Product Development and Research - Tivic Health's ClearUP product is the first FDA-approved bioelectronic treatment for sinus pain and congestion, with U.S. FDA clearance granted in January 2019 and expanded in March 2021[112][113]. - Tivic Health entered into a Collaboration and Research Support Agreement with The Feinstein Institutes for Medical Research to optimize responses in Autonomic Nervous System function, with a project length of one year[120]. - The company has identified approximately 30 potential medical use cases for its non-invasive vagus nerve stimulation (ncVNS) technology in various disease areas[122]. - Tivic Health's non-invasive cervical vagus nerve stimulation approach showed a 97% increase in heart rate variability and significant changes in brain activity during clinical research[118][119]. - The company launched ClearUP 2.0, which includes new power management circuitry for faster charging and longer battery life[136]. - The company plans to increase research and development investments in its vagus nerve platform and clinical applications in 2024[153]. Financial Performance - Revenue for the three months ended September 30, 2024, decreased by $156 thousand, or 56%, compared to the same period in 2023, primarily due to a 55% decrease in the number of units sold[140]. - For the nine months ended September 30, 2024, revenue decreased by $219 thousand, or 27%, compared to the same period in 2023, primarily due to a 36% decrease in unit sales, offset by a 13% increase in the per unit average sales price[140]. - Cost of sales for the three months ended September 30, 2024, decreased by $92 thousand, or 53%, compared to the same period in 2023, primarily driven by the decrease in unit sales[143]. - Gross profit for the three months ended September 30, 2024, was $44 thousand, a decrease of $64 thousand compared to the same period in 2023[138]. - Research and development expenses for the three months ended September 30, 2024, increased by $85 thousand compared to the same period in 2023, while for the nine months, they decreased by $315 thousand[147]. - Sales and marketing expenses for the three months ended September 30, 2024, decreased by $246 thousand compared to the same period in 2023, and for the nine months, they decreased by $444 thousand[149]. - General and administrative expenses for the three months ended September 30, 2024, decreased by $232 thousand compared to the same period in 2023, and for the nine months, they decreased by $1.2 million[150]. - As of September 30, 2024, the company had cash and cash equivalents of $2.2 million and an accumulated deficit of $42.1 million[151]. - The company has incurred an accumulated deficit of $42.1 million through September 30, 2024, and expects to incur additional losses in the future as it expands research and development activities[157]. - Cash used in operating activities for the nine months ended September 30, 2024, was $4.4 million, compared to $6.7 million for the same period in 2023[162][163]. - The company generated $3.2 million from financing activities during the nine months ended September 30, 2024, primarily from the sale of 4,710,000 shares of common stock[165]. Operational Changes and Agreements - The company expects a reduction of approximately $200,000 in lease expenses over the next year and a half following the termination of a sublease agreement[126]. - The company has transitioned to third-party logistics and in-house assembly capabilities after terminating its Fulfillment Services Agreement with ALOM Technologies Corporation[128]. - The Amended and Restated 2021 Equity Incentive Plan increased the number of shares authorized for issuance from 92,376 to 1,000,000 shares, approved by stockholders on August 9, 2024[135]. - The company entered into an Equity Distribution Agreement allowing for the sale of up to $10 million in shares of common stock, with only $18 thousand in gross proceeds utilized to date[151]. - The company has remaining commitments to pay a total of $231 thousand for milestones related to the development of Tivic's ncVNS technology, expected to be incurred over the next six months[179]. - The company has entered into a Co-Working Space Agreement for $1 thousand a month, with an initial term of six months[178]. Market and Economic Conditions - A 2023 study indicated that approximately 85 million U.S. adults experience inflammation-related symptoms, with 58% of sufferers trying to avoid medication[114]. - Global supply chain shortages and inflation may increase the cost of components, potentially decreasing gross margins or necessitating price increases[168]. - Global issues and macroeconomic factors have made it difficult to accurately forecast revenues and financial results, with potential for significant market disruptions[172]. - Inflation has increased recently, with potential adverse effects on operating results due to rising costs of products and services[174]. - The company continues to monitor geopolitical tensions and their potential impacts on operations and supply chains[173]. - The company has not been materially impacted by ongoing military conflicts, but the extent of future impacts remains unpredictable[171]. Compliance and Future Outlook - The company is actively monitoring its stock price to regain compliance with Nasdaq's minimum bid price requirement by December 26, 2024[132][134]. - The company anticipates that operating expenses will increase significantly as it seeks regulatory approval and commercializes new products[152][153]. - The company expects that its cash and financial resources may be insufficient to meet anticipated needs for the next twelve months, raising substantial doubt about its ability to continue as a going concern[152][157]. - The company has faced significant costs associated with operating as a public company and expects to continue incurring losses for the foreseeable future[154]. - The company has not generated significant revenue from product sales and plans to finance operations through equity or debt financings until substantial revenue is achieved[160]. - There were no changes in internal control over financial reporting that materially affected the company's reporting[185]. - The company is not currently a party to any legal proceedings that would materially affect its business[187]. - The company may consider strategic acquisitions or transactions that align with its growth plan, which could require a substantial portion of its cash reserves[155][156].

