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Tivic Reports Second Quarter 2024 Financial Results

Tivic Reports Second Quarter 2024 Financial Results

Tivic公司發佈2024年第二季度財務報告
Tivic Health Systems ·  08/01 00:00

SAN FRANCISCO – (Business Wire) – August 14, 2024 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").

舊金山-(Business Wire)-2024年8月14日-Tivic Health Systems, Inc.(「Tivic」,納斯達克:TIVC)是一家開發和商業化生物電醫學的健康科技公司,今天宣佈其2024年第二季度財務業績,並根據其對迷走神經刺激(「VNS」)的投資討論增長策略。

"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.

「對Tivic來說,這個季度是可能具有變革性的時期的開始。我們宣佈了我們成功的一期新非侵入性迷走神經刺激方法的試驗結果。我們與生物電醫學費因斯坦研究所合作進行優化,並繼續在公司和投資者價值潛力的重要領域中構建我們的知識產權組合」,Tivic首席執行官Jennifer Ernst解釋道。

"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."

「在過去的18個月中,我們額外提高了我們的ClearUP產品毛利率,增加了每個市場支出的創收,並積極降低了營業費用。我們已經將製造業轉移並通過新的第三方物流供應商降低了履行成本。我們評估了各種潛在的授權和戰略交易機會,同時構建我們的有機增長選項。我們在VNS的新的高價值醫療目標中展示了行業領先的臨床結果。我們還沒有完成,但我爲一個小而專注的團隊壯舉感到自豪。」

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."

Ernst進一步表示:「雖然我們預計會繼續改善ClearUP產品線和我們總體營業費用的經濟概貌,但我們認爲未來公司的增長將大大受到我們迷走神經刺激項目的進展的促進。」

The company will be discussing the key results from the Phase 1 VNS trial as part of its Q2 earnings call.

公司將討論第1階段VNS試驗的關鍵結果,作爲其Q2盈利電話的一部分。

2024 Business and Operational Updates

2024年業務和運營更新

In the first half of 2024, Tivic business and operational updates are as follows:

在2024年上半年,Tivic業務和運營更新如下:

  • 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.
  • Tivic與美國十大醫療設備分銷商和供應商之一簽訂了有限排他分銷協議。
  • 公司推出了ClearUP 2.0並開始停用舊版本。 ClearUP 2.0包括用於更快充電和更長電池壽命的新電源管理電路,解決了負面客戶評價的一個關鍵問題。
  • 2024年5月8日,Tivic公佈了與Northwell Health的費因斯坦醫學研究所的試點研究的最終結果。通過這種合作,該公司證實了我們的專利待批准的非侵入性頸椎迷走神經刺激(「ncVNS」)方法的有效性。該研究報告了在自主、心臟和中樞神經系統活動上的反應,表明在多個主要疾病領域中具有潛在的臨床效用。
  • 2024年5月17日,Tivic與菲因斯坦簽署了一份合作和研究支持協議,以進行其迷走神經刺激系統的第1A階段優化研究。第1A個項目將測試並尋求優化公司的非侵入式迷走神經刺激方法,以準備未來的針對特定疾病的第2期試驗。
  • 自2024年5月31日起,公司終止了其在加利福尼亞州海沃德的9091平方英尺的辦公室空間的租約。該公司在解除租約方面遭受了7.7萬美元的一次性終止費。這將使公司在未來一年半內節省大約28.4萬美元的租金支出。
  • 在本期結束後,公司終止了與ALOm Technologies的現有第三方物流和製造協議,其中公司每月最少需付25,000美元費用。該公司與新的第三方物流供應商簽訂了協議,並建立了每月總計小於1,000美元的內部製造能力。

Financial Performance

財務表現

  • 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.
  • 截至2024年6月30日的三個和六個月的收入(淨額)分別爲14萬美元和47.4萬美元,較2023年上半年減少6.3萬美元或12%,主要是由於單位銷售額下降了27%,抵消了單位平均銷售價增加了20%。
  • 截至2024年6月30日的三個和六個月的銷售成本分別爲11萬美元和27.7萬美元,較2023年上半年減少8.6萬美元或24%。
  • 2024年6月30日止三個月和六個月的毛利潤分別爲$3萬和$19.7萬,而2023年分別爲$6.1萬和$17.4萬。
  • 2024年6月30日止六個月的毛利率爲42%,而2023年爲32%。
  • 2024年6月30日止三個月和六個月總營業費用分別爲120萬元和290萬元,而2023年分別爲220萬元和440萬元,年度成本降低了150萬元。
  • 2024年6月30日止三個月的淨虧損爲$130萬,而2019年爲$210萬。 2024年上半年的淨虧損爲$270萬,比2019年同期低了$150萬。
  • 2024年5月13日,該公司以每股0.85美元的價格向某些投資者出售了471萬股普通股和相關認股權證。公司獲得了約400萬美元的總收益。扣除費用(不包括與此次發行相關的認股權證未來行權後公司收益,如果有的話)後,淨收益約爲330萬美元。
  • 截至2024年6月30日和2019年12月31日,現金及現金等價物合計爲370萬美元和340萬美元。

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: .

