Orchard Therapeutics plc(US:ORTX)2023-03-14 11:31Financial Performance - For the year ended December 31, 2022, the company reported a net loss of $150.7 million, with an accumulated deficit of $900.9 million as of the same date[563]. - Total revenues for 2022 were $22.7 million, a significant increase of $21.0 million compared to $1.7 million in 2021[585]. - Product revenue, net, was $20.6 million in 2022, up from $700,000 in 2021, primarily driven by the commercial sale of Libmeldy[586]. - Collaboration revenue increased to $2.0 million in 2022 from $975,000 in 2021, reflecting growth in partnerships[585]. - Collaboration revenue increased from $1.0 million in 2021 to $2.0 million in 2022, reflecting a 100% growth under the collaboration agreement with Pharming[588]. - The company reported a net loss of $150.7 million for the year ended December 31, 2022[601]. Expenses - Research and development expenses for 2022 were $93.8 million, an increase of $6.9 million from $87.0 million in 2021[585]. - Total research and development expenses increased from $86.98 million in 2021 to $93.85 million in 2022, a rise of 8%[590]. - Direct research and development expenses decreased by $1.1 million, or 2%, from $46.6 million in 2021 to $45.5 million in 2022[590]. - Indirect research and development expenses rose by $7.9 million, or 20%, from $40.4 million in 2021 to $48.3 million in 2022[591]. - Selling, general, and administrative expenses decreased from $54.9 million in 2021 to $49.1 million in 2022, a reduction of 11%[592]. - The company expects to incur significant expenses and increasing operating losses for the foreseeable future, necessitating substantial additional funding[564]. Cash Flow and Funding - Net cash used in operating activities was $76.0 million in 2022, compared to $125.1 million in 2021, indicating improved cash flow management[600][601]. - Net cash provided by investing activities was $90.6 million in 2022, primarily from sales and maturities of marketable securities[603]. - The company has $34 million received in March 2023 from a private placement, which will fund operations into 2025[610]. - The company announced a private placement on March 6, 2023, expected to generate up to $68 million, contingent on FDA meeting outcomes and shareholder approval[598]. Product Development and Commercialization - The company plans to continue its commercialization strategy for Libmeldy, focusing on severe neurometabolic diseases and reducing workforce by approximately 30%[565]. - Libmeldy received approval from the European Commission in December 2020, with the first commercial sale occurring in Q1 2022[587]. - The company has transitioned from a clinical development stage to a commercial stage following the approval of Libmeldy in Europe[563]. - Libmeldy product sales began in January 2022, following European Commission approval in December 2020[623]. - The company is actively seeking marketing approvals for its product candidates that successfully complete clinical trials[608]. - The company plans to expand its sales, marketing, and distribution infrastructure for Libmeldy in Europe[608]. - The company is focused on developing additional product candidates and establishing in-house manufacturing operations[614]. Financial Position and Investments - As of December 31, 2022, the company had cash, cash equivalents, marketable securities, and restricted cash totaling $148.0 million[632]. - The company has borrowed $33.0 million under its credit facility, with a carrying value of term loans at $32.7 million[633]. - The credit facility bears a variable interest rate of 5.95% plus LIBOR, which was amended in January 2023 to reference SOFR instead[634]. - The company’s investment portfolio is conservative, focusing on capital preservation with short-term maturities, minimizing the impact of interest rate changes[632]. - The company has not entered into investments for trading or speculative purposes, indicating a risk-averse investment strategy[632]. Currency and Foreign Exchange - The company recorded realized and unrealized foreign currency losses of $24.3 million and $1.2 million for the years ended December 31, 2022, and 2021, respectively[636]. - The company does not currently engage in currency hedging activities but may consider it in the future[638]. - The company’s functional currency is U.S. dollars, as it predominantly raises finance and expends cash in U.S. dollars[635]. - Foreign currency transaction gains and losses are included in other (expense) income in the consolidated statements of operations[636]. - The company may use foreign currency forward and swap contracts in the future to manage currency risks[638].