美國
證券交易委員會
華盛頓特區，郵編：20549
形式
(標記一)
根據1934年《證券交易法》第13或15(D)條規定的季度報告 |
截至本季度末
或
根據1934年證券交易法第13或15（d）條提交的過渡報告 |
從 到
委員會文件號：
(註冊人的確切姓名載於其章程)
(述明或其他司法管轄權 公司或組織) |
(稅務局僱主 |
（主要行政辦公室地址） |
(郵政編碼) |
註冊人的電話號碼，包括區號：(
根據該法第12(B)條登記的證券：
每個班級的標題 |
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交易 符號 |
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註冊的每個交易所的名稱 |
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用複選標記表示註冊人(1)是否在過去12個月內(或註冊人被要求提交此類報告的較短時間內)提交了1934年《證券交易法》第13條或15(D)節要求提交的所有報告，以及(2)在過去90天內是否符合此類提交要求。
用複選標記表示註冊人是否在過去12個月內(或在註冊人被要求提交此類文件的較短時間內)以電子方式提交了根據S-T規則第405條(本章232.405節)要求提交的每個交互數據文件。
用複選標記表示註冊人是大型加速申報公司、加速申報公司、非加速申報公司、較小的報告公司或新興成長型公司。請參閱《交易法》第12b-2條規則中「大型加速申報公司」、「加速申報公司」、「較小申報公司」和「新興成長型公司」的定義。
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加速文件管理器 |
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非加速文件服務器 |
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規模較小的報告公司 |
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新興成長型公司 |
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如果是一家新興的成長型公司，用複選標記表示註冊人是否已選擇不使用延長的過渡期來遵守根據《交易所法》第13(A)節提供的任何新的或修訂的財務會計準則。☐
通過勾選標記檢查註冊人是否是空殼公司（定義見《交易法》第120億.2條）。 是的 否
截至2024年10月30日，登記人已
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頁面 |
第一部分： |
財務信息 |
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第1項。 |
5 |
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5 |
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6 |
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7 |
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9 |
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第二項。 |
24 |
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第三項。 |
35 |
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第四項。 |
35 |
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第二部分。 |
其他信息 |
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第1項。 |
36 |
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第1A項。 |
36 |
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第二項。 |
94 |
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第三項。 |
95 |
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第四項。 |
95 |
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第五項。 |
95 |
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第六項。 |
96 |
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97 |
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關於前瞻性陳述的特別說明
以下討論和分析應與我們的簡明合併財務報表以及本報告其他部分包括的這些報表的簡明附註一起閱讀。本報告包含符合1933年《證券法》(經修訂)第27A節或《證券法》和經修訂的1934年《證券交易法》(或《交易法》)第21E節的含義的前瞻性陳述，這些陳述是基於我們管理層的信念和假設以及我們管理層目前掌握的信息。在本報告中，「我們」、「我們」和「我們」指的是特拉華州的RxSight公司及其合併的子公司。
前瞻性陳述包括但不限於關於以下方面的陳述：
3 |
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前瞻性陳述包括非歷史事實的陳述，可以通過「可能」、「將」、「應該」、「可能」、「將」、「預期」、「計劃」、「打算」、「預期」、「相信」、「估計」、「預測」、「項目」、「潛在」或「繼續」等術語或此類術語和其他相同術語的否定來識別。
前瞻性陳述涉及已知和未知的風險、不確定性和其他因素，這些風險、不確定性和其他因素可能導致我們的實際結果、表現或成就與前瞻性陳述明示或暗示的任何未來結果、表現或成就大不相同。我們在本報告其他部分第二部分第1A項「風險因素」中更詳細地討論了這些風險。鑑於這些不確定性，您不應過度依賴這些前瞻性陳述。此外，我們的運營環境競爭激烈，變化迅速。新的風險時有出現。我們不可能預測所有風險，也不能評估所有因素對我們業務的影響，或任何因素或因素組合可能導致實際結果與我們可能做出的任何前瞻性陳述中包含的結果大不相同的程度。鑑於這些風險、不確定性和假設，本報告討論的未來事件和趨勢可能不會發生，實際結果可能與前瞻性陳述中預期或暗示的結果大不相同。
本報告中所作的前瞻性陳述僅涉及截至作出陳述之日的事件。除非法律要求，我們沒有義務更新這些前瞻性陳述，或更新實際結果可能與這些前瞻性陳述中預期的結果大不相同的原因，即使未來有新的信息可用。
行業、商業和市場數據
該報告還包含關於我們的行業、我們的業務和市場機會的估計、預測和其他信息，包括關於估計的市場規模的數據。基於估計、預測、預測、市場研究或類似方法的信息本身就會受到不確定因素的影響，實際事件或情況可能與該信息中反映的事件和情況大不相同。除非另有明確說明，否則我們從報告、研究調查、研究和由市場研究公司和其他第三方準備的類似數據、行業、醫療和一般出版物、政府數據和類似來源獲得這些行業、商業、市場和其他數據。
商標、服務標記和商號
本報告包含對屬於其他實體的商標和服務標記的引用。僅爲方便起見，本報告中提及的商標和商號可以不帶®或TM符號出現，但此類引用並不意味着適用許可人不會根據適用法律最大程度地主張其對這些商標和商號的權利。我們不打算使用或展示其他公司的商標、商標或服務標誌，以暗示與任何其他公司的關係，或由任何其他公司背書或贊助。
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第一項： 財務報表(未經審計)
RxSIGHt，Inc.
凝結固體BA噴槍牀單
(單位爲千，不包括每股和每股金額)
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9月30日， |
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十二月三十一日， |
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2024 |
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2023 |
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(未經審計) |
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資產 |
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流動資產： |
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現金及現金等價物 |
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$ |
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短期投資 |
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應收賬款淨額 |
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庫存，淨額 |
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預付資產和其他流動資產 |
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流動資產總額 |
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財產和設備，淨額 |
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經營租賃使用權資產 |
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受限現金 |
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其他資產 |
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總資產 |
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$ |
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負債和股東權益 |
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流動負債： |
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應付帳款 |
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$ |
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應計費用和其他流動負債 |
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租賃負債 |
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流動負債總額 |
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長期租賃負債 |
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其他長期負債 |
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總負債 |
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股東權益： |
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普通股，$ |
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優先股，$ |
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額外實收資本 |
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累計其他綜合收益(虧損) |
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累計赤字 |
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股東權益總額 |
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總負債和股東權益 |
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$ |
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$ |
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見未經審計的簡明合併財務報表附註。
5 |
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RxSIGHt，Inc.
濃縮合並聲明運營TS
和全面損失（未經審計）
(單位爲千，不包括每股和每股金額)
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截至9月30日的三個月， |
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截至9月30日的9個月， |
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2024 |
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2023 |
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2024 |
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2023 |
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銷售 |
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$ |
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$ |
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$ |
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銷售成本 |
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毛利 |
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運營費用： |
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銷售、一般和行政 |
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研發 |
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總運營支出 |
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運營虧損 |
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其他收入(費用)，淨額： |
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利息開支 |
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利息和其他收入 |
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定期貸款枯竭損失 |
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所得稅前虧損 |
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所得稅費用 |
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淨虧損 |
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其他綜合(虧損)收入 |
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短期投資的未實現收益 |
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外幣折算收益(虧損) |
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其他全面收入合計 |
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綜合損失 |
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$ |
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$ |
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$ |
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每股淨虧損： |
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基本的和稀釋的 |
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用於計算每股淨虧損的加權平均股份數： |
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歸因於普通股、基本股和稀釋股 |
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見未經審計的簡明合併財務報表附註。
6 |
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RxSIGHt，Inc.
簡明綜合損益表 股東權益
（未經審計）
(單位：千，股份數除外)
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截至2024年9月30日的九個月 |
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普通股 |
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額外實收 |
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累計其他 |
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累計 |
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股東合計 |
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股份 |
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量 |
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資本 |
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綜合損失 |
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赤字 |
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股權 |
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2023年12月31日的餘額 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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爲行使股票期權而發行的股票 |
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— |
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因員工預扣稅而贖回的股份 |
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基於股票的補償費用 |
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短期投資未實現損失 |
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外幣折算調整 |
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— |
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淨虧損 |
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— |
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— |
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2024年3月31日的餘額 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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爲行使股票期權而發行的股票 |
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— |
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基於股票的補償費用 |
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爲員工股票購買計劃發行的股票 |
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公開發行普通股，扣除承銷折扣、佣金和發行成本 |
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— |
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短期投資未實現損失 |
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外幣折算調整 |
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淨虧損 |
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— |
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— |
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— |
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( |
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( |
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2024年6月30日的餘額 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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爲行使股票期權而發行的股票 |
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— |
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— |
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因員工預扣稅而贖回的股份 |
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— |
|
|
|
( |
) |
|
基於股票的補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
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||
短期投資未實現收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
外幣折算調整 |
|
|
— |
|
|
|
— |
|
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|
— |
|
|
|
|
|
|
— |
|
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||
淨虧損 |
|
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— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
2024年9月30日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
請參閱隨附的未經審計簡明綜合財務報表附註
7 |
|
|
RxSIGHt，Inc.
簡明合併股東權益報表
(未經審計)
(單位：千，股份數除外)
|
|
截至2023年9月30日的9個月 |
|
|||||||||||||||||||||
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||||||
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|
普通股 |
|
|
額外實收 |
|
|
累計其他 |
|
|
累計 |
|
|
股東合計 |
|
|||||||||
|
|
股份 |
|
|
量 |
|
|
資本 |
|
|
綜合損失 |
|
|
赤字 |
|
|
股權 |
|
||||||
2022年12月31日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
爲行使股票期權而發行的股票 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
因員工預扣稅而贖回的股份 |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
基於股票的補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
公開發行普通股，扣除承銷折扣、佣金和發行成本 |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
發行普通股進行市場發行， |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
短期投資未實現收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
外幣折算調整 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
2023年3月31日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
爲行使股票期權而發行的股票 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
基於股票的補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
爲員工股票購買計劃發行的股票 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
發行普通股進行市場發行， |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
短期投資未實現損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
外幣折算調整 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
2023年6月30日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
爲行使股票期權而發行的股票 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
因員工預扣稅而贖回的股份 |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
基於股票的補償費用 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
發行普通股進行市場發行， |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
短期投資未實現收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
外幣折算調整 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
2023年9月30日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
請參閱隨附的未經審計簡明綜合財務報表附註
8 |
|
|
RxSIGHt，Inc.
濃縮合並聲明現金流TS
(未經審計)
(單位：千)
|
|
截至9月30日的9個月， |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
經營活動： |
|
|
|
|
|
|
||
淨虧損 |
|
$ |
( |
) |
|
$ |
( |
) |
對淨虧損與經營活動中使用的現金淨額進行的調整： |
|
|
|
|
|
|
||
折舊及攤銷 |
|
|
|
|
|
|
||
壞賬準備 |
|
|
|
|
|
|
||
使用權租賃資產攤銷 |
|
|
|
|
|
|
||
債務發行成本和溢價攤銷 |
|
|
|
|
|
|
||
債務清償損失 |
|
|
|
|
|
|
||
短期投資折扣攤銷 |
|
|
( |
) |
|
|
( |
) |
基於股票的薪酬 |
|
|
|
|
|
|
||
超額和陳舊庫存準備金 |
|
|
|
|
|
|
||
營業資產和負債變動： |
|
|
|
|
|
|
||
應收賬款 |
|
|
( |
) |
|
|
( |
) |
庫存 |
|
|
( |
) |
|
|
( |
) |
預付資產和其他資產 |
|
|
|
|
|
|
||
應付帳款 |
|
|
|
|
|
|
||
應計費用和其他負債 |
|
|
|
|
|
|
||
用於經營活動的現金淨額 |
|
|
( |
) |
|
|
( |
) |
投資活動： |
|
|
|
|
|
|
||
購置財產和設備 |
|
|
( |
) |
|
|
( |
) |
短期投資到期日 |
|
|
|
|
|
|
||
購買短期投資 |
|
|
( |
) |
|
|
( |
) |
投資活動所用現金淨額 |
|
|
( |
) |
|
|
( |
) |
融資活動： |
|
|
|
|
|
|
||
定期貸款收益 |
|
|
|
|
|
|
||
償還定期貸款 |
|
|
|
|
|
( |
) |
|
公開發行普通股的收益 |
|
|
|
|
|
|
||
市場發行普通股的收益 |
|
|
|
|
|
|
||
發行普通股所得款項 |
|
|
|
|
|
|
||
與股票薪酬相關的員工稅款付款 |
|
|
( |
) |
|
|
( |
) |
融資租賃負債的本金支付 |
|
|
( |
) |
|
|
( |
) |
遞延發行費用的支付 |
|
|
( |
) |
|
|
( |
) |
債務發行成本的支付 |
|
|
|
|
|
( |
) |
|
融資活動提供的現金淨額 |
|
|
|
|
|
|
||
外匯匯率對現金、現金等值物和受限制現金的影響 |
|
|
|
|
|
( |
) |
|
現金、現金等價物和限制性現金淨增(減) |
|
|
|
|
|
( |
) |
|
現金、現金等價物和限制性現金--期初 |
|
|
|
|
|
|
||
現金、現金等價物和受限現金--期末 |
|
$ |
|
|
$ |
|
||
補充披露現金流量信息： |
|
|
|
|
|
|
||
來自經營租賃的經營現金流 |
|
|
|
|
|
|
||
繳納所得稅的現金 |
|
|
|
|
|
|
||
爲融資租賃利息支付的現金 |
|
|
|
|
|
|
||
定期貸款利息支付的現金 |
|
|
|
|
|
|
||
非現金投資和融資活動： |
|
|
|
|
|
|
||
以租賃義務換取的使用權資產： |
|
|
|
|
|
|
||
經營租賃 |
|
|
|
|
|
|
||
融資租賃 |
|
|
|
|
|
|
||
就使用權資產記錄的租賃義務： |
|
|
|
|
|
|
||
經營租賃 |
|
|
|
|
|
|
||
融資租賃 |
|
|
|
|
|
|
||
購置財產和設備，計入應付賬款和應計費用 |
|
|
|
|
|
|
||
應付賬款和應計負債中包含的延期發行和融資成本 |
|
|
|
|
|
|
||
遞延融資成本的重新分類 |
|
|
|
|
|
|
||
見未經審計的簡明合併財務報表附註。
9 |
|
|
RxSIGHt，Inc.
對未經審計的簡明合併基金的說明財務報表
注1--列報的組織和依據
業務說明
RxSight®，Inc.(「公司」)是一家特拉華州公司，總部設在加利福尼亞州阿利索·維埃霍，擁有
該公司的產品包括可調光透鏡®(「LAL™」和「LAL+™」，統稱爲「LAL」)和一種專門設計的用於向眼睛傳遞光線的機器--LDD™，獲得了美國(「美國」)的批准。美國食品和藥物管理局(「FDA」)主要在美國銷售，在美國、歐洲、加拿大和墨西哥獲得監管批准。該公司於2019年開始營銷其產品。LAL是一種優質人工晶狀體(IOL)，根據醫療保險可以部分報銷。該公司在高端市場上與其他人工晶狀體競爭。
隨附的未經審計的簡明綜合財務報表包括RxSight，Inc.及其全資子公司RxSight億.V.和RxSight GmbH的賬目。所有重大的公司間餘額和交易都已在合併中沖銷。
列報依據和合並原則
本公司的簡明綜合財務報表乃根據美國公認中期財務資料會計原則(「公認會計原則」)及美國證券交易委員會(「美國證券交易委員會」)S-X表格第10條的規定編制。因此，隨附的未經審計的簡明合併財務報表不包括公認會計准則要求的完整財務報表所需的所有信息和附註。未經審計的中期財務報表反映管理層認爲對所列各期間的結果進行公平陳述所需的所有調整。所有這些調整都是正常的和反覆出現的。2023年12月31日的資產負債表數據來自經審計的財務報表；然而，簡明綜合財務報表的附註並不包括公認會計准則要求的所有年度披露，應與2024年2月28日提交給美國證券交易委員會的公司2023年年報10-k表格中包含的經審計綜合財務報表一併閱讀。這些未經審計的簡明綜合財務報表中列報的經營業績不一定代表未來任何時期的預期結果。
運營細分市場
該公司確定其經營部門的依據與其在內部評估業績時所用的基礎相同。公司首席運營決策者(「CODM」)是公司的首席執行官，他審查公司的綜合經營結果，以分配資源和評估財務業績。該公司決定經營和管理其業務(包括其非美國子公司)在
流動性
貨架登記表
