TriSalus Life Sciences Reports Q4 and Full Year 2024 Financial Results and Provides Business Update
TriSalus Life Sciences (NASDAQ: TLSI) reported strong financial results for Q4 and full-year 2024, with revenues reaching $8.3 million in Q4 and $29.4 million for the full year, showing growth of 44% and 59% respectively versus prior year periods. The company maintained impressive gross margins of 85% in Q4 and 86% for 2024.
Key developments include the launch of TriNav LV Infusion System and TriGuide Guiding Catheter for larger vessels, expanding their addressable market to $375 million. The company completed enrollment in the PERIO-03 Phase 1 trial for pancreatic cancer, with final data expected mid-2025.
For 2025, TriSalus reaffirmed guidance projecting over 50% revenue growth, more than 20% reduction in operating expenses, positive EBITDA, and positive cash flow in H2 2025. The company ended 2024 with $8.5 million in cash and expects sufficient runway throughout 2025.
TriSalus Life Sciences (NASDAQ: TLSI) ha riportato risultati finanziari solidi per il quarto trimestre e per l'intero anno 2024, con ricavi che hanno raggiunto 8,3 milioni di dollari nel Q4 e 29,4 milioni di dollari per l'intero anno, mostrando una crescita del 44% e del 59% rispettivamente rispetto ai periodi dell'anno precedente. L'azienda ha mantenuto margini lordi impressionanti dell'85% nel Q4 e dell'86% per il 2024.
Tra i principali sviluppi c'è il lancio del TriNav LV Infusion System e del TriGuide Guiding Catheter per vasi più grandi, espandendo il loro mercato indirizzabile a 375 milioni di dollari. L'azienda ha completato l'arruolamento nello studio clinico PERIO-03 di Fase 1 per il cancro pancreatico, con i dati finali previsti per metà 2025.
Per il 2025, TriSalus ha confermato le previsioni di una crescita dei ricavi di oltre il 50%, una riduzione di oltre il 20% delle spese operative, EBITDA positivo e flusso di cassa positivo nella seconda metà del 2025. L'azienda ha chiuso il 2024 con 8,5 milioni di dollari in contante e prevede di avere una sufficiente liquidità per tutto il 2025.
TriSalus Life Sciences (NASDAQ: TLSI) reportó resultados financieros sólidos para el cuarto trimestre y el año completo 2024, con ingresos que alcanzaron 8,3 millones de dólares en el Q4 y 29,4 millones de dólares para el año completo, mostrando un crecimiento del 44% y del 59% respectivamente en comparación con los períodos del año anterior. La empresa mantuvo márgenes brutos impresionantes del 85% en el Q4 y del 86% para 2024.
Los desarrollos clave incluyen el lanzamiento del TriNav LV Infusion System y el TriGuide Guiding Catheter para vasos más grandes, expandiendo su mercado direccionable a 375 millones de dólares. La empresa completó la inscripción en el ensayo PERIO-03 de Fase 1 para el cáncer de páncreas, con datos finales esperados para mediados de 2025.
Para 2025, TriSalus reafirmó su guía proyectando más del 50% de crecimiento en ingresos, más de un 20% de reducción en los gastos operativos, EBITDA positivo y flujo de caja positivo en la segunda mitad de 2025. La empresa terminó 2024 con 8,5 millones de dólares en efectivo y espera tener suficiente liquidez durante todo 2025.
TriSalus Life Sciences (NASDAQ: TLSI)는 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고했으며, 4분기 수익은 830만 달러, 전체 연도 수익은 2,940만 달러에 달하며, 각각 전년 대비 44% 및 59%의 성장을 기록했습니다. 이 회사는 4분기 85%, 2024년 86%의 인상적인 총 마진을 유지했습니다.
주요 개발 사항으로는 더 큰 혈관을 위한 TriNav LV Infusion System 및 TriGuide Guiding Catheter의 출시가 있으며, 이로 인해 목표 시장이 3억 7,500만 달러로 확대되었습니다. 이 회사는 췌장암에 대한 PERIO-03 1상 시험의 등록을 완료했으며, 최종 데이터는 2025년 중반에 예상됩니다.
