
Non-current liabilities | ||||
Borrowings | 940,593 | 922,134 | ||
Derivative financial liabilities | 330,976 | 520,553 | ||
Lease liabilities | 110,585 | 105,632 | ||
Contract liabilities | 88,913 | 73,261 | ||
Deferred tax liability | 1,610 | 53 | ||
Total non-current liabilities | 1,472,677 | 1,621,633 | ||
Current liabilities | ||||
Trade and other payables | 50,175 | 80,563 | ||
Lease liabilities | 11,161 | 9,683 | ||
Current maturities of borrowings | 37,550 | 38,025 | ||
Liabilities to related parties | 24,532 | 9,851 | ||
Contract liabilities | 46,258 | 59,183 | ||
Taxes payable | 1,096 | 925 | ||
Other current liabilities | 76,013 | 62,720 | ||
Total current liabilities | 246,785 | 260,950 | ||
Total liabilities | 1,719,462 | 1,882,583 | ||
Total equity and liabilities | 1,060,637 | 950,090 |
Unaudited Condensed Consolidated Interim Statements of Cash Flows | ||||
USD in thousands | Three months ended March 31, 2024 | Three months ended March 31, 2023 | ||
Cash flows from operating activities | ||||
Loss for the year | (218,729) | (276,180) | ||
Adjustments for non-cash items: | ||||
Long-term incentive plan expense | - | 6,449 | ||
Depreciation and amortization | 7,190 | 4,841 | ||
Change in allowance for receivables | - | 18,500 | ||
Change in inventory reserves | (5,379) | - | ||
Share of net loss of joint venture | - | 1,164 | ||
Finance income | (783) | (1,226) | ||
Finance costs | 184,063 | 207,600 | ||
Share-based payments | 2,828 | - | ||
Exchange rate difference | (6,532) | 1,748 | ||
Income tax benefit | (6,438) | (29,380) | ||
Operating cash flow before movement in working capital | (43,780) | (66,484) | ||
Increase in inventories | (12,424) | (3,766) | ||
Increase in trade receivables | 40 | 2,952 | ||
Increase / (decrease) in liabilities with related parties | 14,539 | (573) | ||
(Increase) / decrease in contract assets | 5,634 | 895 | ||
Increase in other assets | (2,959) | 5,246 | ||
Increase in trade and other payables | (28,927) | (18,600) | ||
Increase in contract liabilities | 4,176 | 616 | ||
(Decrease) / increase in other liabilities | (7,139) | (4,477) | ||
Cash used in operations | (70,840) | (84,191) | ||
Interest received | 26 | 21 | ||
Interest paid | (4,403) | (1,845) | ||
Income tax paid | (186) | (116) | ||
Net cash used in operating activities | (75,403) | (86,131) |
Cash flows from investing activities | ||||
Acquisition of property, plant and equipment | (4,069) | (11,327) | ||
Acquisition of intangible assets | (543) | (2,548) | ||
Restricted cash in connection with amended bond agreement | 1,132 | - | ||
Net cash used in investing activities | (3,480) | (13,875) | ||
Cash flows from financing activities | ||||
Repayments of borrowings | (1,629) | (50,812) | ||
Repayments of principal portion of lease liabilities | (2,338) | (1,525) | ||
Proceeds from new borrowings | - | 60,421 | ||
Gross proceeds from equity offering | 138,049 | 136,879 | ||
Fees from equity offering | (5,743) | (4,141) | ||
Proceeds from warrants | 4,841 | 6,365 | ||
Net cash generated from financing activities | 133,180 | 147,187 | ||
Decrease in cash and cash equivalents | 54,297 | 47,181 | ||
Cash and cash equivalents at the beginning of the period | 11,157 | 66,427 | ||
Effect of movements in exchange rates on cash held | (643) | 2,236 | ||
Cash and cash equivalents at the end of the period | 64,811 | 115,844 |