Full Press Release Details
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 Executive Officer and President of TriSalus.
"The release of compelling real-world evidence demonstrating
the impactful benefits of the TriNav method for complex patients, along with the exploration of nelitolimod in conjunction with the TriNav
system through selected phase 1 clinical studies, reinforces our commitment to improving care options for oncology patients. As an example,
the phase 1 clinical trial for locally advanced pancreatic patients utilizes our novel pancreatic infusion device in combination with
nelitolimod with a goal to demonstrate improved outcomes for pancreatic patients.
Furthermore, receiving 510k clearance of a larger vessel size of the
TriNav system, and successfully accessing the public markets underscore our dedication to advancing our company for sustained growth and
success. As we reflect on the achievement of the past year, we recognize not only the milestones achieved but also acknowledge the solid
foundation for continued future progress across the business, and we remain fully focused and committed to delivering benefit to patients."
Fourth Quarter 2023 and Subsequent Highlights
CMS Reimbursement for the TriNav Infusion System via Assignment
of a New Technology Healthcare Common Procedure Coding System (HCPCS) Code
In December, TriSalus announced that the Centers for Medicare &
Medicaid Services (CMS) had created a New Technology Healthcare Common Procedure Coding System (HCPCS) code for procedures involving the
TriNav Infusion System. This new code, HCPCS 9797, has been assigned to the Ambulatory Payment Classification (APC) 5194 - Level
4 Endovascular Procedures. The new code became effective on January 1, 2024, and may be reported by hospital outpatient departments
(HOPDs) and ambulatory surgical centers (ASCs).
Real-World Data Demonstrates Ability of TriNav to Successfully Treat
Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors
In February, the Company announced the publication in Current
Medical Research and Opinion of a manuscript detailing a real-world study of the use of the Pressure-Enabled Drug Delivery
(PEDD ) method with the TriNav device for trans-arterial chemoembolization (TACE) and trans-arterial radioembolization (TARE) in
patients with hepatocellular carcinoma (HCC) and liver metastases. The data presented in the study captured real-world safety and clinical
outcomes data for the TriNav system utilizing a large, 300 million patient dataset covering 98% of U.S. payers.
The study data demonstrates that the TriNav method is preferentially
selected to treat patients with a higher burden of disease than patients treated with standard catheters, yet these patients show similar
results post-treatment compared to patients with a lower disease burden. TriNav patients showed impressive trends toward better outcomes
in matched cohort comparisons, including an increased rate of liver transplants.
Completed Enrollment in Multiple Phase 1 Clinical Trials (100 Patients)
in Uveal Melanoma Liver Metastases, Hepatocellular Cancer, and Intrahepatic Cholangiocarcinoma in Leading Academic Oncology Centers Across
the U.S. to Determine Which Indication to Progress; Full Data Set Will be Analyzed in the Second Half of 2024 to Facilitate the Final
TriSalus presented phase 1 data for the PERIO-01 program, nelitolimod
administered via the PEDD method for uveal melanoma liver metastases, at a late-breaking oral session by our lead investigator from The
University of Texas MD Anderson Cancer Center at the Society for Immunotherapy for Cancer meeting in November 2023.
Data presented included the following:
Initiated Phase 1 Study with Nelitolimod via our Novel Pancreatic
The Pancreatic Infusion System with SmartValve technology is an
FDA-cleared device for delivery of therapeutics to the peripheral vasculature. This device is being studied for the delivery of nelitolimod
into unresectable pancreatic tumors.
Retrograde venous delivery to the pancreas involves the placement of
a PEDD device into the veins draining the pancreas to enable targeted delivery of therapeutics using standard interventional radiology
procedures. Unlike the liver, small vessels and extensive collateralization in the pancreas make the arterial route challenging for targeted
delivery. Retrograde pancreatic venous infusion provides a potentially more feasible and reliable strategy for targeted delivery of therapeutics
through direct venous access.
In November of 2023, TriSalus released study data on three patients
receiving nelitolimod via its novel pancreatic infusion device demonstrating immune signals consistent with previous reported data for
liver metastases. The Company expects to complete enrollment and report the phase 1 data in the second half of 2024.
Received 510k Clearance for TriNav Large and TriGuide
This year, TriSalus received 510k clearance for a larger vessel size
of the TriNav system, TriNav Large, and its dedicated guide catheter, TriGuide. Currently, the Company is in market evaluation for both
devices and intends to launch in the second half of 2024. The launch of this TriNav system provides a significant market expansion since
the larger vessel size can access an incremental 25% of the embolization market.
Unaudited Financial Results for Q4 and Full Year 2023
Notification of Late Filing
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 2023. The Company's need to request
a 15-day extension is primarily due to errors identified in determining the Company's stock-based compensation expense for 2023
due in part to the Company's transition to a new service provider in 2023 and the use of incorrect assumptions. The Company is working
diligently to evaluate the materiality of the errors to determine whether any corrections for the third quarter financial results are
required and to complete the Company's year-end 2023 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 statements as of and for the year ended December 31,
Revenue and Gross Margin
Revenue, all of which is from the sale of the TriNav system, was $5.7
million and $18.5 million, respectively, in the three months and full year ended December 31, 2023. These amounts represent growth
vs. prior year of 77% in the fourth quarter and 49% for the full year, primarily due to increased selling resources and continued market
Gross margins were 90% in the fourth quarter and 86% for the full year
ended December 31, 2023, versus 75% and 82%, respectively, in the fourth quarter and full year in 2022. The improvement is due to
increased factory volumes and improved operations efficiency.
Operating losses were $14.1 million and $54.2 million, respectively,
for the fourth quarter and full year ended December 31, 2023. These amounts include non-recurring professional service fee costs
of $7.9 million year to date, primarily related to the completion of the deSPAC process in August 2023. These amounts compare to
prior year losses of $11.8 million and $36.4 million, respectively. The Company increased investments in 2023 in R&D to support clinical
program progress and in sales and marketing, primarily to expand its sales force to continue to increase market penetration.
Net Results and Earnings per Share
Net losses available to common stockholders were $35.5 million and
$59.0 million, respectively, for the fourth quarter and full year ended December 31, 2023. These amounts compare to prior year losses
of $22.5 million and $47.2 million, respectively. Net losses include the impact of non-cash related gains/(losses) on revaluation of contingent
earnout liabilities of ($9.6) million in the fourth quarter and $10.3 million for the full year period of 2023. In addition, 2023 net
losses include the impact of non-cash related losses associated with revaluation of tranche and warrant liabilities of $11.5 million and
$10.9 million, respectively, for the fourth quarter and full year ended December 31, 2023. These amounts compare to prior year losses
of $2.2 million in the fourth quarter and full year. The fourth quarter and full year ended December 31, 2023, also includes a non-cash
related loss on equity issuance of $0.2 million and $4.4 million, respectively. These amounts compare to prior year losses of $8.3 million
in the fourth quarter and full year.
Basic and diluted loss per share for the fourth quarter and full year
ended December 31, 2023, was $1.56 and $6.73 respectively, compared to a basic and diluted loss per share of $75.01 and $161.55 for
the fourth quarter and full year ended December 31, 2022, respectively.
event will be webcast live 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 for approximately 90 days. 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 along with a personal pin.
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