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Tivic Reports Fiscal Year 2023 Financial Results

Tivic Reports Fiscal Year 2023 Financial Results

Tivic 公布 2023 财年财务业绩
Tivic Health Systems ·  03/01 00:00

SAN FRANCISCO – (Business Wire) – March 25, 2024 Tivic Health Systems, Inc. ("Tivic", Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced its financial results for the year ending December 31, 2023.

旧金山 —(美国商业资讯)— 2024年3月25日 开发和商业化生物电子医学的健康科技公司Tivic Health Systems, Inc.(“Tivic”,纳斯达克股票代码:TIVC)今天公布了截至2023年12月31日的年度财务业绩。

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.

Tivic 的商业平台是一种手持式设计,可与三叉神经、交感神经和其他面部和脑神经结构进行非侵入性接口。该平台是Tivic现有产品的基础,该产品目前已获得美国食品药品管理局的批准,名为ClearUp Sinus Pain Relief,用于治疗鼻窦疼痛和充血。2023年,该公司还开始投资迷走神经刺激的新平台。专有非侵入性迷走神经刺激(VNS)方法的试点临床研究的研究入组已于2024年2月完成。该研究的结果尚未公布。

"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."

Tivic首席执行官詹妮弗·恩斯特表示:“2023年是精简我们的商业业务和定义价值创造新机会的一年。”“通过对我们的商业产品实施新的定价结构,降低商品成本,提高营销效率以及减少员工人数以与当前收入保持一致,我们已经采取了实质性措施来改善公司的财务状况。我们开辟了面向价格不太敏感的医疗保健细分市场的新渠道。而且,我们战略性地投资了临床项目,为股东创造了新的价值创造途径,包括一项迷走神经刺激计划和一项旨在减少鼻窦和面部手术后阿片类药物使用量的计划。”

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.

结果,该公司入选了Fast Company久负盛名的2023年医疗器械类别全球最具创新力的公司年度名单,全球健康与制药(GHP)将Tivic Health评为最具开创性的生物电子医学公司。

2023 Financial Performance

2023 年财务业绩

  • 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, offset by $172 thousand of costs related to write-offs or reserves on old inventory and components primarily related to our ClearUP 1.0 units as our ClearUP 2.0 units began shipping in December of 2023. We do not expect to incur similar costs in 2024.
  • Gross profit for the year ended December 31, 2023 was $330 thousand compared to a gross profit of $299 thousand for the year ended December 31, 2022.
  • Research and development expenses were approximately $1.7M for each of the years ended December 31, 2023 and December 31, 2022. The emphasis of research and development activities in 2023 was primarily related to our work with The Feinstein Institutes.
  • Sales and marketing expenses decreased to $2.1M for the year ended December 31, 2023, compared to $2.8M for the year ended December 31, 2022. The decrease was primarily due to reduction of advertising and agency costs.
  • General and administrative expenses decreased to $4.8M in 2023, compared to $5.9M for the year ended December 31, 2022. The decrease is primarily due to a reduction in legal and professional fees and other corporate expenses as the company worked to reduce overhead costs.
  • As a result, our 2023 full year net loss was $8.2M, compared to $10.1M in 2022.
  • 2023年的收入(扣除回报后)为120万美元,而截至2022年12月31日的年度为180万美元。下降664,000美元,跌幅36%,是由于ClearUp单位销售额下降了52%,但被单位平均销售价格上涨了46%所抵消。2023 年,超过 90% 的销售额是直接面向消费者。
  • 2023年的销售成本为88.9万美元,而截至2022年12月31日的年度为150万美元,下降了65.2万美元,下降了42%。下降是由于我们的ClearUp 2.0单位于2023年12月开始发货时,总销量下降了52%,但与旧库存和零部件的核销或储备相关的17.2万美元成本所抵消,这些成本主要与我们的ClearUp 1.0单位有关。我们预计在2024年不会产生类似的成本。
  • 截至2023年12月31日止年度的毛利为33万美元,而截至2022年12月31日止年度的毛利为29.9万美元。
  • 截至2023年12月31日和2022年12月31日的每年的研发费用约为170万美元。2023 年研发活动的重点主要与我们与费恩斯坦研究所的合作有关。
  • 截至2023年12月31日止年度的销售和营销费用降至210万美元,而截至2022年12月31日的年度为280万美元。下降的主要原因是广告和代理成本的降低。
  • 一般和管理费用在2023年降至480万美元,而截至2022年12月31日的年度为590万美元。下降的主要原因是公司努力降低管理费用,从而减少了法律和专业费用以及其他公司费用。
  • 因此,我们2023年全年净亏损为820万美元,而2022年为1,010万美元。

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 $3.6M. From July 11, 2023 to August 9, 2023, we sold shares of common stock to investors in a series of registered public offerings, resulting in aggregate net proceeds to the company of approximately $4.3M.

