Tivic Reports Fiscal Year 2023 Financial Results
- Tivic Health® Systems, Inc. announced a decrease in revenue for 2023 compared to 2022, with net sales of $1.2M.
- The company reported a gross profit of $330 thousand for 2023, showing an improvement over the previous year.
- Tivic focused on optimizing its commercial business by implementing a new pricing structure, reducing costs, and enhancing marketing efficiency.
- The company invested in clinical programs for vagus nerve stimulation and opiate-use reduction following sinus and facial surgeries.
- Tivic was recognized as one of the World’s Most Innovative Companies for 2023 in the Medical Device category by Fast Company.
- The company's net loss for 2023 was $8.2M, a decrease from $10.1M in 2022.
- Tivic conducted a pilot clinical study on non-invasive vagus nerve stimulation, the results of which are pending.
- The company maintained a no debt balance sheet and had $3.4 million in cash and cash equivalents as of December 31, 2023.
- Tivic conducted financing activities in 2023, including public offerings that resulted in net proceeds of approximately $7.9M.
- The company will file its MD&A and consolidated financial statements for 2023 with the SEC on March 25, 2024.
- The revenue for Tivic Health® Systems, Inc. decreased by 36% in 2023 compared to 2022.
- The company experienced a net loss of $8.2M for the full year of 2023.
- Research and development expenses remained consistent at approximately $1.7M for both 2023 and 2022.
- Sales and marketing expenses decreased in 2023, attributed to a reduction in advertising and agency costs.
- General and administrative expenses also decreased in 2023 due to reductions in legal and professional fees.
- Tivic Health® Systems, Inc. conducted a 1-for-100 reverse stock split in August 2023.
- The company regained compliance with NASDAQ's minimum bid price continued listing requirement in September 2023.
The financial results reported by Tivic Health indicate a challenging fiscal year, with a significant 36% decline in revenue and a net loss of $8.2M. The decrease in revenue is attributed to a substantial drop in unit sales, although this was somewhat mitigated by a higher average selling price per unit. This suggests that while the company's pricing strategy may have positively influenced the revenue per unit, the overall market demand for their product has weakened.
Cost-saving measures such as reducing the cost of goods, improving marketing efficiency and decreasing headcount were important in reducing the net loss compared to the previous year. However, investors should consider the sustainability of these measures in the long term, especially as the company continues to invest in research and development, which remained steady at $1.7M. The company's move to open new channels directed at less price-sensitive healthcare segments could be a strategic attempt to diversify revenue streams, but the effectiveness of this approach remains to be seen.
Financing activities, including a public stock offering and a reverse stock split, indicate efforts to improve capital structure and maintain NASDAQ listing compliance. While these actions have provided short-term liquidity, the dilutive effect on existing shareholders and the potential pressure on stock price should be carefully evaluated. With $3.4 million in cash and cash equivalents and a no debt balance sheet, Tivic appears to have some financial runway, but the burn rate and future capital needs should be monitored closely by investors.
The development and commercialization of bioelectronic medicine, such as Tivic's ClearUP Sinus Pain Relief, represent a growing area in healthcare technology. The company's investment in a new platform for vagus nerve stimulation (VNS) could be significant, as VNS has potential applications in various medical conditions beyond sinus pain relief. The successful completion of study enrollment for the pilot clinical study is a positive step forward, but without the results, it's difficult to assess the potential impact on the company's product pipeline and long-term value creation.
Moreover, the company's strategic focus on opiate-use reduction following sinus and facial surgeries taps into the broader societal need to address opioid dependency. If Tivic's approach proves effective, it could position the company favorably in an important public health area. However, the outcomes of these investments are uncertain and hinge on future clinical success and market acceptance.
Recognition by Fast Company and Global Health & Pharma hints at Tivic's innovation and potential in the bioelectronic medicine field, yet such accolades do not directly translate into financial success. Stakeholders should weigh these recognitions against tangible financial and clinical outcomes when assessing the company's prospects.
Tivic’s commercial platform is a handheld design that interfaces non-invasively with the trigeminal, sympathetic, and other facial and cranial nerve structures. This platform is the basis for Tivic’s existing product, currently marketed with FDA approval as ClearUP Sinus Pain Relief, for the treatment of sinus pain and congestion. In 2023, the company also began investment in a new platform for vagus nerve stimulation. Study enrollment for the pilot clinical study of a proprietary approach to non-invasive vagus nerve stimulation (VNS) was completed on in February 2024. Results of the study have not yet been announced.
“2023 was a year for both streamlining our commercial business and defining new opportunities for value creation,” stated Jennifer Ernst, CEO of Tivic. "We have taken substantial steps towards improving the company’s financial health by implementing a new pricing structure on our commercial product, reducing costs of goods, improving marketing efficiency, and decreasing headcount to align with current revenue. We opened new channels directed to less price-sensitive healthcare segments. And, we strategically invested in clinical programs to create new paths for value creation for our shareholders, including a program in vagus nerve stimulation and one targeted to opiate-use reduction following sinus and facial surgeries."
