TriSalus Life Sciences Reports Third Quarter 2026 Results
Generated third quarter revenue of
Revised 2026 revenue guidance to
Hosting Conference Call and Webcast today at
“The third quarter marked an important period of growth and expansion for TriSalus – we drove double-digit year-over-year growth and received FDA clearance for TriNav Advance, which enables Pressure-Enabled Drug Delivery to small distal vessels through the microcatheter of the physician’s choice. This clearance allows us to address the full range of vessels encountered in liver embolization procedures going forward,” said
"Looking ahead, we believe we are well positioned for 2027. We more than doubled our commercial footprint over the first half of the year, and although our team productivity has ramped slightly slower than anticipated, our representatives continue to educate and drive further TriNav utilization as they build and strengthen relationships with interventional radiologists. Combined with the launch of TriNav Advance, expanded access to office-based labs through the new G-code, and continued cost discipline, we believe we have laid the foundation for continued growth in 2027 and beyond.”
Recent Business Highlights
- Received FDA clearance for TriNav Advance, which enables PEDD to small distal vessels through the microcatheter of the physician’s choice.
-
In the calendar year 2027 Hospital Outpatient Prospective Payment System ("OPPS") final rule, the
Centers for Medicare & Medicaid Services ("CMS") finalized the reassignment of HCPCS code C8004 from APC 5193 to APC 5194, aligning it with C9797, which is already assigned to APC 5194. Based on the final rule, the national Medicare payment rate for procedures billed under C8004 will increase from approximately$11,794 to approximately$20,910 , effectiveJanuary 1, 2027 . -
Additionally, CMS published its calendar year 2027 Physician Fee Schedule final rule, establishing national payment for HCPCS code G0577, vascular embolization using a pressure-generating catheter in the office-based lab setting. Effective
January 1, 2027 , the total national office payment is approximately$13,800 per procedure, extending reimbursement for PEDD. -
Achieved the enrollment cutoff required for the interim analysis of the PROTECT registry in thyroid artery embolization; the Company remains on track to deliver the first multi-center
U.S . data on thyroid artery embolization in the first quarter of 2027.
Financial Results for Q3 2026
-
Revenue from the sale of the TriNav system was
$12.9 million for the three months endedSeptember 30, 2026 , an increase of 11.3% compared to the same period in 2025. The increase in revenue was primarily due to an increase in TriNav units sold. -
Gross margins were 86.2% for the three months ended
September 30, 2026 , compared to 83.5% for the same period in 2025. The year-over-year increase in gross margin was primarily due to a reduction in cost per TriNav unit. -
Operating losses were
$7.7 million for the three months endedSeptember 30, 2026 , compared to losses of$9.0 million for the same period in 2025. The decrease in operating losses was primarily driven by improved gross margins, lower research and development expenses and lower general and administrative expenses, partially offset by higher sales and marketing expenses related to our investment in marketing and our sales organization expansion. -
Net loss attributable to common stockholders was
$8.9 million for the three months endedSeptember 30, 2026 , compared to a net loss of$41.3 million for the same period in 2025. This change is primarily driven by the conversion of our preferred stock to common stock during the third quarter of 2025, resulting in approximately$30.5 million of net loss attributable to common stockholders. The current period includes$0.1 million of non-cash net gains related to changes in the fair value of various derivatives for the three months endedSeptember 30, 2026 , compared to net losses of$0.4 million for the same period in 2025. The basic and diluted loss per share for the three months endedSeptember 30, 2026 was$0.15 , compared to$0.96 for the same period in 2025. -
The non-GAAP measure of adjusted EBITDA is shown in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were
$4.7 million for the three months endedSeptember 30, 2026 , compared to losses of$5.4 million for the same period in 2025. The decrease in adjusted EBITDA losses were primarily driven by improved gross margins, lower research and development and lower general and administrative expenses, partially offset by increased sales and marketing expenses. -
On
September 30, 2026 , cash and cash equivalents totaled$41.1 million . The Company raised$46.0 million in gross proceeds in the first quarter from an equity offering.
