Tivic Reports First Quarter 2024 Financial Results and Subsequent Events
Tivic Health announced its Q1 2024 financial results and subsequent events, marking significant progress in the bioelectronics field. The company reported a gross profit increase of 48% and a reduction in operating loss by nearly 30% year-over-year. Net loss decreased to $1.5 million from $2.1 million in Q1 2023. Despite an 11% drop in revenue to $334 thousand, gross margin improved to 50% from 30%.
Significant milestones included the completion of patient enrollment in a vagus nerve stimulation study and the launch of ClearUP 2.0. A recent public offering raised $4 million, boosting cash reserves to $4.7 million as of May 14, 2024.
Key developments also included a major distribution agreement and positive clinical trial results demonstrating the efficacy of their non-invasive vagus nerve stimulation technology. The company continues to invest in its intellectual property portfolio.
- Gross profit increased by 48% year-over-year.
- Operating loss reduced by nearly 30%.
- Net loss decreased from $2.1 million in Q1 2023 to $1.5 million in Q1 2024.
- Gross margin improved to 50% from 30%.
- Completion of patient enrollment in a significant vagus nerve stimulation study.
- Launch of ClearUP 2.0 with enhanced features.
- Raised $4 million from a recent public offering.
- Cash reserves increased to $4.7 million as of May 14, 2024.
- Entered a exclusive distribution agreement with a top medical equipment distributor.
- Positive clinical trial results for non-invasive vagus nerve stimulation technology.
- Revenue decreased by 11% year-over-year, from $376 thousand to $334 thousand.
- Net loss for Q1 2024 was $1.5 million.
- Total operating expenses were $1.6 million, despite a reduction from the previous year.
- Share dilution from the recent public offering.
- Decreased unit sales volume.
Insights
Tivic Health's Q1 2024 financial results show several significant improvements. Despite a slight decline in revenue to
The recent capital raise, resulting in net proceeds of approximately
Overall, the financial improvements are encouraging, but investors should remain cautious due to the company's net loss and the competitive nature of the health tech industry.
Tivic Health's advancement in non-invasive vagus nerve stimulation (nVNS) is a significant milestone. The completion of the clinical research enrollment and the achievement of results comparable to implanted technologies are notable. The potential applications in treating conditions such as epilepsy, stroke, depression and PTSD are expansive, indicating a broad market opportunity.
The collaboration with The Feinstein Institutes for Medical Research adds credibility and rigor to Tivic's findings. The company's emphasis on non-invasive solutions aligns with the growing demand for less intrusive medical treatments. However, the transition from successful clinical trials to marketable products can be lengthy and fraught with regulatory challenges.
For retail investors, understanding that these clinical milestones, while promising, will require substantial time and investment to translate into commercial success is essential. The potential for high-value medical conditions suggests a lucrative future, provided the company navigates the regulatory and commercial hurdles effectively.
"Q1 2024 and the weeks thereafter represent a critical juncture in Tivic's advancement in the bioelectronics field. We increased gross profit and reduced operating loss year-over-year by stabilizing our cost of goods, improving our technology, simplifying our sales channels, and focusing our marketing strategies, resulting in nearly
"We also passed a major milestone in our non-invasive vagus nerve stimulation (nVNS) program, completing enrollment in our clinical research at the Feinstein Institutes for Medical Research at Northwell Health in Q1 2024. We subsequently announced in May that, with a non-invasive VNS system, we had successfully demonstrate substantive changes in heart rate variability, autonomic nervous system activity and neurologic activity, at magnitudes equivalent in many cases to implanted technologies. We believe that the opportunity for Tivic in this field is significant, and I look forward to discussing this program further with investors as we move forward."
The Company's novel non-invasive cervical vagus nerve stimulation approach opens the door for Tivic to address several high-value medical conditions in neurology, psychiatry and cardiology including potential clinical use cases in epilepsy, stroke, depression and post-traumatic stress disorder.
Recent Events
On May 8, 2024, the Company announced the final results of their pilot research study with The Feinstein Institutes for Medical Research at Northwell Health. Through this collaboration, Tivic Health has confirmed the effectiveness of its patent-pending non-invasive cervical vagus nerve stimulation (ncVNS) approach, which induces responses in the autonomic, cardiac, and central nervous systems and has the potential to have clinical utility in several major disease areas.
On May 13, 2024, we sold an aggregate of 4,710,000 shares of our common stock, together with Series A Warrants to purchase 4,710,000 shares of our common stock and Series B Warrants to purchase 7,065,000 shares of our common stock, to certain investors at a combined public offering price of
Q1 2024 Business Activities and Operational Updates
In the first quarter of 2024, the company:
- Launched ClearUP 2.0 and began decommissioning older models. The new version included new power management circuitry and improved power management for faster charging and longer battery life.
- Entered a limited exclusive distribution agreement with one of the Top 10 Medical Equipment Distributors and Suppliers in the nation. Under the terms of the agreement, the distributor will have certain exclusive distribution rights for Tivic Health’s ClearUP product for Walmart, Target, eBay and Kroger, as well as non-exclusive distribution rights in other specified on-line channels.
- Announced completion of enrollment in our clinical study with The Feinstein Institute for Medical Research at Northwell Health, testing a proprietary approach to non-invasive vagus nerve stimulation.
- Continued to invest in our intellectual property portfolio, filing our first vagus nerve stimulation patent and prosecuting existing filings.