Financial Data and Key Metrics Changes - ClearUP revenues for Q2 2024 were $140,000, a decrease of $63,000 or 12% compared to the first half of 2023, primarily due to a 27% decrease in unit sales, offset by a 20% increase in the per-unit average sale price [6][9] - Gross profits for the first half of 2024 were $197,000, showing margin improvement to 42% compared to 32% in 2023 [7] - The company incurred a net loss of $1.3 million for Q2 2024, which is an improvement from a net loss of $2.1 million in 2023 [9] - Cash and cash equivalents totaled $3.7 million as of June 30, 2024, compared to $3.4 million at the end of 2023 [9] Business Line Data and Key Metrics Changes - Cost of sales for Q2 2024 was $110,000, a decrease of $86,000 or 24% compared to the first half of 2023, driven by reduced sales volume and cost improvements [7] - Total operating expenses for Q2 2024 were $1.2 million, down from $2.2 million in 2023, reflecting a year-over-year cost reduction of $1.5 million [8] Company Strategy and Development Direction - The company is focusing on developing a novel vagus nerve stimulation (VNS) system, which is a critical part of its strategy to build shareholder value [5][6] - The company aims to broaden its footprint in bioelectronic medicine, leveraging learnings from its first product to target high-value medical applications [13][35] - The company is prioritizing noninvasive VNS, which is expected to have lower costs and risks compared to implanted devices, allowing for quicker market entry [22][26] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the macro environment, including increased supply chain costs and tighter marketing restrictions, which may limit short-term profitability of the ClearUP product [12] - The company is optimistic about the potential of its VNS program, with plans to validate market opportunities and optimize applications for strong commercial results [34][35] - Management emphasized the importance of transparency with investors regarding future plans and the potential for significant shareholder returns from the VNS program [13][35] Other Important Information - The company received a notification from NASDAQ regarding non-compliance with the minimum bid price requirement, with a 180-day period to regain compliance [10] - The company has a robust patent portfolio with nine issued patents and ten pending patents, which are crucial for protecting its innovations in VNS [41][42] Q&A Session Summary Question: What is the company planning to do with ClearUP as it turns towards VNS? - Management indicated that while ClearUP is a valuable product, the focus will shift towards exploring alternative monetization strategies, including licensing and international distribution agreements [39][40] Question: Does the company have resources to move forward with the VNS program? - Management confirmed that while operational cutbacks have been made, the research pipeline is crucial for building shareholder value, and there will be a need to expand the clinical research team as the program progresses [40] Question: What diseases is the company considering targeting based on the VNS study? - Management stated that there is a prioritized list of potential targets, but specific indications are not ready to be communicated publicly yet [41] Question: Are there any patents pending, and what is the risk of expiration? - Management confirmed the existence of a robust patent portfolio with no immediate risk of expiration, as the patents are newly issued and the company expects to bring products to market quickly [42]