2026 Financial Guidance
The Company is updating its full-year 2026 revenue guidance to
Conference Call & Webcast
The Company will host a conference call and webcast today at
About
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, 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 regulatory approval of the Company's product candidates, 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, the risk that the Company will not become profitable on its expected timeline, if at all, the risk that the reported financial results will differ from the estimates provided in this press release, 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 Securities and Exchange Commission under the heading “Risk Factors.” All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
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Condensed Consolidated Statements of Operations |
|||||||||||||||
|
(unaudited, in thousands, except share and per share data) |
|||||||||||||||
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
|
|
|
|
|
|
|
|
||||||||
|
Revenue |
$ |
12,878 |
|
|
$ |
11,566 |
|
|
$ |
33,184 |
|
|
$ |
31,946 |
|
|
Cost of goods sold |
|
1,783 |
|
|
|
1,906 |
|
|
|
4,521 |
|
|
|
5,203 |
|
|
Gross profit |
|
11,095 |
|
|
|
9,660 |
|
|
|
28,663 |
|
|
|
26,743 |
|
|
Operating expenses |
|
|
|
|
|
|
|
||||||||
|
Research and development (1) |
|
3,190 |
|
|
|
5,704 |
|
|
|
9,543 |
|
|
|
12,395 |
|
|
Sales and marketing |
|
10,731 |
|
|
|
6,839 |
|
|
|
29,560 |
|
|
|
20,736 |
|
|
General and administrative (1) |
|
4,883 |
|
|
|
6,131 |
|
|
|
15,493 |
|
|
|
17,287 |
|
|
Loss from operations |
|
(7,709 |
) |
|
|
(9,014 |
) |
|
|
(25,933 |
) |
|
|
(23,675 |
) |
|
Other income (expense) |
|
|
|
|
|
|
|
||||||||
|
Interest income |
|
382 |
|
|
|
170 |
|
|
|
1,003 |
|
|
|
378 |
|
|
Interest expense |
|
(1,560 |
) |
|
|
(1,460 |
) |
|
|
(4,486 |
) |
|
|
(4,092 |
) |
|
Change in fair value of SEPA, warrant and revenue base redemption liabilities |
|
(650 |
) |
|
|
(2,932 |
) |
|
|
5,819 |
|
|
|
(4,097 |
) |
|
Change in fair value of contingent earnout liability |
|
740 |
|
|
|
2,524 |
|
|
|
7,146 |
|
|
|
2,404 |
|
|
Other expense, net |
|
(53 |
) |
|
|
(94 |
) |
|
|
(39 |
) |
|
|
(385 |
) |
|
Loss before income taxes |
|
(8,850 |
) |
|
|
(10,806 |
) |
|
|
(16,490 |
) |
|
|
(29,467 |
) |
|
Income tax expense |
|
(4 |
) |
|
|
(5 |
) |
|
|
(12 |
) |
|
|
(7 |
) |
|
Net loss |
$ |
(8,854 |
) |
|
$ |
(10,811 |
) |
|
$ |
(16,502 |
) |
|
$ |
(29,474 |
) |
|
Series A Preferred Stock conversion inducement |
|
— |
|
|
|
(18,516 |
) |
|
|
— |
|
|
|
(18,516 |
) |
|
Deemed dividend related to Series A Preferred Stock conversion |
|
— |
|
|
|
(11,947 |
) |
|
|
— |
|
|
|
(11,947 |
) |
|
Net loss attributable to common stockholders |
$ |
(8,854 |
) |
|
$ |
(41,274 |
) |
|
$ |
(16,502 |
) |
|
$ |
(59,937 |
) |
|
|
|
|
|
|
|
|
|
||||||||
|
Basic loss per share |
$ |
(0.15 |
) |
|
$ |
(0.96 |
) |
|
$ |
(0.29 |
) |
|
$ |
(1.72 |
) |
|
Diluted loss per share |
$ |
(0.15 |
) |
|
$ |
(0.96 |
) |
|
$ |
(0.29 |
) |
|
$ |
(1.72 |
) |
|
Weighted-average common shares outstanding, basic |
|
58,473,499 |
|
|
|
43,057,632 |
|
|
|
56,128,696 |
|
|
|
34,858,162 |
|
|
Weighted-average common shares outstanding, diluted |
|
58,473,499 |
|
|
|
43,057,632 |
|
|
|
56,128,696 |
|
|
|
34,858,162 |
|
|
(1)Amounts presented in the three months ended |
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Condensed Consolidated Balance Sheets |
|||||||
|
(unaudited, in thousands, except share and per share data) |
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||||
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Assets |