2024年5月8日，本公司以S-3表格備案了自動上架登記單(簡稱《上架登記單》)。貨架登記聲明有效期爲三年，允許公司不定期出售普通股、優先股、債務證券、認股權證和/或單位。貨架登記聲明旨在爲公司提供獲得額外資本的靈活性。在提交貨架登記聲明時，該公司還提交了一份招股說明書增刊，出售的總價值高達$
10 |
|
|
公開發行
在……上面
截至2024年9月30日和2023年12月31日，公司擁有現金、現金等價物和短期投資$
該公司於2019年開始從主營業務中產生收入。該公司的經營歷史有限，公司業務和市場的收入和收入潛力尚未得到證實。自成立以來，該公司的經營活動不斷出現淨虧損和負現金流。截至2024年9月30日及2023年9月30日止三個月，本公司因$
隨附的簡明綜合財務報表的編制假設本公司將繼續作爲持續經營的企業。本公司相信，現有現金資源將足以滿足自隨附的簡明綜合財務報表發佈之日起至少12個月的預計經營需求，然而，在不久的將來，本公司預計將繼續出現經營虧損和負現金流。截至2024年9月30日，公司計劃繼續使用現金、現金等價物和短期投資爲運營虧損提供資金並通過股權或債務融資、其他第三方融資、合作、戰略聯盟和許可安排或這些安排的組合來滿足其未來的資本融資需求。如果公司通過發行股權證券籌集額外資金，其股東可能會受到稀釋。本公司未來加入的任何債務融資可能會附加限制業務的契約，包括對其產生留置權或額外債務、支付股息、回購普通股、進行某些投資或從事某些合併、合併或資產出售交易的能力的限制。任何債務融資或額外股權融資可能包含對公司或其股東不利的條款。如果公司被要求達成合作和其他安排以滿足其流動資金需求，它可能不得不放棄限制其開發和商業化候選產品能力的某些權利，或者可能具有對公司或其股東不利的其他條款，這可能對其業務和財務前景產生重大和不利影響。不能保證該公司將能夠以可接受的條件獲得額外的融資，或者根本不能。如果公司無法獲得足夠的額外資金，公司可能被迫削減開支，延長與供應商的付款期限，儘可能清算資產和/或暫停或削減計劃的計劃。這些行動中的任何一項都可能對公司的業務、經營結果和未來前景造成實質性損害。
注2 -會計政策摘要
預算的使用
這個根據公認會計原則編制合併財務報表要求管理層做出知情的估計、判斷和假設，這些估計、判斷和假設會影響截至所附簡明合併財務報表日期的簡明合併財務報表中的報告金額和所附附註中的披露。管理層持續評估最關鍵的估計和假設是否持續合理。實際結果可能與
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製備在不同假設或條件下對隨附的簡明合併財務報表進行比較。
重大會計政策
截至2024年9月30日止三個月內，會計政策並無重大變動與本公司於2024年2月28日向美國證券交易委員會提交的10-k表格年度報告中所載經審計的綜合財務報表中「合併財務報表附註」第2條所述的重要會計政策相比。
現金等價物
現金等價物包括對貨幣市場帳戶的投資。本公司將所有在購買之日原始到期日爲三個月或以下的高流動性投資視爲現金等價物，可以在沒有事先通知或罰款的情況下清算。
短期投資
短期投資根據相關證券的到期日進行分類。根據資產的性質，本公司的短期投資(政府證券)被分類爲可供出售，並按資產負債表日相同或類似證券的價格確定的估計公允價值入賬。該公司的短期投資包括公允價值等級中的二級金融工具。未實現損益計入簡明綜合資產負債表股東權益內的其他全面虧損組成部分。已實現的收益和損失作爲其他收入(費用)計入隨附的簡明綜合經營報表和全面虧損。可供出售證券的已實現損益的成本基礎在特定的識別基礎上確定。管理層在購買時確定其投資的適當分類，並在每個資產負債表日期重新評估這種確定。本公司定期審查其投資中除信貸損失以外的未實現損失，以及當事件或情況變化表明資產的賬面價值可能無法收回時。在確定賬面價值是否可以收回時，管理層考慮以下因素：
該公司有$
信用風險及其他風險和不確定因素集中
可能使公司面臨集中信用風險的金融工具主要包括現金、現金等價物、短期投資和應收賬款。該公司的政策是將現金投資於美國政府的機構貨幣市場基金和有價證券，以限制信貸敞口。該公司目前持有現金等價物和貨幣市場基金和美國國庫券的短期投資組合。公司運營現金的一部分被存放在超過聯邦存款保險公司(「FDIC」)保險限額的帳戶中；然而，公司制定了關於投資多樣化及其到期日的指導方針，旨在維持本金和最大限度地提高流動性。該公司在現金等價物和短期投資方面沒有出現重大損失。
該公司的產品需要獲得FDA和外國監管機構的批准，才能開始商業銷售。不能保證公司的產品將獲得所需的任何產品
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批准。拒絕或推遲此類審批可能會對公司的業務產生重大不利影響，並可能影響未來的業務。此外，在FDA批准後，仍然存在在設備批准過程中沒有出現的不良事件的持續風險。
該公司面臨與醫療器械行業公司相同的風險，包括但不限於新技術創新、臨床開發風險、建立適當的商業夥伴關係、保護專有技術、遵守政府和環境法規、市場對該公司產品接受度的不確定性、產品責任以及獲得額外融資的需要。
本公司面臨與全球交貨期相關的風險，特別是在歐洲和亞洲，導致本公司供應商的供應中斷。此外，該公司目前正在經歷通貨膨脹，某些零部件的供應鏈交貨期延長和供應有限，並繼續面臨與其業務中使用的某些商品、材料和產品的預期採購相關的價格和供應風險。
應收賬款淨額
該公司擁有多元化的客戶基礎，截至2024年9月30日和2023年12月31日該公司沒有任何客戶個人佔比超過
金融工具的公允價值
本公司使用公允價值計量來記錄對某些資產和負債的公允價值調整，並確定公允價值披露。公允價值乃於計量日期於市場參與者之間的有序交易中，於出售資產或轉移資產或負債的本金或最有利市場上的負債而支付的價格。採用與市場法、收益法或成本法一致的估值方法來計量公允價值。公允價值層次結構將用於衡量公允價值的估值技術的輸入劃分爲三個級別：
第1級-可觀察到的投入，如活躍市場的未調整報價，在計量日期可獲得相同的不受限制的資產或負債。
第2級-通過與市場數據的關聯，在基本上整個資產或負債期限內，對資產或負債直接或間接可觀察到的投入(第1級所包括的報價除外)。這些包括活躍市場中類似資產或負債的報價、不活躍市場中相同或類似資產或負債的報價以及對估值模型或其他定價方法的輸入，這些不需要重大判斷，因爲模型中使用的輸入，例如利率和波動率，可以由容易觀察到的市場數據來證實。
第三級--一項或多項重大投入，這些投入是無法觀察到的，並得到很少或根本沒有市場活動的支持，並反映了重大管理判斷和假設的使用。第3級資產和負債包括其公允價值計量是使用定價模型、貼現現金流法或類似的估值技術和重大管理層判斷或估計確定的資產和負債。其中包括布萊克-斯科爾斯期權定價模型，該模型使用預期波動率、無風險利率和預期期限等輸入來確定公平的市場估值。
資產和負債根據對公允價值計量有重要意義的最低投入水平進行分類。本公司於每個報告日期審閱公允價值層次分類。觀察估值投入的能力的變化可能會導致公允價值層次結構內某些資產或負債的水平重新分類。於列報年度內，本公司並無在公允價值計量層級之間進行任何資產及負債轉移。
公司的金融工具主要包括現金、現金等價物、短期投資、應收賬款、應付賬款和經營租賃負債。由於這些資產的短期性質，現金、現金等價物、應收賬款和應付賬款按其估計公允價值列賬
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負債。本公司對政府證券的短期投資按公允價值列賬，公允價值是根據同一證券在計量日期的公開報價市場價格確定的。本公司認爲其經營租賃負債於2024年9月30日及2023年12月31日的公允價值，根據截至該日期類似條款的貸款的借款利率，對其賬面價值進行近似計算。
庫存
庫存包括原材料、在製品和產成品。原材料由用於生產該公司的鏡片、墨盒和LDDS的化學品和部件組成。成品由鏡片、墨盒、配件和LDDS組成。存貨按成本或可變現淨值中較低者計價。成本是使用標準成本計算的，標準成本在先進先出的基礎上近似實際成本。每當指標顯示存貨成本超過賬面價值，而管理層將存貨調整至其可變現淨值時，便會審查存貨的賬面價值，以確定是否存在潛在減值。成品和在製品的成本由原材料、直接人工、其他直接成本和相關的生產間接費用組成，只要這些成本不超過所生產產品的可變現淨值。本公司定期審核存貨是否存在潛在減值、過時、材料過期或滯銷存貨或過剩存貨的估計損失，並在作出有關決定時將存貨成本減記至可變現淨值。可變現淨值按正常業務過程中的估計銷售價格減去完成和處置的估計成本而厘定。
租契
租賃使用權資產代表公司在租賃期內使用標的資產的權利，租賃負債代表公司支付租賃產生的租賃款項的義務。經營租賃使用權資產和負債在公司接管租賃財產時，根據租賃期內租賃付款的現值確認。本公司根據自身債務融資成本、當前市場利率和報價或租賃中隱含的利率估算遞增借款利率。經營租賃使用權資產還包括在租賃開始時或之前支付的任何租賃付款，不包括收到的任何租賃獎勵。用於計算使用權資產和相關租賃負債的租賃條款包括在合理確定公司將行使選擇權時延長或終止租賃的選擇權。包含已知未來預定租金增長的不可撤銷租約的租金支出，在租賃開始日開始的各個租約的期限內以直線法記錄。租金支出與已支付租金之間的差額在隨附的簡明綜合資產負債表中作爲經營租賃使用權資產的組成部分入賬。業主改善津貼和其他這類租賃激勵措施被記錄爲財產和設備以及租賃資產使用權的減少，並以直線法攤銷，作爲運營租賃成本的減少。初始租期爲12個月或以下的租約在產生時計入費用，不在簡明綜合資產負債表中作爲使用權資產入賬。
每股淨虧損
每股基本淨虧損的計算方法是，普通股股東應占淨虧損除以當期已發行普通股的加權平均份額，不考慮潛在的攤薄證券。每股攤薄淨虧損的計算方法是，普通股股東應占淨虧損除以按庫存股和IF折算法確定的期間普通股和潛在攤薄證券的加權平均份額。每股攤薄淨虧損的計算方法是將淨虧損除以當期已發行的普通股和潛在攤薄證券的加權平均數。
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下列已發行的潛在攤薄證券不包括在普通股股東每股攤薄淨虧損的計算中，因爲它們在庫存股方法下的影響在本報告所述期間是反攤薄的：
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截至9月30日的三個月， |
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根據Calhoun Vision，Inc.2006年股票計劃、Calhoun Vision，Inc.2015年股權激勵計劃和2021年股權激勵計劃發行和發行的股票期權 |
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根據2021年股權激勵計劃發行的限制性股票單位 |
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根據2021年員工購股計劃在發售期間可發行的股票 |
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收入確認
該公司的收入來自銷售用於白內障手術的LAL，以及一種專門設計的向眼睛傳遞光線的機器--LDD，以便在手術後根據需要調整晶狀體。收入從美國、加拿大和歐洲的產品銷售中確認。客戶主要由門診手術中心、醫院和私人醫生診所組成。
當承諾的商品或服務以反映公司預期有權換取這些商品和服務的對價的交易價格轉讓給客戶時，公司確認收入。具體地說，公司採用以下五個步驟確認收入：(1)確定與客戶的合同(S)；(2)確定合同中的履約義務；(3)確定交易價格；(4)將交易價格分配到合同中的履約義務；以及(5)當公司履行履約義務時或作爲履行義務時確認收入。當公司很可能會收取它有權獲得的對價，以換取它轉讓給客戶的商品或服務時，公司就會將五步模式應用於合同。在合同開始時，公司評估每個客戶合同中承諾的貨物，以確定其產品供應中作爲單獨履行義務的單獨可交付物，並評估每一項承諾的貨物或服務是否不同。交易價格是根據預期收到的對價、合同安排的規定價值或非合同安排將收取的估計現金確定的。公司將收入確認爲履行履行義務時分配給相應履行義務的交易價格的金額，考慮到這是否在某個時間點或隨時間發生。該公司選擇將運輸成本作爲履行成本而不是承諾的服務來覈算，並將從客戶那裏收取的任何匯給政府當局的稅款排除在收入之外。
該公司的LDD合同包含以一個交易價捆綁的多個履約義務，所有義務通常在一年內履行。對於這些捆綁安排，如果個別產品和服務是不同的，即如果產品或服務可以與捆綁包中的其他項目分開識別，並且如果客戶可以單獨受益或利用客戶隨時可用的其他資源，則公司將個別產品和服務作爲單獨的履約義務進行會計處理。公司的LDD合同包括以下履約義務的組合：(I)LDD資本資產和相關組成部分，(Ii)培訓和(Iii)設備服務(最初一年)。這三項履約義務都被認爲是不同的。LDD資本資產是獨特的，因爲客戶可以從它以及客戶隨時可用的其他資源中受益。機器使用培訓在安裝LDD後作爲一項獨特的活動提供，通過讓行業專業人員提供最佳實踐並根據客戶的特定需求定製培訓來增強客戶使用機器的能力。在第一年之後，服務合同可以單獨購買。公司將收入確認爲通過將產品或服務的控制權轉移給客戶來履行履行義務的義務。具體而言，LDD資本資產的收入在安裝時的某個時間點確認。培訓收入也在某個時間點記錄，通常是在安裝後60天。收入
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對於設備服務，在安裝後的一段時間內(通常爲12個月)會按比例進行確認。本公司已確定交易價格爲扣除調整後的發票價格(如果有)。對單獨的履約義務的分配是基於相對獨立的銷售價格。獨立銷售價格以公司單獨銷售產品或服務的可觀察價格爲基礎。該公司使用市場評估方法估計獨立銷售價格，該方法考慮了市場狀況和特定於實體的因素，包括但不限於產品和服務的特性和功能、地理位置、客戶類型和市場狀況。公司會根據需要定期審查和更新獨立的銷售價格。
LAL通常以寄售方式在客戶地點持有。履行單一性能義務，並在客戶通知已將LAL植入患者體內時確認LAL的銷售收入。在截至2024年9月30日和2023年9月30日的三個月和九個月裏，與價目表價格的退貨和回扣相關的積分並不顯著。
本公司採取了實際的權宜之計，允許直接支出爲獲得合同而產生的費用，而此類費用的攤銷將發生在一年或更短時間內，並且適用於幾乎所有公司的合同。服務協議的收入在每一份合同期限內按比例確認。
對於截至2024年9月30日和2023年9月30日的三個月和九個月，來自與客戶的合同收入包括以下內容(以千爲單位)：
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截至9月30日的三個月， |
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截至9月30日的9個月， |
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2023 |
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LDD(包括培訓) |
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拉爾 |
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服務保修、服務合同和附件 |
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截至2024年和2023年9月30日的三個月和九個月，本公司並無任何客戶個別佔比超過
下表列出了來自銷售活動的合同負債分別截至2024年9月30日和2023年9月30日的9個月(單位：千)：
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截至9月30日的9個月， |
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期初餘額 |
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期內的新增人數 |
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期內確認的收入 |
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期末餘額 |
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基於股票的薪酬
該公司有三個股權激勵薪酬計劃：Calhoun Vision，Inc.2006股票計劃(「2006計劃」)；Calhoun Vision，Inc.2015股權激勵計劃(「2015計劃」)；以及2021年股權激勵計劃(「2021計劃」)，統稱爲「股權計劃」。公司還制定了員工購股計劃，即2021年員工購股計劃(簡稱2021年員工購股計劃)。
公司根據估計的授予日期確認授予員工、董事會和顧問的基於股權的獎勵的補償費用，包括股票期權、限制性股票單位和員工股票計劃購買的基於股權的支付的公允價值。期權獎勵的公允價值是使用布萊克-斯科爾斯期權定價模型估計的，並在必要的服務期(通常爲四年)內作爲費用在精簡的綜合經營報表和全面虧損中確認。本公司按服務條件攤銷股權獎勵的股票薪酬
16 |
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在授予期間的直線基礎上的獎勵。沒收未授予的股票期權獎勵在發生時被確認爲費用的減少。
布萊克-斯科爾斯期權定價模型要求使用關於一些變量的假設，例如公司普通股的公平市場價值、預期波動率、預期期限、無風險利率和股息收益率，如下所述：
公平市價-普通股公允價值採用納斯達克全球市場報告的普通股每股收盤價確定。
預期波幅-自2024年1月1日起，該公司基於其普通股的歷史波動率來確定預期波動率。在截至2023年12月31日的年度內，預期波動率是根據可比上市醫療設備公司在與股票期權授予的預期期限相同的期間內的平均歷史波動率估計的。可比較的公司是根據它們相似的規模、生命週期所處的階段和專業領域來選擇的。
預期期限-公司的預期期限代表公司基於股票的獎勵預計將未償還的時間段。本公司採用簡化方法(基於歸屬日期和合同期限結束之間的中間點)來確定預期期限。
無風險利率-使用的無風險利率是根據美國財政部在授予零息美國國庫券的股票期權時公佈的利率計算的，其到期日接近每一次授予的預期期限。
股息率-該公司從未對其普通股支付過股息，也沒有計劃對其普通股支付股息。因此，該公司使用的預期股息收益率爲零。
近期會計公告
附註3--短期投資
短期投資，主要是美國國庫券，可供出售，包括以下(以千計)：
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截至2024年9月30日 |
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攤銷成本 |
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未實現收益，淨額 |
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估計公允價值 |
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美國國債 |
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$ |
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$ |
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$ |
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截至2023年12月31日 |
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攤銷成本 |
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未實現收益，淨 |
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估計公平值 |
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美國國債 |
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$ |
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$ |
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$ |
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截至2024年9月30日和2023年12月31日持有的所有可供出售證券 成熟度不到
17 |
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注4 -庫存
庫存包括以下內容（以千計）：
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9月30日， |
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十二月三十一日， |
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2024 |
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2023 |
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成品 |
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$ |
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$ |
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原料 |
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在製品 |
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減：超額和廢棄庫存準備金 |
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( |
) |
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( |
) |
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$ |
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$ |
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2024年9月30日和2023年12月31日，包括成品 $
注5 -公允價值衡量
以下列出的期間的表格和披露（單位：千）列出了公司在經常性基礎上按公允價值計量的資產和負債，並指出了公司用於確定此類公允價值的估值技術的公允價值等級。公司在第三級公允價值計量中沒有任何按公允價值經常性計量的資產或負債。
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截至2024年9月30日 |
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I級 |
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II級 |
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總 |
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資產： |
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貨幣市場證券 |
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$ |
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$ |
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美國國債 |
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按公允價值計算的總資產 |
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$ |
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$ |
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$ |
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截至2023年12月31日 |
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I級 |
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II級 |
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總 |
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資產： |
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貨幣市場證券 |
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$ |
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$ |
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美國國債 |
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按公允價值計算的總資產 |
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$ |
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$ |
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$ |
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附註6--基於股票的薪酬費用
公司有2006年計劃、2015年計劃和2021年計劃三個股權激勵薪酬計劃。
2006年計劃
2006年計劃最初由董事會通過，並於2006年由公司股東批准。由於通過了2015年計劃，2006年計劃於2015年終止，因此不能根據2006年計劃頒發新的獎勵。然而，2006年計劃將繼續管理以前根據2006年計劃授予的尚未授予的獎項的條款和條件。
2015年計劃
2015年計劃最初由董事會通過，並於2015年由公司股東批准。2021年7月，2015年計劃在《2021年計劃》生效之前終止，涉及到未來的獎勵。但是，2015年計劃將繼續管理以前根據2015年計劃授予的尚未授予的獎項的條款和條件。
2021年計劃
在……上面2021年7月28日，董事會和股東通過並批准了2021年計劃。2021年計劃規定向員工和任何附屬公司的員工授予激勵性股票期權，並
18 |
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這個授予非法定股票期權、股票增值權、限制性股票、限制性股票單位(RSU)，以及對員工、董事和顧問以及子公司的員工和顧問的績效獎勵。根據2021年計劃，公司原來可供發行的普通股股數爲
常青樹供應
根據2021年計劃爲發行保留的普通股數量將在每個財政年度的第一天自動增加，從2022年財政年度開始，直至董事會批准2021年計劃之日的十週年，增加的數量至少等於：(1)
2021年ESPP
2021年7月28日，董事會和股東通過並批准了2021年ESPP。截至2024年9月30日，根據2021年ESPP，公司可供未來發行的普通股數量相當於
2021年ESPP爲公司及其子公司的合資格員工提供機會，以相當於以下購買價格購買公司普通股
常青樹供應
根據2021年ESPP爲發行保留的普通股數量將在從2022年財政年度開始的每個財政年度的第一天自動增加，增加的數量至少等於：(I)
基於股票的薪酬費用
2021年計劃和2021年ESPP的目的是提供一種手段，使符合條件的股票獎勵接受者有機會從普通股價值的增加中受益，以保留或獲得員工、董事會成員和顧問的服務，併爲他們提供激勵，以促進公司的成功和實現公司目標。
19 |
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與股權計劃相關的股票期權活動摘要 截至2024年9月30日的九個月如下：
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選項數量 |
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加權 |
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加權平均值 |
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截至2023年12月31日的未償還期權 |
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$ |
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授與 |
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已鍛鍊 |
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( |
) |
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被沒收 |
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( |
) |
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過期 |
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( |
) |
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截至2024年9月30日尚未執行的期權 |
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截至2024年9月30日可撤銷 |
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$ |
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截至2024年9月30日和2023年12月31日 歸屬期權的內在價值爲美元
非歸屬限制性股票單位活動摘要 截至2024年9月30日的九個月如下：
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加權 |
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||
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平均值 |
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||
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數量 |
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授予日期 |
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股份 |
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公允價值 |
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未歸屬於2023年12月31日 |
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$ |
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授與 |
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既得 |
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( |
) |
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被沒收 |
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( |
) |
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2024年9月30日未歸屬 |
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$ |
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||
股票補償費用在隨附的簡明綜合經營和全面收益（虧損）表中分類如下（單位：千）：
|
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截至9月30日的三個月， |
|
|
截至9月30日的9個月， |
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||||||||||
|
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2024 |
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2023 |
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2024 |
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2023 |
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研發 |
|
$ |
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$ |
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$ |
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$ |
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||||
銷售、一般和行政 |
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銷售成本 |
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||||
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$ |
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$ |
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$ |
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$ |
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||||
截至2024年9月30日和2023年12月31日，有幾個
截至2024年9月30日和2023年12月31日，與非歸屬限制性股票單位相關的未確認費用總額約爲美元
20 |
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|
下表列出了布萊克-斯科爾斯期權定價模型中用於確定股票期權公允價值的範圍和加權平均假設：
|
|
截至9月30日的9個月， |
||||||
|
|
2024 |
|
2023 |
||||
|
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射程 |
|
加權平均 |
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射程 |
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加權平均 |
預期波幅 |