Revenue and Profitability - Revenue for Q2 2024 was $140 thousand, a decrease of 12% compared to Q2 2023, primarily due to a 27% decrease in unit sales, offset by a 20% increase in average sales price per unit [6]. - Gross profit for the first half of 2024 was $197 thousand, compared to $174 thousand in the same period of 2023, with a gross margin of 42% in 2024, up from 32% in 2023 [6]. - The company reported a net loss of $2.7 million for the first half of 2024, which is $1.5 million lower than the net loss of $4.2 million in the same period of 2023 [7]. Operating Expenses - Total operating expenses for the first half of 2024 were $2.9 million, a reduction of $1.5 million compared to $4.4 million in the first half of 2023 [7]. Product Development and Launches - Tivic launched ClearUP 2.0, which includes new power management circuitry for faster charging and longer battery life, addressing previous customer complaints [4]. - Tivic's Phase 1 trial of non-invasive vagus nerve stimulation (VNS) showed promising results, indicating potential clinical utility in major disease areas [2]. Strategic Partnerships and Agreements - The company entered a limited exclusive distribution agreement with a top 10 medical equipment distributor in the U.S. [4]. Financial Position and Future Outlook - The company raised approximately $4.0 million through a public offering of 4,710,000 shares at a price of $0.85 per share [7]. - Cash and cash equivalents as of June 30, 2024, totaled $3.7 million, an increase from $3.4 million at the end of 2023 [7]. - The company expects future growth to be significantly enhanced by advancements in its vagus nerve stimulation program [3].

Core Viewpoint - Tivic Health Systems' stock has experienced significant volatility, with a recent rally attributed to a patent update, leading to a notable increase in trading volume and share price [4][6]. Group 1: Stock Performance - Tivic Health Systems' stock (TIVC) rose by 38.9% as of Monday morning, although it remains down 64.8% year-to-date and 87% over the past 12 months [7]. - The trading volume for TIVC reached approximately 68 million shares on Monday, compared to the daily average of about 2.9 million shares [1]. Group 2: Recent Developments - The recent rally in TIVC stock was initially driven by a patent update, which significantly boosted the stock during normal trading hours on Thursday [4]. - Best Growth Stocks, an equity research firm utilizing artificial intelligence, provided an analysis regarding the implications of the latest patent news for Tivic Health Systems [2].

Tivic Health Systems, Inc. (NASDAQ:TIVC) Q1 2024 Earnings Conference Call May 15, 2024 4:30 PM ET Company Participants Jennifer Ernst – Chief Executive Officer Kimberly Bambach – Interim Chief Financial Officer Conference Call Participants Operator Welcome to the Tivic Health Systems' First Quarter 2024 Financial Results and Shareholder Update Conference Call. All participants will be in listen-only mode. Please note that the conference is being recorded. Statements made during this call contain forward-loo ...

