MeiraGTx(MGTX) - 2022 Q4 - Annual Report

Financial Performance - The company has incurred significant losses since inception and anticipates continued losses for the foreseeable future, with no assurance of achieving profitability[16]. - Net loss for 2022 was $129,615,000, compared to a net loss of$79,561,000 in 2021, indicating an increase in losses of about 62.9%[668]. - The Company's pre-tax loss for the year ended December 31, 2022, was $129,616,000, compared to a loss of$79,561,000 in 2021, representing a 62.8% increase[788]. - For the year ended December 31, 2022, the Company used $73.1 million in cash flows from operations, with no assurance of generating positive cash flows in the future[674]. - The Company has an accumulated deficit of$470.2 million as of December 31, 2022, and expects to incur substantial losses in future periods[674]. Revenue and Expenses - License revenue from related parties fell significantly from $37,701,000 in 2021 to$15,920,000 in 2022, a decrease of about 57.8%[668]. - Total operating expenses increased from $110,459,000 in 2021 to$132,275,000 in 2022, representing a rise of approximately 19.7%[668]. - Research and development expenses increased from $66,694,000 in 2021 to$85,725,000 in 2022, a rise of about 28.5%[668]. - The Company recognized collaboration revenue of $100.0 million from Janssen as a non-refundable upfront fee during the year ended December 31, 2019, and a milestone payment of$30.0 million in 2021[806]. - For the years ended December 31, 2022 and 2021, the Company recognized $15.9 million and$37.7 million, respectively, as license revenue from deferred revenue related to a related party[807]. Assets and Liabilities - Total assets decreased from $320,164,000 in 2021 to$318,237,000 in 2022, a decline of approximately 0.6%[666]. - Cash and cash equivalents decreased from $137,703,000 at the end of 2021 to$115,516,000 at the end of 2022, a reduction of approximately 16.1%[670]. - Total current liabilities rose from $68,128,000 in 2021 to$82,072,000 in 2022, an increase of about 20.5%[666]. - Shareholders' equity decreased from $185,401,000 in 2021 to$117,738,000 in 2022, a decline of approximately 36.5%[666]. - The company's long-lived assets totaled $163.9 million as of December 31, 2022, compared to$136.9 million in 2021, reflecting a growth of approximately 19.7%[754]. Capital and Financing - The annual interest rate on borrowings under the Note Purchase Agreement was 13.02% as of December 31, 2022, with an outstanding balance of $75.0 million[657]. - The outstanding balance of the Tranche 1 Notes was$75.0 million plus accrued interest of $4.0 million as of December 31, 2022, with an annual interest rate of 13.02$75.0 million, with an option for an additional $25.0 million before August 2, 2024[828]. - The Company may seek additional capital through equity offerings, debt financings, and collaborations to support product development and commercialization[680]. - The Company raised approximately$25.0 million through a private placement of 3,742,514 ordinary shares at $6.68 per share on November 9, 2022[783]. Regulatory and Compliance Risks - The company is heavily dependent on the success of its Most Advanced Product Candidates, which are still in development, and failure to receive regulatory approval could harm the business[16]. - Compliance with privacy and data protection regulations is complex and costly, and failure to comply could materially harm the business[16]. - The Company operates in a highly competitive industry with significant risks, including uncertainty in product development and capital availability[678]. - The impact of the COVID-19 pandemic on the Company's financial position and operations remains uncertain, although it did not materially affect results in 2022[679]. Research and Development - The company has six programs in clinical development and a broad pipeline of preclinical and research programs, focusing on ocular diseases, neurodegenerative diseases, and severe forms of xerostomia[671]. - Research and development costs are charged to expense as incurred, including employee-related expenses and costs associated with clinical studies[740]. - The Company recorded reductions to research and development expenses of$6.8 million and $5.4 million for the years ended December 31, 2022, and 2021, respectively, related to tax incentive programs[689]. Tax and Deferred Tax - As of December 31, 2022, the Company had U.S. federal NOLs of$63,829,000 and UK carryforward tax losses of $187,939,000[11]. - The Company recorded deferred tax assets of$125,365,000 as of December 31, 2022, an increase from $100,340,000 in 2021[791]. - The Company has determined that it is more likely than not that its deferred tax assets will not be fully realized, resulting in a full valuation allowance[791]. - The UK corporation tax rate will increase from 19$16.1 million in 2022, compared to $14.8 million in 2021, representing an 8.8$12.5 million in 2022, significantly higher than $6.0 million in 2021, marking a 108.3$24.7 million, expected to be recognized over 4.0 years[778]. - The total compensation expense related to unvested RSUs as of December 31, 2022, was $26.9 million, expected to be recognized over 3.0 years[781].