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無風險利率 |
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預期壽命(年) |
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預期股息收益率 |
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||||
授予日期公允價值 |
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$ |
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$ |
|
$ |
|
$ |
普通股
每股普通股有權獲得一票。爲未來發行保留的普通股包括以下內容：
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2024年9月30日 |
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2023年12月31日 |
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根據股權計劃已發行和未行使的股票期權 |
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2021年計劃下可供未來發行的股份 |
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2021年計劃下發行的限制性股票單位 |
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2021年ESPP下可供未來發行的股份 |
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預留普通股總股數 |
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附註7-租契
該公司擁有設施和某些設備的運營和融資租賃。初始期限爲12個月或以下的租賃不會記錄在簡明綜合資產負債表中。經營租賃的租賃費用在租賃期內按直線法確認。 公司在確認租賃費用時不將租賃和非租賃部分合並。
截至2024年9月30日 舉行之本公司
2022年4月4日，本公司簽訂了一項
新契約及契約修訂
100哥倫比亞租賃包括120哥倫比亞套房300、400和500
於2024年11月6日，本公司與Accuride International Inc.簽訂了該特定商業租賃協議的第七修正案(租賃延期)，日期爲2015年8月31日，經2024年6月3日修訂，經2024年4月18日修訂，經2015年11月23日、2015年12月22日、2016年1月18日和2016年11月12日修訂，以將100 Columbia租約擴展至包括位於哥倫比亞套房120號的物業300、400和500，總計約
21 |
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千人將在2024年支付，$
100哥倫比亞
於2024年4月18日，本公司與Accuride International Inc.簽訂了該特定商業租賃協議的第五修正案，日期爲2015年8月31日，經修訂的分別爲2015年11月23日、2015年12月22日、2016年1月18日和2016年11月12日，
於2024年6月3日，本公司與Accuride International Inc.就位於加利福尼亞州Aliso Viejo的100 Columbia物業於2024年4月18日、2015年11月23日、2015年12月22日、2016年1月18日及2016年11月12日修訂後的該特定商業租賃協議簽訂了日期爲2015年8月31日的第六修正案(「2024年6月100 Columbia修正案」)。2024年6月通過的《哥倫比亞100修正案》更新了某些通知要求。
125哥倫比亞
2024年4月18日，公司與BML Management，LLC簽訂了標準的工商單租戶租賃網絡(「125 Columbia Lease」)，租期約爲
5哥倫比亞
於二零二四年四月十八日及二零二四年六月三日，本公司分別與Clifford D.Down於2018年1月10日訂立(於2022年4月5日修訂)的該若干租賃協議的第二及第三租賃修正案，金額約爲
22 |
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下表列出了截至2011年的簡明合併資產負債表中的租賃餘額 2024年9月30日和2023年12月31日(單位：千)：
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9月30日， |
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十二月三十一日， |
|
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租契 |
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分類 |
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2024 |
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2023 |
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資產 |
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運營中 |
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經營租賃使用權資產 |
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$ |
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$ |
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金融 |
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租賃資產總額 |
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負債 |
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當前 |
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運營中 |
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金融 |
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非電流 |
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運營中 |
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金融 |
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租賃總負債 |
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$ |
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$ |
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爲 截至2024年和2023年9月30日的三個月和九個月，經營和融資租賃費用的組成部分如下（單位：千）：
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|
截至9月30日的三個月， |
|
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截至9月30日的9個月， |
|
||||||||||
租賃費 |
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分類 |
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2024 |
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2023 |
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2024 |
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2023 |
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||||
經營租賃成本 |
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銷售成本 |
|
$ |
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|
$ |
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$ |
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$ |
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||||
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研發 |
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銷售、一般和行政 |
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融資租賃成本 |
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研發 |
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銷售、一般和行政 |
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融資租賃成本 |
|
利息開支 |
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截至2011年，公司經營和融資租賃負債的到期情況 2024年9月30日如下（以千計）：
|
|
運營中 |
|
|
金融 |
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截至十二月三十一日止的年度： |
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2024年(剩餘部分) |
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$ |
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$ |
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2025 |
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2026 |
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2027 |
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2028 |
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2029 |
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此後 |
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租賃付款總額 |
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減去：推定利息 |
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租賃總負債 |
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$ |
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$ |
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23 |
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截至2024年9月30日和2023年12月31日，用於確定與公司經營和融資租賃相關的租賃負債的加權平均剩餘租期和加權平均貼現率爲：
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9月30日， |
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十二月三十一日， |
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租賃期限和貼現率 |
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2024 |
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2023 |
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加權平均剩餘租賃年限(年) |
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經營租約 |
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融資租賃 |
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加權平均貼現率 |
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經營租約 |
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% |
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% |
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融資租賃 |
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% |
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% |
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附註8--承付款和或有事項
信用證
本公司的備用信用證無需續期，於2024年9月30日到期。
法律事務
本公司可能不時涉及在正常業務過程中出現的某些法律程序或監管事項，包括但不限於與知識產權、僱傭、監管、產品責任和合同事項有關的訴訟。就該等訴訟或事宜而言，本公司會根據該等訴訟或事宜的發展情況，定期評估可能出現的問題的可能性及金額(或範圍)。如果確定可能發生了損失，並且損失的金額(或範圍)可以合理估計，則在合併財務報表中計入負債。由於與任何懸而未決的訴訟或事項相關的不確定性，公司目前無法預測其最終結果，對於任何沒有產生責任的法律訴訟或監管事項，本公司無法對不利結果可能導致的可能損失(或損失範圍)做出合理估計。2024年9月30日和2023年12月31日，有幾個
第二項：M阿吉恩斯的討論與分析 財務狀況和經營成果
以下對我們財務狀況和經營結果的討論和分析應與我們未經審計的簡明綜合財務報表和本報告其他部分包括的那些報表的相關說明以及我們截至2023年12月31日的經過審計的綜合財務報表和相關說明一起閱讀，這些報表包括在我們於2024年2月28日提交給美國證券交易委員會的Form 10-k年度報告中。除歷史財務信息外，以下討論和分析包含涉及風險、不確定性和假設的前瞻性陳述。由於許多因素，包括在第二部分第1A項「風險因素」下討論的因素，我們選定事件的實際結果和時間可能與這些前瞻性陳述中預期的大不相同”，以及萬億.is報告的其他地方。請參閱「關於前瞻性陳述的特別說明」。
我們是一家商業階段的醫療技術公司，致力於爲白內障手術後的患者提供高質量的定製視力。我們專有的RxSight®光線可調透鏡系統(「RxSight系統」)是第一個也是唯一一個商業化的優質白內障技術，使醫生能夠爲手術後的患者定製和優化視力。RxSight系統由我們的RxSight光線可調鏡頭®(「LAL™」和「LAL+™」，統稱爲「LAL」)、RxSight光線傳送裝置(「LDD™」)和配件組成。我們的LAL是一種優質人工晶狀體(「IOL」)，由專有光敏材料製成，可根據LDD產生的特定紫外線(「UV」)模式改變形狀。
24 |
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我們設計的RxSight系統旨在解決競爭性優質IOL技術的缺點，並提供醫生可信賴的解決方案，以改善視覺效果並實現高水平的患者滿意度。競爭性優質人工晶狀體要求患者在手術前明確他們的視力優先順序，並願意接受與這些選擇相關的各種光學權衡。一旦患者選擇了具有競爭力的優質人工晶狀體，外科醫生必須依靠一系列的術前診斷測試和預測公式來選擇合適的晶狀體屈光度。如果醫生的預測不準確，患者可能會經歷不理想的結果，這可能需要隨後的角膜屈光手術或某些其他妥協，以達到視力目標。
相比之下，在RxSight系統中，外科醫生在標準的白內障手術中植入LAL，在手術後幾周根據患者的輸入確定屈光不正，然後使用LDD通過精確的視覺矯正來修改LAL，以實現患者所需的視力結果。我們相信，我們的RxSight系統爲醫生和患者提供了更多的信心和安心，因爲它消除了競爭性優質人工晶狀體常見的高風險術前猜測，並允許患者通過定製的術後調整重複他們的最終視力特徵。
我們主要在美國的IOL市場競爭。LAL是一種溢價IOL，在聯邦醫療保險下可部分報銷，在某些情況下可由私人付款人報銷。優質人工晶狀體的售價高於傳統人工晶狀體，因爲它們提供屈光矯正，而傳統人工晶狀體只用透明晶狀體取代自然晶狀體(這是醫療保險報銷的標準)。我們的RxSight系統已在美國、歐洲、加拿大和墨西哥獲得批准，用於通過調整LAL屈光度來矯正術後殘餘屈光不正，從而提高裸眼視力。我們未來可能會有選擇地在這些或其他接受這些批准的地區進行商業擴張，優先考慮我們看到重大潛在機會的市場。在監管程序更復雜的大型外國白內障市場，如亞洲和歐洲，也可能尋求新的批准。
我們是一家特拉華州的公司，總部設在加利福尼亞州的Aliso Viejo，在荷蘭阿姆斯特丹有一家全資子公司。該全資附屬公司在英國設有註冊分行，並在德國設有全資附屬公司。
我們的商業努力始於2019年，主要集中在美國，我們正在美國建立一種「剃鬚刀和刀片」的商業模式，以推動新客戶的採用和持續的LAL銷量增長。我們的美國商業機構包括由LDD銷售人員和LAL客戶經理組成的直銷團隊，以及臨床專家、現場服務工程師和營銷人員。我們的銷售工作集中在大約4000名美國白內障外科醫生身上，他們進行的高端人工晶狀體手術佔所有高端人工晶狀體手術的70%-80%。截至2024年9月30日，我們已經在眼科實踐中建立了888個LDDS的安裝基礎，從我們成立到2024年9月30日，外科醫生已經植入了超過165,000個LAL。
我們相信，這種商業模式提供了一個有吸引力和集中的市場機會，可以通過專注的銷售隊伍來解決。我們打算繼續對我們的銷售和營銷組織進行重大投資。我們相信，有選擇地增加銷售代表、實踐開發人員和臨床培訓人員的數量將有助於促進現有客戶進一步採用我們的產品，並擴大新客戶對我們產品的認識。我們計劃主要通過擴大我們的LDD客戶群的規模來發展我們的業務，並通過提高對我們的RxSight系統爲患者提供的卓越臨床結果的認識來提高我們的LAL的利用率。爲了繼續加強我們在高端人工晶狀體市場的競爭地位，我們的研發活動主要集中在改善臨床結果、改善客戶體驗、擴大我們的使用適應症、降低製造成本和生命週期管理的項目上。
我們近期的研發活動集中於增強RxSight系統，以改善患者和醫生體驗，擴大可治療的患者範圍，以及擴大RxSight系統的適應症和推動採用。我們相信，隨着時間的推移，我們的可調節透鏡解決方案可以用於解決廣泛的白內障手術患者，包括那些本來會選擇今天的傳統白內障手術的患者。還預計會有更多的開發和臨床研究，旨在爲我們現有和未來幾代產品的安全性和有效性提供臨床證據。最後，我們未來可能尋求收購或投資其他業務、產品或技術，我們認爲這些業務、產品或技術可以補充或擴大我們的投資組合，增強我們的技術能力，或以其他方式提供增長機會。
我們打算繼續對我們的銷售和營銷組織進行投資，主要是銷售代表、臨床應用專家和技術服務人員，以支持新客戶和
25 |
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升級和升級客戶經理，以促進在現有客戶中採用我們的LAL。我們將通過更多的印刷和數字、社交媒體和其他客戶工具來擴大他們的本地廣告，從而擴大我們的營銷努力。我們還將繼續在研發和臨床費用方面進行重大投資，以增強我們現有的產品。此外，作爲一家上市公司，我們已經並預計將繼續產生與員工相關的費用、董事和高級職員保險費、審計費(包括遵守薩班斯-奧克斯利法案第404(B)條的費用)、法律費用、投資者關係費用、董事會成員費用以及遵守上市公司報告要求的費用。由於這些和其他因素，我們預計在不久的將來繼續出現淨虧損和運營現金流爲負的情況。
關鍵業務指標
我們定期審查幾個運營和財務指標，以評估我們的業務，衡量我們的業績，確定影響我們業務的趨勢，制定我們的業務計劃，並做出戰略決策。我們相信，安裝的LDDS和植入的LAL的數量是我們推動採用和創造收入的能力的指標。
我們相信每個季度售出的LDD數量和每個季度結束時我們的LDD客戶群都是重要的指標，因爲它們代表了我們可以向其銷售LAL的客戶群。我們還認爲，每個季度售出的LAL數量(報告爲植入患者體內)是衡量我們的RxSight系統採用和使用情況的重要指標。
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2024 |
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2023 |
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Q1 |
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Q2 |
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Q3 |
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Q1 |
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Q2 |
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|
Q3 |
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|
Q4 |
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|||||||
LDDS售出 |
|
|
|
66 |
|
|
|
78 |
|
|
|
78 |
|
|
|
|
56 |
|
|
|
67 |
|
|
|
66 |
|
|
|
77 |
|
|
期末客戶群 |
|
|
|
732 |
|
|
|
810 |
|
|
|
888 |
|
|
|
|
456 |
|
|
|
523 |
|
|
|
589 |
|
|
|
666 |
|
|
|
|
|
2024 |
|
|
|
2023 |
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|
||||||||||||||||||||||
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|
Q1 |
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Q2 |
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Q3 |
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Q1 |
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Q2 |
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Q3 |
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Q4 |
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|||||||
售出的LAL |
|
|
|
20,218 |
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|
|
24,214 |
|
|
|
24,554 |
|
|
|
|
10,523 |
|
|
|
12,622 |
|
|
|
13,657 |
|
|
|
18,071 |
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|||||||
在截至2024年9月30日的季度內，與截至2023年9月30日的季度相比，我們的LDD銷售額增加了12個，LAL銷售額增加了10,897個，這是由於診所和醫生對我們的RxSight技術的大力採用以及LDD裝機容量的增加。
我們的季度和年度財務業績可能會因各種因素而波動，其中許多因素是我們無法控制的。我們可能還無法準確評估季節性和其他趨勢，未來我們將繼續使用這些和其他財務指標來評估我們的業務，同時觀察我們業務的趨勢。
業務成果的構成部分
銷售
我們的銷售包括銷售用於白內障手術的人工晶狀體，用於向人工晶狀體投射光線以根據需要調整術後晶狀體的LDDS，以及服務和配件。收入主要來自銷售產品，主要是在美國。客戶主要包括眼科診所(LDD銷售)和門診手術中心(LAL銷售)。我們預計，隨着我們擴大銷售組織和銷售區域，增加客戶，擴大受過使用我們產品培訓的醫生基礎，以及隨着醫生使用我們的產品執行更多程序，以及在新客戶和現有客戶中擴大對我們產品的認識，我們的收入將以絕對美元計算增加。
LAL以寄售方式保存在客戶現場。在客戶通知已將LAL植入患者體內時，確認LAL的收入。
我們的LDD合同包含捆綁在一個交易價格中的多個履約義務，所有義務通常在一年內履行。LDD資本資產和相關組件收入在安裝和客戶驗收時確認，培訓收入在至少一名醫生完成培訓時確認，初始保修和服務協議在服務期內按比例確認。在第一年之後，服務合同可以單獨購買。此類服務協議的收入將在每一份合同期限內確認。
26 |
|
|
在截至2024年9月30日和2023年9月30日的三個月和九個月裏，來自與客戶的合同收入包括以下內容(以千爲單位)：
|
|
截至9月30日的三個月， |
|
|
截至9月30日的9個月， |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
LDD(包括培訓) |
|
$ |
10,128 |
|
|
$ |
7,932 |
|
|
$ |
29,030 |
|
|
$ |
22,127 |
|
拉爾 |
|
|
24,231 |
|
|
|
13,502 |
|
|
|
67,975 |
|
|
|
36,308 |
|
服務保修、服務合同和附件 |
|
|
955 |
|
|
|
765 |
|
|
|
2,708 |
|
|
|
2,062 |
|
|
|
$ |
35,314 |
|
|
$ |
22,199 |
|
|
$ |
99,713 |
|
|
$ |
60,497 |
|
在截至2024年9月30日和2023年9月30日的三個月和九個月裏，我們沒有一個客戶單獨佔收入的10%以上。
銷售成本
銷售成本包括生產我們產品的內部材料、勞動力和製造費用，以及運輸和搬運成本。間接費用包括質量保證費用、材料採購費用、庫存控制費用、設施、設備和業務監督和管理費用以及基於庫存的補償費用。銷售成本還包括生產設備的折舊費用和某些直接成本，如運輸成本、特許權使用費和許可費費用。向客戶收取的運輸成本包括在銷售額中。我們預計，隨着我們收入的增長和更多產品的銷售，以絕對美元計算的銷售成本將會增加。
我們用毛利/(虧損)除以銷售額來計算毛利。我們的毛利率一直並將繼續受到各種因素的影響，包括平均銷售價格、產品銷售組合、生產和訂貨量、製造成本、產品產量、員工人數和成本削減戰略。隨着我們推出新產品以及採用新的製造工藝和技術，我們的毛利率可能會隨着季度的變化而波動。
與許多醫療器械資本設備產品一樣，我們的LDD毛利率很低，因爲LDD的材料成本很高，佔總製造成本的50%以上。此外，我們不對LDD加價，因爲LDD一旦售出，就會產生LAL程序。我們的LAL毛利率較高，材料成本較低，但固定間接成本較高。隨着我們的LAL生產量的增加，我們預計毛利率可能會顯著改善。
運營費用
銷售、一般和管理費用
銷售、一般及行政(「SG&A」)開支主要包括與人事有關的開支，包括工資、獎勵獎金、股票薪酬及與行政、銷售及市場推廣職能有關的福利、醫生教育計劃、商業營運及分析、財務、資訊科技及人力資源職能。其他SG&A費用包括銷售佣金、差旅費用、促銷活動、市場推廣活動、市場研究和分析、會議和貿易展覽、醫生培訓、專業服務費，如法律、專利註冊費用、會計、審計費用(包括遵守薩班斯-奧克斯利法案第404(B)條的費用)、稅費、董事會費用、保險費用、一般公司費用和設施相關費用。我們預計，隨着我們擴大銷售和營銷組織以及基礎設施，以推動和支持預期的收入增長，以及額外的法律、會計審計和稅費、保險和其他與上市公司相關的費用，SG&A費用將以絕對美元計算繼續增加。
研發費用
研究和開發費用包括爲新產品和技術、臨床研究和法規提交及合規進行研究和開發及工程活動所產生的費用。這些費用包括與人員有關的費用，包括工資、獎勵獎金、基於股票的薪酬和福利、臨床試驗地點發生的費用、監管和製造工程費用，包括與各種實驗室和研究設備及用品有關的費用，用於
27 |
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臨床試驗和研究目的、超過資本化價值的製造工藝開發所產生的成本、支付給顧問和合同臨床組織的費用、與FDA相關的直接成本以及與FDA上市前審批提交準備相關的成本。研究和開發費用在發生時計入費用。我們預計研發費用佔收入的百分比將隨着時間的推移而變化，這取決於我們新產品開發工作的水平和時機，以及我們的臨床開發、臨床試驗和註冊以及其他相關活動。
利息開支
利息支出主要包括我們的未償債務產生的利息以及與債務攤銷有關的非現金利息、與我們的債務和租賃利息相關的貼現和發行成本。
利息和其他收入，淨額
利息和其他收入，淨額主要由我們的短期投資和現金等價物賺取的利息收入組成。
綜合損失
全面虧損的所有組成部分，包括淨虧損，都在確認期間的合併財務報表中報告。全面虧損被定義爲在一段時間內因非所有者來源的交易和其他事件和情況而發生的權益變化，包括短期投資和外幣換算調整的未實現收益和虧損。
行動的結果
截至2024年9月30日與2023年9月30日的三個月比較
下表彙總了截至2024年9月30日和2023年9月30日的三個月的業務結果，以及這些項目的美元增減和百分比變化。
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|
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|
截至9月30日的三個月， |
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|
變化 |
|
||||||||||
(除百分比外，以千爲單位) |
2024 |
|
|
2023 |
|
|
($) |
|
|
(%) |
|
||||
銷售 |
$ |
35,314 |
|
|
$ |
22,199 |
|
|
$ |
13,115 |
|
|
|
59.1 |
% |
銷售成本 |
|
10,094 |
|
|
|
8,468 |
|
|
|
1,626 |
|
|
|
19.2 |
|
毛利 |
$ |
25,220 |
|
|
$ |
13,731 |
|
|
$ |
11,489 |
|
|
|
83.7 |
% |
運營費用： |
|
|
|
|
|
|
|
|
|
|
|
||||
銷售、一般和行政 |
|
25,608 |
|
|
|
19,142 |
|
|
|
6,466 |
|
|
|
33.8 |
|
研發 |
|
8,838 |
|
|
|
7,101 |
|
|
|
1,737 |
|
|
|
24.5 |
|
總運營支出 |
|
34,446 |
|
|
|
26,243 |
|
|
|
8,203 |
|
|
|
31.3 |
|
運營虧損 |
$ |
(9,226 |
) |
|
$ |
(12,512 |
) |
|
$ |
3,286 |
|
|
|
(26.3 |
)% |
其他收入(費用)，淨額： |
|
|
|
|
|
|
|
|
|
|
|
||||
利息開支 |
|
(5 |
) |
|
|
(230 |
) |
|
|
225 |
|
|
|
(97.8 |
) |
利息和其他收入 |
|
2,906 |
|
|
|
1,746 |
|
|
|
1,160 |
|
|
|
66.4 |
|
定期貸款枯竭損失 |
|
— |
|
|
|
(1,407 |
) |
|
|
1,407 |
|
|
— |
|
|
其他（費用）收入總額，淨額： |
|
2,901 |
|
|
|
109 |
|
|
|
2,792 |
|
|
|
2561.5 |
% |
所得稅前虧損 |
|
(6,325 |
) |
|
|
(12,403 |
) |
|
|
6,078 |
|
|
|
(49.0 |
) |
所得稅費用 |
|
13 |
|
|
|
12 |
|
|
|
1 |
|
|
|
8.3 |
|
淨虧損 |
$ |
(6,338 |
) |
|
$ |
(12,415 |
) |
|
$ |
6,077 |
|
|
|
(48.9 |
)% |
其他綜合損失 |
|
|
|
|
|
|
|
|
|
|
|
||||
短期投資的未實現收益 |
|
633 |
|
|
|
19 |
|
|
|
614 |
|
|
|
3,231.6 |
|
外幣折算收益(虧損) |
|
6 |
|
|
|
(6 |
) |
|
|
12 |
|
|
|
(200.0 |
) |
其他綜合損失合計 |
|
639 |
|
|
|
13 |
|
|
|
626 |
|
|
|
4,815.4 |
|
綜合損失 |
$ |
(5,699 |
) |
|
$ |
(12,402 |
) |
|
$ |
6,703 |
|
|
|
(54.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
||||
28 |
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銷售
截至2024年9月30日的三個月，銷售額增加了1,310美元萬，或59.1%，至3,540美元萬，而截至2023年9月30日的三個月，銷售額爲2,220美元萬。總銷售額的增長主要是由於執業醫生和醫生大力採用我們的RxSight系統，增加了10,897個LAL和12個LDD的銷售額。
銷售成本
在截至2024年9月30日的三個月中，銷售成本增加了160美元萬，從截至2023年9月30日的三個月的850美元萬增加到1,010美元萬，這主要是由於在此期間銷售的LAL和LDD的數量增加。在截至2024年9月30日的三個月中，毛利率從截至2023年9月30日的三個月的61.8%增加到71.4%，這主要是由於運營槓桿的改善，來自LAL銷售收入的更大比例的有利產品組合，以及由於材料成本降低而增加的LDD利潤率。
SG&A費用
截至2024年9月30日的三個月，SG&A費用增加了650美元萬或33.8%，達到2,560美元萬，而截至2023年9月30日的三個月爲1,910美元萬。這一增長主要是由於與截至2023年9月30日的三個月相比，銷售和營銷成本增加了510萬(主要是由於增加了36名員工而增加了工資)，銷售佣金、獎勵獎金和員工福利增加了270萬，基於股票的薪酬支出增加了90萬，主要由於額外的上市後研究增加了萬。與截至2023年9月30日的三個月相比，一般和行政費用增加了130美元萬，這是因爲與截至2023年9月30日的三個月相比，人員費用增加了80美元萬，基於股票的薪酬增加了80美元萬，部分被審計和審計相關費用減少了50美元萬所抵消。
研發費用
