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Tivic Reports Fiscal Year 2023 Financial Results

Tivic Reports Fiscal Year 2023 Financial Results

Tivic 公佈 2023 財年財務業績
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.

舊金山 —(美國商業資訊)— 2024年3月25日 開發和商業化生物電子醫學的健康科技公司Tivic Health Systems, Inc.(“Tivic”,納斯達克股票代碼:TIVC)今天公佈了截至2023年12月31日的年度財務業績。

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 的商業平台是一種手持式設計,可與三叉神經、交感神經和其他面部和腦神經結構進行非侵入性接口。該平台是Tivic現有產品的基礎,該產品目前已獲得美國食品藥品管理局的批准,名爲ClearUp Sinus Pain Relief,用於治療鼻竇疼痛和充血。2023年,該公司還開始投資迷走神經刺激的新平台。專有非侵入性迷走神經刺激(VNS)方法的試點臨床研究的研究入組已於2024年2月完成。該研究的結果尚未公佈。

"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首席執行官詹妮弗·恩斯特表示:“2023年是精簡我們的商業業務和定義價值創造新機會的一年。”“通過對我們的商業產品實施新的定價結構,降低商品成本,提高營銷效率以及減少員工人數以與當前收入保持一致,我們已經採取了實質性措施來改善公司的財務狀況。我們開闢了面向價格不太敏感的醫療保健細分市場的新渠道。而且,我們戰略性地投資了臨床項目,爲股東創造了新的價值創造途徑,包括一項迷走神經刺激計劃和一項旨在減少鼻竇和麪部手術後阿片類藥物使用量的計劃。”

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.

結果,該公司入選了Fast Company久負盛名的2023年醫療器械類別全球最具創新力的公司年度名單,全球健康與製藥(GHP)將Tivic Health評爲最具開創性的生物電子醫學公司。

2023 Financial Performance

2023 年財務業績

  • 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(扣除回報後)爲120萬美元,而截至2022年12月31日的年度爲180萬美元。下降664,000美元,跌幅36%,是由於ClearUp單位銷售額下降了52%,但被單位平均銷售價格上漲了46%所抵消。2023 年,超過 90% 的銷售額是直接面向消費者。
  • 2023年的銷售成本爲88.9萬美元,而截至2022年12月31日的年度爲150萬美元,下降了65.2萬美元,下降了42%。下降是由於我們的ClearUp 2.0單位於2023年12月開始發貨時,總銷量下降了52%,但與舊庫存和零部件的核銷或儲備相關的17.2萬美元成本所抵消,這些成本主要與我們的ClearUp 1.0單位有關。我們預計在2024年不會產生類似的成本。
  • 截至2023年12月31日止年度的毛利爲33萬美元,而截至2022年12月31日止年度的毛利爲29.9萬美元。
  • 截至2023年12月31日和2022年12月31日的每年的研發費用約爲170萬美元。2023 年研發活動的重點主要與我們與費恩斯坦研究所的合作有關。
  • 截至2023年12月31日止年度的銷售和營銷費用降至210萬美元,而截至2022年12月31日的年度爲280萬美元。下降的主要原因是廣告和代理成本的降低。
  • 一般和管理費用在2023年降至480萬美元,而截至2022年12月31日的年度爲590萬美元。下降的主要原因是公司努力降低管理費用,從而減少了法律和專業費用以及其他公司費用。
  • 因此,我們2023年全年淨虧損爲820萬美元,而2022年爲1,010萬美元。

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.

關於2023年的融資活動,我們在2023年2月13日通過註冊公開發行向投資者出售了普通股,淨收益約爲360萬美元。從2023年7月11日到2023年8月9日,我們在一系列註冊的公開募股中向投資者出售了普通股,使公司的淨收益總額約爲430萬美元。

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,我們實施了 1 比 100 的反向股票拆分,2023 年 9 月 15 日,我們收到納斯達克的確認,我們已恢復遵守最低出價繼續上市要求。

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,該公司擁有340萬澳元的現金及現金等價物,我們繼續保持無債務資產負債表。

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.

該公司截至2023年12月31日的年度管理與分析和合並財務報表將與公司10-K表年度報告一起於2024年3月25日向美國證券交易委員會提交。該公司先前的公開文件可以在以下網址找到 www.sec.gov 也可以在 Tivic 的網站上找到: https://tivichealth.com/investor/#SEC

Conference Call and Webcast Information

電話會議和網絡直播信息

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.

管理層將在週一主持網絡直播/電話會議, 太平洋時間2024年3月25日下午1點30分/美國東部時間下午4點30分,討論公司2023年年底的財務業績,並提供最新業務情況,包括對2023年研究方向的評論。

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.

電話會議將通過電話進行,本地來電者可撥打免費電話888-506-0062;國際來電者撥打973-528-0011,並使用輸入代碼434944。

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

電話會議也將通過網絡直播鏈接播出: 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/.

電話會議的音頻重播將在Tivic Health網站上的 “投資者” 頁面上播出,網址爲 https://tivichealth.com/investor/

About Tivic

關於 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是一家推進生物電子醫學領域的商業健康科技公司。Tivic 的專利技術平台利用對三叉神經結構、交感神經和迷走神經結構的刺激。Tivic的非侵入性和有針對性的慢性炎症性疾病治療方法爲消費者和提供商提供了安全性高、風險低和應用廣泛的無藥物治療解決方案。Tivic的首款商用產品ClearUp是美國食品藥品管理局批准的、屢獲殊榮的手持式生物電子鼻竇設備。ClearUp 經臨床驗證,經醫生推薦,可通過在線零售商和商業分銷商購買。欲了解更多信息,請訪問 http://tivichealth.com@TivicHealth

Forward-Looking Statements

前瞻性陳述

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.

本新聞稿可能包含受重大風險和不確定性影響的 “前瞻性陳述”。本新聞稿中包含的所有陳述,除歷史事實陳述外,均爲前瞻性陳述。本新聞稿中包含的前瞻性陳述可以通過使用 “預期”、“相信”、“考慮”、“可以”、“估計”、“期望”、“打算”、“尋求”、“可能”、“可能”、“計劃”、“潛力”、“預測”、“項目”、“目標”、“目標”、“應該”、“將” 或儘管並非所有前瞻性陳述都包含這些詞語,但對這些詞語或其他類似表達方式持否定態度。前瞻性陳述基於 Tivic Health Systems, Inc.的當前預期,並受難以預測的固有不確定性、風險和假設的影響。此外,某些前瞻性陳述基於對未來事件的假設,這些假設可能並不準確。 由於各種因素,實際業績可能與任何前瞻性陳述中的業績存在重大差異,包括但不限於:市場、經濟和其他條件;供應鏈限制;宏觀經濟因素,包括通貨膨脹;公司的財務狀況;公司在必要時以優惠條件籌集額外資本的能力;監管要求的變化;以及減少Tivic資本資源的意外成本、費用或支出。鑑於這些風險和不確定性,提醒您不要過分依賴此類前瞻性陳述。有關其他風險和不確定性以及其他重要因素的討論,其中任何一個都可能導致Tivic的實際業績與前瞻性陳述中的不同,請參閱Tivic向美國證券交易委員會提交的文件,包括將於2024年3月25日向美國證券交易委員會提交的標題爲 “風險因素” 的10-K表年度報告,以及該公司隨後向美國證券交易委員會提交的文件。本新聞稿中包含的前瞻性陳述自該日起作出,除非適用法律要求,否則Tivic Health Systems, Inc.沒有義務更新此類信息。

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

投資者聯繫人:
漢諾威國際有限公司
ir@tivichealth.com

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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