|
|
|
||||
|
Current assets |
|
|
|
||||
|
Cash and cash equivalents |
$ |
41,057 |
|
|
$ |
20,439 |
|
|
Accounts receivable (net of allowance of |
|
6,126 |
|
|
|
6,558 |
|
|
Inventory, net |
|
4,638 |
|
|
|
3,077 |
|
|
Prepaid expenses |
|
3,076 |
|
|
|
2,170 |
|
|
Total current assets |
|
54,897 |
|
|
|
32,244 |
|
|
Property and equipment, net |
|
1,830 |
|
|
|
1,808 |
|
|
Right-of-use assets |
|
766 |
|
|
|
861 |
|
|
Other assets |
|
69 |
|
|
|
418 |
|
|
Total assets |
$ |
57,562 |
|
|
$ |
35,331 |
|
|
Liabilities and Stockholders’ Equity (Deficit) |
|
|
|
||||
|
Current liabilities |
|
|
|
||||
|
Trade payables |
$ |
4,231 |
|
|
$ |
3,002 |
|
|
Accrued liabilities |
|
8,393 |
|
|
|
8,096 |
|
|
Short-term lease liabilities |
|
277 |
|
|
|
167 |
|
|
Other current liabilities |
|
113 |
|
|
|
234 |
|
|
Total current liabilities |
|
13,014 |
|
|
|
11,499 |
|
|
Long-term debt |
|
32,367 |
|
|
|
33,046 |
|
|
Revenue base redemption liability |
|
903 |
|
|
|
383 |
|
|
Long-term lease liabilities |
|
1,047 |
|
|
|
1,228 |
|
|
Contingent earnout liability |
|
2,998 |
|
|
|
10,144 |
|
|
Warrant liabilities |
|
6,553 |
|
|
|
12,892 |
|
|
Total liabilities |
|
56,882 |
|
|
|
69,192 |
|
|
Commitments and contingencies |
|
|
|
||||
|
Stockholders’ equity (deficit) |
|
|
|
||||
|
Preferred Stock, |
|
— |
|
|
|
— |
|
|
Common stock, |
|
5 |
|
|
|
4 |
|
|
Additional paid-in capital |
|
347,760 |
|
|
|
296,718 |
|
|
Accumulated deficit |
|
(347,085 |
) |
|
|
(330,583 |
) |
|
Total stockholders’ equity (deficit) |
|
680 |
|
|
|
(33,861 |
) |
|
Total liabilities and stockholders’ equity (deficit) |
$ |
57,562 |
|
|
$ |
35,331 |
|
|
|
|||||||
|
Condensed Consolidated Statements of Cash Flows |
|||||||
|
(unaudited, in thousands) |
|||||||
|
|
Nine Months Ended |
||||||
|
|
|
|
|
||||
|
Cash flows from operating activities |
|
|
|
||||
|
Net loss |
$ |
(16,502 |
) |
|
$ |
(29,474 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
||||
|
Depreciation |
|
400 |
|
|
|
500 |
|
|
Non-cash lease expense |
|
95 |
|
|
|
407 |
|
|
Change in fair value of SEPA, warrant and revenue base redemption liabilities |
|
(5,819 |
) |
|
|
4,097 |
|
|
Change in fair value of contingent earnout liability |
|
(7,146 |
) |
|
|
(2,404 |
) |
|
Paid-in-kind interest |
|
— |
|
|
|
800 |
|
|
Stock-based compensation expense |
|
7,922 |
|
|
|
6,934 |
|
|
Allowance for credit losses |
|
14 |
|
|
|
130 |
|
|
Loss on disposal of property and equipment |
|
1 |
|
|
|
117 |
|
|
Amortization of debt issuance costs |
|
1,026 |
|
|
|
767 |
|
|
Changes in operating assets and liabilities |
|
|
|
||||
|
Accounts receivable |
|
418 |
|
|
|
(43 |
) |
|
Inventory, net |
|
(1,561 |
) |
|
|
772 |
|
|
Prepaid expenses and other assets |
|
(907 |
) |
|
|
648 |
|
|
Operating lease liabilities |
|
(94 |
) |
|
|
(107 |
) |
|
Trade payables and accrued liabilities |
|
269 |
|
|
|
1,328 |
|
|
Net cash used in operating activities |
|
(21,884 |
) |
|
|
(15,528 |
) |
|
Cash flows from investing activities |
|
|
|
||||
|
Purchases of property and equipment |
|
(313 |
) |
|
|
(877 |
) |
|
Proceeds from disposal of property and equipment |
|
— |
|
|
|
80 |
|
|
Net cash used in investing activities |
|
(313 |
) |
|
|
(797 |
) |
|
Cash flows from financing activities |
|
|
|
||||
|
Proceeds from the issuance of common stock, net of issuance costs |
|
42,625 |
|
|
|
20,451 |
|
|
Proceeds from the exercise of stock options for common stock |
|
264 |
|
|
|
423 |
|
|
Proceeds from the issuance of common stock through employee stock purchase plan |
|
270 |
|
|
|
211 |
|
|
Taxes paid related to net share settlement of restricted stock units |