在截至2024年9月30日的三個月中，研發費用增加了170美元萬，增幅爲24.5%，從截至2023年9月30日的三個月的710美元萬增至880美元萬。這一增長主要是由於與截至2023年9月30日的三個月相比，設施成本增加導致的100美元萬和股票薪酬增加的50美元萬以及人員成本增加的60美元萬。
其他收入(費用)，淨額
在截至2024年9月30日的三個月中，其他收入(支出)淨額增加了280美元萬，達到290美元萬，而截至2023年9月30日的三個月的收入爲10萬。增加的主要原因是：(I)利息收入較上年同期增加120萬，這是由於短期投資餘額較高所賺取的利率較高，以及(Ii)償還牛津定期貸款所產生的140萬債務清償虧損較上年同期減少所致。
29 |
|
|
截至2024年9月30日和2023年9月30日的九個月比較
下表總結了我們截至2024年和2023年9月30日的九個月的經營業績，以及這些項目的美元漲跌和百分比變化：
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|
|
|
||||||||||
|
截至9月30日的9個月， |
|
|
變化 |
|
||||||||||
(除百分比外，以千爲單位) |
2024 |
|
|
2023 |
|
|
($) |
|
|
(%) |
|
||||
銷售 |
$ |
99,713 |
|
|
$ |
60,497 |
|
|
$ |
39,216 |
|
|
|
64.8 |
% |
銷售成本 |
|
29,558 |
|
|
|
24,386 |
|
|
|
5,172 |
|
|
|
21.2 |
|
毛利 |
$ |
70,155 |
|
|
$ |
36,111 |
|
|
$ |
34,044 |
|
|
|
94.3 |
% |
運營費用： |
|
|
|
|
|
|
|
|
|
|
|
||||
銷售、一般和行政 |
|
73,225 |
|
|
|
53,634 |
|
|
|
19,591 |
|
|
|
36.5 |
|
研發 |
|
25,160 |
|
|
|
21,710 |
|
|
|
3,450 |
|
|
|
15.9 |
|
總運營支出 |
|
98,385 |
|
|
|
75,344 |
|
|
|
23,041 |
|
|
|
30.6 |
|
運營虧損 |
$ |
(28,230 |
) |
|
$ |
(39,233 |
) |
|
$ |
11,003 |
|
|
|
(28.0 |
)% |
其他收入(費用)，淨額： |
|
|
|
|
|
|
|
|
|
|
|
||||
利息開支 |
|
(16 |
) |
|
|
(3,304 |
) |
|
|
3,288 |
|
|
|
(99.5 |
) |
利息和其他收入 |
|
6,767 |
|
|
|
4,913 |
|
|
|
1,854 |
|
|
|
37.7 |
|
定期貸款枯竭損失 |
|
— |
|
|
|
(1,769 |
) |
|
|
1,769 |
|
|
— |
|
|
其他收入（費用）總額，淨額： |
|
6,751 |
|
|
|
(160 |
) |
|
|
6,911 |
|
|
|
(4319.4 |
)% |
所得稅前虧損 |
|
(21,479 |
) |
|
|
(39,393 |
) |
|
|
17,914 |
|
|
|
(45.5 |
) |
所得稅費用 |
|
38 |
|
|
|
38 |
|
|
|
— |
|
|
|
0.0 |
|
淨虧損 |
$ |
(21,517 |
) |
|
$ |
(39,431 |
) |
|
$ |
17,914 |
|
|
|
(45.4 |
)% |
其他綜合損失 |
|
|
|
|
|
|
|
|
|
|
|
||||
短期投資的未實現收益 |
|
524 |
|
|
|
38 |
|
|
|
486 |
|
|
|
1,278.9 |
|
外幣折算收益(虧損) |
|
2 |
|
|
|
(3 |
) |
|
|
5 |
|
|
|
(166.7 |
) |
其他全面收入合計 |
|
526 |
|
|
|
35 |
|
|
|
491 |
|
|
|
1,402.9 |
|
綜合損失 |
$ |
(20,991 |
) |
|
$ |
(39,396 |
) |
|
$ |
18,405 |
|
|
|
(46.7 |
)% |
銷售
截至2024年9月30日的9個月，銷售額增加了3,920美元萬，或64.8%，達到9,970美元萬，而截至2023年9月30日的9個月，銷售額爲6,050美元萬。這一增長主要是由於LDD安裝基數的增加，以及診所和醫生對我們的RxSight技術的大力採用以及LDD安裝基數的增加，增加了32,184個LAL的銷售額。
銷售成本
在截至2024年9月30日的9個月中，銷售成本增加了520美元萬，從截至2023年9月30日的9個月的2,440美元萬增加到2,960美元萬，這主要是由於在此期間銷售的LAL和LDD的數量增加。截至2024年9月30日的9個月的毛利率從截至2023年9月30日的9個月的59.7%增加到70.4%，這主要是由於LAL銷售收入的更大比例帶來了有利的產品組合，以及我們的LDD利潤率因2023年第三季度推出緊湊型LDD而降低了材料成本而增加。
SG&A費用
截至2024年9月30日的9個月，SG&A費用增加了1960年萬，增幅爲36.5%，從截至2023年9月30日的9個月的5,360美元萬增至7,320萬。這一增長主要是由於銷售和營銷成本增加了1,400美元萬(主要是由於增加了36名員工而增加了工資)，銷售佣金、激勵獎金和員工福利增加了720萬，股票薪酬支出增加了230萬，市場後研究成本增加了240美元，以及與截至2023年9月30日的9個月相比，每種情況下的新客戶獲取成本和差旅成本增加了90萬。一般和行政費用增加5.5美元
30 |
|
|
由於與截至2023年9月30日的9個月相比，人員支出增加了210美元萬，基於股票的薪酬增加了140美元萬，設施成本增加了140美元萬。
研發費用
在截至2024年9月30日的9個月中，研發費用增加了350美元萬或15.9%，達到2,520美元萬，而截至2023年9月30日的9個月的研發費用爲2,170美元萬。這一增長主要是由於人員成本增加了90美元萬，主要是因爲增加了員工人數，增加了基於股票的薪酬，增加了120美元萬。
其他收入(費用)，淨額
截至2024年9月30日的9個月，其他收入(支出)淨額爲680美元萬，而截至2023年9月30日的9個月的支出爲20美元萬。增加主要是由於(I)期內利息開支減少330萬，(Ii)因償還牛津定期貸款而於2023年到期的定期貸款虧損減少180萬，及(Iii)期間利息收入增加190萬，因短期投資結餘較高所賺取的利率較高。
流動資金和資本資源
流動資金來源
自成立以來，我們已經發生了嚴重的運營虧損和運營現金流爲負的情況，我們預計未來將出現重大虧損。
截至2024年9月30日，我們擁有23710美元的現金、現金等價物和短期投資萬。在截至2024年和2023年9月30日的9個月中，我們的運營虧損分別爲2,820美元萬和3,920美元萬。截至2024年9月30日，我們的累計赤字爲61620美元萬。
最新發展動態
貨架登記表
2024年5月8日，我們在S-3表格上提交了自動入庫登記書(《入庫登記書》)。貨架登記聲明有效期爲三年，並允許我們不時出售普通股、優先股、債務證券、權證和/或單位。擱置登記聲明旨在爲我們提供獲得額外資本的靈活性。在提交貨架登記聲明時，我們還提交了一份招股說明書補充資料，擬通過公開發行(「公開發行」)出售總價值高達11500萬美元的普通股。
公開發行
2024年5月8日，我們與美國銀行證券公司達成承銷協議，根據擱置登記聲明，我們同意在公開發行中發行和出售1,785,714股我們的普通股。普通股以每股56.00美元的價格向公衆出售。根據承銷協議的條款，吾等亦向承銷商授予可於承銷協議日期起計30天內按相同條款及條件購買最多267,857股普通股的選擇權。承銷商購股權於2024年5月10日全面行使，公開發售(包括承銷商購股權股份)於2024年5月13日截止。我們從公開募股中獲得了大約10750美元的萬淨收益，扣除了690美元萬的承銷商折扣和佣金以及60美元萬的其他發售費用。
合同義務和承諾
2024年11月租賃活動
100哥倫比亞租賃包括120哥倫比亞套房300、400和500
2024年11月6日，我們對我們現有的一份租約簽訂了新的租約修正案，該租約包括我們位於加利福尼亞州Aliso Viejo的總部、製造、研發和行政辦公室。我們
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簽訂新的經修訂租約，以繼續長期使用我們的設施，並獲得額外的面積。
2024年4月租賃活動
2024年4月18日，我們簽訂了新的租約，並對現有的兩個租約進行了修訂，包括我們位於加利福尼亞州阿利索·維埃霍的總部、製造、研發和行政辦公室等四個設施中的三個。我們簽訂了新的租約並修訂了兩份現有租約，以延長租賃條款和選項，確保繼續長期使用我們的設施，購買額外的面積以擴大生產，並調整我們四家設施的租賃結束日期。
見本報告載於簡明綜合財務報表附註內的附註7-租賃。
備用信用證
我們的備用信用證不需要續期，於2024年9月30日到期。
資金需求
我們未來的流動資金和資本資金需求將取決於許多因素，包括：
我們相信，截至本報告提交之日，我們目前的現金、現金等價物和短期投資將足以爲我們的運營提供至少未來12個月的資金。儘管根據我們目前計劃的業務，我們預計不需要籌集額外資本或招致額外債務來實現業務利潤，正如公司未來提交給美國證券交易委員會的10-K表格年度報告或10-Q表格季度報告中所披露的那樣，但爲了滿足我們的流動性要求，我們可能需要通過公開發行或私募股權發行或債務融資、信貸或貸款安排來籌集額外資本，或通過與這些資金來源中的一個或多個資金來源的組合進行合作來籌集更多資本。我們也可能不時在有利的情況下進行機會性融資，如公開募股，以支持我們在美國和國際上的銷售和業務擴張，並尋求其他商業機會。如果我們確定我們需要籌集額外的資金，而這些資金在需要時或在我們認爲有利的條款下可能無法獲得。如果我們通過出售股權或可轉換債務證券來籌集額外資本，我們股東的所有權權益將被稀釋，這些證券的條款可能包括清算或其他對普通股股東權利產生不利影響的優惠。債務融資和優先股融資，如果可用，可能涉及的協議包括限制或限制我們
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有能力採取具體行動，如招致額外債務、進行收購或資本支出或宣佈股息。如果我們無法維持足夠的財務資源，我們的業務、財務狀況和經營結果將受到實質性和不利的影響，包括可能要求我們推遲、限制、減少或終止某些產品發現和開發活動或未來的商業化努力。如果我們通過發行股權證券來籌集更多資金，我們的股東可能會受到稀釋。
有關與我們的大量資本要求相關的額外風險，請參閱本報告第二部分第1A項(「風險因素」)。
現金流量彙總表
下表列出了以下各期間現金、現金等價物和限制性現金的主要來源和用途(以千計)：
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在截至9月30日的9個月內， |
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(未經審計) |
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2024 |
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2023 |
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提供的現金淨額(用於)： |
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|
|
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||
經營活動 |
|
$ |
(12,686 |
) |
|
$ |
(33,292 |
) |
投資活動 |
|
|
(100,631 |
) |
|
|
(26,695 |
) |
融資活動 |
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120,343 |
|
|
|
57,962 |
|
外匯匯率對現金、現金等價物的影響 |
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3 |
|
|
|
(2 |
) |
現金、現金等價物和限制性現金淨增(減) |
|
$ |
7,029 |
|
|
$ |
(2,026 |
) |
用於經營活動的現金
截至2024年9月30日的9個月，經營活動中使用的現金淨額爲1,270美元萬，主要包括淨虧損2,150美元萬和營業資產和負債變化5，60美元萬，部分被基於非現金股票的薪酬1,740美元萬和折舊和攤銷3，10美元萬所抵消。
截至2023年9月30日的9個月，經營活動中使用的現金淨額爲3,330萬美元，主要包括淨虧損3,940美元萬和營業資產和負債變化5，90美元萬，但被基於非現金股票的薪酬1,130美元萬和折舊及攤銷300美元萬部分抵消。
用於投資活動的現金
截至2024年9月30日的9個月，用於投資活動的現金淨額爲10060美元萬，其中包括淨買入9,600美元萬的短期投資以及購買460美元萬的財產和設備。
截至2023年9月30日的九個月，用於投資活動的現金淨額爲2,670美元萬，其中包括2,350美元萬的短期投資淨到期日以及320美元萬的物業和設備購買額。
融資活動提供的現金
截至2024年9月30日的九個月內，融資活動提供的淨現金爲12030萬美元，主要包括公開發行普通股的收益10810萬美元，以及股票期權行使普通股的收益1780萬美元，部分被480萬美元員工股票補償稅款所抵消。
截至2023年9月30日的九個月內，融資活動提供的淨現金爲5800萬美元，主要包括我們公開募股發行普通股的收益5410萬美元，發行普通股進行市場發行的收益爲4240萬美元，發行普通股的收益爲4240萬美元590萬被2023年6月LSA 4000萬美元的淨償還額部分抵消。
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關鍵會計政策、重大判斷和估計的使用
我們管理層對財務狀況和經營結果的討論和分析是基於我們的財務報表，這些報表是按照美國公認的會計原則(「GAAP」)編制的。在編制這些財務報表時，我們需要做出估計和假設，以影響報告的資產和負債的報告金額、財務報告日期的或有資產和負債的披露以及報告期內發生的報告費用。我們的估計是基於我們的歷史經驗和我們認爲在當時情況下是合理的各種其他因素，這些因素的結果構成了對資產和負債的賬面價值作出判斷的基礎，而這些資產和負債的賬面價值從其他來源看起來並不明顯。在不同的假設或條件下，實際結果可能與這些估計值不同，這可能會影響我們未來的財務報表列報、財務狀況、經營結果和現金流。我們的重要會計政策在我們於2024年2月28日提交給美國證券交易委員會的10-k表格年度報告中的財務報表附註中得到了更全面的描述。我們相信，我們使用的會計政策對於在編制我們的財務報表以及了解和評估我們報告的財務結果時做出重大判斷和估計的過程至關重要。
我們認爲，與我們的其他會計政策相比，我們認定爲關鍵的會計政策涉及更大程度的判斷和複雜性。因此，我們認爲這些政策對於了解和評估我們的綜合財務狀況和運營結果是最關鍵的。
有關我們的關鍵會計政策和估計的摘要，請參閱我們於2024年2月28日提交給美國證券交易委員會的Form 10-k年報中包含的《管理層對財務狀況和運營結果的討論和分析》。在截至2024年9月30日的三個月裏，我們的關鍵會計政策和估計沒有實質性變化。
賠償協議
我們在正常的業務過程中達成了標準的賠償安排。根據這些安排，我們賠償、保持無害，並同意賠償因任何第三方對我們的技術提出的任何商業祕密、版權、專利或其他知識產權侵權、挪用或其他侵權索賠而遭受或發生的損失，並同意賠償被賠償方。這些賠償協議的期限一般在協議簽署後的任何時候永久有效。根據這些安排，我們未來可能需要支付的最高金額無法確定。我們從未承擔過爲訴訟辯護或解決與這些賠償協議相關的索賠的費用。因此，我們認爲這些協議的公允價值微乎其微。
最近的會計聲明
有關更多信息，請參閱本報告其他部分財務報表附註2中題爲「重要會計政策摘要--最近的會計聲明」的章節。
供應鏈約束與通貨膨脹
我們依賴第三方，包括單一和獨家供應商，製造我們產品的某些組件和子組件，併爲我們的LAL提供原材料，主要是化學品。我們與我們的供應商，包括單一和唯一來源的供應商，沒有長期的供應協議，也沒有保證承諾。我們的大多數供應商都使用18-24個月的中期採購訂單或一攬子訂單。雖然我們依賴我們的供應商及時向我們和我們的客戶提供滿足我們和他們的質量、數量和成本要求的材料，但供應商將錯過預期的交貨日期、延長交貨日期或在某些情況下取消採購訂單，因爲這些供應商在製造過程中可能會因各種原因遇到問題，任何一種原因都可能推遲或阻礙他們滿足我們需求的能力。全球交貨期的擴大導致缺乏原材料，包括半導體、計算機、顯示器電子部件、金屬、包裝、粘合劑、化學品、樹脂和分包塗漆部件。某些供應商轉嫁了更高的價格、附加費和加急運費，以支付由於供應短缺而支付的更高的大宗商品價格，並推遲了交貨期。此外，我們將識別和鑑定新供應商，以降低單一和唯一來源供應商帶來的風險，並緩解供應鏈限制。我們將識別和鑑定需要測試、驗證和文檔的新供應商或替代組件，這增加了內部成本，並轉移了其他項目的工程資源。雖然我們已採取措施降低業務連續性風險，包括增加標準銷售線索
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我們的供應商可能會停止生產我們從他們那裏購買的組件，或以其他方式決定停止與我們的業務往來。我們供應商的任何供應中斷或未能爲我們產品中使用的任何組件或子組件獲得更多供應商將限制我們生產當前和新產品的能力，並可能對我們的業務、財務狀況和運營結果產生重大不利影響。
不確定的宏觀經濟狀況，包括最近的通脹壓力和利率上升，給美國經濟和資本市場帶來了巨大的不確定性，這種不確定性可能會持續到2024年剩餘時間和以後，並可能對我們的財務業績和流動性產生負面影響。
第三項。 定量與定性IVE關於市場風險的披露
我們在正常的業務過程中面臨着市場風險。市場風險是指由於市場利率和價格的不利變化而產生的潛在損失。
利率波動風險
截至2024年9月30日，我們擁有23710美元的現金和現金等價物以及短期投資，其中包括22040美元的高流動性貨幣市場萬和期限不超過12個月的美國國債。我們投資政策的主要目標是流動性和保本。我們不以交易或投機爲目的進行投資。我們相信，由於我們的現金和現金等價物以及短期投資的短期性質而導致的利率變化，我們對這些資產的公允價值變化沒有任何實質性的風險敞口。然而，利率的下降將減少未來的投資收入。我們考慮了短期利率的歷史波動，並確定短期內有可能經歷100個點子的不利變化。假設利率變化1.00%(100個點子)，不會對我們的有價證券在2024年9月30日和2023年12月31日的公允價值產生實質性影響。如果整體利率上升或下降1.00%(100個點子)，我們的利息收入在截至2024年9月30日或2023年9月30日的季度內不會受到實質性影響。
外幣兌換風險
截至2024年9月30日，我們擁有以美元以外的貨幣計價的最低收入和支出金額。
第四項。 控制 和程序
信息披露控制和程序的評估
截至2024年9月30日，我們的管理層在首席執行官和首席財務官的參與和監督下，評估了我們的披露控制和程序(如《交易法》規則13a-15(E)和15d-15(E)所定義)。基於這一評估，我們的首席執行官和首席財務官得出結論，截至2024年9月30日，我們的披露控制和程序在合理的保證水平下是有效的。《交易法》規則13a-15(E)和15d-15(E)中定義的術語「披露控制和程序」是指公司的控制和其他程序，旨在確保公司在根據交易法提交或提交的報告中要求披露的信息在美國證券交易委員會規則和表格指定的時間段內得到記錄、處理、彙總和報告。披露控制和程序包括但不限於旨在確保公司根據交易所法案提交或提交的報告中要求披露的信息被累積並傳達給公司管理層(包括其主要高管和主要財務官)的控制和程序，以便及時做出關於要求披露的決定。管理層認識到，任何控制和程序，無論設計和操作多麼良好，都只能爲實現其目標提供合理的保證，管理層在評估可能的控制和程序的成本效益關係時必須運用其判斷。
財務報告內部控制的變化
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在截至2024年9月30日的季度內，我們對財務報告的內部控制(根據《交易法》第13a-15(F)和15d-15(F)規則的定義)沒有發生重大影響或合理地可能對我們的財務報告內部控制產生重大影響的變化。
對控制措施有效性的限制
無論控制系統的構思和操作如何完善，其設計都是爲了提供合理的、但不是絕對的保證，確保控制系統的目標得以實現。此外，控制系統的設計必須反映這樣一個事實，即存在資源限制，並且必須考慮控制的好處相對於其成本。由於所有控制系統的固有侷限性，任何控制評價都不能絕對保證所有控制問題和舞弊事件都已被發現。由於任何控制系統的固有限制，由於錯誤或欺詐而導致的錯誤陳述可能會發生，並且不會被發現。
第二部分：其他 信息
第一項：法律規定訴訟程序
有時，我們可能會捲入各種索賠和法律程序。無論結果如何，訴訟和其他法律和行政訴訟可能會因爲辯護和和解成本、管理資源分流等因素而對我們產生不利影響。我們目前並不參與任何法律程序，而這些法律程序的結果如果對我們不利，將個別或總體上對我們的業務、財務狀況和運營結果產生重大不利影響。
項目1A：風險因素
我們在一個快速變化的環境中運營，其中包含許多不確定因素和風險。除了本報告中包含的其他信息外，下列風險和不確定因素可能對我們的業務、財務狀況、經營結果或股票價格產生重大不利影響。您應仔細考慮這些風險和不確定性，以及本報告中通過引用包含或併入的所有其他信息。下面描述的風險和不確定性可能並不是我們面臨的唯一風險和不確定性。如果我們面臨的任何風險或不確定性發生，我們證券的交易價格可能會下跌，您可能會損失全部或部分投資。本報告還包含涉及風險和不確定因素的前瞻性陳述。見本報告其他部分題爲「關於前瞻性陳述的特別說明」的部分。由於本報告下文和其他部分描述的因素，我們的實際結果可能與前瞻性陳述中預期的結果大不相同。
彙總風險因素
以下風險和不確定性是我們面臨的最重大風險和不確定性之一。然而，本小節中確定的風險和不確定因素並不是我們面臨的唯一風險和不確定因素，它們完全符合本文所述的所有風險因素：
與我們的業務和產品相關的風險：
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有關知識產權的風險：
與政府監管相關的風險：
與依賴第三方相關的風險：
與我們的普通股相關的風險：
一般風險因素：
與我們的業務和產品相關的風險
我們的經營歷史有限，如果我們不能有效地培訓我們的銷售隊伍，提高我們的銷售和營銷能力，或者以具有成本效益的方式發展廣泛的品牌知名度，我們的增長將受到阻礙，我們的業務將受到影響。
我們於1997年3月成立，並於2019年下半年開始將我們的產品商業化，當時我們開始全面推出TLR和LDI。因此，我們有限的商業化經驗和有限的批准或許可的產品數量使得評估我們當前的業務和評估我們的前景變得困難。我們目前的銷售和營銷經驗也有限。如果我們無法建立或擴大有效銷售規模
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或者，如果我們無法將我們的任何產品商業化，我們可能無法產生足夠的產品收入、持續收入增長和有效競爭。爲了創造未來的增長，我們計劃繼續擴大和利用我們的銷售和營銷基礎設施，以增加我們的客戶基礎和發展我們的業務。
尋找和招聘合格的銷售和營銷人員，並就我們的產品、適用的聯邦和州法律法規以及我們的內部政策和程序對他們進行培訓，需要大量的時間、費用和精力。銷售代表通常需要幾個月或更長的時間才能接受充分的培訓並提高工作效率。如果我們擴大和培訓銷售隊伍的努力不能產生相應的收入增長，或者如果我們無法在產品需求意外下降的情況下降低成本，我們的業務可能會受到損害。任何未能招聘、培養和留住有才華的銷售和營銷人員、未能在合理的時間內達到預期的生產率水平或及時利用我們的固定成本都可能對我們的業務、財務狀況和運營結果產生重大不利影響。此外，我們的直銷團隊成員都是隨心所欲的員工。這些人員流失到競爭對手或其他方面可能會對我們的業務造成實質性的損害。如果我們不能留住我們的直銷人員或用具有同等技術專長和資質的人員來取代他們，或者如果我們不能成功地向替代人員灌輸技術專長，我們的收入和運營結果可能會受到實質性的損害。
我們是否有能力擴大我們的客戶基礎，並使我們的產品獲得更廣泛的市場接受，這在很大程度上也將取決於我們擴大營銷努力的能力。如果我們的營銷努力和支出不能帶來相應的收入增長，我們的業務可能會受到損害。此外，我們認爲，以經濟高效的方式發展和保持對我們品牌的廣泛認識，對於實現我們的產品被廣泛接受和滲透新客戶至關重要。品牌推廣活動可能不會提高患者或醫生的知名度或增加收入，即使有，任何收入的增加也可能無法抵消我們在建立品牌時產生的成本和支出。如果我們未能成功推廣、維護和保護我們的品牌，我們可能無法吸引或保持醫生的認可，以實現我們的品牌建設努力的足夠回報，或達到對我們的產品的廣泛採用至關重要的品牌知名度水平。
這些因素也使我們很難預測我們的財務表現和增長，此類預測受到許多不確定性的影響，包括我們成功開發額外產品以增加功能、降低產品銷售成本和擴大我們的商業產品組合的能力，以及我們根據國內和國際適用法律(包括FDA 510(K)許可或上市前批准或PMA)獲得必要的監管批准和許可的能力，以便在美國或國際市場成功地商業化、營銷和銷售我們計劃或未來的產品。如果我們對我們面臨的風險和不確定性的假設是不正確的，或者由於我們的業務或市場的情況而發生變化，或者如果我們沒有成功地應對這些風險，我們的運營和財務結果可能與我們的預期大不相同，我們的業務可能會受到影響。
我們有過淨虧損的歷史，我們預計未來還會繼續虧損。如果我們曾經實現盈利，我們可能無法持續下去。
我們自成立以來一直因運營而蒙受虧損，預計未來將繼續因運營而蒙受虧損。截至2023年12月31日和2022年12月31日的年度，我們報告的運營虧損分別爲5,010美元萬和6,330美元萬，截至2024年9月30日的三個月，我們報告的運營虧損爲9，20美元萬。由於這些損失，截至2024年9月30日，我們累積了61620美元的萬赤字。我們預計，隨着我們擴大營銷努力以增加產品的採用率、擴大與客戶的現有關係、爲我們計劃或未來的產品獲得監管許可或批准、對我們現有和計劃中的或未來的產品進行臨床試驗以及開發新產品或爲現有產品添加新功能，我們預計將繼續產生大量的銷售和營銷、研發、監管和其他費用。此外，我們預計，由於與上市公司相關的成本，我們的一般和行政費用將增加。
我們造成的淨損失可能會在不同的時期波動。我們將需要創造可觀的額外收入，以實現並維持盈利能力。即使我們實現了盈利，我們也不能確定我們在很長一段時間內都會保持盈利。
爲了支持我們的持續運營和業務的增長，我們可能會尋求籌集額外的資本，這些資本可能無法以可接受的條款提供給我們，或者根本無法獲得。
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我們預計，隨着我們繼續經營我們的業務，擴大我們的基礎設施、商業運營和研發活動，未來幾年的資本支出和運營費用將會增加。我們資本的主要用途是，我們預計將繼續用於對我們商業組織的投資和相關費用、臨床研發服務、實驗室和相關用品、法律和其他監管費用、一般行政成本和營運資本。此外，我們未來可能尋求收購或投資於我們認爲可以補充或擴大我們的產品組合、增強我們的技術能力或以其他方式提供增長機會的更多業務、產品、服務或技術。
由於這些和其他因素，我們預計未來將繼續出現淨虧損和運營現金流爲負的情況。我們未來的流動資金和資本資金需求將取決於許多因素，包括：
如果我們確定我們需要籌集額外的資金，我們可能會通過股權或債務融資來實現，但在需要時或在我們認爲有利的條款下，我們可能無法獲得這些融資。如果我們通過出售股權或可轉換債務證券來籌集額外資本，我們股東的所有權權益將被稀釋，這些證券的條款可能包括清算或其他對普通股股東權利產生不利影響的優惠。債務融資和優先股融資可能涉及的協議包括限制或限制我們採取具體行動的能力的契約，例如招致額外債務、進行收購或資本支出或宣佈股息。如果我們無法維持足夠的財務資源，我們的業務、財務狀況和經營結果將受到實質性和不利的影響，包括可能要求我們推遲、限制、減少或終止某些產品發現和開發活動或未來的商業化努力。
此外，如果我們達成合作或許可安排來籌集資金，我們可能會被要求接受不利的條款。這些協議可能要求我們以不利的條款將我們對產品或技術的權利放棄或許可給第三方，否則我們將尋求開發或商業化自己的產品或技術，或者爲未來的潛在安排保留某些機會，屆時我們可能會獲得更有利的條款。我們可能無法籌集更多資金或達成此類協議或安排
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優惠的條件，或者根本不是。我們籌集更多資金的能力可能會受到潛在的全球經濟狀況惡化以及最近美國和世界各地的信貸和金融市場因東歐、中東和其他地區的衝突而中斷和波動的不利影響。
截至2024年9月30日和2023年12月31日，我們分別擁有23710美元的萬和12720美元的萬，分別是現金、現金等價物和短期投資。雖然我們相信我們現有的現金、現金等價物和短期投資以及銷售我們產品所產生的預期現金將足以滿足我們在本報告日期後至少12個月的預期現金需求，但我們不能向您保證，我們將能夠在需要時產生足夠的流動性。此外，雖然我們預計不需要籌集額外資本或招致額外債務來從經營中賺取利潤，但這一指標可能會在公司未來提交給美國證券交易委員會的10-K表格年度報告或10-Q表格季度報告中披露，儘管我們可能會在有利的情況下不時地尋求籌集資金，以支持我們在美國及國際上的銷售和業務規模的擴張，並尋求其他商機。我們基於可能被證明是錯誤的假設做出了這一估計，我們可以比目前預期的更快地使用我們的資本資源。不斷變化的情況--其中一些可能超出了我們的控制--可能會導致我們消耗資本的速度大大快於我們目前的預期，我們可能需要比計劃更早地尋求額外資金。我們不能向您保證，我們將能夠在需要時產生足夠的流動性。
全球經濟、政治和市場狀況，包括美國信用評級的下調，可能會對我們的業務、運營結果和財務狀況產生不利影響，包括我們的收入增長和盈利能力。
當前的全球經濟和金融環境，以及美國和世界各地的各種社會和政治緊張局勢，可能會加劇市場波動，可能會對美國和世界金融市場產生長期影響，可能會導致美國和世界經濟的不確定或惡化。評級機構下調美國政府的主權信用評級或其公認的信譽，以及政府可能關門的影響，可能會對美國和全球金融市場和經濟狀況產生不利影響。對美國債務上限和預算赤字的擔憂增加了信用評級進一步下調、經濟放緩或美國經濟衰退的可能性。此外，圍繞聯邦預算的分歧導致美國聯邦政府停擺一段時間。持續的不利政治和經濟狀況可能會對我們的業務、財務狀況、運營結果和前景產生實質性的不利影響。
全球經濟狀況惡化導致全球金融市場不穩定，包括以下因素，可能對我們的業務構成風險：通貨膨脹和利率上升、歐洲和新興市場司法管轄區幾個國家的巨額主權債務和財政赤字、歐洲銀行資產負債表上的不良貸款水平、英國退出歐盟的影響以及資本市場的不穩定。
美國和世界各地的各種社會和政治環境(包括戰爭和其他形式的衝突、恐怖主義行爲、安全行動以及火災、洪水、地震、龍捲風、颶風和全球衛生流行病等災難性事件)也可能加劇美國和世界各地的市場波動和經濟不確定性或惡化，並對我們的業務、財務狀況、運營結果和前景產生實質性的不利影響。
我們目前將所有現金、現金等價物和短期投資放在一家金融機構，因此，如果我們持有現金、現金等價物和短期投資的金融機構倒閉，我們的現金、現金等價物和短期投資可能會受到不利影響。
我們目前在一家金融機構維持所有現金、現金等價物和短期投資。目前，我們與這類金融機構的現金、現金等價物和短期投資餘額主要以期限不到12個月的美國國庫券持有。我們運營現金的一部分存放在超過聯邦存款保險公司(「FDIC」)保險限額的帳戶中。持有我們現金、現金等價物和短期投資的金融機構的失敗，導致我們無法從該金融機構獲得我們的資金返還，或該金融機構遭受的任何其他不利條件，可能會影響我們獲得運營現金，並暫時無法獲得我們對美國國庫券的短期投資，這可能會對我們的業務、財務狀況和運營結果產生不利影響。
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我們的成功在很大程度上取決於我們的RxSight系統。如果我們不能成功地營銷和銷售我們的RxSight系統，我們的業務前景將受到嚴重損害，我們可能無法實現收入增長。
我們未來的財務成功將在很大程度上取決於我們有效和有利可圖地向眼科診所營銷和銷售我們的RxSight系統的能力。我們的RxSight系統和我們計劃或未來的任何產品的商業成功將取決於許多因素，包括以下因素：
如果我們未能成功營銷和銷售我們的產品，我們將無法增長收入或實現盈利能力，這將對我們的業務、財務狀況和經營業績產生重大不利影響。
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我們在未來時期的收入增長將取決於我們成功滲透我們的目標市場並增加我們的RxSight系統和我們推出的任何新產品或產品標誌的銷售的能力，而這又將在一定程度上取決於我們在擴大用戶基礎和推動產品更多使用方面的成功。新產品或產品適應症還需要在我們目標的任何國際市場上獲得FDA和類似的非美國監管機構的批准或批准，才能將其商業化。如果我們不能實現收入增長或實現或維持盈利，可能會對我們的業務、財務狀況和運營結果產生實質性的不利影響。
採用我們的產品依賴於對醫生的適當培訓，而培訓不足可能會導致負面的患者結果，影響我們產品的採用，並對我們的業務產生不利影響。
我們產品的成功在一定程度上取決於我們的客戶堅持在我們的培訓人員進行的培訓課程中選擇適當的患者和提供適當的技術。例如，我們對客戶進行培訓，以確保正確使用我們的RxSight系統。然而，醫生依賴於他們以前的醫學培訓和經驗，我們不能保證所有這些醫生都有必要的技能或培訓來有效地利用我們的產品。我們不控制哪些醫生使用我們的產品或他們接受了多少培訓，但沒有完成我們培訓課程的醫生可能會嘗試使用我們的產品。此外，醫生可能使用我們的產品的方式與他們的標籤適應症不一致，沒有培訓可用。如果醫生使用我們的產品的方式與他們標記的適應症不一致，使用的組件與我們的產品不兼容，或者沒有堅持或完成我們的培訓課程，他們的患者結果可能與其他醫生或我們的臨床試驗中取得的結果不一致。這一結果可能會對患者的益處和安全性產生負面影響，並限制對我們產品的採用，這將對我們的業務、財務狀況和運營結果產生實質性的不利影響。
我們目前需要有限的產品使用培訓，因爲我們主要面向在使用我們的設備所需的特定技術方面經驗豐富的醫生。如果對我們產品的需求繼續增長，經驗較少的醫生可能會使用我們的產品，這可能會導致更多的傷害和產品責任索賠的風險增加。使用或誤用我們的產品可能會在未來導致併發症，並可能導致產品責任索賠。
我們的RxSight系統的商業成功將取決於這些產品在患者和醫生中獲得顯著的市場接受度。
我們的成功將在一定程度上取決於人們是否接受我們的RxSight系統是安全、有效的，而且就醫生而言，它具有成本效益。我們無法預測患者、醫生或付款人多快(如果有的話)會接受我們的RxSight系統，或者如果被接受，它將被使用的頻率。我們的RxSight系統以及我們可能開發或營銷的計劃或未來的產品可能永遠不會因爲我們的部分或全部目標適應症而獲得廣泛的市場接受。患者和醫生必須相信，我們的產品提供了比替代治療方法更好的好處。到目前爲止，我們的大部分產品銷售和收入來自採用我們的RxSight系統的有限數量的客戶。我們未來的增長和盈利能力在很大程度上取決於我們提高醫生對我們的RxSight系統和產品的認識的能力，以及患者和醫生採用這些系統的意願。這些締約方不得采用我們的產品，除非他們能夠根據經驗、臨床數據、醫學會建議和其他分析確定我們的產品是安全、有效的，並且就提供商而言，獨立和相對於競爭對手的產品而言，我們的產品具有成本效益。患者和醫生必須相信，我們的產品提供了比替代治療方法更好的好處。即使我們能夠提高認識，醫生往往在改變他們的醫療做法方面行動遲緩，並且可能出於各種原因而不願選擇我們的產品向他們的患者推薦，包括：
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爲了讓醫生使用我們的RxSight系統，他們必須進行大量的前期投資來購買LDD。這可能會導致較長的銷售週期，並需要廣泛的談判和管理時間。如果我們不能成功地向供應商銷售LDDS，我們的銷售額可能會下降，我們的經營業績可能會受到損害。
醫生在決定病人的治療過程中發揮着重要作用，因此，決定將被利用和提供給病人的治療類型。我們的銷售、營銷和教育工作主要集中在醫生身上，我們的目標是教育轉診醫生，讓他們了解將從我們的產品中受益的患者群體。然而，我們不能向您保證，我們將在醫生中獲得廣泛的市場接受。
例如，一些醫生可能選擇只在他們總患者群體的一部分使用我們的RxSight系統，或者可能根本不採用我們的RxSight系統。如果我們不能有效地證明我們的RxSight系統在廣泛的患者中的使用是有益的，我們的產品的採用將受到限制，可能不會像我們預期的那樣迅速發生，甚至根本不會，這將對我們的業務、財務狀況和運營結果產生實質性的不利影響。我們不能向您保證我們的產品將在醫生中獲得廣泛的市場認可。此外，即使我們的產品獲得了市場接受，但如果競爭對手的產品、程序或技術被認爲更安全、更具成本效益或更優越，隨着時間的推移，它們可能無法保持這種市場接受度。如果我們的產品未能產生足夠的需求，或未能獲得有意義的市場接受度和滲透率，都將損害我們未來的前景，並對我們的業務、財務狀況和經營業績產生重大不利影響。
我們在現有或潛在客戶以及醫生中的聲譽也可能受到涉及我們或我們的產品的安全或客戶滿意度問題的負面影響，包括產品召回。未來產品召回或其他與我們聲譽相關的安全或客戶滿意度問題可能會對我們建立或保持廣泛採用我們產品的能力產生負面影響，這將損害我們的未來前景，並對我們的業務、財務狀況和運營結果產生重大不利影響。
我們的RxSight系統涉及手術風險，在某些患者中是禁忌，這可能會限制採用。
使用我們產品的風險包括與白內障手術和人工晶狀體植入相關的風險。由於使用LDD的紫外線，也可能出現併發症，包括暫時或長期的視力變化，但這種情況很少見。我們意識到我們的RxSight系統的某些特性和功能可能會阻礙廣泛的市場採用，包括醫生需要採用新的程序，以及需要對醫生進行培訓，以使他們能夠有效地操作我們的產品。
我們面臨着激烈的競爭，如果我們無法有效競爭，我們可能無法實現或保持顯著的市場滲透率，也無法提高我們的運營業績。
醫療器械行業競爭激烈，變化迅速，並受到行業參與者推出新產品和其他市場活動的顯著影響。我們與優質和傳統人工晶狀體的製造商和經銷商競爭。我們在人工晶狀體領域最重要的競爭對手包括愛爾康、強生視力和博士倫。我們的許多競爭對手都是資本雄厚的大型公司，擁有比我們大得多的市場份額和資源。因此，他們可以在產品開發、營銷、銷售和其他產品計劃上比我們花更多的錢。我們還與規模較小的醫療器械公司競爭，這些公司只有一個產品或有限的產品範圍。此外，接受LAL的患者將被要求佩戴紫外線防護眼鏡，直到最終鎖定，大約是手術後4至5周。與傳統的單竈性白內障手術相比，他們還需要多去兩到三次診所就診。額外的診所就診是非手術的，但確實需要患者的眼睛
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擴張了。由於這些額外要求，LAL的市場接受度可能會受到影響。我們相信，我們市場上的主要競爭因素包括：
我們的主要競爭基礎是，我們的產品旨在使更多的醫生能夠更有效地治療更多的患者。我們的持續成功有賴於我們有能力：
我們不能保證我們將成功地開發新產品或以獲得市場接受的方式將其商業化。如果我們開發新產品，這些產品的銷售可能會減少我們現有產品的收入。此外，我們產品發佈的任何重大延誤都可能嚴重阻礙我們進入特定市場或在特定市場競爭的能力，並可能減少我們能夠從這些產品中產生的銷售額。我們可能會在產品開發的任何階段遇到延誤，包括研發、臨床試驗、監管審查、製造和營銷期間。產品推出的延遲可能會對我們的業務、財務狀況和運營結果產生實質性的不利影響。
此外，許多醫療器械公司正在進行整合，以創建具有更大市場力量的新公司。隨着醫療器械行業的整合，向行業參與者提供商品和服務的競爭將變得更加激烈。這些行業參與者可能會試圖利用他們的市場力量來談判我們產品的價格讓步或降價。如果我們因爲醫療保健行業的整合而降低價格，我們的收入可能會減少，這可能會對我們的業務、財務狀況和運營結果產生實質性的不利影響。
如果我們的設施受損或無法運營，或者如果我們被要求騰出設施，我們可能無法生產我們的產品，或者我們可能會遇到生產延遲或成本增加的情況，這可能會對我們的運營結果產生不利影響。
我們目前在加利福尼亞州的Aliso Viejo維持着我們的研發、製造和行政業務，我們沒有多餘的設施。我們在四個不同的設施中運營，指定爲
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如果這些設施中的任何一個受到自然災害或人爲災難的嚴重破壞或摧毀，例如地震、火災(這兩種災害在加利福尼亞州都很常見)或其他事件，我們可能需要幾個月的時間才能搬遷或重建，在此期間，我們的員工可能會尋找其他工作崗位，我們的研發和製造將停止或延遲，我們的產品可能無法獲得。如果該工廠的製造作業發生重大中斷，將對我們的運營能力造成實質性影響。由於根據聯邦、州和非美國監管要求授權在新工廠進行生產所需的時間，即使我們能夠更換產能，我們也可能無法及時恢復生產。雖然我們維持財產和業務中斷保險，但此類保險是有限度的，不會涵蓋所有損失，包括地震造成的損失或由於我們的產品被競爭對手的產品取代而可能遭受的損失。如果我們的設施無法運行，無法執行我們的研究、開發和製造活動，再加上我們有限的材料、組件和製成品庫存，可能會導致醫生停止使用我們的產品或損害我們的聲譽，我們未來可能無法與此類醫生重新建立關係。因此，我們現有設施或任何未來設施發生的災難性事件可能會對我們的業務、財務狀況和運營結果產生重大不利影響。
此外，我們四個設施的現有租約到期或可選擇續期至2031年1月31日，每個租約有兩個續期五年的選項。我們可能無法以商業上合理的條款續簽租約或找到新的設施，或者根本無法續約。如果我們不能或不願意以建議的費率續訂，搬遷我們的製造設施將涉及與移動和安裝關鍵製造設備以及向監管機構進行任何必要的重新認證相關的巨額費用，我們不能向您保證此類轉移不會延遲或以其他方式對我們的製造活動或經營結果產生不利影響。如果我們的製造能力因任何此類舉措而受損，我們可能無法及時製造和發貨，這將對我們的業務造成不利影響。
技術變化可能會對我們產品的銷售產生不利影響，並可能導致我們的產品過時。
醫療器械市場的特點是研發廣泛，技術變革迅速。不能保證其他公司，包括現有的競爭對手或新進入者，不會成功地開發或營銷比我們的產品更有效的產品，或者使我們的產品過時或缺乏競爭力的產品。此外，可以開發新的外科手術程序、藥物和其他療法，以取代或降低我們產品的重要性。如果我們不能成功創新，我們的產品可能會過時，隨着我們的客戶購買競爭對手的產品，我們的收入將會下降。我們未能開發新產品、應用程序或功能可能是由於現金資源不足、員工流動率高、無法招聘具有足夠技術技能的人員、缺乏其他研發資源或其他限制。我們未能投入足夠的研發資源，或無法有效地與當前或未來競爭對手的研發項目競爭，可能會對我們的業務、財務狀況和運營結果產生重大不利影響。
關於我們的RxSight系統的安全性和有效性，我們的數據和經驗有限。早期研究的結果可能不能預測未來的臨床試驗結果，計劃中的研究可能無法爲我們的RxSight系統和其他計劃或未來的產品建立足夠的安全性或有效性概況，這將影響我們的RxSight系統的市場接受度。
由於我們的RxSight系統技術是一種相對較新的治療方法，可以在白內障手術後優化視力，因此我們只在有限的患者群體中進行了臨床試驗。在大量患者中使用我們的產品的長期效果尚未進行研究，此類產品的短期臨床使用結果不一定能預測長期臨床益處或顯示長期不良反應。到目前爲止對我們產品進行的臨床前研究和臨床試驗的結果以及對我們當前、計劃或未來產品的正在進行的或未來的研究和試驗的結果可能不能預測後來的臨床試驗的結果，臨床試驗的中期結果也不一定能預測最終結果。我們對臨床試驗的數據和結果的解釋並不能確保我們在未來的其他患者群體的臨床試驗中也能獲得類似的結果。此外，臨床前和臨床數據往往容易受到各種解釋和分析的影響，許多公司認爲他們的產品在臨床前研究和早期臨床試驗中表現令人滿意，但在後來的臨床試驗中未能複製結果，隨後也未能獲得上市批准。儘管通過非臨床研究和早期臨床試驗取得了進展，但臨床試驗後期階段的產品可能無法顯示出預期的安全性和有效性。
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如果我們的臨床試驗不成功或嚴重延遲，或者如果我們沒有完成臨床試驗，我們的業務可能會受到損害。
臨床開發是一個漫長、昂貴和不確定的過程，可能會受到延誤，產品可能最終被證明在治療它們設計的適應症方面不安全或無效的風險。我們目前正在進行RxSight系統的上市後臨床試驗。臨床試驗的完成可能需要幾年或更長時間。臨床試驗可能會因各種原因而推遲，包括延遲獲得監管部門的批准以開始試驗、與預期地點就可接受的臨床試驗條款達成協議、在每個地點獲得機構審查委員會的批准、招募患者參與試驗或獲得足夠的臨床試驗材料供應。我們不能保證我們將成功或及時地登記我們的臨床試驗，我們的臨床試驗將達到它們的主要終點，或者這些試驗或其結果將被FDA或外國監管機構接受。
在臨床試驗過程中或由於臨床試驗過程，我們可能會遇到許多不可預見的事件，這些事件可能會推遲或阻止我們獲得新產品、現有產品的修改或現有產品的新適應症的監管批准或批准，包括：
我們臨床試驗中的失敗或被認爲的失敗將推遲並可能阻止我們的產品開發和監管審批過程，損害我們的業務前景，並對我們的聲譽和競爭地位產生負面影響。
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未經授權的第三方可能試圖訪問我們的設備或其他產品和服務，或相關的設備、產品和服務，並以不符合我們FDA許可和批准的方式修改或使用它們，這可能會給用戶帶來風險。
醫療設備越來越多地連接到互聯網、醫院網絡和其他醫療設備，以提供改善醫療保健的功能，並提高醫療保健提供者治療患者和患者管理其病情的能力。雖然目前我們的RxSight系統與其他設備、本地網絡和互聯網的雙向連接和互操作性尚未啓用，但這種情況在未來可能會改變。啓用這些功能可能會增加網絡安全風險以及第三方未經授權訪問和使用的風險。例如，未經授權的第三方可能試圖訪問我們的設備或其他產品和服務，或相關的設備、產品和服務，並以不符合我們FDA許可和批准的方式修改或使用它們，這可能會給用戶帶來風險，並可能對公司造成風險。
我們可能會經歷信息技術系統的重大中斷或數據安全遭到破壞。
我們依賴我們的信息技術基礎設施的容量、可靠性和安全性，以及我們擴展和持續更新該基礎設施以響應我們的業務需求的能力。在某些情況下，我們依賴第三方託管和支持服務來滿足這些需求。互聯網經歷了越來越複雜和破壞性的威脅，其形式包括釣魚電子郵件、惡意軟件、惡意網站、勒索軟件、利用應用程序漏洞和民族國家攻擊。這些攻擊利用以前未知的漏洞也變得越來越常見。不斷增長和不斷髮展的網絡風險環境意味着，個人、公司和各種規模的組織，包括我們自己、我們的客戶、供應商以及我們的託管和支持合作伙伴，越來越容易受到各種行爲者持續和定期對其網絡和系統的攻擊和破壞。
例如，如之前披露的，2024年5月2日，未經授權的行爲者瞄準了RxSight員工的個人手機號碼。2024年5月3日，未經授權的行爲者獲得了對該員工基於雲的工作帳戶以及可從該帳戶訪問的電子郵件和文件的未經授權的訪問權限。我們在2024年5月3日當天發現了這一事件，立即禁用了該員工的帳戶，啓動了應對和調查程序，聯繫了我們的保險提供商，並聘請了外部網絡安全專家來協助我們的應對和調查。雖然未經授權的行爲者訪問並獲取了可從員工的基於雲的工作帳戶訪問的電子郵件和其他材料的副本，但在此未經授權的訪問期間，我們的信息系統從未中斷並保持運行，我們沒有觀察到此事件的任何方面會對我們的運營、財務系統或財務狀況產生實質性影響。然而，無法保證該事件是否會對我們的運營、金融系統或財務狀況產生未來的重大影響，我們仍因該事件而面臨各種風險。
我們維護信息安全工具和技術、員工、政策和程序，以管理我們網絡和信息系統的風險，並開展旨在緩解持續和不斷髮展的網絡安全威脅的員工網絡安全培訓。我們的網絡安全控制包括行政、物理和技術控制，包括但不限於防火牆、防病毒保護、補丁、日誌監視器、例行備份、異地存儲、網絡審計和其他例行更新和修改的實施。我們還定期監測和開發內部信息技術系統，以應對信息系統面臨的風險。任何系統故障、事故或安全漏洞都可能導致我們的業務流程中斷、網絡降級和系統停機，以及第三方可能未經授權訪問或獲取與我們的員工、客戶、供應商和業務合作伙伴相關的知識產權、專有業務信息和數據，包括個人數據。如果任何中斷、降級、停機或其他安全事件導致我們的數據或系統丟失或損壞，或導致機密或個人數據的不當披露，可能會對我們和我們的客戶造成不利影響，可能導致財務損失、客戶或業務損失、我們無法進行業務交易、對我們的聲譽造成不利影響、違反適用的隱私、數據保護、安全和其他法律、監管罰款、處罰、訴訟、聲譽損害、補償或額外的合規和監管成本。我們還可能產生與網絡安全風險管理和補救相關的額外成本。我們不能保證我們或我們的服務提供商(如果適用)不會在未來遭受與網絡攻擊或安全漏洞或事件有關的損失，也不能保證我們的保險覆蓋範圍足以支付此類事件造成的所有成本。我們不能保證我們降低此類攻擊風險或檢測到發生的攻擊的努力會成功，如果我們做不到這一點，可能會對我們的業務、財務狀況和運營結果產生實質性的不利影響。
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我們可能會花費有限的資源來追求特定的產品或適應症，而無法利用可能更有利可圖或成功可能性更大的產品或適應症。
由於我們的財務和管理資源有限，我們專注於特定的產品和適應症。因此，我們可能會放棄或推遲尋求與其他人合作的其他機會，這些機會本來可以有更大的商業潛力。我們的資源分配決策可能會導致我們無法利用可行的商業產品或有利可圖的市場機會。我們在當前和未來特定適應症或增強的研究和開發計劃上的支出可能不會產生任何商業上可行的產品。如果我們沒有準確評估特定潛在產品的商業潛力或目標市場，我們可能會通過未來的合作、許可和其他類似安排放棄對該潛在產品的寶貴權利，而在這種情況下，保留該潛在產品的獨家開發權和商業化權利對我們更有利。
我們可能無法開發、授權或獲取新產品，無法增強現有產品的能力以跟上快速變化的技術和客戶要求，也無法成功管理向新產品的過渡，其中任何一項都可能對我們的業務、財務狀況和運營結果產生重大不利影響。
我們的成功取決於我們有能力開發、授權或收購更多產品並將其商業化，並在現有和新的市場上爲我們的技術開發新的應用程序，同時提高我們現有產品的性能和成本效益，在每種情況下都能滿足當前和預期的客戶需求。我們打算通過我們的研發計劃以及許可或從第三方獲得更多產品和技術來開發更多產品並將其商業化。我們的成功取決於幾個因素，包括功能性、有競爭力的定價、易用性、我們產品的安全性和有效性，以及我們以我們可以接受的條款識別、選擇和獲得產品和技術權利的能力。
醫療器械行業的特點是快速的技術變革和創新。與我們當前或未來的產品相比，可能會出現新的技術、技術或產品，這些技術、技術或產品可能會提供更好的性價比組合，或者更好地滿足客戶需求。競爭對手可能比我們擁有更多的財務、營銷和銷售資源，他們可能比我們更快、更有效地響應新的或不斷變化的機會、技術、標準或客戶要求。我們確定用於內部開發、許可或收購的任何新產品在商業銷售之前可能需要額外的開發工作，包括廣泛的臨床測試以及FDA和適用的外國監管機構的批准或批准。由於將新產品推向市場需要大量的交付期和複雜性，我們需要對新產品的商業可行性做出許多假設和估計。這些假設和估計可能被證明是不正確的，導致我們推出的產品在發佈時沒有競爭力。我們預計，隨着現有公司和競爭對手開發新的或改進的產品，以及新公司帶着新技術進入市場，我們未來將面臨日益激烈的競爭。我們緩解銷售價格下行壓力的能力將取決於我們保持或增加我們向醫生和付款人提供的價值的能力。所有新產品都容易面臨醫療器械產品開發中固有的失敗風險，包括產品可能不會被證明足夠安全和有效，無法獲得監管機構的批准或批准。此外，我們不能向您保證，任何經批准或批准的此類產品都將以經濟的方式生產或生產，成功商業化或被市場廣泛接受。與不成功的產品開發或發佈活動相關的費用或損失，或我們的新產品缺乏市場接受度，可能會對我們的業務、財務狀況和運營結果產生不利影響。
我們吸引新客戶的能力在很大程度上取決於我們增強和改進現有產品以及推出引人注目的新產品的能力。我們產品的任何改進能否成功取決於幾個因素，包括醫生的採用和繼續使用、有競爭力的定價和整體市場接受度。我們開發的任何新產品可能不會以及時或具有成本效益的方式推出，可能存在缺陷，或者可能無法獲得產生大量收入所需的市場接受度。如果我們不能成功地開發、授權或獲得新產品、改進我們的現有產品以滿足客戶的要求或以其他方式獲得市場認可，我們的業務、財務狀況和經營業績將受到損害。
新醫療器械產品的典型開發週期可能既長又複雜，可能需要複雜的技術和工程。這種發展可能涉及外部供應商和服務提供商，
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使開發項目的管理變得複雜，並受到有關時間安排、所需部件或服務的及時交付以及此類部件或組裝產品的令人滿意的技術性能等方面的風險和不確定性的影響。如果我們沒有達到要求的技術規範或成功地管理新產品開發流程，或者如果開發工作沒有按計劃進行，那麼這些新技術或產品可能會受到不利影響，我們的業務和經營結果可能會受到損害。
如果我們不能識別、收購和開發其他產品，我們可能無法發展我們的業務。
作爲我們增長戰略的重要組成部分，我們打算通過我們的研發計劃或通過許可或從第三方獲得更多產品和技術來開發更多產品並將其商業化。這一戰略的成功取決於我們是否有能力識別、選擇和獲得以我們可以接受的條件獲得產品和技術的權利。
我們確定、許可或獲得的任何產品在商業銷售之前都可能需要額外的開發工作，包括廣泛的臨床測試以及FDA和適用的外國監管機構的批准或批准。所有產品都容易面臨醫療器械產品開發中固有的失敗風險，包括產品可能不會被證明足夠安全和有效，無法獲得監管機構的批准或批准。此外，我們不能向您保證，任何經批准或批准的此類產品都將以經濟的方式生產或生產，成功商業化或被市場廣泛接受。
提出、談判和實施經濟上可行的產品或技術收購或許可是一個漫長而複雜的過程。其他公司，包括那些擁有更多財務、營銷和銷售資源的公司，可能會與我們競爭收購或許可批准或批准的產品。我們可能無法以我們認爲可接受的條款或根本無法獲得或許可其他經批准或批准的產品的權利。
如果我們不能通過內部研究計劃或從第三方獲得權利來開發合適的潛在產品，這可能會對我們的業務、財務狀況和運營結果產生實質性的不利影響。
我們可能會收購其他公司或技術，這可能無法產生商業產品或增加收入，轉移我們管理層的注意力，導致對我們股東的進一步稀釋，並以其他方式擾亂我們的運營並損害我們的經營業績。
儘管我們目前沒有達成協議或承諾完成任何此類交易，但我們未來可能會尋求收購或投資於我們認爲可以補充或擴大我們的產品組合、增強我們的技術能力或提供增長機會的業務、應用程序或技術。然而，我們不能向您保證，我們將能夠成功完成我們選擇進行的任何收購，或者我們將能夠以具有成本效益和非破壞性的方式成功整合任何收購的業務、產品或技術。對潛在收購的追求可能會轉移管理層的注意力，並導致我們在確定、調查和尋求合適的收購時產生各種成本和支出，無論這些收購是否完成。我們可能無法確定理想的收購目標，或無法成功地與任何特定目標達成協議，或無法從任何收購或投資中獲得預期的好處。
到目前爲止，我們業務的增長基本上是有機的，我們在收購其他業務或技術方面的經驗有限。我們可能無法成功整合任何收購的人員、運營和技術，或在收購後有效管理合併後的業務。收購還可能導致股權證券的稀釋發行、我們可用現金的使用或債務的產生，這可能會損害我們的經營業績。此外，如果被收購的企業未能達到我們的預期，我們的經營業績、業務和財務狀況可能會受到影響。
我們的產品可能無法在足夠的市場上獲得承保範圍、足夠的報銷和/或患者支付實踐收取的價格和報銷金額之間的差額的能力，這可能會減少我們的銷售額或影響我們銷售產品的能力。
在美國和非美國市場，我們能否成功地將我們的產品商業化並獲得市場認可，在很大程度上取決於醫生和外科中心能否獲得足夠的經濟報酬。這種報酬可以來自多種來源，包括第三方付款人，如美國的聯邦醫療保險和醫療補助計劃、管理式醫療保健組織和私人健康保險公司。第三方付款人決定他們將承保哪些治療，併爲這些治療建立報銷率。他們還可以阻止患者支付額外的費用來獲得額外的服務，例如與
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優質人工晶狀體的放置。我們的產品是由醫生購買的，然後他們將向第三方付款人和患者尋求使用我們產品進行的手術的補償。國際市場上的報銷制度和患者賬單規則在一些國家內因國家和地區的不同而有很大差異，必須在國家/地區的基礎上獲得報銷和/或不報銷批准。在某些國際市場，產品必須獲得報銷批准，才能獲准在該國銷售。此外，許多國際市場都有政府管理的醫療體系，控制新設備和程序的報銷，以及直接向患者收取未報銷設備和程序的費用。在大多數市場中，既有私人保險體系，也有政府管理的體系。
雖然第三方付款人目前承擔並報銷使用我們目前批准或批准的產品進行的部分手術的費用，但我們不能保證這些第三方付款人將繼續爲未報銷的部分提供保險和足夠的報銷，或允許患者支付足以允許醫生向需要治療的患者提供使用我們的產品的程序。如果在美國或我們進入的任何國際市場，使用我們的產品進行的手術沒有足夠的覆蓋範圍和報銷或靈活性來實現患者付款，對我們產品的需求和我們的收入將受到不利影響。
此外，用於治療白內障和眼睛屈光不正的產品和程序的總報銷金額可能保持在目前的水平，或在未來下降。如果醫生未能獲得並維持使用我們產品進行的手術的承保範圍和足夠的補償，以及患者的費用，將對我們的業務、財務狀況和運營結果產生重大不利影響。
第三方支付者在做出保險和付款決定時，除了安全性和有效性外，還越來越多地審查產品的成本效益。第三方支付者還制定了限制醫療成本增長的舉措，例如使用價格監管或控制以及競爭性定價計劃。一些第三方付款人還需要在隨機臨床試驗的基礎上，或在預先批准覆蓋範圍的基礎上，爲新的或創新的設備或程序證明優勢，然後才會向使用此類設備或程序的醫療保健提供者報銷。此外，美國沒有統一的承保和報銷政策，不同支付者的承保和報銷可能有很大差異。第三方付款人在設置自己的報銷費率時通常依賴於聯邦醫療保險覆蓋政策和支付限制，但除了聯邦醫療保險確定之外，也有自己的方法和審批流程。不確定我們目前的產品或任何計劃或未來的產品是否會被視爲(或繼續被視爲)具有足夠的成本效益，以保證在任何特定司法管轄區使用此類產品的程序的保險範圍和足夠的補償水平。
如果對我們提起產品責任訴訟，我們可能會承擔重大責任，並可能被要求限制或停止我們產品的營銷和銷售。對於我們產品所產生的責任，保險的費用和潛在的不可獲得性可能會損害我們和我們銷售產品的能力。
由於我們產品的營銷和銷售，我們面臨着固有的產品責任風險。例如，如果我們的產品在製造、營銷或銷售過程中導致或被認爲造成傷害或被發現不適合，我們可能會被起訴。任何此類產品責任索賠可能包括對製造缺陷、設計缺陷、未能就產品固有危險發出警告、疏忽、嚴格責任或違反保修的指控。此外，我們可能會受到針對我們的索賠，即使表面上的傷害是由於他人的行爲或患者原有的健康狀況造成的。例如，在患者身上使用我們的產品時，我們依賴醫生。如果這些醫生沒有經過適當的培訓或疏忽，我們產品的能力可能會降低，或者患者可能會受到重傷。我們還可能受到供應商活動引起的索賠，例如爲我們提供零部件和子組件的供應商。
如果我們不能成功地在產品責任索賠中爲自己辯護，我們可能會招致重大責任，或者被要求限制或停止我們產品的商業化。即使是成功的防禦也需要大量的財政和管理資源。無論案情如何或最終結果如何，賠償責任可能會導致：
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我們相信我們有足夠的產品責任保險，但它可能不足以覆蓋我們可能產生的所有責任。保險範圍越來越貴。我們可能無法以合理的費用或足夠的金額維持或獲得保險，以支付可能出現的任何責任。我們的保險單包含各種免責條款，我們可能會受到產品責任索賠的影響，而我們沒有承保範圍。可能無法以可接受的成本獲得足夠的產品責任保險，以防止產品責任索賠，這可能會阻止或抑制我們開發的產品的營銷和銷售。我們可能需要支付任何超出我們的承保範圍限制或不在我們的保險覆蓋範圍內的法院裁決或和解協議中達成的任何金額，並且我們可能沒有或能夠獲得足夠的資本來支付這些金額，這將對我們的業務、財務狀況和運營結果產生重大不利影響。此外，任何針對我們的產品責任索賠，無論是否合理，都可能增加我們的產品責任保險費率，或阻止我們獲得持續的保險，損害我們在行業中的聲譽，顯著增加我們的費用，並減少產品銷售。
我們的一些客戶和潛在客戶可能也難以購買或維護責任保險，以涵蓋他們的運營和使用我們的產品。醫療事故承運人正在撤回某些州的保險範圍或大幅提高保費。如果這一趨勢繼續或惡化，我們的客戶可能會停止使用我們的產品，潛在客戶可能會因爲成本或無法購買保險而選擇不購買我們的產品。
我們打算在未來擴大產品在國際上的銷售，但即使獲得批准，我們也可能在獲得監管部門的批准或在國際上成功營銷我們的產品方面遇到困難。與在國際上營銷我們的產品相關的各種風險可能會對我們的業務產生實質性的不利影響。
我們的產品在美國以外的銷售將受到管理臨床試驗和上市批准的外國監管要求的約束。我們將在國際擴張方面產生大量費用。與在國外運營相關的其他風險包括：
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這些和其他與國際業務相關的風險可能會對我們在國際市場獲得或維持盈利業務的能力產生重大不利影響，這將對我們的業務、財務狀況和運營結果產生重大不利影響。
此外，我們的產品可能受到美國和外國的出口管制、貿易制裁和進口法律法規的約束。政府對我們產品進出口的監管，或我們未能爲我們的產品獲得任何必要的進出口授權(如果適用)，可能會損害我們的國際銷售，並對我們的收入造成不利影響。遵守有關我們產品出口的適用法規要求可能會延遲我們的產品在國際市場上的推出，或者在某些情況下，完全阻止我們的產品出口到一些國家。此外，美國出口管制法律和經濟制裁禁止向美國製裁目標國家、政府和個人運送某些產品和服務。如果我們不遵守進出口條例和這種經濟制裁，可能會受到懲罰，包括罰款和/或剝奪某些出口特權。此外，任何新的出口或進口限制、新的立法或在現有法規的執行或範圍內、或在這些法規所針對的國家、個人或產品中改變方法，都可能導致我們的產品被現有或具有國際業務的潛在客戶使用的減少，或我們向現有或潛在客戶出口我們產品的能力下降。任何對我們產品的使用減少或對我們出口或銷售產品能力的限制都可能對我們的業務產生不利影響。
特別是，目前美國與其他國家的未來關係在貿易政策、條約、關稅、稅收和其他對跨境經營的限制方面存在重大不確定性，最明顯的是中國。美國政府已經並將繼續對美國貿易政策做出更多重大調整，並可能在未來繼續採取可能對美國貿易產生負面影響的行動。例如，美國國會已經提出立法，限制某些美國生物技術公司使用特定中國生物技術公司生產或提供的設備或服務，國會中的其他人也主張利用現有的行政部門權力來限制這些中國服務提供商在美國從事業務的能力。我們無法預測在美國與中國或其他國家之間的貿易關係上最終可能採取什麼行動，哪些產品和服務可能受到此類行動，或者其他國家可能採取什麼行動進行報復。如果我們無法從現有服務提供商獲得或使用服務，或無法向我們的任何客戶或服務提供商出口或銷售我們的產品，我們的業務、流動資金、財務狀況和/或經營業績將受到重大不利影響。
此外，我們不能保證我們的產品將獲得在我們目標國際市場銷售的批准，也不能保證即使獲得批准也會有任何銷售。即使FDA批准了一種產品的上市，外國的可比監管機構也必須批准該產品在這些國家的製造或營銷。在美國或任何其他司法管轄區的批准並不確保在其他司法管轄區獲得批准。獲得外國批准可能會導致我們的重大延誤、困難和成本，並需要額外的試驗和額外的費用。各國的監管要求可能會有很大差異，可能會推遲我們的產品在這些國家的推出。在一個國家進行的臨床試驗可能不會被其他國家接受，一個國家的監管批准並不意味着將在任何其他國家獲得監管批准。如果我們未能遵守這些監管要求，或未能獲得並維持所需的批准，我們的目標市場將會減少，我們創造收入的能力將會減弱。我們不能成功地進入我們期望的所有國際市場並在全球範圍內管理業務，可能會對我們的業務、財務業績和運營業績產生負面影響。
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我們可能無法實現或保持令人滿意的產品定價和利潤率。
醫療器械製造商有着價格競爭的歷史，我們不能保證我們的產品能夠達到令人滿意的價格，或者將價格保持在我們歷史上達到的水平。付款人向執行白內障手術的醫生支付的報銷金額的任何下降，或向患者收取非報銷手術的靈活性的任何降低，都可能使我們難以說服客戶在我們的LDD上進行前期投資，並可能在患者決定支付與我們的LAL相關的額外成本方面產生額外的定價壓力，並可能減少使用RxSight系統執行的手術數量以及相應的LDDS、LAL、配件和服務的銷售。如果我們被迫降低產品價格，我們的收入和毛利率將會下降，這將對我們投資和發展業務的能力產生不利影響。如果我們無法維持我們的價格，或者如果我們的成本增加，我們無法用我們的價格上漲來抵消這種增長，我們的利潤率可能會受到侵蝕。我們將繼續承受巨大的定價壓力，這可能會損害我們的業務、財務狀況和運營結果。
我們目前和未來產品的市場規模尚未準確確定，可能比我們估計的要小。
我們對當前產品和正在開發的產品的年度潛在市場總量的估計是基於一些內部和第三方估計，包括但不限於接受過白內障手術的患者數量，以及我們銷售RxSight系統的假設價格。雖然我們相信我們的假設和支持我們估計的數據是合理的，但這些假設和估計可能不正確，支持我們的假設或估計的條件可能隨時發生變化，從而降低這些潛在因素的預測準確性。此外，我們對白內障手術患者群體規模的估計包括可能永遠不會適合使用我們的產品進行治療的患者。因此，我們對當前或未來產品的年度潛在市場總量的估計可能被證明是不正確的。如果將從我們的產品中受益的實際患者數量、我們可以銷售未來產品的價格或我們產品的年度潛在市場總量低於我們的估計，可能會削弱我們的銷售增長，並對我們的業務產生不利影響。
只要國家法規和驗光實踐的解釋發生變化，我們的產品和相關程序的保險範圍和政府報銷費率的變化，和/或使用我們產品進行手術的醫生的醫療或專業事故保險範圍的變化，這些變化可能會影響我們產品的採用和我們未來的收入。
各州對驗光實踐進行管理，包括每個州授權驗光師進行的程序類型。如果各州針對那些有資格執行涉及我們RxSight系統的LDD程序的人改變驗光範圍，這種州法規或政策可能會對我們的業務產生實質性影響。此外，付款人對使用我們的RxSight系統的程序的承保範圍和/或報銷水平的限制可能會對我們的業務產生負面影響。對於使用我們的產品進行手術的醫生，醫療或專業醫療事故保險政策的變化也會影響我們產品的採用和我們的業務運營。我們不能保證當前和未來的聯邦和州立法、行政和行政行動的影響，包括州檢查委員會在驗光方面實施的措施，以及醫療事故保險承保人和付款人對我們、我們的業務運營和我們客戶業務的政策。成本控制措施的實施或其他政策和法規的變化可能會阻止我們創造收入、實現盈利或將我們的產品商業化。
聯邦政府正在考慮如何改變，並已經改變了美國醫療服務的支付方式。個別州也可能制定影響向醫生支付醫療補助的立法。此外，CMS每年爲醫生建立醫療保險支付水平，這可以增加或減少對此類實體的支付。在國際上，醫療報銷制度因國家而異，一些國家通過固定預算限制醫療中心的支出，而不考慮患者的治療水平，另一些國家要求申請和批准政府或第三方報銷。此外，不同國家直接向患者收取優質人工晶狀體及相關服務費用的能力也存在很大差異，可能會受到更多限制。即使我們成功地將我們的產品推向國際市場，有關未來醫療政策、法律和法規以及私人市場實踐的不確定性也可能影響我們以商業上可接受的數量以可接受的價格銷售產品的能力。
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我們的季度和年度業績可能會有很大波動，可能不能完全反映我們業務的基本表現。
我們的季度和年度運營業績，包括我們的收入、盈利能力和現金流，未來可能會有很大差異，對我們的運營業績進行期間間的比較可能沒有意義。因此，不應依賴任何一個季度或期間的業績作爲未來業績的指標。我們的季度和年度財務結果可能會因各種因素而波動，其中許多因素是我們無法控制的，因此可能不能完全反映我們業務的基本表現。季度和年度業績的波動可能會降低我們普通股的價值。由於我們的季度業績可能會波動，期間與期間的比較可能不是我們業務潛在結果的最佳指示，應該只作爲確定我們業務表現的一個因素。
我們已經擴大了我們的組織，並預計將繼續擴大，包括擴大我們的銷售和營銷能力，並創建額外的基礎設施來支持我們作爲上市公司的運營，因此，我們在管理增長方面可能會遇到困難，這可能會擾亂我們的運營。
我們已經並預計我們的員工數量和業務範圍將出現顯著增長，特別是在銷售和營銷以及財務和會計領域。爲了管理我們預期的未來增長，我們必須繼續實施和改進我們的管理、運營和財務系統，擴大我們的設施，並繼續招聘和培訓更多合格的人員。由於我們有限的財政資源和管理這種預期增長的經驗有限，我們可能無法有效地管理我們業務的擴張或招聘和培訓更多合格的人員。我們業務的擴張可能會導致巨大的成本，並可能以我們可能意想不到的方式轉移或擴展我們的管理和業務發展資源。任何無法管理增長的情況都可能推遲我們業務計劃的執行或擾亂我們的運營。
由於季節性因素，我們的某些經營業績和財務指標可能難以預測。
在我們的行業中，在夏季和年終假期期間經歷季節性收入疲軟的情況並不少見。我們未來可能會受到其他季節性趨勢的影響，包括惡劣天氣(這可能會影響進行的選擇性手術的數量)，特別是隨着我們業務的成熟。此外，這種季節性可能在我們的收入中反映的程度要小得多，有時可能不會立即體現出來。在我們經歷這種季節性的程度上，它可能會導致我們的經營業績和財務指標出現波動，並使預測我們未來的經營業績和財務指標變得更加困難。
我們使用我們的淨營業虧損結轉和某些其他稅務屬性來抵消未來應納稅收入的能力可能會受到某些限制。
截至2023年12月31日，我們有大約31120萬的聯邦淨營業虧損結轉(「NOL」)，其中一些將在2024年至2037年的不同年份開始到期。我們的NOL可能到期而未使用，並且由於其有限的期限或美國稅法的限制，無法用於抵消未來的所得稅債務。根據經冠狀病毒援助、救濟和經濟安全法案或CARE法案修訂的《減稅和就業法案》(下稱《稅法》)，我們在截至2017年12月31日的納稅年度產生的聯邦NOL可以無限期結轉，但此類聯邦NOL在2020年12月31日之後開始的納稅年度的扣除額限制爲應稅收入的80%。目前還不確定各州是否以及在多大程度上會遵守經CARE法案修改的稅法。
此外，根據修訂後的1986年《國內稅法》(以下簡稱《守則》)第382和383條，如果一家公司經歷了「所有權變更」(通常定義爲「5%的股東」在三年滾動期間內對我們所有權的累計變更超過50個百分點)，該公司使用變更前的NOL和某些其他變更前的稅收屬性來抵銷變更後的收入和稅項的能力可能會受到限制。類似的規則可能適用於州稅法。我們過去可能經歷過這樣的所有權變化，未來我們可能會因爲隨後的股票所有權變化而經歷所有權變化，其中一些變化不在我們的控制範圍之內。我們沒有進行任何研究，以確定我們的股票所有權的這種變化可能導致的年度限制(如果有的話)。我們利用這些NOL和某些其他稅收屬性的能力可能會受到如上所述的「所有權變更」的限制，因此，我們可能無法利用我們的NOL和某些其他稅收屬性的重要部分，這可能會對我們的現金流和運營結果產生重大不利影響。
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有關知識產權的風險
如果我們無法爲我們的技術和產品獲得、維護、保護和執行專利和其他知識產權保護，或者如果獲得的專利和其他知識產權保護的範圍不夠廣泛，我們可能無法在我們的市場上有效競爭。
我們的成功在很大程度上取決於我們在美國和其他國家就我們開發的產品和技術獲得、維護、保護和執行專利和其他知識產權保護的能力。如果我們無法獲得、維護、保護和執行我們的知識產權，第三方可能會更有效地與我們競爭，我們可能會失去我們的技術或競爭優勢，或者我們可能會在試圖追回或限制使用我們的知識產權時招致巨額訴訟費用。
我們尋求通過授權與我們的產品相關的知識產權，並在美國和國外提交與我們的技術和產品相關的專利申請來保護我們的地位，這些技術和產品對我們的業務非常重要。我們還依靠合同條款、保密程序以及版權、商標、商業祕密和其他知識產權來保護我們的品牌、產品、技術和數據的專有方面。這些法律措施只能提供有限的保護，競爭對手或其他人可能獲得或使用我們的知識產權和專有信息。我們的成功將在一定程度上取決於獲得和維護專利、版權、商標、商業祕密、數據和專有技術以及其他知識產權。
我們可能無法獲得和維護我們的業務所需的知識產權或其他專有權利，或無法以爲我們提供競爭優勢的形式獲得和維護知識產權或其他所有權。例如，我們的商業祕密、數據和專有技術可能會被未經授權地使用、挪用或泄露給未經授權的人，儘管我們努力與我們的員工、顧問、承包商、客戶和其他供應商簽訂保密協議，他們可以訪問這些信息，否則可能會被第三方知道或獨立發現。此外，專利訴訟過程昂貴、耗時和複雜，我們可能無法以合理的成本及時提交、起訴、維護、執行或許可所有必要或可取的專利申請，或者在保護可能具有商業優勢的所有司法管轄區，或者我們可能根本無法保護我們的知識產權。儘管我們努力保護我們的知識產權，但未經授權的各方可能能夠獲取和使用我們認爲是專有的信息。
專利的頒發對於其發明性、範圍、有效性或可執行性並不是決定性的，我們擁有的和未授權的已頒發的專利可能會在美國和國外的法院或專利局受到挑戰。例如，我們可能會受到第三方向USPTO提交現有技術的約束，質疑我們擁有的或未授權的已發佈專利的一項或多項權利要求的有效性。此類提交也可以在專利發佈之前提交，從而排除基於我們擁有的或未獲許可的未決專利申請授予專利的可能性。
我們也有可能無法及時確定我們的研發成果中的可申請專利的方面，從而無法獲得專利保護。儘管我們與我們的員工、顧問、承包商、合作者、供應商和其他第三方等有權獲得我們研發成果的機密或可專利方面的各方簽訂了保密和保密協議，但這些各方中的任何一方都可能違反協議並在提交專利申請之前披露此類成果，從而危及我們尋求專利保護的能力。我們可能無法獲得或維護專利申請和頒發的專利，原因是此類專利申請和頒發的專利屬於公有領域的披露，我們可能無法阻止任何第三方使用我們在公有領域中的任何技術與我們的技術競爭。此外，科學文獻中發表的發現往往落後於實際發現，美國和其他司法管轄區的專利申請通常在申請18個月後才發表，有時甚至根本不發表。因此，我們不能確定我們是第一個在我們擁有或未授權的已發佈或未決專利申請中提出權利要求的發明，或者我們是第一個爲此類發明申請專利保護的公司。如果第三方能夠證明我們或我們的許可人不是第一個作出或第一個爲此類發明申請專利保護的人，我們擁有的或許可中的專利申請可能不會作爲專利發佈，即使發佈，也可能會受到質疑和無效或無法執行。
醫療器械公司的專利地位普遍高度不確定，涉及複雜的法律和事實問題，近年來一直是許多訴訟的對象。美國和其他國家專利法或其解釋的變化可能會削弱我們保護我們的發明、獲得、維護和執行我們的知識產權的能力，更廣泛地說，可能會影響我們的知識產權的價值或縮小我們擁有和許可的專利的範圍。關於未獲得許可的和
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owned intellectual property, we cannot predict whether the patent applications we and our licensors are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from competitors. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.
Moreover, the coverage claimed in a patent application can be significantly reduced before a patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications we license or own currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents that we hold or in-license may be challenged, narrowed or invalidated by third parties. Additionally, our competitors or other third parties may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. Third parties may also have blocking patents that could prevent us from marketing our own products and practicing our own technology. Alternatively, third parties may seek approval to market their own products similar to or otherwise compete with our products. In these circumstances, we may need to defend and/or assert our patents, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or agency with jurisdiction may find our patents invalid, unenforceable or not infringed, in which case, our competitors and other third parties may then be able to market products and use manufacturing and analytical processes that are substantially similar to ours. Even if we have valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives.
Given that patent applications are confidential for a period of time after filing, we cannot be certain that we were the first to file any patent application related to our products. Competitors may also contest our patents, if issued, by showing the USPTO, or the applicable other foreign patent agency that the invention was not original, was not novel or was obvious. In litigation, a competitor could claim that our patents, if issued, are not valid for a number of reasons. If a court agrees, we would lose our rights to those challenged patents.
In addition, given the amount of time required for the development, testing and regulatory review of new products, patents protecting such products might expire before or shortly after such products are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Moreover, some of our owned and in-licensed patents and patent applications may in the future be co-owned with third parties. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us.
Our other intellectual property, including our trademarks, could also be challenged, invalidated, infringed and circumvented by third parties, and our trademarks could also be diluted, declared generic or found to be infringing on other marks, in which case we could be forced to re-brand our products, resulting in loss of brand recognition and requiring us to devote resources to advertising and marketing new brands, and suffer other competitive harm. Third parties may also adopt trademarks similar to ours, which could harm our brand identity and lead to market confusion.
We may in the future also be subject to claims by our former employees, consultants or contractors asserting an ownership right in our patents or patent applications, as a result of the work they performed on our behalf. Although we generally require all of our employees, consultants, contractors and any other partners or collaborators who have access to our proprietary know-how, information or technology to assign or grant similar rights to their inventions to us, we cannot be certain that we have executed such agreements with all parties who may have contributed to our intellectual property, nor can we be certain that our agreements with such parties will be upheld in the face of a potential challenge, or that they will not be breached, for which we may not have an adequate remedy.
Failure to obtain and maintain patents, trademarks and other intellectual property rights necessary to our business and failure to protect, monitor and control the use of our intellectual property rights could negatively impact our ability to compete and cause us to incur significant expenses. The intellectual property laws and other statutory and contractual arrangements in the United States and other jurisdictions we depend upon may not provide sufficient protection in the future to prevent the infringement, use, violation or misappropriation of our patents, trademarks, data, technology and other intellectual property, and may not provide an adequate remedy if our intellectual property rights are infringed, misappropriated or otherwise violated. Any of the foregoing could have a
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material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.
Furthermore, our owned and in-licensed patents may be subject to a reservation of rights by one or more third parties. For example, this could arise if the research resulting in certain of our owned or in-licensed patent rights and technology was funded in part by the United States government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention for non-commercial purposes. These rights may permit the government to disclose our confidential information to third parties and to exercise march-in rights to use or allow third parties to use our licensed technology. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to United States industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States. Recently, the government released a draft framework that may be used by an agency when deciding to exercise its march-in rights for public comments, and as such, the framework for deciding when march-in rights are exercised may change. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations and prospects.
Moreover, a portion of our intellectual property has been acquired from one or more third parties. While we have conducted diligence with respect to such acquisitions, because we did not participate in the development or prosecution of much of the acquired intellectual property, we cannot guarantee that our diligence efforts identified and/or remedied all issues related to such intellectual property, including potential ownership errors, potential errors during prosecution of such intellectual property, and potential encumbrances that could limit our ability to enforce such intellectual property rights.
Patent terms may be inadequate to protect our competitive position on technology for an adequate amount of time.
Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest claimed U.S. non-provisional or Patent Cooperation Treaty application filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our products are obtained, once the patent life has expired for a product, we may be open to competition. Given the amount of time required for the development, testing and regulatory review of new products, patents protecting such products might expire before or shortly after such products are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours for a meaningful amount of time, or at all.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various other government fees on any issued patents and patent applications are due to be paid to the USPTO and other foreign patent agencies in several stages over the lifetime of such issued patents and patent applications. The USPTO and various foreign national or international patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. We are dependent on our licensors to take the necessary action to comply with these requirements with respect to certain of our in-licensed intellectual property, and if we or any of our current or future licensors fail to maintain the patents and patent applications covering our RxSight system or any future products, our competitors may be able to enter the market, which would have a material adverse effect on our business, financial condition, results of operations and prospects.
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We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
We cannot guarantee that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our current and future products in any jurisdiction.
The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our products. We may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, and our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products.
Our future reliance on third parties may require us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
Because we expect to rely on a third party to manufacture our RxSight system, and any future products, and we expect to collaborate with third parties on the continuing development of our RxSight system, and any future products, we must, at times, share trade secrets with them. We also expect to conduct R&D programs that may require us to share trade secrets under the terms of our partnerships or agreements with CROs. We seek to protect our proprietary technology in part by entering into agreements containing confidentiality and use restrictions and obligations with our advisors, employees, contractors, CMOs, CROs, other service providers and consultants prior to disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations.
In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors, CMOs, CROs, other service providers and consultants to publish data potentially relating to our trade secrets, although our agreements may contain certain limited publication rights. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication of information by any of our third-party collaborators. A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.
We may be subject to claims that we or our employees have misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors and third parties may claim an ownership interest in intellectual property we regard as our own.
Many of our employees and consultants were previously employed at or engaged by other medical device, biotechnology or pharmaceutical companies, including our competitors or potential competitors. Some of these employees, consultants and contractors, may have executed proprietary rights, non-disclosure and non-competition agreements in connection with such previous employment. Although we try to ensure that our employees and consultants do not use the intellectual property, proprietary information, know-how or trade secrets of others in their work for us, we may be subject to claims that we or these individuals have, inadvertently or otherwise, misappropriated the intellectual property or disclosed the alleged trade secrets or other proprietary information, of these former employers or competitors. Litigation may be necessary to defend against these claims, and if we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. In addition, we may lose personnel as a result of such claims. Any such litigation, or the threat thereof, may adversely affect our ability to hire employees or contract with independent contractors. A loss of key personnel or
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their work product could hamper or prevent our ability to commercialize our products, which would have a material adverse effect on our business, results of operations, financial condition and prospects.
Additionally, we may be subject to claims from third parties challenging our ownership interest in intellectual property we regard as our own, based on claims that our employees or consultants have breached an obligation to assign inventions to another employer, to a former employer, or to another person or entity. Litigation may be necessary to defend against any other claims, and it may be necessary or we may desire to enter into a license to settle any such claim; however, there can be no assurance that we would be able to obtain a license on commercially reasonable terms, if at all. If our defense to those claims fails, in addition to paying monetary damages, a court could prohibit us from using technologies or features that are essential to our products, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers.
In addition, we or our licensors may in the future be subject to claims by former employees, consultants or other third parties asserting an ownership right in our owned or in-licensed issued patents or patent applications. An adverse determination in any such submission or proceeding may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar technology and therapeutics, without payment to us, or could limit the duration of the patent protection covering our technology. Such challenges may also result in our inability to develop, manufacture or commercialize our technology without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our owned or in-licensed issued patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.
An inability to incorporate technologies or features that are important or essential to our products could have a material adverse effect on our business, financial condition and results of operations, and may prevent us from selling our products. In addition, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against these claims, litigation could result in substantial costs and could be a distraction to management. Any litigation or the threat thereof may adversely affect our ability to hire employees or contract with independent sales representatives. A loss of key personnel or their work product could hamper or prevent our ability to commercialize our products, which could have an adverse effect on our business, financial condition and results of operations.
We may become a party to intellectual property litigation or administrative proceedings that could be costly and could interfere with our ability to sell and market our products.
The medical device industry has been characterized by extensive litigation regarding patents, trademarks, trade secrets and other intellectual property rights, and companies in the industry have used intellectual property litigation to gain a competitive advantage. It is possible that U.S. and foreign patents and pending patent applications, copyrights, or trademarks controlled by third parties may be alleged to cover our products, or that we may be accused of misappropriating third parties’ trade secrets. Additionally, our products include components that we purchase from vendors, and may include design components that are outside of our direct control. Our competitors, many of which have substantially greater resources and have made substantial investments in patent portfolios, trade secrets, copyrights, trademarks and competing technologies, may have applied for or obtained, or may in the future apply for or obtain, patents, copyrights, or trademarks that will prevent, limit or otherwise interfere with our ability to make, use, sell and/or export our products or to use product names. Because patent applications can take years to issue and are often afforded confidentiality for some period of time, there may currently be pending applications, unknown to us, that later result in issued patents that could cover one or more of our products. Moreover, in recent years, individuals and groups that are non-practicing entities, commonly referred to as “patent trolls,” have purchased patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. From time to time, we may receive threatening letters, notices or “invitations to license,” or may be the subject of claims that our products and business operations infringe or violate the intellectual property rights of others. We may face patent infringement claims from non-practicing entities that have no relevant product revenue and against whom our owned or in-licensed patent portfolio may therefore have no deterrent effect. We may in the future become party to adversarial proceedings or litigation where our competitors or other third parties may assert claims against us, alleging that our products or services infringe, misappropriate or otherwise violate their intellectual property rights, including patents and trade secrets. The defense of these matters can be time consuming, be costly, divert management’s attention and resources, damage our reputation and brand and cause us to incur
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significant expenses or make substantial payments. Vendors from whom we purchase hardware or software may not indemnify us in the event that such hardware or software is accused of infringing a third party’s patent or trademark or of misappropriating a third party’s trade secret, or any indemnification granted by such vendors may not be sufficient to address any liability and costs we incur as a result of such claims. Additionally, we may be obligated to indemnify our customers or business partners in connection with litigation and to obtain licenses or refund subscription fees, which could further exhaust our resources.
Even if we believe a third party’s intellectual property claims are without merit, there is no assurance that a court would find in our favor, including on questions of infringement, validity, enforceability or priority of patents. The strength of our defenses will depend on the patents asserted, the interpretation of these patents, and our ability to invalidate the asserted patents. A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially and adversely affect our ability to commercialize any products or technology we may develop, and any other products or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such United States patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such United States patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such United States patent. Conversely, the patent owner need only prove infringement by a preponderance of the evidence, which is a lower burden of proof.
Further, if patents, trademarks, copyrights, or trade secrets are successfully asserted against us, this may harm our business and result in injunctions preventing us from developing, manufacturing, marketing or selling our products, or result in obligations to pay license fees, damages, attorney fees and court costs, which could be significant. In addition, if we are found to willfully infringe third-party patents or trademarks or to have misappropriated trade secrets, we could be required to pay treble damages in addition to other penalties.
Although patent, copyright, trademark, trade secret and other intellectual property disputes in the medical device area have often been settled through licensing or similar arrangements, costs associated with such arrangements may be substantial and could include ongoing royalties. We may be unable to obtain necessary licenses on satisfactory terms, if at all. In addition, if any license we obtain is non-exclusive, we may not be able to prevent our competitors and other third parties from using the intellectual property or technology covered by such license to compete with us. If we do not obtain necessary licenses, we may not be able to redesign our products to avoid infringement. Any of these events could materially and adversely affect our business, financial condition and results of operations.
Similarly, interference or derivation proceedings provoked by third parties or brought by the USPTO, may be necessary to determine priority with respect to our patents, patent applications, trademarks or trademark applications. We may also become involved in other proceedings, such as reexamination, inter partes review, derivation or opposition proceedings before the USPTO or other jurisdictional body relating to our intellectual property rights or the intellectual property rights of others. Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing our products or using product names, which would have a significant adverse impact on our business, financial condition and results of operations.
Additionally, we may file lawsuits or initiate other proceedings to protect or enforce our patents or other intellectual property rights, which could be expensive, time consuming and unsuccessful. Competitors may infringe our issued patents or other intellectual property, which we may not always be able to detect. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property or alleging that our intellectual property is invalid or unenforceable. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may raise challenges to the validity of certain of our owned or in-licensed patent claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). In any such lawsuit or other proceedings, a court or other administrative body may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the
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other party from using the technology at issue on the grounds that our patents do not cover the technology in question.
The outcome following legal assertions of invalidity and unenforceability is unpredictable. If a third party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our products or products that we may develop. If our patents are found to be valid and infringed, a court may refuse to grant injunctive relief against the infringer and instead grant us monetary damages and/or ongoing royalties. Such monetary compensation may be insufficient to adequately offset the damage to our business caused by the infringer’s competition in the market. An adverse result in any litigation or other proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. Any of these events could materially and adversely affect our business, financial condition and results of operations.
Even if resolved in our favor, litigation or other proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential or sensitive information could be compromised by disclosure in the event of litigation. Uncertainties resulting from the initiation and continuation of patent and other intellectual property litigation or other proceedings could have a material adverse effect on our business, financial condition and results of operations.
Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
Because of the expense and uncertainty of litigation, we may conclude that even if a third party is infringing, misappropriating or otherwise violating our owned or in-licensed patents, any patents that may be issued as a result of our future patent applications, or other intellectual property rights, the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best interest of our company or our shareholders. In such cases, we may decide that the more prudent course of action is to simply monitor the situation or initiate or seek some other non-litigious action or solution.
Our rights to develop and commercialize our products are subject, in part, to the terms and conditions of licenses granted to us by others.
Although we do not currently rely upon any material licenses to any patent rights, proprietary technology, or other intellectual property from any third parties for the development of our products and technology, we may in the future rely, in part, upon licenses to certain patent rights, proprietary technology and other intellectual property from third parties that are important or necessary to the development of our products and technology, including future products and technology. Further development and commercialization of our current products, and development of any future products, may require us to enter into license or collaboration agreements. These and other licenses may not provide exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and products in the future. As a result, we may not be able to prevent competitors from developing and commercializing competitive products in territories included in all of our licenses.
In addition, and as such, in the future we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement and defense of patents and patent applications covering the technology that we license from third parties. Therefore, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, enforced and defended in a manner consistent with the best interests of our business. Additionally, patents that may be licensed to us could be put at risk of being invalidated or interpreted narrowly in litigation filed by or against our licensors or another licensee or in administrative proceedings brought by or against our licensors or another licensee in response to such litigation or for other reasons. If our potential licensors fail to prosecute, maintain, enforce and defend such patents, or lose rights to those patents or patent applications, the rights
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we have licensed may be reduced or eliminated, and our right to develop and commercialize any of our products that are subject of such licensed rights could be adversely affected.
Our potential licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not the sole and exclusive owners of the patents we in-license. This could materially and adversely affect our business, financial condition and results of operations.
The agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the relevant agreement. In spite of our best efforts, our licensors might also conclude that we have materially breached our license agreements and terminate the license agreements, thereby removing our ability to develop and commercialize products and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, products identical to ours. In addition, we may seek to obtain additional licenses from our licensors and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensors, including by agreeing to terms that could enable third parties (potentially including our competitors) to receive licenses to a portion of the intellectual property that is subject to our existing licenses. Moreover, if disputes over intellectual property that we license prevent or impair our ability to maintain other licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected products. Any of these events could materially and adversely affect our business, financial condition and results of operations.
In the future, we may enter agreements involving licenses or collaborations that provide for access or sharing of intellectual property. If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our current and future products.
We currently, and in the future may continue to, license from third parties certain intellectual property relating to our current and future products. In the event we do so, we may have certain obligations to such licensors. If we breach any material obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture, and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology.
Disputes may arise between us and our future licensors regarding intellectual property subject to a license agreement, including:
If disputes over intellectual property that we license in the future prevent or impair our ability to maintain our licensing arrangements on acceptable terms, we may not be able to successfully develop and commercialize the affected products, which would have a material adverse effect on our business.
In addition, certain of our future agreements with third parties may limit or delay our ability to consummate certain transactions, may impact the value of those transactions, or may limit our ability to pursue certain activities.
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For example, we may in the future enter into license agreements that are not assignable or transferable, or that require the licensor’s express consent in order for an assignment or transfer to take place.
Further, we or our future licensors, if any, may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, we may miss potential opportunities to strengthen our patent position. It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. If we or our future licensors fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If our future licensors are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form, preparation, prosecution, or enforcement of our patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.
In addition, even where we have the right to control patent prosecution of patents and patent applications under future license from third parties, we may still be adversely affected or prejudiced by actions or inactions of our predecessors or licensors and their counsel that took place prior to us assuming control over patent prosecution.
Our technology acquired or licensed in the future from various third parties may be subject to retained rights. Our predecessors or licensors may retain certain rights under their agreements with us, including the right to use the underlying technology for noncommercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether our predecessors or future licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse.
If we are limited in our ability to utilize acquired or future licensed technologies, or if we lose our rights to critical future in-licensed technology, we may be unable to successfully develop, out-license, market and sell our products, which could prevent or delay new product introductions. Our business strategy depends on the successful development of acquired technologies, and possibly in the future licensed technology, into commercial products. Therefore, any limitations on our ability to utilize these technologies may impair our ability to develop, out-license or market and sell our products.
We may not be successful in obtaining necessary rights to any products we may develop through acquisitions and in-licenses.
We may need to obtain additional licenses from our existing licensors or otherwise acquire or in-license any intellectual property rights from third parties that we identify as necessary for our products. It is possible that we may be unable to obtain any additional licenses or acquire such intellectual property rights at a reasonable cost or on reasonable terms, if at all. The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. In that event, we may be required to expend significant time and resources to redesign our technology, products, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize the affected products, which could materially and adversely affect our business, financial condition and results of operations.
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Any collaboration or partnership arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products.
Any future collaborations that we enter into may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include that:
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
We or our licensors may be subject to claims that former consultants, contractors or other third parties have an interest in our owned or in-licensed patents, trade secrets or other intellectual property as an inventor or co-inventor. While it is our policy to require our employees, consultants and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our products. Furthermore, individuals executing invention assignment agreements with us may have preexisting or competing obligations to a third party, such as an academic institution, and thus an agreement with us may be ineffective in perfecting ownership of inventions developed by that individual. Any such events could have a material adverse effect on our business, financial condition and results of operations.
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If we are unable to protect the confidentiality of our trade secrets and other proprietary information, our business and competitive position may be harmed.
In addition to patent protection, we also rely on other proprietary rights, including protection of trade secrets, and other proprietary information that is not patentable or that we elect not to patent. However, trade secrets can be difficult to protect and some courts inside and outside the United States are less willing or unwilling to protect trade secrets. To maintain the confidentiality of our trade secrets and proprietary information, we rely heavily on confidentiality provisions that we have in contracts with our employees, consultants, collaborators and others upon the commencement of their relationship with us. We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by such third parties, despite the existence generally of these confidentiality restrictions. These contracts may not provide meaningful protection for our trade secrets, know-how, or other proprietary information in the event of any unauthorized use, misappropriation, or disclosure of such trade secrets, know-how, or other proprietary information. There can be no assurance that such third parties will not breach their agreements with us, that we will have adequate remedies for any breach, or that our trade secrets will not otherwise become known or independently developed by competitors. Despite the protections we do place on our intellectual property or other proprietary rights, monitoring unauthorized use and disclosure of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property or other proprietary rights will be adequate. In addition, the laws of many foreign countries will not protect our intellectual property or other proprietary rights to the same extent as the laws of the United States. Consequently, we may be unable to prevent our proprietary technology from being exploited abroad, which could affect our ability to expand to international markets or require costly efforts to protect our technology.
To the extent our intellectual property or other proprietary information protection is incomplete, we are exposed to a greater risk of direct competition. A third party could, without authorization, copy or otherwise obtain and use our products or technology, or develop similar technology. Our competitors could purchase our products and attempt to replicate some or all of the competitive advantages we derive from our development efforts or design around our protected technology. Our failure to secure, protect and enforce our intellectual property rights could substantially harm the value of our products, brand and business. The theft or unauthorized use or publication of our trade secrets and other confidential business information could reduce the differentiation of our products and harm our business, the value of our investment in development or business acquisitions could be reduced and third parties might make claims against us related to losses of their confidential or proprietary information. Any of the foregoing could materially and adversely affect our business, financial condition and results of operations.