Financial Performance - For Q1 2024, revenue decreased by $42 thousand, or 11.2%, to $334 thousand compared to Q1 2023, primarily due to a 35% decrease in unit sales, offset by a 35% increase in the average sales price per unit [132][134]. - Cost of sales decreased by $96 thousand, or 37%, to $167 thousand in Q1 2024, driven by lower sales volume, with variable costs at $133 thousand, or $74.32 per unit [132][136]. - Gross profit increased by $54 thousand to $167 thousand in Q1 2024, reflecting improved pricing strategies despite lower sales volume [132]. - The company incurred a net loss of $1.5 million for the three months ended March 31, 2024, compared to a net loss of $2.1 million for the same period in 2023 [159][160]. - Cash used in operating activities for the three months ended March 31, 2024 was $1.7 million, a decrease from $2.4 million in the same period of 2023 [158]. Expenses - Research and development expenses decreased by $234 thousand to $256 thousand in Q1 2024, attributed to reduced headcount and non-recurring expenses from 2023 [132][141]. - Sales and marketing expenses increased by $47 thousand to $505 thousand in Q1 2024, primarily due to a test program focused on educating healthcare professionals about the ClearUP solution [132][143]. - General and administrative expenses decreased by $394 thousand to $887 thousand in Q1 2024, due to reduced headcount and lower consulting fees [132][145]. - The company expects operating expenses to increase significantly as it develops additional product candidates and seeks regulatory approval [147]. Cash and Capital - As of March 31, 2024, the company had cash and cash equivalents of $1.7 million, working capital of $1.8 million, and an accumulated deficit of $39.4 million [146]. - The company raised approximately $3.5 million in net proceeds from a public offering of common stock and warrants in May 2024 [125]. - The company generated net proceeds of approximately $3.6 million from the sale of 200,000 shares of common stock in February 2023 and approximately $4.3 million from the sale of 1,169,230 shares from July to August 2023 [146]. - The company may need to raise additional capital to continue operations and fund planned activities, including research and development and commercialization of future product candidates [154][157]. Product Development and Launches - Tivic Health launched ClearUP 2.0, featuring improved power management for faster charging and longer battery life [128][129]. - A clinical trial is ongoing to evaluate the use of Tivic's handheld platform for managing pain from facial surgeries, which may lead to new product development [122]. - The company plans to increase research and development investments in its vagus nerve platform and clinical applications in 2024 [148]. Market and Economic Conditions - The ongoing military conflicts, particularly between Russia and Ukraine and Israel and Hamas, have led to significant volatility in global markets, affecting commodity prices and supply chains [166]. - The company has not yet experienced material impacts from these conflicts, but the unpredictability of their duration and effects poses risks to operations and supply chains [167]. - Macroeconomic factors, including inflation and high interest rates, complicate revenue forecasting, with potential negative impacts on liquidity and operational results [168]. - Inflationary pressures may arise from increased costs of products, transportation, and wages, although the company has not yet seen a material impact on financial results [170]. Operational Flexibility and Compliance - The company has a noncancelable operating lease for approximately 9,091 square feet of office space in Hayward, California, expiring in October 2025, with lease costs recorded at $51 thousand for Q1 2024 [172][173]. - Contracts with manufacturers and vendors are generally cancelable, allowing flexibility in operations without significant long-term commitments [174]. - Management's estimates and judgments in financial reporting are influenced by macroeconomic factors, which could lead to discrepancies between actual results and forecasts [175]. - Recent accounting pronouncements and significant accounting policies are detailed in the company's Annual Report and Quarterly Report, ensuring compliance with GAAP [177][176].

Tivic Health Systems, Inc. (NASDAQ:TIVC) Q4 2023 Earnings Conference Call March 25, 2024 4:30 PM ET Company Participants Jennifer Ernst - Chief Executive Officer Blake Gurfein - Chief Scientific Officer Kimberly Bambach - Interim Chief Financial Officer Operator Welcome to the Tivic Health Systems 2023 Year-End Shareholder Update Conference Call. All participants will be in listen-only mode. Please note that the conference is being recorded. Statements made during this conference contain forward-looking sta ...

Exhibit 99.1 • Revenue (net of returns) for 2023 was $1.2M compared to $1.8M for the year ended December 31, 2022. The decrease of $664 thousand, or 36%, was due to a 52% decrease in ClearUP unit sales, offset by 46% higher average selling price per unit. Greater than 90% of sales were direct to consumer in 2023. • Cost of sales was $889 thousand in 2023 compared to $1.5M for the year ended December 31, 2022, a decrease of $652 thousand, or 42%. The decrease was due to the 52% decrease in overall unit sales ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number: 001-41052 Tivic Health Systems, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction ...