|
(65 |
) |
|
|
— |
|
|
Debt issuance costs |
|
(613 |
) |
|
|
(520 |
) |
|
Proceeds from the issuance of debt |
|
— |
|
|
|
10,000 |
|
|
Payments on finance lease liabilities |
|
(43 |
) |
|
|
(78 |
) |
|
Short-swing profit settlement |
|
27 |
|
|
|
— |
|
|
Net cash provided by financing activities |
|
42,465 |
|
|
|
30,487 |
|
|
Increase in cash, cash equivalents and restricted cash |
|
20,268 |
|
|
|
14,162 |
|
|
Cash, cash equivalents and restricted cash, beginning of period |
|
20,789 |
|
|
|
8,875 |
|
|
Cash, cash equivalents and restricted cash, end of period |
$ |
41,057 |
|
|
$ |
23,037 |
|
|
Supplemental disclosures of cash flow information |
|
|
|
||||
|
Cash paid for interest |
|
3,460 |
|
|
|
2,528 |
|
|
Cash paid for income taxes |
|
— |
|
|
|
16 |
|
|
Supplemental disclosure of non-cash items |
|
|
|
||||
|
Right-of-use assets obtained in exchange for new finance lease liabilities |
|
69 |
|
|
|
— |
|
|
Non-cash capital expenditures included in trade payables |
|
41 |
|
|
|
63 |
|
|
Debt issuance costs in accrued liabilities |
|
1,092 |
|
|
|
— |
|
|
Fixed assets purchased through exchange of finance lease right-of-use asset |
|
— |
|
|
|
85 |
|
|
Derecognition of finance lease right-of-use asset |
|
— |
|
|
|
(85 |
) |
|
Fair value of warrants issued with OrbiMed debt |
|
— |
|
|
|
366 |
|
Non-GAAP Financial Measure
To supplement the financial results presented in accordance with GAAP, TriSalus has also included in this press release non-GAAP adjusted EBITDA, which excludes from net loss, income tax expense, interest expense, interest income, change in fair value of SEPA, warrant and revenue-base redemption liabilities, change in fair value of contingent earnout liability, stock-based compensation expense, other expense, net and depreciation. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. TriSalus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand TriSalus’ business.
TriSalus believes that the presentation of these non-GAAP financial measures provides useful supplemental information to, and facilitates additional analysis by, investors. In particular, TriSalus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare TriSalus’ results from period to period, and to identify operating trends in TriSalus’ business.
|
Supplemental Schedule of Non-GAAP Adjusted EBITDA |
|||||||||||||||
|
(unaudited, in thousands) |
|||||||||||||||
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
|
|
|
|
|
|
|
|
||||||||
|
Net loss |
$ |
(8,854 |
) |
|
$ |
(10,811 |
) |
|
$ |
(16,502 |
) |
|
$ |
(29,474 |
) |
|
Interest expense |
|
1,560 |
|
|
|
1,460 |
|
|
|
4,486 |
|
|
|
4,092 |
|
|
Interest income |
|
(382 |
) |
|
|
(170 |
) |
|
|
(1,003 |
) |
|
|
(378 |
) |
|
Income tax expense |
|
4 |
|
|
|
5 |
|
|
|
12 |
|
|
|
7 |
|
|
Depreciation |
|
129 |
|
|
|
163 |
|
|
|
400 |
|
|
|
500 |
|
|
EBITDA |
$ |
(7,543 |
) |
|
$ |
(9,353 |
) |
|
$ |
(12,607 |
) |
|
$ |
(25,253 |
) |
|
|
|
|
|
|
|
|
|
||||||||
|
Change in fair value of SEPA, warrant and revenue base redemption liabilities |
|
650 |
|
|
|
2,932 |
|
|
|
(5,819 |
) |
|
|
4,097 |
|
|
Change in fair value of contingent earnout liability |
|
(740 |
) |
|
|
(2,524 |
) |
|
|
(7,146 |
) |
|
|
(2,404 |
) |
|
Other expense, net |
|
53 |
|
|
|
94 |
|
|
|
39 |
|
|
|
385 |
|
|
Stock-based compensation expense |
|
2,834 |
|
|
|
3,422 |
|
|
|
7,922 |
|
|
|
6,934 |
|
|
Adjusted EBITDA |
$ |
(4,746 |
) |
|
$ |
(5,429 |
) |
|
$ |
(17,611 |
) |
|
$ |
(16,241 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20261110152164/en/
For Investor & Media Inquiries:
Chief Financial Officer
investor.relations@trisaluslifesci.com
Source: