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Tivic Health Systems, Inc. (TIVC)

Q1 2024 Earnings Call· Wed, May 15, 2024

$1.38

+3.76%

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Transcript

Operator

Operator

Welcome to the Tivic Health Systems' First Quarter 2024 Financial Results and Shareholder Update Conference Call. [Operator Instructions] Please note that the conference is being recorded. Statements made during this call contain forward-looking statements about Tivic's business. You should not place undue reliance on forward-looking statements as these statements are based upon management's current expectations, forecasts and assumptions and are subject to significant risks and uncertainties. These statements may be identified by words such as may, will, should, could, expect, intend, plan, anticipate, believe, estimate, predict, potential, forecast, continue or the negative of these terms or other words or terms of similar meaning. Risks and uncertainties that could cause Tivic's actual results to differ materially from those set forth in any forward-looking statements include, but are not limited to, the matters listed under Risk Factors in the company's annual report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 25, 2024 as well as the company's subsequent filings with the SEC. Statements and information, including forward-looking statements speak only to the date that they are provided, unless an earlier date is indicated, and Tivic does not undertake any obligation to publicly update any statements or information, including forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Now let me hand over the call to Jennifer Ernst, Tivic Health's Chief Executive Officer.

Jennifer Ernst

Analyst

Hello, everyone, and thank you for joining us today. I'm Jennifer Ernst, CEO of Tivic Health, and I'm joined today by our Interim CFO, Kimberly Bambach. So today, we will be taking a little bit different tactic as we go through our discussions. Of course, I'll be touching on our Q1 results, and Kim will go into those in much more detail. However, we've had some pretty important events in the past few weeks, and that's what I want to spend more time discussing with you today. Specifically, I am focusing on the importance of the results we announced from our vagus nerve stimulation program. Results we announced last week coming out of the clinical study we conducted with the Feinstein Institute for bioelectronic medicine at Northwell Health. So those of you that have been following Tivic for a while know that we have one FDA-approved product in market sold under the brand name ClearUp and used for the treatment of sinus pain and congestion. That product is based on a patented handheld bioelectronic design that targets the activity of the trigeminal and sympathetic nerves. Now on that, we generated just over $1 million in revenue last year and $334,000 in Q1. Direct sales, of course, are representing our largest share. In Q1, we executed a limited exclusive distribution agreement with McKesson, one of the top 10 medical product distributors in the U.S. Through their affiliates, Simply Medical McKesson will be serving as the exclusive distributor of ClearUp to major retail outlets such as CVS, Walmart, Target, eBay and other online brick-and-mortar retailers. They have already begun ordering. And I'm excited about the opportunity for this particular relationship as it begins to simplify our channel strategies. If you've been tracking us, you also know that we are continuing to improve…

Kimberly Bambach

Analyst

Thanks, Jennifer, and good afternoon, everyone. I am pleased to report the first quarter of 2024 financial results. We posted first quarter revenue of $334,000, a decrease of $42,000 or 11.2% compared to the same quarter last year, primarily due to a price point increase of our single commercial product, ClearUp. This resulted in a 35% decrease in unit sales, offset by a corresponding increase in the per unit average sale price. We expect some continued variability in ClearUp sales due to the reduction in marketing spend and price point positioning for target markets with a net impact resulting in a higher gross profit and lower loss from operations. For the 3 months ended March 31, cost of sales decreased by $96,000 or 37% compared to the same quarter last year, primarily driven by the decrease in sales volume. Gross profit for the first quarter was $167,000, an increase of $54,000 or 48% compared to $113,000 in the same quarter last year. The improvement, again, primarily due to the ClearUp price increase and the lower cost per unit. Total operating expenses were $1.6 million for the first quarter of 2024 compared to $2.2 million in the same quarter last year. The decrease of $581,000 or 26% is attributed to a first quarter 2023 onetime segmentation study for ClearUp as well as lower staff consulting, professional fees and other reduced general and administrative expenses. As a result, our first quarter net loss was $1.5 million compared to $2.1 million in the same quarter last year. On May 13, 2024, we sold an aggregate of 4,710,000 shares of our common stock, together with the Series A warrants of 4,710,000 and Series B warrants of 7,065,000 to certain investors at a public offering price of $0.85 per share. This offering resulted in aggregate gross proceeds to the company of $4 million. Aggregate net proceeds to the company after deducting placement agent fees and offering expenses was approximately $3.5 million. Maxim Group served as the placement agent for the offering. The securities issued in connection with the offering were registered pursuant to the registration statement, which was initially filed with the commission on March 29, 2024, in which the commission declared effective as amended on May 9, 2024. As of May 14, 2024, including proceeds from the offering, the company had approximately $4.7 million of cash and cash equivalents, and we continue to maintain a no-debt balance sheet. I will now hand the call back to Jennifer for ending remarks.

Jennifer Ernst

Analyst

Thanks, Kim, for taking us through all of the details, particularly of the financing section. Now 2023, as I look back, this has been the time of resetting, rebuilding and recovery. 2024, now that we can finally begin talking with you about the exciting work that we are doing and the new possibilities for bioelectronic medicine, based on our VNS work, this is an exciting year. So yes, we've got a commitment to fiscal responsibility. We remain focused on decreasing our expenses, optimizing our operations for efficiency. We've revamped the administrative cost structure of the business. We continue to reduce the overhead expenses and continue to hone and focus the marketing strategy. Our most important investments, though, at this time are likely to be the investments we make in furthering the VNS program to continue to deliver on a new set, a new initiative of milestones and potential value inflection points. As we have done in the past, we continue to evaluate business combinations, licensing opportunities, other types of strategic transactions that may help enrich our product portfolio with complementary offerings. We also recognize though that they must be the right opportunities at the right time. Market conditions have to be conducive to being able to close and manage those opportunities. So we remain vigilant in assessing the opportunities that may disproportionately benefit our shareholders. While we continue to make a concurrent investment in the internal and organic development of our own technology. Our research pipeline is beginning to become an even more important part of our strategy to build shareholder value. We believe -- I believe that the VNS opportunity as well as the medical extensions of our trigeminal nerve stimulation platform that are currently in trial have the potential to be great significance to the company and to our shareholders. VNS is a growing market segment. It's part of an $8.3 billion neuro stimulation market. And we at Tivic, along with collaborators such as the Feinstein Institute for bioelectronic medicine, hope to lead the way to meaningful improvements in how VNS devices can precisely target and modulate the vagus nerve activity. We're seeking to achieve these intended biological and clinical outcomes with noninvasive or perhaps may be minimally invasive, but with noninvasive devices. And with that, I want to thank you for taking the time with us today. I hope you have heard now a vision that unlocks new potential for the company. And I look forward to speaking with you as we make progress through the year and continue to report out on both our financial and research progress.

Operator

Operator

Thank you, everyone. This concludes today's event. You may disconnect at this time, and have a wonderful day. Thank you for your participation.