Q1 2024 Financial Performance
-
Revenue for Q1 2024 was
$334 thousand $376 thousand $42 thousand 11% , due reduced unit sales volume offset by increased selling price. -
Gross profit was
$167 thousand $113 thousand 48% . -
Gross margin was
50% in Q1 2024, compared to30% in Q1 2023. -
Total operating expenses for Q1 2024 were
$1.6 million $2.2 million $581 thousand 26% . -
Net loss was
$1.5 million $2.1 million 29% . -
Cash and cash equivalents totaled
$1.7 million
As of May 14, 2024, including the net proceeds of the May public offering, the company had approximately
The company’s MD&A and consolidated financial statements for the quarter ended March 31, 2024 will be filed with the Securities and Exchange Commission on May 15, 2024 with the company’s Quarterly Report on Form 10-Q. The company's previous public filings may be found on www.sec.gov and can also be located on Tivic’s website at: https://tivichealth.com/investor/#SEC.
Conference Call and Webcast Information
Management will host a webcast/conference call on Wednesday, May 15, 2024, at 1:30 PM PT / 4:30 PM ET to discuss the company’s first quarter 2024 financial results and provide a business update, including comments on the direction the company is heading in 2024.
The conference call will be available via telephone by dialing toll-free 877-545-0523 for local callers; or 973-528-0016 for international callers and using entry code 464810.
The conference call will also be available via Webcast link: https://www.webcaster4.com/Webcast/Page/2865/50489
An audio replay of the call will be available from the “Investor” page on the Tivic Health website at https://tivichealth.com/investor/.
About Tivic
Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic’s first commercial product, ClearUP, is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information, visit http://tivichealth.com @TivicHealth
Forward-Looking Statements
This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: market, economic and other conditions; supply chain constraints; macroeconomic factors, including inflation; the company's financial condition; the company’s ability to raise additional capital on favorable terms if and when necessary; changes in regulatory requirements; and unexpected costs, charges or expenses that reduce Tivic’s capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic’s actual results to differ from those contained in the forward-looking statements, see Tivic’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 25, 2024, under the heading “Risk Factors”; as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.
Tivic Health Systems, Inc. Condensed Balance Sheets (in thousands, except share and per share data) |
||||||||
|
|
March 31, 2024 |
|
December 31, 2023 |
||||
|
|
(Unaudited) |
|
(Audited) |
||||
ASSETS |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
1,668 |
|
|
$ |
3,395 |
|
Other current assets |
|
|
1,159 |
|
|
|
1,257 |
|
TOTAL CURRENT ASSETS |
|
|
2,827 |
|
|
|
4,652 |
|
PROPERTY AND EQUIPMENT, NET |
|
|
121 |
|
|
|
122 |
|
NONCURRENT ASSETS |
|
|
338 |
|
|
|
383 |
|
TOTAL ASSETS |
|
$ |
3,286 |
|
|
$ |
5,157 |
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
||||
Accounts payable and accrued expenses |
|
$ |
812 |
|
|
$ |
1,208 |
|
Other current liabilities |
|
|
180 |
|
|
|
193 |
|
TOTAL CURRENT LIABILITIES |
|
|
992 |
|
|
|
1,401 |
|
TOTAL LONG-TERM LIABILITIES |
|
|
141 |
|
|
|
176 |
|
STOCKHOLDERS' EQUITY |
|
|
|
|
||||
Common stock |
|
|
0 |
|
|
|
0 |
|
Additional paid in capital |
|
|
41,520 |
|
|
|
41,466 |
|
Accumulated deficit |
|
|
(39,367 |
) |
|
|
(37,886 |
) |
TOTAL STOCKHOLDERS' EQUITY |
|
|
2,153 |
|
|
|
3,580 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
3,286 |
|
|
$ |
5,157 |
|
Tivic Health Systems, Inc. Condensed Statements of Operations (in thousands, except share and per share data) |
||||||||
|
|
Three Months Ended March 31, |
||||||
|
|
2024 |
|
2023 |
||||
REVENUES |
|
$ |
334 |
|
|
$ |
376 |
|
COST OF SALES |
|
|
167 |
|
|
|
263 |
|
GROSS PROFIT |
|
|
167 |
|
|
|
113 |
|
OPERATING EXPENSES |
|
|
|
|
||||
Research and development |
|
|
256 |
|
|
|
490 |
|
Sales and marketing |
|
|
505 |
|
|
|
458 |
|
General and administrative |
|
|
887 |
|
|
|
1,281 |
|
TOTAL OPERATING EXPENSES |
|
|
1,648 |
|
|
|
2,229 |
|
NET OPERATING LOSS |
|
|
(1,481 |
) |
|
|
(2,116 |
) |
NET LOSS |
|
$ |
(1,481 |
) |
|
$ |
(2,116 |
) |
NET LOSS PER SHARE - BASIC AND DILUTED |
|
$ |
(1.01 |
) |
|
$ |
(10.52 |
) |
WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED |
|
|
1,467,740 |
|
|
|
201,222 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240515519015/en/
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Source: Tivic Health Systems, Inc.
FAQ
What were Tivic Health's Q1 2024 financial results?
What is the significance of Tivic Health's recent clinical trial results?
What new product did Tivic launch in Q1 2024?
How much did Tivic raise in their recent public offering?
What was the impact of Tivic's recent public offering on its cash reserves?
How did Tivic's operating expenses change in Q1 2024?
What are the future prospects for Tivic's non-invasive vagus nerve stimulation technology?
What distribution agreement did Tivic enter in Q1 2024?
