Tivic Health® Systems, Inc. (“Tivic”, Nasdaq: TIVC), a health
tech company that develops and commercializes bioelectronic
medicine, today announced its second quarter 2024 financial results
and discussed growth strategies based on its investments in vagus
nerve stimulation ("VNS").
“This quarter is the start of a potentially transformational
period for Tivic. We announced the results of our successful Phase
1 trial of a new approach to non-invasive vagus nerve stimulation.
We are partnering with The Feinstein Institute of Bioelectronic
Medicine for optimization, and we are continuing to build our
intellectual property portfolio in an area of significant potential
value to the company and our investors,” explained Jennifer Ernst,
CEO of Tivic.
"Over the last 18 months, we have improved gross margins of our
ClearUP product, increased the revenue-produced-per-marketing
dollar spent, and aggressively reduced operating expenses. We have
relocated manufacturing and driven down costs of fulfillment with a
new third-party logistics provider. We evaluated various potential
licensing and strategic transaction opportunities, while
simultaneously building our organic growth options. We have
demonstrated industry-leading clinical results in the new
high-value medical target of VNS. We are not yet done, but I am
proud of what has been accomplished with a small and dedicated
team.”
Ernst expanded to say, "While we expect to continue to make
improvements in the economic profile of the ClearUP product line
and our overall operating expenses, we believe the future growth of
the company will be greatly enhanced by advancements in our vagus
nerve stimulation program.”
The company will be discussing the key results from the Phase 1
VNS trial as part of its Q2 earnings call.
2024 Business and Operational Updates
In the first half of 2024, Tivic business and operational
updates are as follows:
- Tivic entered a limited exclusive distribution agreement with
one of the Top 10 Medical Equipment Distributors and Suppliers in
the nation.
- The company launched ClearUP 2.0 and began decommissioning
older versions. ClearUP 2.0 includes new power management circuitry
for faster charging and longer battery lifetime, addressing a key
source of negative customer reviews.
- On May 8, 2024, Tivic announced the final results of its pilot
research study with The Feinstein Institutes for Medical Research
at Northwell Health (“Feinstein”). Through this collaboration, the
company has confirmed the effectiveness of our patent-pending
non-invasive cervical vagus nerve stimulation (“ncVNS”) approach.
The study reported responses in the autonomic, cardiac, and central
nervous system activity the indicate potential clinical utility in
several major disease areas.
- On May 17, 2024, Tivic entered into a Collaboration and
Research Support Agreement with Feinstein for the company's Phase
1a optimization study of its vagus nerve stimulation system. The
Phase 1a program will test and seek to optimize the company's
non-invasive vagus nerve stimulation approach in preparation for
future disease-specific Phase 2 trials.
- Effective on May 31, 2024, the company terminated the lease on
its 9,091 square feet of office space in Hayward, California. The
company incurred one-time termination charges of $77 thousand in
connection with the lease termination. This will provide the
company a savings of approximately $284 thousand in lease expense
over the next year and a half.
- Following the close of the period, the company terminated its
standing third-party logistics and manufacturing agreement with
ALOM Technologies, under which the company incurred minimum monthly
charges of $25,000. The company entered agreements with a new
third-party logistics provider and established in-house
manufacturing capabilities with monthly minimum expenses <$1,000
per month in total.
Financial Performance
- Revenue (net of returns) for the three and six months ended
June 30, 2024 was $140 thousand and $474 thousand, respectively, a
decrease of $63 thousand, or 12%, as compared to first half 2023
primarily due to a 27% decrease in unit sales, offset by a 20%
increase in the per unit average sales price.
- Cost of sales for the three and six months ended June 30, 2024
was $110 thousand and $277 thousand, respectively, a decrease of
$86 thousand, or 24%, compared to the first half of 2023.
- Gross profit in the three and six months ended June 30, 2024
was $30 thousand and $197 thousand, respectively, compared to $61
thousand and $174 thousand in 2023.
- Gross margin was 42% in the six months ended June 30, 2024,
compared to 32% in 2023.
- Total operating expenses in the three and six months ended June
30, 2024 was $1.2 million and $2.9 million, respectively, compared
to $2.2 million and $4.4 million in 2023 with year over year cost
reductions of $1.5 million.
