TriSalus Life Sciences Reports Q4 and Full Year 2024 Financial Results and Provides Business Update
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Revenues of
$8.3 Million in Q4 and$29.4 Million for Full-Year 2024, Representing Growth of 44% And 59%, Respectively, Versus the Prior Year Periods
- Gross Margin of 85% and 86% for Q4 and Full-Year 2024
- Reaffirmed 2025 Guidance of Greater than 50% Revenue Growth, Greater than 20% Reduction in Operating Expenses, Positive EBITDA, and Positive Cash flow in H2 2025
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Management to host earnings conference call on
March 27 at8:00 a.m. EDT
“We achieved commercial and clinical progress throughout 2024, and positioning TriSalus for greater success in 2025,” said
“We were also pleased to strengthen our Board of Directors with the additions of
Clinical and Commercial Advancements
Expanded Product Portfolio
In the second half of 2024, TriSalus expanded its portfolio of PEDD devices with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter to optimize therapeutic delivery for patients with larger vessels. The TriNav LV is suitable for patients with vessels sized between 3.5 and 5.0mm. The TriGuide Guiding Catheter is equipped with a larger inner diameter, lubricious inner lining, and reverse curve design to support femoral access for the TriNav LV.
These new products are eligible for the same HCPCS reimbursement codes as existing TriNav products, which should enable seamless integration into current billing structures. The Company believes these expanded features will allow physicians to address more complex cases, enhance procedural efficiency, meaningfully expand its addressable market, and provide full access to the
Expanding the DELIVER Clinical Program
The Company continues to advance its DELIVER clinical program, a series of Investigator Initiated Trials (IITs) designed to further underscore the impact of PEDD technology by demonstrating enhanced safety and efficacy of the TriNav system across a broad spectrum of complex, difficult-to-treat patients. A key focus of the DELIVER program is to investigate the potential of combining use of the TriNav system with other therapies to enhance effectiveness and address resistance mechanisms in challenging cancers.
The first IIT is a registry study called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease). The PROTECT study has been initiated and intends to enroll 100 patients across five leading academic sites. It is estimated that approximately 5% of adults have multinodular goiters, prevalence in adults over 50 is estimated to be up to 50%. The Company estimates that this may expand the addressable market by approximately 50,000 procedures, representing an incremental
Advancing Pancreatic Cancer Treatment – Enrollment was completed in the PERIO-03 Phase 1 trial investigating nelitolimod in locally advanced pancreatic cancer. Final data are expected mid-2025, with next steps to be determined based on results.
Clinical Progress in Immunotherapy – In
Strengthened Board and Financial Position
New Board Members – Industry veterans
Extended Cash Runway – TriSalus secured a
Unaudited Financial Results for Fourth Quarter and Full Year 2024
The Company will file a Form 12b-25, Notification of Late Filing, with the
Full year 2024 revenue was
Operating Cash Flow in the fourth quarter of 2024 was
Cash and Cash Equivalents were
2025 Guidance
The company is reaffirming previously issued guidance for 2025, including:
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Sales are expected to grow by more than 50% in 2025, driven by further market share increases in TriNav, the commercial launch of TriNav LV, and the TriNav target market expansion driven by the DELIVER program and the new HCPCS reimbursement code for TriNav simulation angiograms —commonly known as mapping procedures—conducted prior to transarterial radioembolization (TARE) from
Centers for Medicare & Medicaid Services (CMS). - Gross margins are expected to exceed 87%.
- Operating expenses are expected to decline greater than 20% in 2025 due to reductions in R&D associated with the completion of the PERIO phase 1b trials and reductions in G&A expenses due to the non-recurrence of certain costs related to becoming a public Company in 2024.
- The company expects to be EBITDA positive for 2025 and achieve positive cash flow by the second half of 2025, extending total cash runway beyond 2025.
Conference Call
The company will host a conference call and webcast on
About
In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on Twitter and LinkedIn.
