Full Press Release Details
TriSalus Reports Q3 2024 Financial
Results and Provides Business Update
| Reported Q3 and nine-month revenues of $7.3 million and $21.2 million respectively, up 42% and 66% year-over-year | ||
| Provided 2025 guidance with expectations of over 50% annual sales growth, 20%+ reduction in operating expenses, positive full-year EBITDA, and positive cash flow in H2 2025 | ||
| Launched TriNav LV Infusion System and TriGuide Guiding Catheter for larger vessels and complex cases, expanding the TriNav system's full access to the $375 million embolization market | ||
| Initiated the PROTECT registry trial using the TriNav system to treat multinodular goiters, expanding the TriNav system's reach into the $400 million thyroid embolization market | ||
| Presented positive Phase 1 data from PERIO-01 trial in patients with uveal melanoma with liver metastases (UM-LM) at the Society for Immunotherapy of Cancer (SITC) meeting and announced the strategic decision to seek a partner to drive further development of this indication | ||
| Hosting earnings call on November 14, 2024 at 9:00 a.m. EST |
DENVER, CO - November 14, 2024
- TriSalus Life Sciences Inc., (Nasdaq: TLSI), an oncology company integrating novel delivery technology with immunotherapy to
transform treatment for patients with liver and pancreatic tumors, today announced its financial results for the third quarter ended
September 30, 2024, and provided a business update.
"We enter the final quarter of
2024 with great momentum, both commercially and clinically, and we are positioned well for an even greater 2025," stated Mary Szela,
President and Chief Executive Officer of TriSalus Life Sciences. "Commercially, we enjoyed a strong third quarter highlighted by
42% revenue growth. We recently launched the TriNav LV system to address patients with larger vessels, an opportunity we believe will
meaningfully expand our addressable market and provide full access to the $375 million liver embolization market."
"With the successful completion
of our Phase 1 dose escalation study enrollment in UM-LM, we are actively pursuing a strategic partnership for nelitolimod," continued
Szela. "This follows the successful presentation of positive Phase 1 results from our PERIO-01 dose escalation study in UM-LM at
SITC. Additionally, by mid-2025, we anticipate data from our Phase 1 study in locally advanced pancreatic cancer, which will guide our
"Our clinical development efforts
for the TriNav system have expanded with the launch of the DELIVER program, starting with the PROTECT registry trial for patients with
multinodular goiter. There is significant potential to broaden our addressable market by $400 million, and we are committed to providing
further updates on PROTECT and additional programs within the DELIVER initiative."
"Finally, we are initiating 2025
guidance that calls for greater than 50% revenue growth, a greater than 20% reduction in operating expenses, positive full-year EBITDA,
and positive cash flow in the second half of the year," concluded Ms. Szela.
Third Quarter Business Update
TriNav System Large Vessel Launch
TriSalus recently expanded its portfolio
of Pressure-Enabled Drug Delivery (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 system is suitable for patients with vessels
sized between 3.5 and 5.0mm and is expected to allow the Company to meaningfully expand its addressable liver embolization market. The
TriGuide Guiding Catheter has a larger inner diameter, lubricious inner lining, and reverse curve design to support femoral access for
the TriNav LV system, which the Company believes will enhance procedural efficiency. These new products are eligible for the same HCPCS
reimbursement codes as existing TriNav products, enabling seamless integration into current billing structures.
DELIVER and PROTECT Updates
During the quarter, TriSalus advanced
the DELIVER clinical program, a series of clinical trials designed to demonstrate enhanced safety and efficacy across a broad spectrum
of complex, difficult-to-treat patients through investigator-initiated studies, further underscoring the impact of PEDD technology. A
key focus of the DELIVER program is to investigate the potential of combining use of the TriNav system with these therapies to enhance
effectiveness and address resistance mechanisms in challenging cancers.
The first of these is a registry study
called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease), which has been initiated,
and TriSalus intends to enroll 100 patients across five leading academic sites. It is estimated that approximately 5% of adults have
multinodular goiters, and the prevalence in adults over 50 is estimated to be up to 50%. The Company estimates that this could expand
the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity and putting the
Company's total addressable market at more than $1 billion in the U.S. This new procedure utilizing the TriNav system is also eligible
for the same Healthcare Common Procedure Coding System (HCPCS) reimbursement code allowing for seamless integration into current
The Company anticipates opening additional
DELIVER studies in the first half of 2025 and will provide more details as those studies commence.
TriSalus presented Phase 1 results from
the PERIO-01 clinical trial at the recent SITC meeting. This dose escalation trial investigated the use of the PEDD method of nelitolimod
in patients with UM-LM. The results suggested that PEDD-administered nelitolimod, combined with immune checkpoint inhibitors, provides
promising clinical benefits and durable survival in heavily pretreated patients with UM-LM and a favorable safety profile. The Company
is actively exploring strategic partnerships to advance this indication further.
The Company also completed enrollment
of 13 patients in its PERIO-03 Phase 1 dose escalation study of nelitolimod in locally advanced pancreatic cancer. Evidence gathered
thus far supports a strong safety profile and further exploration of nelitolimod combined with the TriNav pancreatic infusion technology.
The Company will outline the next steps once the final data are available in mid-2025.
Financial Results for Q3 2024
Revenue, all from the sale of the TriNav
system, was $7.3 million and $21.2 million, respectively, for the three and nine months ended September 30, 2024. These were up 42% and
66%, respectively, compared to the same periods in 2023. Revenue growth was driven primarily by increased selling resources and increased
Gross margins were 86% and 86% for the
three and nine months ended September 30, 2024, respectively, compared to 89% and 84%, respectively, for the same periods in 2023. The
year-to-date improvement is due to increased factory volumes and improved operational efficiency.
Operating losses were $8.7 million and
$28.6 million, respectively, for the three and nine months ended September 30, 2024, respectively, compared to losses of $18.6 million
and $40.2 million, respectively, for the same periods in 2023. These amounts include non-cash stock compensation and depreciation expenses
of $1.6 million and $4.3 million for the three- and nine-month periods in 2024 and $0.4 million and $0.9 million for the same periods
in 2023. Current year reductions in operating losses are due to increased sales, reduced general and administrative expenses due to non-recurrence
of prior year costs related to becoming a public company, and reduced research and development spending associated with the ramp-down
of clinical trial spending.
Net losses available to common stockholders
were $2.4 million and $19.9 million, respectively, for the three and nine months ended September 30, 2024, compared to losses of $1.4
million and $23.7 million, respectively, for the same periods in 2023. Net losses in 2024 include non-cash related gains on change in
fair value of various derivatives of $7.3 million and $10.5 million, respectively, for the three and nine months ended September 30,
2024, compared to gains of $17.1 million and $16.4 million, respectively, for the same periods in 2023. The basic and diluted loss per
share for the three and nine months ended September 30, 2024, were $0.12 and $0.91, respectively, compared to $0.14 and $5.72 for the
three and nine months ended September 30, 2023, respectively.
On September 30, 2024, cash and cash
equivalents totaled $11.3 million. The Company expects existing liquidity sources and $25 million of available capacity on the OrbiMed
debt facility to provide sufficient cash runway throughout 2025. In addition, 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.
The Company is providing guidance for
2025 for the first time, including:
| Sales are expected to grow by more than 50% in 2025, driven by further market share increases in the TriNav system, the commercial launch of the TriNav LV system, and the TriNav target market expansion driven by the DELIVER program. | ||
| Operating expenses are expected to decline greater than 20% in 2025 due to reductions in R&D associated with completing the PERIO Phase 1 trials and reductions in G&A expenses due to the non-recurrence of certain costs related to becoming a public Company. | ||
| The Company expects to achieve positive full-year EBITDA and positive cash flow in the second half of the year. |
TriSalus will host a webcast to discuss
its third quarter 2024 financial results and business highlights on November 14, 2024, at 9:00 a.m. EST. The webcast can be accessed
on the investor relations section of TriSalus' website at https://investors.trisaluslifesci.com/news-events/events-presentations.
Following the conclusion of the event, a webcast replay will be available on the website. Interested parties participating by phone
will need to register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated
e-mail containing a link to the conference phone number and a personal pin.
About TriSalus Life Sciences
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