2025년을 위해 TriSalus는 50% 이상의 수익 성장, 운영 비용 20% 이상 절감, 긍정적인 EBITDA 및 2025년 하반기 긍정적인 현금 흐름을 예상한다고 재확인했습니다. 이 회사는 2024년을 850만 달러의 현금으로 마감했으며, 2025년 내내 충분한 자금을 확보할 것으로 예상합니다.
TriSalus Life Sciences (NASDAQ: TLSI) a rapporté de solides résultats financiers pour le quatrième trimestre et l'année complète 2024, avec des revenus atteignant 8,3 millions de dollars au Q4 et 29,4 millions de dollars pour l'année entière, affichant une croissance de 44 % et 59 % respectivement par rapport aux périodes de l'année précédente. L'entreprise a maintenu des marges brutes impressionnantes de 85 % au Q4 et de 86 % pour 2024.
Les développements clés incluent le lancement du TriNav LV Infusion System et du TriGuide Guiding Catheter pour des vaisseaux plus grands, élargissant leur marché adressable à 375 millions de dollars. L'entreprise a terminé le recrutement dans l'essai de phase 1 PERIO-03 pour le cancer du pancréas, avec des données finales attendues pour le milieu de 2025.
Pour 2025, TriSalus a réaffirmé ses prévisions, projetant une croissance des revenus de plus de 50 %, une réduction de plus de 20 % des dépenses d'exploitation, un EBITDA positif et un flux de trésorerie positif au second semestre 2025. L'entreprise a terminé 2024 avec 8,5 millions de dollars en liquidités et s'attend à disposer de suffisamment de liquidités tout au long de 2025.
TriSalus Life Sciences (NASDAQ: TLSI) hat starke Finanzzahlen für das vierte Quartal und das Gesamtjahr 2024 berichtet, mit Einnahmen von 8,3 Millionen Dollar im Q4 und 29,4 Millionen Dollar für das gesamte Jahr, was einem Wachstum von 44% bzw. 59% im Vergleich zu den Vorjahreszeiträumen entspricht. Das Unternehmen hielt beeindruckende Bruttomargen von 85% im Q4 und 86% für 2024 aufrecht.
Zu den wichtigsten Entwicklungen gehört die Einführung des TriNav LV Infusion System und des TriGuide Guiding Catheter für größere Gefäße, wodurch der adressierbare Markt auf 375 Millionen Dollar ausgeweitet wird. Das Unternehmen hat die Rekrutierung in die PERIO-03 Phase-1-Studie für Bauchspeicheldrüsenkrebs abgeschlossen, mit finalen Daten, die Mitte 2025 erwartet werden.
Für 2025 hat TriSalus die Prognose bekräftigt und geht von einem über 50%igen Umsatzwachstum, einer Reduzierung der Betriebskosten um mehr als 20%, positivem EBITDA und positivem Cashflow in der zweiten Jahreshälfte 2025 aus. Das Unternehmen beendete 2024 mit 8,5 Millionen Dollar in bar und erwartet, dass es während des gesamten Jahres 2025 über ausreichende Mittel verfügt.
- Revenue growth of 59% YoY to $29.4M in 2024
- Strong gross margins of 85-86%
- Expanded product portfolio with TriNav LV and TriGuide launch
- Secured $10M drawdown from $50M OrbiMed credit facility
- Positive Phase 1 results in uveal melanoma liver metastases trial
- Operating cash flow remained negative at -$5.7M in Q4 2024
- Low cash position of $8.5M as of December 31, 2024
- Delayed 10-K filing due to accounting errors in stock-based compensation
- Required additional funding through credit facility drawdown
Insights
TriSalus Life Sciences' Q4 and full-year 2024 results demonstrate exceptional commercial momentum, with revenues reaching $29.4 million for the full year—a
The company's aggressive 2025 financial targets deserve attention: projected revenue growth exceeding
The improving operating cash flow trend—from
With a current market cap of approximately
TriSalus' product portfolio expansion with the TriNav LV Infusion System and TriGuide Guiding Catheter represents significant technological advancement with immediate revenue implications. By addressing vessels sized between 3.5-5.0mm, these devices effectively unlock the full
The DELIVER clinical program demonstrates strategic foresight by generating evidence to support PEDD technology adoption across broader therapeutic applications. The first PROTECT registry study targeting thyroid disease could add 50,000 procedures annually, representing a
On the immunotherapy front, the completed enrollment in the PERIO-03 pancreatic cancer trial and the promising PERIO-01 trial results in uveal melanoma liver metastases position the company at the intersection of device and biologics innovation. The pursuit of strategic partnerships for the immunotherapy program is logical given the company's primary focus on device commercialization and the significant capital requirements for late-stage oncology trials.