关于2023年的融资活动,我们在2023年2月13日通过注册公开发行向投资者出售了普通股,净收益约为360万美元。从2023年7月11日到2023年8月9日,我们在一系列注册的公开募股中向投资者出售了普通股,使公司的净收益总额约为430万美元。

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.

2023 年 8 月 23 日,我们实施了 1 比 100 的反向股票拆分,2023 年 9 月 15 日,我们收到纳斯达克的确认,我们已恢复遵守最低出价继续上市要求。

As of December 31, 2023, the company had $3.4 million of cash and cash equivalents and we continued to maintain a no debt balance sheet.

截至2023年12月31日,该公司拥有340万澳元的现金及现金等价物,我们继续保持无债务资产负债表。

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.

该公司截至2023年12月31日的年度管理与分析和合并财务报表将与公司10-K表年度报告一起于2024年3月25日向美国证券交易委员会提交。该公司先前的公开文件可以在以下网址找到 www.sec.gov 也可以在 Tivic 的网站上找到: https://tivichealth.com/investor/#SEC

Conference Call and Webcast Information

电话会议和网络直播信息

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.

管理层将在周一主持网络直播/电话会议, 太平洋时间2024年3月25日下午1点30分/美国东部时间下午4点30分,讨论公司2023年年底的财务业绩,并提供最新业务情况,包括对2023年研究方向的评论。

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.

电话会议将通过电话进行,本地来电者可拨打免费电话888-506-0062;国际来电者拨打973-528-0011,并使用输入代码434944。

The conference call will also be available via Webcast link: https://www.webcaster4.com/Webcast/Page/2865/50026

电话会议也将通过网络直播链接播出: 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/.

电话会议的音频重播将在Tivic Health网站上的 “投资者” 页面上播出,网址为 https://tivichealth.com/investor/

About Tivic

关于 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

Tivic是一家推进生物电子医学领域的商业健康科技公司。Tivic 的专利技术平台利用对三叉神经结构、交感神经和迷走神经结构的刺激。Tivic的非侵入性和有针对性的慢性炎症性疾病治疗方法为消费者和提供商提供了安全性高、风险低和应用广泛的无药物治疗解决方案。Tivic的首款商用产品ClearUp是美国食品药品管理局批准的、屡获殊荣的手持式生物电子鼻窦设备。ClearUp 经临床验证,经医生推荐,可通过在线零售商和商业分销商购买。欲了解更多信息,请访问 http://tivichealth.com@TivicHealth

Forward-Looking Statements

前瞻性陈述

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.

本新闻稿可能包含受重大风险和不确定性影响的 “前瞻性陈述”。本新闻稿中包含的所有陈述,除历史事实陈述外,均为前瞻性陈述。本新闻稿中包含的前瞻性陈述可以通过使用 “预期”、“相信”、“考虑”、“可以”、“估计”、“期望”、“打算”、“寻求”、“可能”、“可能”、“计划”、“潜力”、“预测”、“项目”、“目标”、“目标”、“应该”、“将” 或尽管并非所有前瞻性陈述都包含这些词语,但对这些词语或其他类似表达方式持否定态度。前瞻性陈述基于 Tivic Health Systems, Inc.的当前预期,并受难以预测的固有不确定性、风险和假设的影响。此外,某些前瞻性陈述基于对未来事件的假设,这些假设可能并不准确。 由于各种因素,实际业绩可能与任何前瞻性陈述中的业绩存在重大差异,包括但不限于:市场、经济和其他条件;供应链限制;宏观经济因素,包括通货膨胀;公司的财务状况;公司在必要时以优惠条件筹集额外资本的能力;监管要求的变化;以及减少Tivic资本资源的意外成本、费用或支出。鉴于这些风险和不确定性,提醒您不要过分依赖此类前瞻性陈述。有关其他风险和不确定性以及其他重要因素的讨论,其中任何一个都可能导致Tivic的实际业绩与前瞻性陈述中的不同,请参阅Tivic向美国证券交易委员会提交的文件,包括将于2024年3月25日向美国证券交易委员会提交的标题为 “风险因素” 的10-K表年度报告,以及该公司随后向美国证券交易委员会提交的文件。本新闻稿中包含的前瞻性陈述自该日起作出,除非适用法律要求,否则Tivic Health Systems, Inc.没有义务更新此类信息。

Investor Contact:
Hanover International, Inc.
ir@tivichealth.com

投资者联系人:
汉诺威国际有限公司
ir@tivichealth.com

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
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