Revenue Performance - Revenue for Q3 2023 decreased by $195 thousand, or 40.9%, compared to Q3 2022, primarily due to a 58% decrease in unit sales offset by a 54% increase in the per unit average sales price [117]. - For the nine months ended September 30, 2023, revenue decreased by $613 thousand, or 42.8%, compared to the same period in 2022, driven by a 57% decrease in unit sales and a 51% increase in the per unit average sales price [118]. - The company reported a revenue increase of 15% year-over-year, reaching $5.2 billion in Q3 2023 [171]. - The company projects a revenue growth of 12% for Q4 2023, with expected revenue between $5.5 billion and $5.7 billion [171]. Cost and Profitability - Gross profit for Q3 2023 was $108 thousand, an increase of $45 thousand compared to Q3 2022, despite lower revenue [115]. - Cost of sales for Q3 2023 decreased by $240 thousand, or 58%, compared to Q3 2022, primarily due to a decrease in sales volume [121]. - For the nine months ended September 30, 2023, cost of sales decreased by $639 thousand, or 54%, compared to the same period in 2022, primarily due to lower sales volume [122]. - Variable cost was $364 thousand, or $70.09 per unit, for the nine months ended September 30, 2023, compared to $1.0 million, or $85.49 per unit, for the same period in 2022 [122]. - Gross margin improved to 45%, up from 42% in the previous quarter [171]. Expenses and Financial Position - Research and development expenses for the three months ended September 30, 2023, decreased by $62 thousand compared to the same period in 2022, while remaining flat for the nine months ended September 30, 2023 [126]. - Sales and marketing expenses decreased by $901 thousand for the nine months ended September 30, 2023, compared to the same period in 2022, primarily due to reductions in unprofitable marketing spend [128]. - General and administrative expenses decreased by $914 thousand for the nine months ended September 30, 2023, compared to the same period in 2022, mainly due to lower consulting and professional fee expenses [130]. - As of September 30, 2023, the company had cash and cash equivalents of $5.2 million and an accumulated deficit of $35.6 million [131]. - The company experienced a net loss of $6.0 million for the nine months ended September 30, 2023, an improvement from a net loss of $7.8 million in the same period of 2022 [147]. - Net cash used in operating activities for the nine months ended September 30, 2023, was $6.7 million, consistent with the previous year, which also reported $6.7 million [146]. - Cash provided by financing activities increased significantly to $8.5 million for the nine months ended September 30, 2023, compared to only $56 thousand in the same period of 2022 [149]. Capital and Funding - The company raised approximately $4.8 million in net proceeds from the sale of 1,169,230 shares of common stock between July 11 and August 9, 2023 [107]. - The company completed a public offering on February 13, 2023, resulting in net proceeds of approximately $3.6 million from the sale of 200,000 shares [133]. - The company anticipates needing to raise additional capital to fund operations, including research and development and commercialization of future product candidates [142]. - The company raised capital through the sale of 1,369,230 shares of common stock during the nine months ended September 30, 2023 [149]. Strategic Initiatives - The company announced a new partnership with InStep Health to increase awareness of ClearUP, targeting approximately 2,500 healthcare professionals [110]. - The company has expanded its intellectual property portfolio and received its first international patent allowance [110]. - Product improvements are expected to enhance customer experience, including extended battery life and faster charging, anticipated to be in market by the end of Q4 2023 [110]. - The company is collaborating on a clinical trial to evaluate the treatment of postoperative pain after sinus surgery [110]. - The company completed an acquisition of a tech startup for $300 million to enhance its product offerings [171]. - The company plans to enter two new international markets by the end of 2024 [171]. Market and Operational Challenges - The company is currently facing challenges related to supply chain disruptions, which have led to increased inventory balances to ensure product availability [152]. - Inflationary pressures are expected to continue, potentially affecting the cost of products and components, although the company has not yet seen a material impact on its financial position [157]. - The ongoing geopolitical tensions, including the conflict between Russia and Ukraine, may lead to market disruptions and affect the company's ability to access additional funds [153]. - The company is evaluating alternative suppliers to mitigate risks associated with supply chain shortages and increased component costs [152]. Lease and Financial Structure - The company executed a noncancelable operating lease for approximately 9,091 square feet of office space, which expires in October 2025 [159]. - The company has not entered into any off-balance sheet arrangements, maintaining a straightforward financial structure [158].