Further, it is possible that others will independently develop the same or similar technology or otherwise obtain access to our unpatented technology, and in such cases we could not assert any trade secret rights against such parties or those to whom they communicate such trade secrets. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our trade secret rights and related confidentiality and nondisclosure provisions. If we fail to obtain or maintain trade secret protection, or if our competitors obtain our trade secrets or independently develop technology similar to ours or competing technologies, our competitive market position could be materially and adversely affected. In addition, some courts are less willing or unwilling to protect trade secrets and agreement terms that address non-competition are difficult to enforce in many jurisdictions and might not be enforceable in certain cases.
We also seek to preserve the integrity and confidentiality of our data and other confidential information by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached and detecting the disclosure or misappropriation of confidential information and enforcing a claim that a party illegally disclosed or misappropriated confidential information is difficult, expensive and time-consuming, and the outcome is unpredictable. Further, we may not be able to obtain adequate remedies for any breach.
Changes in United States patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. The United States has enacted and implemented wide-ranging patent reform legislation. Assuming that
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other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. The America Invents Act also includes a number of significant changes that affect the way patent applications are prosecuted and also may affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. The America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.
In addition, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. We cannot predict how decisions or actions by the courts, the U.S. Congress or the USPTO may impact the value of our patents. Depending on actions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have licensed or that we might obtain in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain in the future. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.
We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
Filing, prosecuting, and defending patents covering our RxSight system, and any of our future products throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States are less extensive than those in the United States. In some cases, we or our licensors may not be able to obtain patent protection for certain technology outside the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our or our licensors’ inventions in all countries outside the United States, even in jurisdictions where we or our licensors do pursue patent protection, or from selling or importing products made using our or our licensors’ inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we or our licensors have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may have or obtain patent protection, but where patent enforcement is not as strong as that in the United States. These unauthorized products may compete with our products in such jurisdictions and take away our market share where we do not have any issued or in-licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.
Many companies have encountered significant problems in enforcing and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, which could make it difficult for us to stop the infringement of our patents, if pursued and obtained, or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our or our licensors’ patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We or our licensors may not prevail in any lawsuits that we or our licensors initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
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Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our business, financial condition, results of operations and prospects could be materially and adversely affected.
Since June 1, 2023, European applications have the option, upon grant of a patent, of becoming a Unitary Patent which will be subject to the jurisdiction of the Unitary Patent Court (“UPC”). This is a significant change in European patent practice. As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative:
Our use of “open source” software could subject our proprietary software to general release, adversely affect our ability to sell our products and subject us to possible litigation.
We may incorporate open source software in products or technologies licensed, developed and/or distributed by us. Open source software is generally licensed by its authors or other third parties under open source licenses. Some open source licenses contain requirements that we disclose source code for modifications we make to the open source software and that we license such modifications to third parties at no cost. In some circumstances, distribution of our software in connection with open source software could require that we disclose and license some or all of our proprietary source code in that software, as well as distribute our products that use particular open source software at no cost to the user. We intend to monitor our use of open source software in an effort to avoid uses in a manner that would require us to disclose or grant licenses under our proprietary source code; however, there can be no assurance that such efforts will be successful. Open source license terms are often ambiguous and
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such use could inadvertently occur. There is little legal precedent governing the interpretation of many of the terms of these licenses, and the potential impact of these terms on our business may result in unanticipated obligations regarding our products and technologies. Companies that incorporate open source software into their products have, in the past, faced claims seeking enforcement of open source license provisions and claims asserting ownership of open source software incorporated into their product. If an author or other third party that distributes such open source software were to allege that we had not complied with the conditions of an open source license, we could incur significant legal costs defending ourselves against such allegations. In the event such claims were successful, we could be subject to significant damages or be enjoined from the distribution of our products. In addition, if we combine our proprietary software with open source software in certain ways, under some open source licenses, we could be required to release the source code of our proprietary software, which could substantially help our competitors develop products that are similar to or better than ours and otherwise adversely affect our business. These risks could be difficult to eliminate or manage, and, if not addressed, could harm our business, financial condition and results of operations.
If our trademarks, service marks and tradenames are not adequately protected, then we may not be able to build name recognition in our markets and our business may be adversely affected.
We rely on trademarks, service marks, tradenames and brand names to distinguish our products from the products of our competitors and have registered or applied to register these trademarks. We cannot assure you that our trademark and service mark applications will be approved. During trademark and service mark registration proceedings, we may receive rejections. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in proceedings before the USPTO and comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark and service mark applications and to seek to cancel registered trademarks and service marks. Opposition or cancellation proceedings may be filed against our trademarks and service marks, and our trademarks and service marks may not survive such proceedings. In the event that our trademarks and service marks are successfully challenged, we could be forced to rebrand our products, which could result in loss of brand recognition and could require us to devote resources towards advertising and marketing new brands. At times, competitors may adopt trade names, trademarks or service marks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. As a means to enforce our trademark and service mark rights and prevent infringement and other violations, we may be required to file claims against third parties or initiate opposition proceedings. This can be expensive and time-consuming. In addition, there could be potential trademark or service mark infringement claims brought by owners of other registered trademarks, service marks, or trademarks or service marks that incorporate variations of our registered or unregistered trademarks or service marks. Certain of our current or future trademarks or service marks may become so well known by the public that their use becomes generic and they lose trademark or service mark protection. Over the long term, if we are unable to establish name recognition based on our trademarks, service marks and trade names, then we may not be able to compete effectively and our business, financial condition and results of operations may be adversely affected.
Risks related to government regulation
If we fail to obtain and maintain necessary regulatory clearances or approvals for our products, or if clearances or approvals for future products and indications are delayed or not issued, our commercial operations would be harmed.
Our products are subject to extensive regulation by the FDA in the United States and by regulatory agencies in other countries where we may choose to do business. Government regulations specific to medical devices are wide ranging and govern, among other things:
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Before a new medical device, or a new intended use for an existing product, can be marketed in the United States, a company must first submit and receive either 510(k) clearance pursuant to Section 510(k) of the FDCA, or approval of a premarket approval, or PMA, application from the FDA, unless an exemption applies.
In many cases, the process of obtaining PMA approval is much more rigorous, costly, lengthy and uncertain than the 510(k) clearance process. In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a device legally on the market, known as a “predicate” device, in order to clear the proposed device for marketing. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data is sometimes required to support substantial equivalence. In the PMA approval process, the FDA must determine that a proposed device is safe and effective for its intended use based on extensive data, including technical, pre-clinical, clinical trial, manufacturing and labeling data. The PMA process is typically required for devices for which the 510(k) process cannot be used and that are deemed to pose the greatest risk. Modifications to products that are approved through a PMA application generally need prior FDA approval of a PMA supplement. Similarly, some modifications made to products cleared through a 510(k) may require a new 510(k), or such modification may put the device into class III and require PMA approval. The FDA’s 510(k) clearance process usually takes from three to 12 months but may last longer. The process of obtaining a PMA generally takes from one to three years, or even longer, from the time the PMA is submitted to the FDA until an approval is obtained. Any delay or failure to obtain necessary regulatory approvals or clearances would have a material adverse effect on our business, financial condition and results of operations.
The FDA can delay, limit or deny clearance or approval of a device for many reasons, including:
Similarly, regulators may determine that our financial relationships with our principal investigators resulted in a perceived or actual conflict of interest that may have affected the interpretation of a study, the integrity of the data generated at the applicable clinical trial site or the utility of the clinical trial itself. Even if we are granted regulatory
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clearances or approvals, they may include significant limitations on the indicated uses for the product, which may limit the market for the product. Moreover, the FDA and European Union regulatory authorities strictly regulate the labeling, promotion and advertising of medical devices, including comparative and superiority claims vis a vis competitors’ products, that may be made about products.
As a condition of approving a PMA application, the FDA may also require some form of post-approval study or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional safety and effectiveness data for the device. Failure to conduct the post-approval study in compliance with applicable regulations or to timely complete required post-approval studies or comply with other post-approval requirements could result in withdrawal of approval of the PMA, which would harm our business.
In addition, we are required to timely file various reports with the FDA, including, Medical Device Reporting (“MDR”), that requires that we report to the regulatory authorities if our products may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur. If these reports are not filed in a timely manner, regulators may impose sanctions and we may be subject to product liability or regulatory enforcement actions, all of which could harm our business.
If we initiate a correction or removal action for our products to reduce a significant risk to health posed by our products, we would be required to submit a publicly available correction and removal report to the FDA and, in many cases, similar reports to other regulatory agencies. This report could be classified by the FDA as a device recall which could lead to increased scrutiny by the FDA, other international regulatory agencies and our customers regarding the quality and safety of our products. Furthermore, the submission of these reports could be used by competitors against us and cause doctors to delay or cancel procedures, which could harm our reputation.
The FDA and the Federal Trade Commission, or FTC, also regulate the advertising, promotion and labeling of our products to ensure that the claims we make are consistent with our regulatory clearances and approvals, that there is adequate and reasonable scientific data to substantiate the claims and that our promotional labeling and advertising is neither false nor misleading in any respect. If the FDA or FTC determines that any of our advertising or promotional claims are misleading, not substantiated or not permissible, we may be subject to enforcement actions, including adverse publicity and warning letters, and we may be required to revise our promotional claims and make other corrections or restitutions.
The FDA and state authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following sanctions:
If any of these events were to occur, our business and financial condition could be harmed. In addition, the FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our products. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, financial condition and results of operations.
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Our products and operations are subject to extensive government regulation and oversight in the United States.
Medical devices regulated by the FDA are subject to “general controls” which include: registration with the FDA; listing commercially distributed products with the FDA; complying with all applicable requirements under the QSR, or QSMR when its goes into effect in February 2026; filing reports with the FDA of and keeping records relative to certain types of adverse events associated with devices under the medical device reporting regulation; assuring that device labeling complies with device labeling requirements; reporting certain device field removals and corrections to the FDA; and obtaining pre-market notification 510(k) clearance for devices prior to marketing. Some devices known as “510(k)-exempt” devices can be marketed without prior marketing-clearance or approval from the FDA. In addition to the “general controls,” some Class II medical devices are also subject to “special controls,” including adherence to a particular guidance document and compliance with the performance standard. Instead of obtaining 510(k) clearance, most Class III devices are subject to PMA.
Although our products have received regulatory approval or clearance from FDA in the United States for a particular patient population, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, effectiveness and other post-market information, including both federal and state requirements in the United States and requirements of comparable non-U.S. regulatory authorities in any international markets we choose to enter.
Any regulatory clearances or approvals that we have received for our products will be subject to limitations on the cleared or approved indicated uses for which the product may be marketed and promoted, will be subject to the conditions of approval, or will contain requirements for potentially costly post-marketing testing. We are required to report certain adverse events and production problems, if any, to the FDA and comparable foreign regulatory authorities. Any new legislation addressing product safety issues could result in increased costs to assure compliance. The FDA and other agencies, including the DOJ, closely regulate and monitor the post-clearance or approval marketing and promotion of products to ensure that they are marketed and distributed only for the cleared or approved indications and in accordance with the provisions of the cleared or approved labeling. We have to comply with requirements concerning advertising and promotion for our products.
Promotional communications with respect to devices are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the products’ cleared or approved labeling. As such, we may not promote our products for indications or uses for which they do not have clearance or approval. We received a PMA for the LAL and LDD, which is indicated for the reduction of residual astigmatism to improve uncorrected visual acuity after removal of the cataractous natural lens by phacoemulsification and implantation of the intraocular lens in the capsular bag, in adult patients with pre-existing corneal astigmatism of > 0.75 diopters and without pre-existing macular disease. We also received a 510(k) clearance for our contact lens, which is indicated for visualization and treatment in the anterior segment of the eye. We train our marketing and sales force against promoting our products for uses outside of the cleared or approved indications for use, known as “off-label uses.” However, doctors may use our products for off-label purposes and are allowed to do so when in the doctor’s independent professional medical judgment he or she deems it appropriate. If the FDA determines that our promotional materials or training constitute promotion of an off-label or other improper use, or that our internal policies and procedures are inadequate to prevent such off-label uses, it could subject us to regulatory or enforcement actions as discussed below.
In addition, we cannot make comparative claims regarding the use of our products against any alternative treatments without conducting head-to-head comparative clinical studies, which would be expensive and time-consuming. If the FDA determines that our promotional, reimbursement or training materials for sales representatives or doctors constitute promotion of an off-label use, the FDA could request that we modify our training, promotional or reimbursement materials and/or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, disgorgement of profits, significant penalties, including civil fines and criminal penalties. Other federal, state or foreign governmental authorities also might take action if they consider our promotion, reimbursement or training materials to constitute promotion of an off-label use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. Although we train our sales force not to promote our products for off-label uses, and our instructions for use in all markets specify that our products are not intended for use outside of those indications cleared or approved for use, the FDA or another regulatory agency could conclude that we have engaged in off-label promotion. For example, the government may take the position that off-label promotion resulted in inappropriate
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reimbursement for an off-label use in violation of the federal civil False Claims Act for which it might impose significant civil fines and even pursue criminal action. In those possible events, our reputation could be damaged, and adoption of the products would be impaired.
If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with our facility where the product is manufactured or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market.
If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:
In addition, violations of the FDCA relating to the promotion of approved products may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws.
Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products. If regulatory sanctions are applied or if regulatory clearance or approval is withdrawn, it would have a material adverse effect on our business, financial condition and results of operations.
In addition, the policies of the FDA and of comparable foreign regulatory authorities may change and additional laws, regulations and government actions may be enacted that could prevent, limit, or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. Recently, the U.S. Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous. This landmark Supreme Court decision may invite more companies and other stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, which could undermine the FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, any of which could delay the FDA’s review of our regulatory submissions. We cannot predict the full impact of this decision, future judicial challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative action.
Material modifications to our products may require new 510(k) clearances or pre-market approvals or may require us to recall or cease marketing our products until clearances or approvals are obtained.
Modifications that could significantly affect the safety and effectiveness of our approved or cleared products, such as changes to the intended use or technological characteristics of our products, will require new 510(k) clearances or PMAs or require us to recall or cease marketing the modified devices until these clearances or approvals are obtained. Based on FDA published guidelines, the FDA requires device manufacturers to initially make and document a determination of whether or not a modification requires a new approval, supplemental approval or clearance; however, the FDA can review a manufacturer’s decision. Any modification to an
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FDA-cleared device that could significantly affect its safety or efficacy or that would constitute a major change in its intended use would require a new 510(k) clearance or possibly a PMA. We may not be able to obtain the required 510(k) clearances or PMAs, or PMA supplements, or similar marketing authorization in applicable foreign jurisdictions, for new products or for modifications to, or additional indications for, our products in a timely fashion, or at all. Delays in obtaining required future clearances or approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth. We have made modifications to our products in the past and expect to make additional modifications in the future that we believe do not or will not require additional clearances or approvals. If the FDA or a comparable foreign regulatory authority disagrees and requires new clearances or approvals for these modifications, we may be required to recall and to stop selling or marketing such products as modified, which could harm our operating results and require us to redesign such products. In these circumstances, we may be subject to significant enforcement actions.
Obtaining and maintaining regulatory approval of our current and future products in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our current and future products in other jurisdictions. The FDA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
Obtaining and maintaining regulatory approvals or clearances of our current and future products in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction. For example, even if the FDA grants marketing approval or clearance of a current or future product, comparable regulatory authorities in foreign jurisdictions must also approve or clear the manufacturing, marketing and promotion and reimbursement of a current or future product in those countries. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.
The RxSight system is approved for improving uncorrected visual acuity by adjusting the LAL power to correct residual postoperative refractive error, including for -2.0 to + 2.0 diopters of sphere and -3.0 to -0.50 diopters of cylinder and by changing lens curvature to introduce controlled amounts of spherical aberration (+/- 1 micron) and center near add (up to 2.0 diopters) which is also registered with the MHRA in the United Kingdom, in Canada and in Mexico. Obtaining additional foreign regulatory approvals and establishing and ensuring compliance with foreign regulatory requirements in jurisdictions where we conduct business currently or in the future, could be time-consuming and expensive, and could delay the introduction of our products in certain countries. If we or any future collaborator fail to comply with the regulatory requirements in international markets or fail to receive applicable marketing approvals or clearances, our target market will be reduced and our ability to realize the full market potential of our current and future products will be harmed.
In addition, we have conducted clinical trials in Mexico and may choose to conduct further international clinical trials. The acceptance of study data by the FDA or other comparable foreign regulatory authority from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (1) the data are applicable to the U.S. population and U.S. medical practice; (2) the trials are performed by clinical investigators of recognized competence and pursuant to current good clinical practices regulations; and (3) audits by regulatory authorities of the clinical data do not identify significant data integrity issues. Additionally, the FDA’s clinical trial requirements, including the adequacy of the patient population studied and statistical powering, must be met. In addition, such foreign trials are subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any applicable foreign regulatory authority will accept data from trials conducted outside of its applicable jurisdiction. If the FDA or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our products not receiving approval or clearance for commercialization in the applicable jurisdiction.
Our products may be subject to recalls after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation and adversely affect our business.
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The FDA and similar foreign governmental authorities have the authority to require the recall of our products because of any failure to comply with applicable laws and regulations, or defects in design or manufacture. A government mandated or voluntary product recall by us could occur because of, for example, component failures, device malfunctions or other adverse events, such as serious injuries or deaths, or quality-related issues, such as manufacturing errors or design or labeling defects. Any future recalls of our products could divert managerial and financial resources, harm our reputation and adversely affect our business.
If we initiate a correction or removal for one of our devices to reduce a risk to health posed by the device, we would be required to submit a publicly available Correction and Removal report to the FDA and, in many cases, similar reports to other regulatory agencies. This report could be classified by the FDA as a device recall which could lead to increased scrutiny by the FDA, other international regulatory agencies and our customers regarding the quality and safety of our devices. Furthermore, the submission of these reports has been and could be used by competitors against us in competitive situations and cause customers to delay purchase decisions or cancel orders and would harm our reputation.
In addition, we are subject to medical device reporting regulations that require us to report to the FDA or similar foreign governmental authorities if one of our products may have caused or contributed to a death or serious injury or if we become aware that it has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction recurred. Failures to properly identify reportable events or to file timely reports, as well as failure to address each of the observations to the FDA’s satisfaction, can subject us to sanctions and penalties, including warning letters and recalls.
Doctors may make similar reports to regulatory authorities. Any such reports may trigger an investigation by the FDA or similar foreign regulatory bodies, which could divert managerial and financial resources, harm our reputation and have a material adverse effect on our business, financial condition and results of operations.
If we, or our suppliers, fail to comply with the FDA’s QSR or QSMR when it goes into effect in February 2026, or other applicable foreign regulations, our manufacturing or distribution operations could be delayed or shut down and our revenue could suffer.
Our manufacturing and design processes and those of our third-party component suppliers are required to comply with the FDA’s QSR, which covers procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of our products in the United States. We are also subject to similar state requirements and licenses, and to ongoing ISO 13485 compliance in our operations, including design, manufacturing, and service, to maintain our CE Mark in Europe. In addition, we must engage in extensive recordkeeping and reporting and must make available our facilities and records for periodic unannounced inspections by governmental agencies, including the FDA, state authorities, EU Notified Bodies, and comparable agencies in other countries. Further, the FDA issued a final rule in February 2024 replacing the QSR with Quality Management System Regulation (“QMSR”), which incorporates by reference the quality management system requirements of ISO 13485:2016. The FDA has stated that the standards contained in ISO 13485:216 are substantially similar to those set forth in the existing QSR. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026. If we or any of our suppliers or contractors fail to meet the regulatory requirements or a regulatory inspection, our operations could be disrupted and our manufacturing interrupted. Failure to take timely and adequate corrective action in response to an adverse regulatory inspection could result in, among other things, a shutdown of our manufacturing or product distribution operations, significant fines, suspension of marketing clearances and approvals, seizures or recalls of our device, operating restrictions and criminal prosecutions, any of which would cause our business to suffer. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements, which may result in manufacturing delays for our products and cause our revenue to decline.
The FDA has broad post-market and regulatory enforcement powers. We are subject to unannounced inspections by the FDA and the Food and Drug Branch of the California Department of Public Health (“CDPH”), and our Notified Body to determine our compliance with the QSR and other regulations at both our design and manufacturing facilities, and these inspections may include the manufacturing facilities of our suppliers.
We can provide no assurance that we will continue to remain in material compliance with the QSR, or QSMR when it goes into effect in February 2026. If the FDA, CDPH, or any applicable notified body in the European Union or United Kingdom inspects any of our facilities and discover compliance problems, we may have to cease manufacturing and product distribution until we can take the appropriate remedial steps to correct the audit findings.
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Taking corrective action may be expensive, time consuming and a distraction for management and if we experience a delay at our manufacturing facility, we may be unable to produce our products, which would harm our business.
Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business, financial condition, results of operations and cash flows in our key markets.
There have been and continue to be proposals by the federal government, state governments, regulators and third-party payors to control or manage the increased costs of healthcare and, more generally, to reform the U.S. healthcare system. Certain of these proposals could limit the prices we are able to charge for our products or the coverage and reimbursement available for our products and could limit the acceptance and availability of our products. The adoption of proposals to control costs could have a material adverse effect on our business, financial condition and results of operations.
For example, in the United States, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, together, the Affordable Care Act (“ACA”), was enacted. The ACA is a sweeping measure intended to expand healthcare coverage within the United States, primarily through the imposition of health insurance mandates on employers and individuals, the provision of subsidies to eligible individuals enrolled in plans offered on the health insurance exchanges and the expansion of the Medicaid program. The ACA has impacted existing government healthcare programs and has resulted in the development of new programs.
Certain provisions of the ACA have been subject to judicial and Congressional challenges. For example, various portions of the ACA have been the subject of legal and constitutional challenges, including legal proceedings in the Fifth Circuit Court of Appeals. In June 2021, the United States Supreme Court held that Texas and other challengers had no legal standing to challenge the ACA, dismissing the case on procedural grounds without specifically ruling on the constitutionality of the ACA. Thus, the ACA will remain in effect in its current form. It is unclear how this Supreme Court decision, future litigation, and healthcare measures promulgated by the Biden administration will impact the ACA, our business, financial condition and results of operations. Complying with any new legislation or reversing changes implemented under the ACA could be time-intensive and expensive, resulting in a material adverse effect on our business.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, includes reductions to Medicare payments to providers of, on average, 2% per fiscal year, which went into effect on April 1, 2013, which, due to subsequent legislative amendments, will stay in effect through 2032, with the exception of a temporary suspension implemented under various COVID-19 relief legislation. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our products, if approved, and accordingly, our financial operations. We cannot assure you that the ACA, as currently enacted or as amended in the future, will not harm our business and financial results, and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect our business.
There likely will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future or their full impact. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare may harm:
Further, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several United States Congressional inquiries and proposed and enacted federal legislation designed to bring transparency to product pricing and reduce the cost of products and services under government healthcare programs. While some of these measures may require additional authorization to become effective, Congress and the federal administration have each indicated that it will continue to seek new
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legislative and/or administrative measures to control healthcare costs. Additionally, individual states in the United States have also increasingly passed legislation and implemented regulations designed to control product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures. Moreover, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what products to purchase and which suppliers will be included in their healthcare programs. Adoption of price controls and other cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures may prevent or limit our ability to generate revenue and attain profitability. Various new healthcare reform proposals are emerging at the federal and state level. Any new federal and state healthcare initiatives that may be adopted could limit the amounts that federal and state governments will pay for healthcare products and services and could have a material adverse effect on our business, financial condition and results of operations.
If we fail to comply with United States federal and state fraud and abuse and other healthcare laws and regulations, we could face substantial penalties and our business operations and financial condition could be adversely affected.
Healthcare providers and third-party payors play a primary role in the distribution, recommendation, ordering and purchasing of any medical device for which we have or obtain marketing clearance or approval. Through our arrangements with principal investigators, healthcare professionals, third-party payors and customers, we are exposed to broadly applicable anti-fraud and abuse, anti-kickback, false claims and other healthcare laws and regulations that may constrain our business, our arrangements and relationships with customers, and how we market, sell and distribute our marketed medical devices. We have a compliance program, a Code of Conduct and associated policies and procedures, but it is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent noncompliance may not be effective in protecting us from governmental investigations for failure to comply with applicable fraud and abuse or other healthcare laws and regulations.
In the United States, we are subject to various state and federal anti-fraud and abuse laws, including, without limitation, the federal healthcare Anti-Kickback Statute and federal civil False Claims Act. There are similar laws in other countries. Our current and future arrangements with healthcare providers, third-party payors, customers, and others may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which we research, as well as, sell, market, and distribute any products for which we obtain marketing approval. Healthcare fraud and abuse laws and related regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. The laws that may affect our ability to operate include:
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State and federal regulatory and enforcement agencies continue to actively investigate violations of healthcare laws and regulations, and the U.S. Congress continues to strengthen the arsenal of enforcement tools. Most recently, the Bipartisan Budget Act of 2018 (“BBA”), increased the criminal and civil penalties that can be imposed for violating certain federal health care laws, including the Anti-Kickback Statute. Enforcement agencies also continue to pursue novel theories of liability under these laws. In particular, government agencies recently have increased regulatory scrutiny and enforcement activity with respect to manufacturer reimbursement support activities and patient support programs, including bringing criminal charges or civil enforcement actions under the Anti-Kickback Statute, federal civil False Claims Act and HIPAA’s healthcare fraud and privacy provisions.
Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions or safe harbors, it is possible that some of our activities, such as stock-option compensation paid to doctors that have entered into consulting agreements with us, could be subject to challenge under one or more of such laws. Any action brought against us for violations of these laws or regulations, even successfully defended, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. We may be subject to private “qui tam” actions brought by individual whistleblowers on behalf of the federal or state governments.
The growth of our business and sales organization and our expansion outside of the United States may increase the potential of violating these laws or our internal policies and procedures. The risk of our being found in violation of these or other laws and regulations is further increased by the fact that many have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Any action brought against us for violation of these or other laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of the federal, state and foreign laws described above or any other current or future fraud and abuse or other healthcare laws and regulations that apply to us, we may be subject to penalties, including significant criminal, civil, and administrative penalties, damages, fines, imprisonment of individuals, exclusion from participation in government programs, such as Medicare and Medicaid, and we could be required to curtail or cease our operations. Any of the foregoing consequences could seriously harm our business and our financial results.
Achieving and sustaining compliance with applicable federal and state anti-fraud and abuse laws may prove costly. If we or our employees are found to have violated any of the above laws we may be subjected to substantial criminal, civil and administrative penalties, including imprisonment, exclusion from participation in federal healthcare programs, such as Medicare and Medicaid, and significant fines, monetary penalties, forfeiture,
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disgorgement and damages, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. Any action or investigation against us for the violation of these healthcare fraud and abuse laws, even if successfully defended, could result in significant legal expenses and could divert our management’s attention from the operation of our business. Companies settling federal civil False Claims Act, Anti-Kickback Statute or civil monetary penalties law cases also may be required to enter into a Corporate Integrity Agreement with the OIG in order to avoid exclusion from participation (i.e., loss of coverage for their products) in federal healthcare programs such as Medicare and Medicaid. Corporate Integrity Agreements typically impose substantial costs on companies to ensure compliance. Defending against any such actions can be costly, time-consuming and may require significant personnel resources, and may have a material adverse effect on our business, financial condition and results of operations.
