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]

Product Development and Market Opportunity - Tivic Health's ClearUP product is the first FDA-approved bioelectronic treatment for sinus pain and congestion, with a market opportunity identified for approximately 85 million U.S. adults experiencing related symptoms[98] - A pilot study confirmed a 97% increase in heart rate variability (RMSSD) due to the company's non-invasive cervical vagus nerve stimulation (ncVNS) approach, indicating potential clinical utility in major disease areas[102] - The market for peripheral nerve stimulation in bioelectronic medicine is forecasted to grow at a 35% CAGR from 2019 through 2029, indicating strong growth potential in the sector[96] - The company has entered into a collaboration agreement with Feinstein to advance research on autonomic nervous system function in response to neuromodulation[104] Financial Performance - Revenue for the three months ended June 30, 2024, decreased by $21 thousand, or 13%, compared to the same period in 2023, primarily due to a 12% decrease in the per unit average sales price[119] - For the six months ended June 30, 2024, revenue decreased by $63 thousand, or 12%, compared to the same period in 2023, primarily due to a 27% decrease in unit sales, offset by a 20% increase in the per unit average sales price[119] - Cost of sales for the three months ended June 30, 2024, increased by $10 thousand, or 10%, compared to the same period in 2023, driven by a $20 thousand increase in the inventory reserve for obsolescence[121] - Gross profit for the three months ended June 30, 2024, was $30 thousand, a decrease of $31 thousand compared to $61 thousand for the same period in 2023[117] Expense Management - Research and development expenses for the three months ended June 30, 2024, decreased by $166 thousand compared to the same period in 2023, and for the six months ended June 30, 2024, decreased by $400 thousand[126] - Sales and marketing expenses for the three months ended June 30, 2024, decreased by $245 thousand compared to the same period in 2023, and for the six months ended June 30, 2024, decreased by $198 thousand[127] - General and administrative expenses for the three months ended June 30, 2024, decreased by $539 thousand compared to the same period in 2023, and for the six months ended June 30, 2024, decreased by $933 thousand[128] Cash Flow and Capital Needs - As of June 30, 2024, the company had cash and cash equivalents of $3.7 million and an accumulated deficit of $40.6 million[130] - Net cash used in operating activities for the six months ended June 30, 2024, was $3.0 million, compared to $4.9 million for the same period in 2023[141][142] - The company generated $3.3 million from financing activities during the six months ended June 30, 2024, primarily from the sale of 4,710,000 shares of common stock[144] - The company anticipates needing to raise additional capital to fund operations, including research and development and clinical trials, due to insufficient cash resources[135][138] Operational Changes - The company terminated its Fulfillment Services Agreement with ALOM Technologies to reduce costs and has transitioned to third-party logistics and in-house assembly capabilities[112] - 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[107] - The company has not entered into any off-balance sheet arrangements and terminated its previous office lease, now renting co-working space for $1,000 a month[154] Challenges and Risks - The Nasdaq notified the company of non-compliance with the minimum bid price requirement due to the closing bid price being below $1.00 for 33 consecutive business days, with a compliance period until December 26, 2024[109] - The company faces challenges from global supply chain shortages and inflation, which could increase component costs and affect gross margins[147][153] - The ongoing geopolitical tensions and economic uncertainties may negatively impact the company's ability to forecast revenues and secure additional funding[145][151] Research Outcomes - A study on postoperative pain following sinus surgeries showed no statistically significant differences between the active microcurrent device and a sham device, leading the company to halt further research in this area[114] - The company plans to increase research and development investments in its vagus nerve platform and clinical applications in 2024[132] - The company has incurred an accumulated deficit of $40.6 million through June 30, 2024, and expects to incur additional losses as it expands research and development activities[135] Accounting and Compliance - Recent accounting pronouncements are detailed in Note 2 of the condensed financial statements[158] - There are no applicable quantitative and qualitative disclosures about market risk[158]

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].

Core Insights - Tivic Health Systems has updated its intellectual property portfolio, which has positively impacted its stock performance [2][6] - The company received two new patents, enhancing protection for its devices and methods related to treatment [6] - TIVC stock experienced a significant increase of 44% on Thursday, although it remains down 83.1% year-to-date [4] Intellectual Property Developments - The newly granted US Patent 12,011,592 and European Patent EP3615133 cover methods to identify preferred treatment points and trigger treatment modes [6] - The company emphasizes the unique features of its adaptive design and personalization of treatment parameters, which contribute to the effectiveness and comfort of its products [6] - The company is committed to building a robust intellectual property portfolio to support current and future products, including non-invasive vagus nerve stimulation [6] Stock Performance - TIVC stock saw heavy trading activity with over 33 million shares traded on Thursday, compared to a daily average of approximately 816,000 shares [6] - The stock's recent rise follows a significant decline earlier in the year, highlighting volatility in its market performance [4]

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 ...