Forward Looking Statements
Statements made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company’s PEDD drug delivery technology, TriNav system and nelitolimod investigational immunotherapy, the expected timing for reporting results from the Company’s clinical trials for nelitolimod, the Company’s expectation that the development of nelitolimod for the indications covered by PERIO-02 will continue through investigator led trials, the Company’s ability to achieve the revenue milestones under the credit facility, the Company’s expectations about its cash runway, the Company’s expectations about its revenue growth for 2024, the expected benefits from the Company’s DELIVER program, the Company’s expected timing to launch PROTECT study and any future studies, and the Company’s ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with the credit facility, including the Company’s ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, and other risks described in the Company’s filings with the
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|
|||||||||||||||
| Consolidated Statement of Operations (unaudited, in thousands) | |||||||||||||||
|
Three Months Ended |
|
Twelve Months Ended |
|||||||||||||
|
|
|
|
|||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
| Revenue |
$ |
8,261 |
|
$ |
5,721 |
|
$ |
29,431 |
|
$ |
18,511 |
|
|||
| Cost of goods sold |
|
1,216 |
|
|
582 |
|
|
4,103 |
|
|
2,605 |
|
|||
| Gross Profit |
|
7,045 |
|
|
5,139 |
|
|
25,328 |
|
|
15,906 |
|
|||
| Operating expenses: | |||||||||||||||
| Research and development |
|
2,959 |
|
|
7,769 |
|
|
17,688 |
|
|
29,835 |
|
|||
| Sales and marketing |
|
7,010 |
|
|
5,604 |
|
|
25,839 |
|
|
17,034 |
|
|||
| General and administrative |
|
4,656 |
|
|
6,014 |
|
|
17,966 |
|
|
23,512 |
|
|||
| Loss from operations |
|
(7,580 |
) |
|
(14,248 |
) |
|
(36,165 |
) |
|
(54,475 |
) |
|||
| Interest income |
|
57 |
|
|
244 |
|
|
404 |
|
|
431 |
|
|||
| Interest expense |
|
(1,068 |
) |
|
(3 |
) |
|
(3,090 |
) |
|
(16 |
) |
|||
| Loss on equity issuance |
|
(183 |
) |
|
(5,874 |
) |
|||||||||
| Extinguishment of tranche liability |
|
1,520 |
|
||||||||||||
| Change in fair value of warrant, SEPA and revenue base redemption liabilities |
|
(586 |
) |
|
(11,515 |
) |
|
(2,107 |
) |
|
(10,855 |
) |
|||
| Change in fair value of contingent earnout liability |
|
(830 |
) |
|
(9,611 |
) |
|
11,231 |
|
|
10,293 |
|
|||
| Other expense, net |
|
(102 |
) |
|
(323 |
) |
|
(312 |
) |
|
(379 |
) |
|||
| Loss before income taxes |
|
(10,109 |
) |
|
(35,639 |
) |
|
(30,039 |
) |
|
(59,355 |
) |
|||
| Income tax expense |
|
1 |
|
|
(1 |
) |
|
(6 |
) |
|
(9 |
) |
|||
| Net loss available to common stockholders |
$ |
(10,108 |
) |
$ |
(35,640 |
) |
$ |
(30,045 |
) |
$ |
(59,364 |
) |
|||
| Deemed dividend related to Series B-2 preferred stock down round provision |
|
(2,981 |
) |
||||||||||||
| Undeclared dividends on Series A preferred stock |
|
(783 |
) |
|
(800 |
) |
|
(3,188 |
) |
|
(1,258 |
) |
|||
| Net loss attributable to common stockholders |
$ |
(10,891 |
) |
$ |
(36,440 |
) |
$ |
(33,233 |
) |
$ |
(63,603 |
) |
|||
| Net loss per common share, basic and diluted |
$ |
(0.40 |
) |
$ |
(1.57 |
) |
$ |
(1.31 |
) |
$ |
(6.77 |
) |
|||
| Weighted average common shares outstanding, basic and diluted |
|
27,551,189 |
|
|
23,231,975 |
|
|
25,331,753 |
|
|
9,395,748 |
|
|||
| Consolidated Balance Sheets (unaudited, in thousands) | |||||
|
|
|
|
|||
|
2024 |
|
2023 |
|||
| Assets | |||||
| Assets | |||||
| Cash and cash equivalents |
8,525 |
|
11,777 |
|
|
| Accounts receivable |
5,087 |
|
3,554 |
|
|
| Inventory, net |
4,048 |
|
2,545 |
|
|
| Prepaid expenses |
3,009 |
|
2,986 |
|
|
| Total current assets |
20,669 |
|
20,862 |
|
|
| Property and equipment, net |
1,669 |
|
2,091 |
|
|
| Right-of-use assets |
1,210 |
|
1,179 |
|
|
| Other assets |
423 |
|
466 |
|
|
| Total assets |
23,971 |
|
24,598 |
|
|
| Liabilities and Stockholders' Equity (Deficit) | |||||
| Current liabilities: | |||||
| Trade payables |
2,274 |
|
3,391 |
|
|
| Accrued liabilities |
7,355 |
|
10,556 |
|
|
| Short-term lease liabilities |
216 |
|
351 |
|
|
| Other current liabilities |
383 |
|
389 |
|
|
| Total current liabilities |
10,228 |
|
14,687 |
|
|
| Long-term debt, net of unamortized discount and debt issuance costs |
22,084 |
|
|||
| Revenue base redemption liability |
507 |
|
|||
| Long-term lease liabilities |
1,329 |
|
1,244 |
|
|
| Contingent earnout liability |
7,401 |
|
18,632 |
|
|
| Warrant and SEPA liabilities |
8,316 |
|
17,100 |
|
|
| Total liabilities |
49,865 |
|
51,663 |
|
|
| Stockholders' deficit: | |||||
| Preferred Stock, Convertible preferred stock, Series A |
|||||
| and 2023, respectively; issued and outstanding, 3,985,002 and 4,015,002 shares at | |||||
| Common stock, |
|||||
| and 26,413,213 shares at |
3 |
|
2 |
|
|
| Additional paid-in capital |
253,652 |
|
222,437 |
|
|
| Accumulated deficit |
(279,549 |
) |
(249,504 |
) |
|
| Total stockholders' deficit |
(25,894 |
) |
(27,065 |
) |
|
| Total liabilities, convertible preferred stock and stockholders' deficit |
23,971 |
|
24,598 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20250327096302/en/
For Media Inquiries:
917.749.1494
jfeffer@lifesciadvisors.com
For Investor Inquiries:
Chief Financial Officer
847.337.0655
james.young@trisaluslifesci.com
Source: