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Tivic Health Systems, Inc. (TIVC)

Q4 2024 Earnings Call· Fri, Mar 21, 2025

$1.38

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Transcript

Operator

Operator

Welcome to Tivic Health Systems year-end 2024 financial results and operational update conference call. This call has been prerecorded, and the questions you have submitted in advance will be answered following the prior remarks. This call is being webcast and the replay will be available on the IR section of the company website for three months. Before we begin, let me remind you that today's call management will make various forward-looking statements. Investors are cautioned that these forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward-looking statements. Please read the Safe Harbor statement contained in the press release we issued today, as well as those contained in Tivic Health Systems, Inc.'s filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2024, to be filed with the SEC on or about March 21, 2024, under the heading risk factors, as well as the company's other filings with the SEC. On today's call with Tivic Health Systems, Inc.'s Chief Executive Officer, Jennifer Ernst, and interim Chief Financial Officer, Lisa Wolf. Now let me turn the call over to Jennifer.

Jennifer Ernst

Management

Thank you for that introduction. I am Jennifer Ernst, the CEO of Tivic Health Systems, Inc., and welcome to our 2024 year-end corporate update. Now while this is formally a look back at 2024, I have to say that much of what we did in 2024 has culminated in the last few weeks and considerably reshaped the company. We have advanced our vagus nerve stimulation program, and in February of 2025, we announced that we have acquired worldwide exclusive rights to a phase three immunomodulatory drug candidate. So I would like to spend a portion of this. The front end, I will tell you more about the drug candidate itself. I will talk with you a little bit more about the vagus nerve work and how this represents a very, very different company than Tivic Health Systems, Inc. has been over the last year and a half. To say that we reshaped the company in the last several weeks really is quite an understatement. We announced that we have acquired worldwide exclusive rights to a phase three immunomodulatory drug candidate. Over $140 million has previously been invested in the candidate. This is a toll-like receptor. We will go into a little bit more about what that what's TLR agonist is about. It's an immunotherapy drug candidate called Intellimod. And we acquired a license for this clinical asset from Staterra Biopharma. With this license, we not only got exclusive rights to the first indication for Intellimod, but also to five additional indications and to an additional molecular structure called Entelasta. So we now have two drug candidates in the pipeline in addition to the vagus nerve stimulation works that you have heard me talk about before. By adding a newly licensed TLR Tollified agonist to the pipeline, this gives us a…

Lisa Wolf

Management

Thank you, Jennifer. For ease of listening, all of the financial metrics I will be reporting today compare the year ended December 31, 2024, to the prior year ended December 31, 2023, unless otherwise stated. Revenue net of returns totaled $0.8 million compared to $1.2 million a year ago. The decline was primarily due to a decrease in unit sales of 41% associated with reductions in our overall marketing spend. Cost of sales decreased 12% to $0.8 million from $0.9 million in the prior year, primarily due to a 41% decrease in unit sales. Cost of sales in 2024 included an inventory reserve of $354,000 compared with $32,000 in reserves for 2023. Disposal costs of $21,000 were incurred in 2024 related to the move to a new logistics provider. The change in logistics providers in August 2024 has resulted in cost savings and improved margins on a recurring basis. We are exploring new opportunities to increase cash flow generated by the ClearUp business. We deployed a new e-commerce web infrastructure for ClearUp, improving user experience, and also upgraded Tivic Health Systems, Inc. investor relations website. Gross profit was $2,000 compared with $287,000 for the prior year. The lower gross profit in 2024 was primarily due to the $354,000 in inventory reserves recorded in 2024 compared to $32,000 in 2023. Total operating expenses were $5.7 million compared to $8.5 million for 2023. We plan to increase our research and development investments in our Vagus nerve platform and clinical applications and to advance the development of Tivic Health Systems, Inc.'s licensed TLR5 agonist programs specifically in Intellimod and Entelasta. Net loss for the year decreased to $5.7 million from $8.2 million for 2023. Cash and cash equivalents at December 31, 2024, totaled $2 million compared with $3.4 million at December 31, 2023. The company had working capital of $2.4 million at December 31, 2024. We have no debt as of year-end 2024 or 2023. We recently effected a reverse stock split. One of the greatest challenges of drug and device development is the need for constant capital infusions over time until full commercialization occurs. We have taken preemptive actions to solidify a promising future for Tivic Health Systems, Inc. and its shareholders which included the shareholders' approval of a seventeen-for-one reverse stock split which went into effect on March 7th. The objective of this action is to gain compliance with exchange listing requirements by potentially increasing the market price of Tivic Health Systems, Inc.'s common stock and making it more attractive to investors. We feel confident that with the progress we have made on meeting NASDAQ requirements, and reshaping the company to become a more diversified organization, we are well-positioned for growth opportunities ahead. Now let me turn the call back to Jennifer for closing remarks.

Jennifer Ernst

Management

Thank you, Lisa. Now as we start 2025, Tivic Health Systems, Inc. is a completely different company than we were a year ago. I look forward to this year more than I have any other year in the company's history. We continue with a determined focus on achieving the upcoming key milestones associated with the Intellimod commercialization and with advancing our VNS programs in particular. And we view 2025 as a year of growth, and progress that will continue to reshape Tivic Health Systems, Inc. We will continue to move the company closer to securing regulatory approvals for what we expect will be life-changing treatments for patients in need. And on a final note, I invite you to visit our newly updated investor website web pages where we have updated our clinical pipeline and investor deck to capture the broadened opportunities for product development and expansion. While there, you can also sign up to receive company news, and filing alerts that will help you stay informed of the exciting progress that is ahead of us. In real-time. So I look forward to communicating with you very soon as we come back for the next earnings call, and thank you so much I want to offer my thanks to our team, to our investors, and also to Craft Capital who brought this incredible opportunity to us to help us build this company going forward. So I want to thank all of our collaborators across this process of a transformation turning Tivic Health Systems, Inc. now into a diversified therapeutics company.

Operator

Operator

Thank you. And with that, that does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time.