該公司的MD&A和截至2024年6月30日的合併財務報表將隨信報與證券交易委員會一起在2024年8月14日提交公司的季度報告10-Q。該公司以前的公開文件可在 www.sec.gov 上找到,也可以在Tivic的網站上找到: .

Conference Call and Webcast Information

電話會議和網絡直播信息

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.

管理層將於2024年8月14日星期三下午1:30 Pm Pt / 4:30 Pm Et舉行網絡研討會/電話會議,討論公司2024年第二季度財務業績並提供業務更新,包括對公司2024年發展方向的評論。

The conference call will be available via telephone by dialing toll-free 888-506-0062for local callers; or 973-528-0011 for international callers and using entry code 316159.

會議電話可通過免費拔打888-506-0062(本地呼叫)或973-528-0011(國際呼叫)並輸入316159參與。

The conference call will also be available via Webcast link:

會議電話也可以通過Webcast鏈接獲得:

An audio replay of the call will be available from the "Investor" page on the Tivic Health website at .

通話的音頻回放將從Tivic Health網站的「投資者」頁面上提供。 .

About Tivic Health

關於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 @TivicHealth

Tivic Health是一家商業化健康科技公司,推動生物電子醫學領域的發展。Tivic Health的技術平台利用三叉神經、交感神經和迷走神經結構的刺激。Tivic Health的非侵入性和靶向治療炎性慢性疾病的方法爲消費者和提供者提供了高安全性、低風險和廣泛應用的無藥物治療方案。Tivic Health的第一個商業產品ClearUP是一款經FDA批准、屢獲殊榮的手持式生物電子鼻竇設備。ClearUP經過臨床驗證,得到醫生的推薦,並通過在線零售商和商業分銷商提供。有關更多信息,請訪問 @TivicHealth

Forward-Looking Statements

前瞻性聲明

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.

本新聞稿可能包含"前瞻性聲明",受到重大風險和不確定性的影響。本新聞稿中包含的除歷史事實陳述之外的所有陳述均屬前瞻性聲明。本新聞稿中所包含的前瞻性聲明可以通過使用諸如"預測"、"相信"、"思考"、"可能"、"估計"、"期望"、"打算"、"尋求"、"可能"、"計劃"、"潛在"、"預測"、"項目"、"目標"、"瞄準"、"應該"、"將會"、"將要"等詞語或這些詞語的否定形式或其他類似表達方式來識別,雖然並非所有前瞻性聲明都包含這些詞語。前瞻性聲明基於Tivic Health Systems,Inc.的當前預期,並且受到難以預測的內在不確定性、風險和假設的影響。此外,某些前瞻性聲明基於未來事件的假設,這些事件可能不會被證明是準確的。結果可能會因各種因素而與任何前瞻性聲明不一致,包括但不限於:ncVNS治療的未來發展;Tivic Health能否將產生的ncVNS治療產品商業化,並計劃爲這些臨床產品尋求監管批准;Tivic Health在繼續開發ncVNS治療方面的關注點,包括在癲癇、創傷後應激障礙和/或缺血性中風領域;預期的臨床效用,包括可能追求的患者人群;市場和其他條件;供應鏈約束;宏觀經濟因素,包括通貨膨脹;Tivic Health在需要時能否以有利的條件或根本不能籌集額外資金;Tivic Health能否維持其納斯達克上市地位;以及不預期的成本、費用或支出,這些成本、費用或支出會減少Tivic Health的資本資源。鑑於這些風險和不確定性,建議您不要過度依靠這些前瞻性聲明。有關其他風險和不確定性的討論,以及其他重要因素,其中任何一項都可能導致Tivic Health的實際結果與前瞻性聲明中的不同,請參閱Tivic Health向證交會提交的文件,包括於2024年3月29日向證交會提交的截至2023年12月31日的10-k年度報告中的"風險因素"一節,以及公司隨後向證交會提交的文件。本新聞稿中所含的前瞻性聲明是截至本日期的,Tivic Health Systems, Inc.除法律法規規定應進行修改外,無需更新此類信息。

Media Contact:

媒體聯繫人:

Morgan Luke

Morgan Luke

Morgan.Luke@tivichealth.com

Morgan.Luke@tivichealth.com

Investor Contact:

投資者聯繫人:

Hanover International, Inc.

Hanover International, Inc.

ir@tivichealth.com

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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