- During the three months ended June 30, 2024 and 2023, the
company incurred a net loss of $1.3 million and $2.1 million,
respectively. Net loss for the first half of 2024 was $2.7 million,
$1.5 million lower than for the same period in 2023.
- On May 13, 2024, the company sold 4,710,000 shares of common
stock with accompanying warrants to certain investors in a
registered public offering at a combined price of $0.85 per share
and warrants. The company received gross proceeds of approximately
$4.0 million. Net proceeds after deducting expenses (excluding
proceeds to the company, if any, from the future exercise of the
warrants issued in connection with the offering), were
approximately $3.3 million.
- As of June 30, 2024 and December 31, 2023, cash and cash
equivalents totaled $3.7 million and $3.4 million,
respectively.
The company’s MD&A and consolidated financial statements for
the quarter ended June 30, 2024 will be filed with the Securities
and Exchange Commission on August 14, 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,
August 14, 2024, at 1:30 PM PT / 4:30 PM ET to discuss the
company’s second 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 888-506-0062 for local callers; or 973-528-0011 for
international callers and using entry code 316159.
The conference call will also be available via Webcast link:
https://www.webcaster4.com/Webcast/Page/2865/50901
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 Health
Tivic Health is a commercial health tech company advancing the
field of bioelectronic medicine. Tivic Health’s technology
platforms leverage stimulation of the trigeminal, sympathetic, and
vagus nerve structures. Tivic Health’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
Health’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: the future development of ncVNS
treatment; Tivic Health’s ability to commercialize products arising
out of the ncVNS treatment and Tivic Health’s plans to seek
regulatory approval for such clinical products; Tivic Health’s
continued focus on developing ncVNS treatment, including in the
epilepsy, post-traumatic stress disorder, and/or ischemic stroke
space; expected clinical utility, including which patient
populations may be pursued; market and other conditions; supply
chain constraints; macroeconomic factors, including inflation;
Tivic Health's ability to raise additional capital on favorable
terms, or at all, when needed; Tivic Health's ability to maintain
its Nasdaq listing; and unexpected costs, charges or expenses that
reduce Tivic Health’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 Health’s actual results to differ from those contained
in the forward-looking statements, see Tivic Health’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 29, 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)
June 30, 2024
December 31, 2023
(Unaudited)
(Audited)
ASSETS
Cash and cash equivalents
$
3,693
$
3,395
Other current assets
970
1,257
TOTAL CURRENT ASSETS
4,663
4,652
PROPERTY AND EQUIPMENT, NET
120
122
NONCURRENT ASSETS
—
383
TOTAL ASSETS
$
4,783
$
5,157
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable and accrued expenses
$
591
$
1,208
Other current liabilities
—
193
TOTAL CURRENT LIABILITIES
591
1,401
TOTAL LONG-TERM LIABILITIES
—
176
STOCKHOLDERS' EQUITY
Common stock
1
—
Additional paid in capital
44,824
41,466
Accumulated deficit
(40,633
)
(37,886
)
TOTAL STOCKHOLDERS' EQUITY
4,192
3,580
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY
$
4,783
$
5,157
Tivic Health Systems, Inc.
Condensed Statements of
Operations
(in thousands, except share and per
share data)
Three Months Ended June
30,
Six Months Ended
2024
2023
2024
2023
REVENUES
$
140
$
161
$
474
$
537
COST OF SALES
110
100
277
363
GROSS PROFIT
30
61
197
174
OPERATING EXPENSES
Research and development
302
468
558
958
Sales and marketing
207
452
712
910
General and administrative
727
1,266
1,614
2,547
TOTAL OPERATING EXPENSES
1,236
2,186
2,884
4,415
NET OPERATING LOSS
(1,206
)
(2,125
)
(2,687
)
(4,241
)
OTHER EXPENSE
60
—
60
—
NET LOSS
$
(1,266
)
$
(2,125
)
$
(2,747
)
$
(4,241
)
NET LOSS PER SHARE - BASIC AND DILUTED
$
(0.32
)
$
(7.16
)
$
(1.00
)
$
(17.01
)
WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC
AND DILUTED
4,009,746
296,778
2,738,743
249,264
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240814989979/en/
Media Contact: Morgan Luke
Morgan.Luke@tivichealth.com
Investor Contact: Hanover International, Inc.
ir@tivichealth.com
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