Kala Pharmaceuticals(US:KALA)2024-11-12 21:01Financial Performance - The net loss for the three and nine months ended September 30, 2024, was $9.0 million and $30.3 million, respectively, with an accumulated deficit of $659.7 million as of that date[116]. - Net loss for Q3 2024 was $8.95 million, compared to a net loss of $8.70 million in Q3 2023, an increase in loss of $0.25 million[139]. - Net loss for the nine months ended September 30, 2024, was $30.34 million, a decrease in loss of $3.24 million compared to a net loss of $33.57 million in the same period of 2023[147]. - Grant income for Q3 2024 was $1.9 million, down from $3.0 million in Q3 2023, a decrease of $1.1 million[145]. - Grant income for the nine months ended September 30, 2024, was $4.0 million, up from $3.0 million in 2023, related to the CIRM Award[154]. - Total operating expenses for Q3 2024 were $9.99 million, an increase of $1.23 million compared to $8.76 million in Q3 2023[139]. - Total operating expenses for the nine months ended September 30, 2024, were $31.52 million, an increase of $1.48 million from $30.04 million in the same period of 2023[147]. Research and Development - KPI-012 is currently in Phase 2b clinical development, with topline safety and efficacy data expected to be reported in the second quarter of 2025[110]. - The company has initiated the CHASE trial, which includes approximately 90 patients and aims to evaluate the safety and tolerability of two doses of KPI-012[109]. - The company expects research and development costs for 2024 to be higher than those for the year ended December 31, 2023, due to ongoing clinical development activities[124]. - Research and development expenses for Q3 2024 were $5.17 million, a decrease of $0.39 million from $5.55 million in Q3 2023[142]. - Research and development expenses for the nine months ended September 30, 2024, were $16.84 million, an increase of $2.97 million from $13.87 million in the same period of 2023[149]. - Research and development expenses are expected to increase substantially as Combangio advances the clinical development of KPI-012 and other product candidates[180]. Financing and Cash Flow - The company has incurred significant losses from operations and negative cash flows, financing operations primarily through the sale of its Commercial Business to Alcon and various stock offerings[116]. - The company has paid $2.6 million in cash and $2.4 million in shares of common stock as part of the contingent consideration related to the Combangio acquisition[128]. - The company may be required to pay up to $105.0 million in contingent milestone payments to former Combangio equityholders based on specified development and commercialization milestones[128]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $24.8 million, an increase of $4.6 million compared to the same period in 2023[177]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $23.2 million, significantly up from $6.0 million in the prior year[179]. - The company entered into a Loan Agreement with Oxford Finance for a term loan of up to $125.0 million, with an outstanding principal balance of $34.0 million as of January 25, 2023[162]. - As of September 30, 2024, the aggregate principal amount outstanding under the Loan Agreement was $34.0 million[191]. - The interest rate on the Loan Agreement changed to a floating rate effective July 1, 2023, with a minimum of 8.00%[191]. Acquisitions and Milestones - The company sold its Commercial Business to Alcon in July 2022 for an upfront cash payment of $60.0 million and is eligible for up to $325.0 million in milestone payments based on future sales of EYSUVIS and INVELTYS[156]. - The acquisition of Combangio includes potential milestone payments totaling $40 million for development and regulatory achievements, and an additional $65 million based on future sales[173]. - Combangio received a $15 million grant from CIRM to support the KPI-012 program, with $5.9 million disbursed in August 2023 and an additional $3.2 million expected in August 2024 upon milestone achievement[172]. Operational Insights - The company has opened 44 trial sites for the CHASE trial in the United States and is expanding to Latin America[109]. - The company expects general and administrative expenses for 2024 to be comparable to those for the year ended December 31, 2023[121]. - General and administrative expenses for the nine months ended September 30, 2024, were $14.14 million, a decrease of $1.80 million from $15.94 million in the same period of 2023[148]. - Interest income for Q3 2024 was $0.57 million, down from $0.70 million in Q3 2023, a decrease of $0.13 million[143]. - Interest expense for Q3 2024 was $1.48 million, slightly up from $1.46 million in Q3 2023[144]. - Interest expense for the nine months ended September 30, 2024, was $4.4 million, compared to $4.3 million for the same period in 2023, with $34.0 million of indebtedness outstanding under the Loan Agreement[153]. Risks and Uncertainties - The company faces significant risks and uncertainties in achieving profitability, with no expected revenue from KPI-012 or other candidates in the foreseeable future[185]. - Future financing needs may require Combangio to raise additional capital through various means, which could dilute existing ownership interests[187]. - The company may need to delay or limit product development if it fails to secure additional funding when needed[189]. - Combangio anticipates that existing cash resources will fund operations into the fourth quarter of 2025, but may not be sufficient for completing clinical development of KPI-012[183]. Compliance and Controls - There were no changes in internal control over financial reporting during the three-month period ended September 30, 2024[194]. - The company’s disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of September 30, 2024[193]. - The company is not currently subject to any material legal proceedings[195].