TriSalus Life Sciences(TLSI)

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TriSalus Life Sciences(TLSI) - 2024 Q2 - Quarterly Report
2024-08-14 20:05
Financial Performance - Revenue increased by $2.8 million, or 59.7%, for the three months ended June 30, 2024, compared to the same period in 2023, primarily due to increased sales of TriNav[175]. - Gross profit increased by $2.6 million, or 68.0%, for the three months ended June 30, 2024, with gross margin rising to 87.6% from 83.3% in the same period last year[176]. - Revenue increased by $6.2 million, or 82.0%, for the six months ended June 30, 2024, compared to the same period in 2023, primarily due to increased sales of TriNav[188]. - Gross profit increased by $5.8 million, or 93.7%, for the six months ended June 30, 2024, with gross margin percentage rising to 86.4% from 81.1%[188]. - The net loss attributable to common stockholders was $5.1 million for the three months ended June 30, 2024, compared to a net loss of $15.996 million in the same period of 2023[173]. - The company incurred net losses of $17.6 million for the six months ended June 30, 2024, and expects to continue incurring losses due to ongoing investments in R&D and marketing[195]. Research and Development - The DELIVER program aims to evaluate the TriNav system across complex patient populations, with the first clinical study named "PROTECT" focusing on thyroid disease[154][155]. - TriSalus is currently in Phase 1 human trials for nelitolimod, with no guarantee of favorable data or FDA approval[144]. - R&D expenses decreased by $2.2 million, or 32.2%, for the three months ended June 30, 2024, mainly due to reduced clinical trial expenses related to nelitolimod[178]. - R&D expenses decreased by $2.0 million, or 15.8%, primarily due to a reduction in clinical trial expenses related to nelitolimod[189]. Capital and Financing - TriSalus reported a total consideration of $220.0 million for the Business Combination, payable in approximately 22,000,000 shares of MTAC common stock[142]. - The OrbiMed Credit Agreement provides for up to $50.0 million in senior secured term debt, with an initial commitment of $25.0 million borrowed on April 30, 2024[146][147]. - The company raised $6.7 million from the sale of 750,000 shares of common stock under the SEPA during the six months ended June 30, 2024[196]. - The company anticipates needing additional capital to fund operations and execute its long-term business strategy, with substantial doubt regarding its ability to continue as a going concern as of June 30, 2024[206]. Expenses - Sales and marketing expenses increased by $2.5 million, or 71.9%, for the three months ended June 30, 2024, driven by higher payroll and travel expenses due to increased headcount[179]. - General and administrative expenses decreased by $0.9 million, or 19.2%, for the three months ended June 30, 2024, primarily due to prior period legal and consulting expenses not repeated this year[180]. - Sales and marketing expenses increased by $6.0 million, or 88.3%, driven by higher payroll and travel expenses due to increased headcount[189]. Liabilities and Obligations - As of June 30, 2024, the company has lease obligations totaling $1.5 million for its principal administrative and production facility and other office spaces[207]. - The company has paid Dynavax $12 million as of June 30, 2024, with potential additional payments of up to $158 million upon achieving certain development and regulatory milestones for nelitolimod[208]. - Subject to marketing approval for nelitolimod, the company may also pay up to $80 million upon achieving certain commercial milestones[208]. - The Dynavax Agreement includes low double-digit royalties based on future net sales of products containing nelitolimod, with potential reductions of up to 50% under certain circumstances[208]. Other Financial Information - The expiration of the TPT payment program on December 31, 2023, may impact TriNav sales and revenue generation[144]. - The company has yet to generate sufficient revenues to drive positive cash flows from operations[141]. - Interest income increased by $0.1 million, or 169.4%, for the three months ended June 30, 2024, attributed to additional interest from investments in short-term money market funds[181]. - Interest expense increased by $0.9 million for the three months ended June 30, 2024, due to interest incurred on the OrbiMed loan[182]. - The change in fair value of SEPA, warrant, and revenue base redemption liabilities resulted in a loss of $9.0 million for the three months ended June 30, 2024, compared to a gain of $1.1 million in the same period last year[184]. - The change in fair value of contingent earnout liability resulted in a gain of $13.7 million for the three months ended June 30, 2024, due to the lower market price of the underlying common stock[185]. - A gain of $9.7 million was recorded for the change in fair value of earnout liabilities for the six months ended June 30, 2024, due to a lower market price of the underlying common stock[193]. - There are no off-balance sheet financing arrangements or relationships with unconsolidated entities as of the reporting period[209]. - There have been no significant changes in critical accounting policies during the six months ended June 30, 2024, compared to the previous year[210].
