Verona Pharma(VRNA) - 2023 Q4 - Annual Results

Financial Performance - The net loss for Q4 2023 was $14.1 million, compared to a net loss of $10.5 million in Q4 2022[10][15]. - Revenue for Q4 2023 was $0, unchanged from Q4 2022, while total revenue for the year was also $0, consistent with the previous year[21]. - Gross profit for Q4 2023 was $0, maintaining the same level as Q4 2022, with a gross profit of $112,000 for the year[21]. - The net loss for Q4 2023 was $14,132,000, compared to a net loss of $10,451,000 in Q4 2022, with a total net loss of $54,369,000 for the year versus $68,701,000 in 2022[21]. - Loss per ordinary share for Q4 2023 was $0.02, consistent with Q4 2022, while the annual loss per share was $0.09 compared to $0.13 in 2022[21]. Research and Development - R&D expenses for the fourth quarter of 2023 were $4.1 million, down from $6.8 million in Q4 2022, primarily due to reduced clinical trial costs[10][11]. - Full-year R&D expenses for 2023 totaled $17.2 million, significantly down from $49.3 million in 2022, reflecting the completion of the Phase 3 ENHANCE program[10][15]. - The company plans to submit an IND for a fixed-dose combination formulation of ensifentrine and glycopyrrolate in the second half of 2024[10][12]. Selling, General and Administrative Expenses - SG&A expenses for Q4 2023 were $15.0 million, up from $8.3 million in Q4 2022, driven by increased personnel and commercialization preparation costs[10][15]. - Full-year SG&A expenses for 2023 were $50.4 million, an increase from $26.6 million in 2022, largely due to costs associated with building commercial infrastructure[10][15]. - Selling, general and administrative expenses increased to $14,972,000 in Q4 2023 from $8,323,000 in Q4 2022, with total expenses for the year rising to $50,353,000 from $26,579,000[21]. Cash and Assets - Cash and cash equivalents at December 31, 2023, were $271.8 million, an increase from $227.8 million at the end of 2022[10]. - Cash and cash equivalents increased to $271,772,000 in Q4 2023 from $227,827,000 in Q4 2022[21]. - Total assets rose to $308,124,000 in Q4 2023, up from $259,468,000 in Q4 2022[21]. - Shareholders' equity increased to $249,283,000 in Q4 2023 from $230,466,000 in Q4 2022[21]. Debt Financing and Future Plans - The company completed a $400 million debt financing facility in December 2023 to support commercialization and pipeline expansion[5][10]. - The FDA has assigned a PDUFA target action date of June 26, 2024, for the NDA of ensifentrine, which is aimed at treating COPD[10]. - The company expects to launch ensifentrine in the US market in the second half of 2024, pending FDA approval[10][7]. - The weighted average shares outstanding for Q4 2023 was 642,139,211, compared to 604,204,929 in Q4 2022[21].