The addition of board members with deep expertise in medical devices and oncology strengthens strategic oversight during this critical commercialization phase. The company's ability to maintain above-
-
Revenues of
in Q4 and$8.3 Million for Full-Year 2024, Representing Growth of$29.4 Million 44% And59% , Respectively, Versus the Prior Year Periods
-
Gross Margin of
85% and86% for Q4 and Full-Year 2024
-
Reaffirmed 2025 Guidance of Greater than
50% Revenue Growth, Greater than20% Reduction in Operating Expenses, Positive EBITDA, and Positive Cash flow in H2 2025
- Management to host earnings conference call on March 27 at 8:00 a.m. EDT
“We achieved commercial and clinical progress throughout 2024, and positioning TriSalus for greater success in 2025,” said Mary Szela, President and Chief Executive Officer of TriSalus Life Sciences. “We achieved
“We were also pleased to strengthen our Board of Directors with the additions of William Valle and Dr. Gary Gordon. Additionally, we want to sincerely thank Sean Murphy for his leadership in guiding the Company through the process of going public, a milestone that would not have been possible without his dedication and expertise. We are thrilled to welcome him back to the Board of Directors and look forward to his continued contributions to our success,” concluded Ms. Szela.
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
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 November 2024, we presented positive Phase 1 results from our PERIO-01 trial at the Society for Immunotherapy of Cancer (SITC), demonstrating promising clinical benefits and durable survival in heavily pretreated uveal melanoma liver metastases (UM-LM) patients. We are actively seeking strategic partnerships to advance this program.
Strengthened Board and Financial Position
New Board Members – Industry veterans William Valle and Dr. Gary Gordon joined the Board of Directors, bringing deep expertise in medical devices and oncology. Additionally, Sean Murphy retired from the management team and rejoined the Board.
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 SEC related to the Company’s Annual Report on Form 10-K for fiscal year 2024. The Company’s need to request a 15-day extension is primarily due to errors identified in determining the Company’s stock-based compensation and clinical trial related research and development expense timing in 2024. The Company is working diligently to evaluate the materiality of the errors to determine whether any corrections for previously issued quarterly financial statements are required and to complete the Company’s year end 2024 financial statements. As a result, the results below and elsewhere in this press release are unaudited and subject to change pending the completion of the Company’s financial statement as of and for the year ended December 31, 2024.
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:
-
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 March 27, 2025, at 8:00 a.m. ET to discuss financial results for the fourth quarter and full year ended December 31, 2024, and provide a business update. A press release detailing the fourth quarter and full year results will be issued prior to the call. To register for the webcast, click here.
About TriSalus Life Sciences
TriSalus Life Sciences® is an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. Nelitolimod delivered by the PEDD technology will be studied across several indications in an effort to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas.
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 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.
TriSalus Life Sciences |
|||||||||||||||
Consolidated Statement of Operations (unaudited, in thousands) | |||||||||||||||
Three Months Ended |
|
Twelve Months Ended |
|||||||||||||
December 31, |
|
December 31, |
|||||||||||||
|
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 |
|
|||
TriSalus Life Sciences | |||||
Consolidated Balance Sheets (unaudited, in thousands) | |||||
December 31, |
|
December 31, |
|||
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 | |||||
December 31, 2024 and 2023, respectively | |||||
Common stock, |
|||||
December 31, 2024 and 2023, respectively; issued and outstanding 31,279,264 shares | |||||
and 26,413,213 shares at December 31, 2024 and 2023, respectively | 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:
Jeremy Feffer, Managing Director
LifeSci Advisors
917.749.1494
jfeffer@lifesciadvisors.com
For Investor Inquiries:
James Young
Chief Financial Officer
847.337.0655
james.young@trisaluslifesci.com
Source: TriSalus Life Sciences