TriSalus Life Sciences: Falling Despite Moving Forward Into The Market
Seeking Alpha· 2024-06-25 19:17
Core Viewpoint - TriSalus Life Sciences, Inc. (TLSI) is a device manufacturer focused on organ-targeted therapy delivery mechanisms, with ongoing efforts to develop its own drug to complement its devices, presenting a potential investment opportunity as the market cap has declined significantly [1][13]. Pipeline Updates - TLSI's platform aims to improve tumor uptake of chemotherapy agents in organ-restricted cancers, particularly liver and pancreatic cancers, with optimism surrounding its use in liver metastases from uveal melanoma [2]. - The company is developing nelitolimod (formerly SD-101), a TLR9 activator, which is being evaluated in various solid tumors, including liver metastases and primary liver cancers [3]. Clinical Data - At the Annual Meeting of the Society of Interventional Radiology, the PERIO-03 study demonstrated the feasibility of delivering nelitolimod via pancreatic retrograde venous infusion in 5 patients without immediate complications [4]. - The ASCO Annual Meeting presented more promising data from the PERIO-02 study, where nelitolimod achieved disease control in all 3 patients treated, with no safety concerns noted across 23 patients [5]. Financial Overview - As of the latest quarterly filing, TLSI reported $13.2 million in current assets, including $4.0 million in cash, with a net loss of $13.2 million after operational expenses of $11.7 million [7]. - The company secured $50 million in financing from OrbiMed, extending its cash runway to just over one year, with an additional potential $25 million based on revenue targets [8]. Strengths and Risks - TLSI has seen rapid sales growth from its approved devices, which supports ongoing drug development efforts and provides some financial stability [9]. - Early clinical data for nelitolimod is encouraging, with no major safety concerns reported, although caution is advised due to the small patient cohorts [10]. - Despite securing financing, TLSI's cash runway remains a concern, with quarterly sales doubling year-over-year but still facing significant cash burn [11][12]. Bottom Line Summary - TLSI's market cap has dropped to around $150 million, making it appear more attractive given its two marketed devices generating growing sales, although cash concerns persist [13].
TriSalus Life Sciences(TLSI) - 2024 Q1 - Earnings Call Transcript
2024-05-15 15:40
Financial Data and Key Metrics Changes - Company reported a remarkable 116% growth in revenues, reaching $6.5 million, driven solely by the success of the TriNav device in the U.S. This represents the highest quarterly sales in the company’s history [9][15]. - Gross margin improved to 85% in Q1 2024, up from 78% in Q1 2023, attributed to increased factory volumes and operational efficiencies [17][25]. - Operating losses for Q1 2024 totaled $11.7 million, compared to $10.1 million in Q1 2023, primarily due to higher operating expenses in sales and marketing, R&D, and general administrative expenses [37]. Business Line Data and Key Metrics Changes - The growth in revenue was entirely from the sale of TriNav, with the company capturing 32 net new hospital accounts, exceeding internal projections due to pent-up demand [15][16]. - Account utilization increased to 14.5 units per account compared to 11.2 units in Q1 2023, indicating stronger adoption of the TriNav device [16]. Market Data and Key Metrics Changes - The company has achieved a compound annualized growth rate of approximately 50% since the launch of the TriNav product in 2020, with expectations for continued growth over 50% in 2024 [26]. Company Strategy and Development Direction - The company is positioning TriNav to become the standard-of-care for complex patients and is implementing educational and reimbursement support programs to facilitate adoption [12]. - The launch of TriNav Large is anticipated in the second half of the year, with ongoing clinical trials for nelitolimod expected to yield promising results [12][13]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% top-line revenue growth and advancing the pipeline, supported by recent positive developments in reimbursement and robust clinical data [14]. - The company is focused on pursuing indications with low competitive environments and significant treatment effects, with a comprehensive evaluation of clinical data expected in the third quarter [27]. Other Important Information - The company closed a debt financing facility in April, borrowing $25 million with an additional $25 million available, which is expected to provide sufficient runway to fund operations through the end of 2025 [38]. - General and administrative expenses increased by 30% compared to Q1 2023, primarily due to costs associated with becoming a public company [20]. Q&A Session Summary Question: Upcoming data readouts for nelitolimod and their impact on future decisions - Management is waiting for recently enrolled patients to reach the six-month mark for a comprehensive evaluation, with plans to pursue indications based on competitive environment and treatment effect [27]. Question: Preparation efforts for the commercial launch of TriNav Large - The company has conducted extensive market evaluations and validated the need for a larger size of TriNav, with plans to launch in the fourth quarter [34][42].
TriSalus Life Sciences(TLSI) - 2024 Q1 - Quarterly Report
2024-05-15 13:07
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission file number 001-39813 TRISALUS LIFE SCIENCES, INC. Registrant's telephone number, including area code N/A (Forme ...
TriSalus Life Sciences(TLSI) - 2024 Q1 - Quarterly Results
2024-05-15 12:30
Exhibit 99.1 In May, TriSalus announced the appointment of Liselotte Hyveled to its Board of Directors. Ms. Hyveled currently serves as the Chief Patient Officer at Novo Nordisk, where she is responsible for ensuring the integration of patient needs and perspectives into the company's decision-making processes and operations. She brings over two decades of experience stimulating scientific innovation and advancing pharmaceutical pipelines through research and development excellence. · Reported revenues of $ ...
TriSalus Life Sciences(TLSI) - 2023 Q4 - Annual Report
2024-04-11 20:36
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________ FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number 001-39813 __________________________________ TRISALUS LIFE SCIENCES, INC. ...
TriSalus Life Sciences(TLSI) - 2023 Q4 - Earnings Call Transcript
2024-04-01 14:56
TriSalus Life Sciences, Inc. (NASDAQ:TLSI) Q4 2023 Earnings Conference Call April 1, 2024 9:00 AM ET Company Participants Jim Young - Senior Vice President, Investor Relations and Treasurer Mary Szela - President and CEO Sean Murphy - Chief Financial Officer Dr. Steven Katz - Chief Medical Officer Conference Call Participants Jason McCarthy - Maxim Group Operator Good morning. And welcome to TriSalus Life Sciences Fourth Quarter and Full Year 2023 Earnings Conference Call. Currently, all participants are on ...
TriSalus Life Sciences(TLSI) - 2023 Q4 - Annual Results
2024-04-01 12:05
Exhibit 99.1 TriSalus Reports Q4 and Full Year 2023 Financial Results and Business Update TriSalus Life Sciences Inc., (Nasdaq: TLSI), today announced its financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update. "2023 was a critical year for TriSalus, underscored by significant growth in TriNav revenue, a landmark achievement of permanent reimbursement, and disciplined progress within our technology and clinical pipelines," said Mary Szela, Chief Execut ...
TriSalus Life Sciences(TLSI) - 2023 Q3 - Quarterly Report
2023-11-14 13:32
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission file number 001-39813 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) (S ...
TriSalus Life Sciences(TLSI) - 2023 Q2 - Quarterly Report
2023-08-01 21:36
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39813 MEDTECH ACQUISITION CORPORATION (Exact Name of Registrant as Specified in Its Charter) (State or other j ...