As a result, the company was named to Fast Company’s prestigious annual list of the World’s Most Innovative Companies for 2023 in the Medical Device category and Global Health & Pharma (GHP) named Tivic Health the Most Pioneering Bioelectronic Medicine Company.
2023 Financial Performance
-
Revenue (net of returns) for 2023 was
$1.2M $1.8M $664 thousand 36% , was due to a52% decrease in ClearUP unit sales, offset by46% higher average selling price per unit. Greater than90% of sales were direct to consumer in 2023. -
Cost of sales was
$889 thousand $1.5M $652 thousand 42% . The decrease was due to the52% decrease in overall unit sales, offset by$172 thousand -
Gross profit for the year ended December 31, 2023 was
$330 thousand $299 thousand -
Research and development expenses were approximately
$1.7M -
Sales and marketing expenses decreased to
$2.1M $2.8M -
General and administrative expenses decreased to
$4.8M $5.9M -
As a result, our 2023 full year net loss was
$8.2M $10.1M
Regarding 2023 financing activities, on February 13, 2023, we sold shares of common stock to investors in a registered public offering, resulting in net proceeds of approximately
On August 23, 2023, we implemented a 1-for-100 reverse stock split, and on September 15, 2023, we received confirmation from NASDAQ that we had regained compliance with the minimum bid price continued listing requirement.
As of December 31, 2023, the company had
The company’s MD&A and consolidated financial statements for the year-ended December 31, 2023 will be filed with the Securities and Exchange Commission on March 25, 2024 with the company’s Annual Report on Form 10-K. 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 Monday, March 25, 2024, at 1:30 PM PT / 4:30 PM ET to discuss the company’s year-end 2023 financial results and provide a business update, including comments on research directions undertaken in 2023.
The conference call will be available via telephone by dialing toll-free 888-506-0062 for local callers; or 973-528-0011 for international callers and using entry code 434944.
The conference call will also be available via Webcast link: https://www.webcaster4.com/Webcast/Page/2865/50026
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, to be 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. |
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Condensed Balance Sheets |
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(in thousands, except share and per share data) |
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|
|
December 31, 2023 |
|
December 31, 2022 |
||||
ASSETS |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
3,395 |
|
|
$ |
3,517 |
|
Other current assets |
|
|
1,257 |
|
|
|
1,789 |
|
TOTAL CURRENT ASSETS |
|
|
4,652 |
|
|
|
5,306 |
|
PROPERTY AND EQUIPMENT, NET |
|
|
122 |
|
|
|
12 |
|
NONCURRENT ASSETS |
|
|
383 |
|
|
|
557 |
|
TOTAL ASSETS |
|
$ |
5,157 |
|
|
$ |
5,875 |
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
||||
Accounts payable and accrued expenses |
|
$ |
1,208 |
|
|
$ |
1,715 |
|
Other current liabilities |
|
|
193 |
|
|
|
163 |
|
TOTAL CURRENT LIABILITIES |
|
|
1,401 |
|
|
|
1,878 |
|
TOTAL LONG-TERM LIABILITIES |
|
|
176 |
|
|
|
367 |
|
STOCKHOLDERS' EQUITY |
|
|
|
|
||||
Common stock |
|
|
— |
|
|
|
— |
|
Additional paid in capital |
|
|
41,466 |
|
|
|
33,272 |
|
Accumulated deficit |
|
|
(37,886 |
) |
|
|
(29,642 |
) |
TOTAL STOCKHOLDERS' EQUITY |
|
|
3,580 |
|
|
|
3,630 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
5,157 |
|
|
$ |
5,875 |
|
Tivic Health Systems, Inc. |
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Condensed Statements of Operations |
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(in thousands, except share and per share data) |
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Year Ended December 31, |
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|
|
2023 |
|
|
2022 |
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REVENUES |
|
$ |
1,176 |
|
|
$ |
1,840 |
|
COST OF SALES |
|
|
889 |
|
|
|
1,541 |
|
GROSS PROFIT |
|
|
287 |
|
|
|
299 |
|
OPERATING EXPENSES |
|
|
|
|
||||
Research and development |
|
|
1,655 |
|
|
|
1,730 |
|
Sales and marketing |
|
|
2,125 |
|
|
|
2,792 |
|
General and administrative |
|
|
4,752 |
|
|
|
5,875 |
|
TOTAL OPERATING EXPENSES |
|
|
8,532 |
|
|
|
10,397 |
|
NET OPERATING LOSS |
|
|
(8,245 |
) |
|
|
(10,098 |
) |
NET LOSS |
|
$ |
(8,244 |
) |
|
$ |
(10,096 |
) |
NET LOSS PER SHARE - BASIC AND DILUTED |
|
$ |
(10.40 |
) |
|
$ |
(104.32 |
) |
WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED |
|
|
793,043 |
|
|
|
96,778 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240325512073/en/
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Source: Tivic Health Systems, Inc.
FAQ
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