Revenue and Sales Performance - TriSalus reported a revenue increase driven primarily by sales of its PEDD infusion systems, particularly the TriNav, with a gross margin that allows for substantial funding of growth and R&D [227][230]. - Revenue increased by $2.7 million, or 42.0%, for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to increased sales of TriNav [239]. Product Development and Clinical Trials - The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter in 2024, expanding its PEDD device portfolio to optimize therapeutic delivery for larger vessels [215][216]. - A registry study called PROTECT aims to enroll 100 patients and is expected to expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity [217]. - The company completed Phase I clinical trials for nelitolimod and is exploring partnerships for further development, with data expected in 2025 [218]. - The MDACC Agreement was modified and extended to include a sixth year, enhancing collaboration for ongoing clinical studies [222]. Financial Position and Cash Flow - Cash and cash equivalents were approximately $13.0 million at March 31, 2025, with a minimum cash requirement increased from $5.0 million to $10.0 million [250]. - Net cash used in operating activities was $4.5 million for the three months ended March 31, 2025, compared to $10.9 million for the same period in 2024 [251]. - Net cash provided by financing activities was $9.7 million for the three months ended March 31, 2025, primarily from the First Delayed draw under the OrbiMed Credit Agreement [256]. Expenses and Losses - Gross profit increased by $2.2 million, or 39.8%, for the three months ended March 31, 2025, with gross margin decreasing to 83.7% from 85.0% [241]. - Research and development expenses decreased by $2.5 million, or 43.6%, for the three months ended March 31, 2025, primarily due to reduced clinical trial expenses [242]. - General and administrative expenses increased by $0.3 million, or 7.4%, for the three months ended March 31, 2025, mainly due to professional services related to filing and audit expenses [245]. - Net loss available to common stockholders was $10.4 million for the three months ended March 31, 2025, compared to a net loss of $13.2 million for the same period in 2024 [238]. Funding and Capital Requirements - TriSalus secured a $10 million loan under the OrbiMed Credit Agreement, contingent on achieving a $30 million revenue base [221]. - The company anticipates gross proceeds of approximately $22 million from a private placement of 5.5 million shares at $4.00 per share, closing on May 2, 2025 [225]. - The company expects to finance its cash needs through a combination of securities offerings, debt financings, collaborations, strategic alliances, and licensing arrangements [260]. - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2025, due to its reliance on generating sufficient cash flows or obtaining additional capital [263]. - If the company is unable to raise additional capital, it may have to delay or terminate product development efforts [261]. - The company may face dilution of existing ownership interests if it raises additional capital through equity or convertible debt securities [260]. Regulatory and Compliance Matters - TriSalus received a permanent HCPCS code for the TriNav Infusion System effective January 1, 2024, which may enhance reimbursement clarity and support sales [214]. - The expiration of the TPT payment program in December 2023 poses a risk to maintaining current pricing and gross margins for TriNav [219]. - The company is subject to affirmative and restrictive covenants under the OrbiMed Credit Agreement, which may limit its operational flexibility [260]. - The company does not currently have any off-balance sheet financing arrangements or relationships with unconsolidated entities [266]. - The company’s critical accounting policies have not changed significantly during the three months ended March 31, 2025, compared to the previous year [267]. Other Financial Liabilities - The fair value of the SEPA, warrant, and revenue base redemption liabilities changed by $3.4 million, resulting in a loss of $0.8 million for the three months ended March 31, 2025 [247]. - The company has paid Dynavax $12.0 million as of March 31, 2025, with potential additional payments of up to $158 million upon achieving certain milestones related to nelitolimod [265]. - The company may be required to pay up to $80 million upon achieving certain commercial milestones for nelitolimod, subject to obtaining marketing approval [265].
TriSalus Life Sciences(TLSI) - 2025 Q1 - Quarterly Report