Eagle Pharmaceuticals(US:EGRX)2022-11-08 16:00Revenue and Sales Performance - The company reported revenue from product sales, including PEMFEXY, vasopressin, Ryanodex, Belrapzo, Bendeka, Treakisym, BARHEMSYS, and BYFAVO, through September 30, 2022[216]. - Total revenue for the three months ended September 30, 2022, was $65.9 million, an increase of $26 million compared to $39.9 million for the same period in 2021[224]. - Product sales increased by $26 million, primarily driven by vasopressin sales of $13.8 million and Pemfexy sales of $1.7 million, both launched in Q1 2022[224]. - Total revenue for the nine months ended September 30, 2022, was $255.9 million, an increase of $126.7 million (98.1%) compared to $129.2 million for the same period in 2021[237]. - Product sales increased by $128.5 million, primarily driven by the launches of Pemfexy and vasopressin, which together contributed $114.9 million in sales[239]. Acquisitions and Investments - The company acquired Acacia Pharma Group plc on June 9, 2022, adding two FDA-approved products, BARHEMSYS and BYFAVO, which expand its presence in the acute care market[196]. - The company entered into a Securities Purchase Agreement with Enalare Therapeutics Inc. on August 8, 2022, committing up to $55 million in equity investments[198]. - The company invested $12.5 million in Enalare in August 2022, with a contractual obligation to invest an additional $12.5 million six months later[264]. Expenses and Financial Metrics - Total cost of revenue for the three months ended September 30, 2022, was $23.7 million, an increase of $15.4 million from $8.3 million in the same period in 2021[227]. - Research and development expenses decreased by $14 million to $9.3 million, primarily due to lower spending on CAL02 and landiolol[230]. - Selling, general and administrative expenses increased by $5 million to $23.5 million, attributed to external sales and marketing costs and headcount costs for product re-launches[231]. - Interest expense rose by $0.8 million to $1.1 million due to a higher level of outstanding debt[234]. - Other net expenses increased to $13.1 million, primarily due to $6.4 million in foreign exchange losses and $4.2 million in fair value adjustments related to a promissory note write-off[235]. - The effective tax rate for the three months ended September 30, 2022, was (95)%, reflecting non-deductible executive compensation and acquisition costs[236]. - Net income for the nine months ended September 30, 2022, was $27.5 million, with a working capital surplus of $63.2 million[254]. - Cash and cash equivalents decreased to $15.4 million as of September 30, 2022, down from $99.7 million in the prior year[252]. - Net cash used in investing activities was $86.8 million, primarily due to the acquisition of Acacia and an equity investment in Enalare[257]. - The effective tax rate for the nine months ended September 30, 2022, was 43%, reflecting an interim tax provision impacted by non-deductible costs from the Acacia acquisition[250]. Research and Development - The company has several pipeline projects with potential for first-in-class or best-in-class products, including Ryanodex for acute radiation syndrome and EA-114 for HR-positive advanced breast cancer[197]. - The company expects to start a Phase 2b/3 clinical trial for CAL02, a novel anti-infective agent, later in 2022[211]. - Research and development expenses decreased by $20.6 million (43.4%) to $26.9 million, primarily due to the non-recurrence of costs related to vasopressin and Ryanodex projects[243]. - Clinical trial timelines for certain product candidates have been delayed due to limited patient enrollment, with ongoing impacts expected for the duration of the pandemic[259]. - The company anticipates potential delays in regulatory activities and clinical development timelines due to the pandemic[259]. Impact of COVID-19 and Macroeconomic Conditions - The company has taken measures to mitigate the impact of the COVID-19 pandemic on its business, including remote working policies and frequent updates to management[213]. - The COVID-19 pandemic has caused variable impacts on the company's business and financial condition, with expectations of continued effects on operations and supply chains[259]. - The company is monitoring global macroeconomic conditions, including inflation and supply chain disruptions, which could adversely affect its business[214]. - The company is monitoring the impacts of geopolitical tensions, inflation, and supply chain disruptions on its business operations[262]. - The company has not experienced material adverse effects on liquidity from the COVID-19 pandemic but acknowledges the evolving situation could impact future capital access[261]. - The company has incurred an insignificant amount of incremental administrative costs related to the COVID-19 pandemic[259]. - As of September 30, 2022, the company had purchase obligations totaling $99.4 million under contract manufacturing and supply agreements[264]. - The company expects future cash flows from operations to be sufficient to meet working capital requirements for the next 12 months, despite potential disruptions in global financial markets[261]. - Total obligations as of September 30, 2022, amounted to $174.8 million, including operating leases and credit facilities[265].