Changes in the CMS fee schedules may harm our revenue and operating results.
Government payers, such as CMS as well as insurers, have increased their efforts to control the cost, utilization and delivery of healthcare services. From time to time, the United States Congress has considered and implemented changes in the CMS fee schedules in conjunction with budgetary legislation. Reductions of reimbursement by Medicare or Medicaid for procedures that use our products or changes in policy regarding coverage of these procedures, such as adding requirements for payment, or prior authorizations, may be implemented from time to time. Reductions in the reimbursement rates and changes in payment policies of other third-party payers may occur as well. Similar changes in the past have resulted in reduced payments for procedures that use medical device products as well as added costs and have added more complex regulatory and administrative requirements. Further changes in federal, state, local and third-party payer regulations or policies may have a material adverse impact on the demand for our products and on our business. Actions by agencies regulating insurance or changes in other laws, regulations, or policies may also have a material adverse effect on our business, financial condition and results of operations.
Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of our planned or future products and to manufacture, market and distribute our products after clearance or approval is obtained.
From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of planned or future products. It is impossible to predict whether legislative changes will be enacted, or FDA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be.
Any change in the laws or regulations that govern the clearance and approval processes relating to our current, planned and future products could make it more difficult and costly to obtain clearance or approval for new products or to produce, market and distribute existing products. Significant delays in receiving clearance or approval or the failure to receive clearance or approval for our new products would have an adverse effect on our ability to expand our business.
Compliance with the EU Medical Device Regulation, applicable regulations in the United Kingdom, and other applicable foreign regulations, as well as any changes to existing regulations, may be costly and disruptive to our business, and expose us to increased liability.
In 2017, the European Union (“EU”) published the new EU Medical Device Regulation (“EU MDR”) (2017/745), the application of which was postponed until May 26, 2021 for class I devices (lowest risk) and May 26, 2024 for all other class devices (higher risk devices). In February 2023, EU Parliament voted to extend the EU MDR transition timelines, which postpones application until December 2027 for higher-risk Class III and implantable IIb devices and until December 2028 for lower-risk Class I and IIa devices. The new regulations replace predecessor directives and emphasize a global convergence of regulations. With the transition from the Medical Devices Directive (“MDD”), to the EU MDR, notified bodies are required to seek designation to operate as conformity assessment authorities under the new law. While we are currently in compliance with the EU MDR and in process of transferring certification from MDD to EU MDR, compliance with any new or changing regulations in the EU or other jurisdictions where we currently commercialize our products or intend to commercialize in the future is a time
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consuming process that may require comprehensive quality system audits and new conformity assessment certifications for our products. Major changes include:
Implementation of the Medical Device Regulations introduces substantial changes to the obligations with which medical device manufacturers must comply in the EU. High risk medical devices will be subject to additional scrutiny during the conformity assessment procedure. For any products that we may develop in the future, complying with these new regulations may result in Europe being less attractive as a “first market” destination. Marketing authorization timelines will become more protracted and the costs of operating in Europe will increase. A significantly more costly path to regulatory compliance is anticipated.
Our clinical trials may fail to demonstrate competent and reliable evidence of the safety and effectiveness of our products, which would prevent or delay commercialization of our products in development.
We may be required to conduct clinical studies that demonstrate competent and reliable evidence that our products are safe and effective before we can commercialize our products. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. We cannot be certain that our planned clinical trials or any other future clinical trials will be successful. In addition, even if such clinical trials are successfully completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our products for approval. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our products. Even if regulatory approval is secured for any of our products, the terms of such approval may limit the scope and use of our products, which may also limit their commercial potential.
Defects or failures associated with our products could lead to recalls, safety alerts or litigation, as well as significant costs and negative publicity.
Our business is subject to significant risks associated with manufacture, distribution and use of medical devices that are placed inside the human body, including the risk that patients may be severely injured by or even die from the misuse or malfunction of our products caused by design flaws or manufacturing defects. In addition, component failures, design defects, off-label uses, or inadequate disclosure of product-related information could also result in an unsafe condition or the injury or death of a patient. These problems could lead to a recall or market withdrawal of, or issuance of a safety alert relating to, our products and result in significant costs, negative publicity and adverse competitive pressure. The circumstances giving rise to recalls are unpredictable, and any recalls of existing or future products could have a material adverse effect on our business, financial condition and results of operations.
We provide a limited warranty that our products are free of material defects and conform to specifications and offer to repair the LDD in the event of a defect and replace or refund the purchase price of a defective LAL. As a result, we bear the risk of potential warranty claims on our products. In the event that we attempt to recover some or all of the expenses associated with a warranty claim against us from our suppliers or vendors, we may not be successful in claiming such recovery, or any recovery from such vendor or supplier may be inadequate or unavailable.
The medical device industry has historically been subject to extensive litigation over product liability claims. We may be subject to product liability claims if our products cause, or merely appear to have caused, an injury or
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death, even if due to doctor error. In addition, an injury or death that is caused by the activities of our suppliers, such as those that provide us with components and raw materials, or by an aspect of a treatment used in combination with our products, such as a complementary drug or anesthesia, may be the basis for a claim against us by patients, doctors or others purchasing or using our products, even if our products were not the actual cause of such injury or death. We may choose to settle any claims to avoid a determination of fault, even if we believe fault was not due to failure of our products. An adverse outcome involving one of our products could result in reduced market acceptance and demand for such products or any or all of our other products and could harm our brand and reputation and our ability to market our products in the future. In some circumstances, adverse events arising from or associated with the design, manufacture or marketing of our products could result in the suspension or delay of regulatory reviews of our premarket notifications or applications for marketing. Any of the foregoing problems could disrupt our business and have a material adverse effect on our business, financial condition and results of operations.
Although we carry product liability insurance in the United States and in other countries in which we conduct business, including for clinical trials and product marketing, we can give no assurance that such coverage will be available or adequate to satisfy any claims. Product liability insurance is expensive, subject to significant deductibles and exclusions, and may not be available on acceptable terms, if at all. If we are unable to obtain or maintain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against potential product liability claims, we could be exposed to significant liabilities. A product liability claim recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could have a material adverse effect on our business, financial condition and results of operations. Defending a suit, regardless of its merit or eventual outcome, could be costly, could divert management’s attention from our business and might result in adverse publicity, which could result in reduced acceptance of our products in the market, product recalls or market withdrawals.
We are required to file adverse event reports under MDR, regulations with the FDA that are publicly available on the FDA’s website. We are required to file MDRs if our products may have caused or contributed to a serious injury or death or malfunctioned in a way that could likely cause or contribute to a serious injury or death if it were to recur. Any such MDR that reports a significant adverse event could result in negative publicity, which could harm our reputation and future sales. If we fail to report events required to be reported to the FDA within the required timeframes, or at all, the FDA could take enforcement action and impose sanctions against us. Any such adverse event involving our products also could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, would require our time and capital, distract management from operating our business and may harm our reputation and have a material adverse effect on our business, financial condition and results of operations.
Our employees, independent contractors, consultants, commercial partners, distributors and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
We are exposed to the risk that our employees, independent contractors, consultants, commercial partners, distributors and vendors may engage in fraudulent or illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (i) the laws of the FDA and other similar foreign regulatory bodies, including those laws requiring the reporting of true, complete and accurate information to such regulators; (ii) manufacturing standards; (iii) healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or (iv) laws that require the true, complete and accurate reporting of financial information or data. These laws may impact, among other things, future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commissions, certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.
We have adopted a code of business conduct and ethics, but it is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from
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governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant fines or other sanctions, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, additional integrity reporting and oversight obligations, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of operations, any of which could adversely affect our ability to operate our business and our results of operations. Whether or not we are successful in defending against any such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations, which could have a material adverse effect on our business, financial condition and results of operations.
Environmental health and safety laws may result in liabilities, expenses and restrictions on our operations. Failure to comply with environmental laws and regulations could subject us to significant liability.
Our research and development and manufacturing operations involve the use of hazardous substances and are subject to a variety of federal, state, local and foreign environmental laws and regulations relating to the storage, use, discharge, disposal, remediation of, and human exposure to, hazardous substances and the sale, labeling, collection, recycling, treatment and disposal of products containing hazardous substances. Liability under environmental laws and regulations can be joint and several and without regard to fault or negligence. Compliance with environmental laws and regulations may be expensive and noncompliance could result in substantial liabilities, fines and penalties, personal injury and third-party property damage claims and substantial investigation and remediation costs. Environmental laws and regulations could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We cannot assure you that violations of these laws and regulations will not occur in the future or have not occurred in the past as a result of human error, accidents, equipment failure or other causes. The expense associated with environmental regulation and remediation could harm our financial condition and operating results.
Federal, state, local and foreign laws regarding environmental protection, hazardous substances and human health and safety may adversely affect our business. Our research and development and manufacturing operations involve the use of hazardous substances and are subject to a variety of federal, state, local and foreign environmental laws and regulations relating to the storage, use, discharge, disposal and remediation of, as well as human exposure to, hazardous substances and the sale, labeling, collection, recycling, treatment and disposal of products containing hazardous substances. These operations are permitted by regulatory authorities, and the resultant waste materials are disposed of in material compliance with environmental laws and regulations. Using hazardous substances in our operations exposes us to the risk of accidental injury, contamination or other liability from the use, storage, importation, handling or disposal of hazardous materials. If our or our suppliers’ operations result in the contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and fines, and any liability could significantly exceed our insurance coverage and have a material adverse effect on our on our business, financial condition and results of operations. Liability under environmental laws and regulations can be joint and several and without regard to fault or negligence. Compliance with environmental laws and regulations may be expensive, and non-compliance could result in substantial liabilities, fines and penalties, personal injury and third-party property damage claims and substantial investigation and remediation costs. Environmental laws and regulations could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We cannot assure you that violations of these laws and regulations will not occur in the future or have not occurred in the past as a result of human error, accidents, equipment failure or other causes. The expense associated with environmental regulation and remediation could harm our business, financial condition and results of operation.
We face risks related to our collection and use of data, which could result in investigations, inquiries, litigation, fines, legislative and regulatory action and negative press about our privacy and data and security protection practices.
Our business processes personal data, including some data related to health. When conducting clinical trials, we face risks associated with collecting trial participants’ data, especially health data, in a manner consistent with applicable laws and regulations, such as the Common Rule (“GCP”) guidelines, or FDA human subject protection regulations. We also face risks inherent in handling large volumes of data and in protecting the security of such data. We have been and could again be subject to attacks on our systems by outside parties, or by fraudulent or
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inappropriate behavior by our service providers or employees. Third parties may also gain access to users’ accounts using stolen or inferred credentials, computer malware, viruses, spamming, sim-swap attacks, phishing attacks or other means, and may use such access to obtain users’ personal data or prevent use of their accounts. Data breaches or other incidents could result in a violation of applicable United States and international privacy, data protection, security and other laws, and subject us to individual or consumer class action litigation and governmental investigations and proceedings by federal, state and local regulatory entities in the United States and by international regulatory entities, resulting in exposure to material civil and/or criminal liability. Further, our general liability insurance and corporate risk program may not cover all potential claims to which we are exposed and may not be adequate to indemnify us for all liability that may be imposed.
This risk is enhanced in certain jurisdictions and, as we expand our operations domestically and internationally, we may be subject to additional laws in other jurisdictions. Any failure, or perceived failure, by us to comply with privacy, data protection or security laws, rules and regulations could result in proceedings or actions against us by governmental entities or others. These proceedings or actions may subject us to significant penalties and negative publicity, require us to change our business practices, increase our costs and severely disrupt our business. In the United States, various federal and state regulators, including governmental agencies like the Consumer Financial Protection Bureau and the Federal Trade Commission, have adopted, or are considering adopting, laws, regulations or rules concerning personal information and data security and have prioritized privacy and security violations for enforcement actions. Additionally, in the United States, California adopted the CCPA in January 2020, which requires certain companies that process information of California consumers to, among other things, provide certain disclosures to California consumers and afford such consumers abilities to exercise certain rights with respect to their personal information and opt out of certain sales of personal information, in addition to severely limiting our ability to use their information. The CCPA provides for civil penalties for violations, as well as a private right of action for certain data breaches that result in the unauthorized access and exfiltration, theft, or disclosure of personal information. Furthermore, in November 2020, California voters passed the CPRA, which became effective January 1, 2023. The CPRA imposes additional obligations on covered companies and significantly modifies the CCPA, including by expanding California residents’ rights with respect to certain sensitive personal information. Other states have proposed or enacted privacy laws that are similar to the CCPA and CPRA, further complicating the legal landscape. Further, other states have enacted laws that cover certain aspects of the collection, use, disclosure, and/or other processing of health information, such as Washington’s My Health, My Data Act, which, among other things, provides for a private right of action. It remains unclear how various provisions of the CCPA and these other new and evolving state laws will be interpreted and enforced. In addition, laws in all 50 states require businesses to provide notice to consumers whose personal information has been accessed or acquired as a result of a data breach (and, in some cases, to regulators). The effects of the CCPA, CPRA and other such privacy laws are potentially significant, and may require us to modify our practices and policies and to incur substantial costs and expenses in an effort to comply.
In addition, we are subject to international laws, regulations and standards in many jurisdictions, which apply broadly to the collection, use, retention, security, disclosure, transfer and other processing of personal information. For example, the GDPR, which was adopted by the EU and became effective in May 2018, applies extraterritorially and imposes several stringent requirements for controllers and processors of personal data, including, for example, higher standards for obtaining consent from individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime, shortened timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to special categories of personal data and pseudonymized (i.e., key-coded) data and additional obligations when we contract third-party processors in connection with the processing of the personal data.
The GDPR provides that EU member states may make their own laws and regulations limiting the (i) processing of personal data, including special categories of data (e.g., racial or ethnic origin, political opinions, religious or philosophical beliefs) and (ii) profiling and automated individual decision-making of individuals, which could limit our ability to use and share personal data or other data and could cause our costs to increase, harming our business and financial condition. Non-compliance with the GDPR is subject to significant penalties, including fines of up to €20 million or 4% of total worldwide revenue, whichever is greater. Interpretations of the GDPR by local data protection authorities in EU member states, along with the complexity of the regime itself, create uncertainty regarding the interpretation and enforcement of the law, with potential inconsistencies across EU member states. Other jurisdictions outside the EU are similarly introducing or enhancing laws and regulations relating to privacy, data protection or security, which enhances risks relating to compliance with such laws. Further, the United
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Kingdom has adopted the UK General Data Protection Regulation and UK Data Protection Act, which retain the GDPR in the United Kingdom’s national law and provide for a penalty structure similar to the GDPR. These recent developments have required us to review and modify the legal means by which we process personal data and may require us to make other modifications. The implementation and enforcement of the GDPR and other evolving legislation may subject us to enforcement risk and requirements to change certain of our data collection, processing and other policies and practices. We could incur significant costs investigating and defending such claims and, if we are found liable, significant damages. If any of these events were to occur, our business and financial results could be adversely affected.
Additionally, we are subject to laws and regulations regarding cross-border transfers of personal data, including laws relating to transfer of personal data outside of the European Economic Area (“EEA”), Switzerland, and the United Kingdom. We rely on transfer mechanisms permitted under these laws, including EU Standard Contractual Clauses (“SCCs”). Such mechanisms have received heightened regulatory and judicial scrutiny in recent years. The Court of Justice of the European Union (“CJEU”) issued a decision in 2020 invalidating a transfer of personal data from the EEA and Switzerland to the U.S. and imposing additional obligations on companies using the SCCs. The European Commission has adopted new SCCs that are required to be implemented, and the United Kingdom has adopted new standard contractual clauses that also are required to be implemented. In June 2021, the European Commission issued an adequacy decision in respect of the United Kingdom’s data protection framework, enabling data transfers from EU member states to the United Kingdom to continue without requiring contractual or other additional measures. While it is intended to last for at least four years, the European Commission may revoke the adequacy decision at any point, and if this occurs it could lead to additional costs and increase our overall risk exposure. These developments and other regulatory guidance or developments may impose additional obligations with respect to the transfer of personal data from the EEA, Switzerland, and the United Kingdom, all of which could restrict our activities in those jurisdictions, limit our ability to provide our products and services in those jurisdictions, require us to modify our policies and practices, and to engage in additional contractual negotiations, or increase our costs and obligations and impose limitations upon our ability to efficiently transfer personal data from the EEA, Switzerland, and the United Kingdom to the U.S. This could adversely affect the manner in which we provide our services and thus materially affect our operations and financial results.
Because the interpretation and application of laws, regulations, standards and other obligations relating to privacy, data protection and security are still uncertain, it is possible that these laws, regulations, standards and other obligations may be interpreted and applied in a manner that is inconsistent with our practices and policies. Any noncompliance, or perceived noncompliance, with laws, regulations, standards and other obligations or changes in interpretations or applications of existing laws, regulations, standards and other obligations, may subject us to fines, audits, inquiries, whistleblower complaints, adverse media coverage, investigations, lawsuits, loss of export privileges, severe criminal or civil sanction or other penalties. Additionally, although we endeavor to comply with our public statements and documentation, we may at times fail to do so or be alleged to have failed to do so. The publication of our privacy policies and other statements that provide notices and representations about privacy, data protection or security can subject us to potential government or legal action if they are found to be deceptive, unfair or misrepresentative of our actual practices. Any concerns about our privacy, data protection or security practices, even if unfounded, could damage the reputation of our businesses and discourage potential users from our products and services. Any of the foregoing could have an adverse effect on our business, financial condition, results of operations and prospects.
Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result.
Disruptions at the FDA and other agencies, including delays, travel restrictions, and staffing shortages, may also slow the time necessary for new medical devices to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in 2018 and 2019, the U.S. government shut down several times and certain regulatory agencies such as the FDA had to furlough critical employees and stop critical activities.
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In March 2020, in response to the COVID-19 pandemic, foreign and domestic inspections of facilities were largely placed on hold, the FDA worked to resume routine surveillance, bioresearch monitoring and pre-approval inspections on a prioritized basis. During 2020 and 2021 a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications. While the FDA has largely caught up with domestic preapproval inspections, it continues to work through its backlog of foreign inspections. However, the FDA may not be able to continue its current inspection pace or may be unable to complete required inspections during the review period, which can delay clinical development and result in a complete response letter. On May 11, 2023, the federal government ended the COVID-19 public health emergency, which ended a number of temporary changes made to federally funded programs while some continue to be in effect. The full impact of such policy changes and the wind-down of the public health emergency on the FDA and other regulatory policies and operations is unclear. Disruptions at the FDA could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Our global operations can expose us to numerous and sometimes conflicting legal and regulatory requirements, including to anti-bribery and anti-corruption laws, such as the FCPA and the U.K. Bribery Act, and violation of these requirements could result in substantial penalties and prosecution and harm our business.
We have commercialized the RxSight system outside of the United States, and each component is registered with the MHRA in the United Kingdom. We are subject to numerous, and sometimes conflicting, legal regimes in the countries in which we operate, including on matters as diverse as health and safety standards, marketing and promotional activities, anticorruption, import/export controls, content requirements, trade restrictions, tariffs, taxation, sanctions, immigration, internal and disclosure control obligations, securities regulation, anti-competition, data protection privacy, security and labor relations. This includes in emerging markets where legal systems may be less familiar to us. We strive to abide by and maintain compliance with these laws and regulations. Compliance with diverse legal requirements is costly, time-consuming and requires significant resources. Violations of one or more of these regulations in the conduct of our business could result in significant fines, criminal sanctions against us or our officers, prohibitions on doing business and damage to our reputation. Violations of these regulations in connection with the performance of our obligations to our customers also could result in liability for significant monetary damages, fines and/or criminal prosecution, unfavorable publicity and other reputational damage, restrictions on our ability to process information and allegations by our customers or distributors that we have not performed our contractual obligations. Due to the varying degrees of development of the legal systems of the countries in which we operate, local laws might be insufficient to protect our rights.
Our operations outside of the United States are subject to various heavily enforced anti-bribery and anti-corruption laws, such as the FCPA, U.K. Bribery Act and similar laws around the world. These laws generally prohibit U.S. companies and their employees and intermediaries from offering, promising, authorizing or making improper payments to foreign government officials for the purpose of obtaining or retaining business or gaining any advantage. We face significant risks if we, which includes our third-party business partners and intermediaries, fail to comply with the FCPA or other anti-corruption and anti-bribery laws. Responding to any enforcement action or related investigation may result in a materially significant diversion of management’s attention and resources and significant defense costs and other professional fees. Any violation of the FCPA or other applicable anti-bribery, anti-corruption or anti-money laundering laws could result in whistleblower complaints, adverse media coverage, investigations, loss of export privileges, severe criminal or civil sanctions and, in the case of the FCPA, suspension or debarment from U.S. government contracts, which could have a material and adverse effect on our business, financial condition and results of operations.
Our international operations could be affected by changes in laws, trade regulations, labor and employment regulations, and procedures and actions affecting approval, products and solutions, pricing, reimbursement and marketing of our products and solutions, as well as by inter-governmental disputes. Any of these changes could adversely affect our business. The imposition of new laws or regulations, including potential trade barriers, may increase our operating costs, impose restrictions on our operations or require us to spend additional funds to gain compliance with the new rules, if possible, which could have an adverse impact on our financial condition and results of operations.
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Risks related to reliance on third parties
From time to time, we engage outside parties to perform services related to certain of our clinical studies and trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our products.
From time to time, we engage consultants to help design, monitor and analyze the results of certain of our clinical studies and trials. The consultants we engage interact with clinical investigators to enroll patients in our clinical trials. We depend on these consultants and clinical investigators to conduct clinical studies and trials and monitor and analyze data from these studies and trials under the investigational plan and protocol for the study or trial and in compliance with applicable regulations and standards, such as GCP guidelines, the Common Rule, and FDA human subject protection regulations. We may face delays in our regulatory approval process if these parties do not perform their obligations in a timely, compliant or competent manner. If these third parties do not successfully carry out their duties or meet expected deadlines, or if the quality, completeness or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical trial protocols or for other reasons, our clinical studies or trials may be extended, delayed or terminated or may otherwise prove to be unsuccessful, and we may have to conduct additional studies, which would significantly increase our costs, in order to obtain the regulatory clearances or approvals that we need to commercialize our products.
We and our component suppliers may not meet regulatory quality standards applicable to our manufacturing processes, which could have an adverse effect on our business, financial condition and results of operations.
As a medical device manufacturer, we must register with the FDA and non-U.S. regulatory agencies in jurisdictions where we commercialize our products, and we are subject to periodic inspection by the FDA and foreign regulatory agencies, for compliance with certain good manufacturing practices, including design controls, product validation and verification, in process testing, quality control and documentation procedures. Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA and foreign regulatory agencies. Our manufacturer, component, and sub-component suppliers are also required to meet certain standards applicable to their manufacturing processes.
We cannot assure you that we or our component suppliers comply or can continue to comply with all regulatory requirements. The failure by us or one of our component suppliers to achieve or maintain compliance with these requirements or quality standards may disrupt our ability to supply products sufficient to meet demand until compliance is achieved or, with a component supplier, until a new supplier has been identified and evaluated. Our or any of our component supplier’s failure to comply with applicable regulations could cause sanctions to be imposed on us, including warning letters, fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our products, delays, suspension or withdrawal of approvals or clearances, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, which could harm our business. We cannot assure you that if we need to engage new suppliers to satisfy our business requirements, we can locate new suppliers in compliance with regulatory requirements at a reasonable cost and in an acceptable timeframe. Our failure to do so could have a material adverse effect on our business, financial condition and results of operations.
For products that we currently distribute or market in the EU and the United Kingdom, as well as future products for which we obtain the applicable marketing authorization, we must maintain certain International Organization for Standardization (“ISO”), certifications to sell our products and must undergo periodic inspections by notified bodies, such as BSI, to obtain and maintain these certifications. If we fail these inspections or fail to meet these regulatory standards, it could have a material adverse effect on our business, financial condition and results of operations.
We depend upon third parties, including single and sole source suppliers, to manufacture certain components and subcomponents of the RxSight system making us vulnerable to supply disruptions and price fluctuations.
We rely on third parties, including single and sole source suppliers, to manufacture certain components and subcomponents of our products and to provide raw materials, primarily chemicals for our LAL. We do not have long-term supply agreements with, or guaranteed commitments from our suppliers, including single and sole source suppliers. We utilize purchase orders or blanket orders covering the medium term of 18–24 months for the majority of our supplier base. While we depend on our suppliers to provide us and our customers with materials in a timely manner that meet our and their quality, quantity and cost requirements, vendors will miss delivery dates, extend delivery dates or in some circumstances cancel purchase orders because these suppliers may encounter problems during manufacturing for a variety of reasons, any of which could delay or impede their ability to meet our demand.
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The expansion of global lead times has resulted in the lack of availability of raw materials, including semiconductors, computers, monitors electronic parts, metals, packaging, adhesives, chemicals, resins and subcontract painted components. Certain suppliers have passed on higher prices, surcharges and expedited shipping fees to defray the higher commodity prices they are paying due to short supply and pushed out delivery dates. Additionally, we identify and qualify new suppliers to mitigate risk due to single and sole source suppliers and to alleviate supply chain constraints we will identify and qualify new vendors or substitute components which requires testing, validations and documentation adding to internal costs and diverting engineering resources from other projects. While we have taken measures to mitigate business continuity risk, including increasing standard lead times, payment of expedite fees, issuance of a limited number of non-cancelable purchase orders, advance delivery of critical components ahead of normal delivery dates and second sourcing, our suppliers may cease producing the components we purchase from them or otherwise decide to cease doing business with us. Any supply interruption from our suppliers or failure to obtain additional suppliers for any of the components or subcomponents used in our products would limit our ability to manufacture our current and new products and could have a material adverse effect on our business, financial condition and results of operations.
The failure of third parties to meet their contractual, regulatory, and other obligations could adversely affect our business.
We rely on suppliers, vendors, outsourcing partners, consultants, and other third parties to research, develop, manufacture and commercialize our products. Using these third parties poses a number of risks, such as: (i) they may not perform to our standards or legal requirements; (ii) they may not produce reliable results; (iii) they may not perform in a timely manner; (iv) they may not maintain confidentiality of our proprietary information; (v) disputes may arise with respect to ownership of rights to technology developed with our partners; and (vi) disagreements could cause delays in, or termination of, the research, development or commercialization of our products or result in litigation or arbitration. Moreover, some third parties are located in markets subject to political and social risk, corruption, infrastructure problems and natural disasters, in addition to country-specific privacy, data protection and security risk given current legal and regulatory environments. Failure of third parties to meet their contractual, regulatory and other obligations may have a material adverse effect on our business, financial condition and results of operations.
Risks related to our common stock
The price of our stock may be volatile, and you could lose all or part of your investment.
The trading price of our common stock has been and may continue to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which we cannot control. From the date of our initial public offering through August 1, 2024, our common stock has traded at a low of $8.80 and a high of $66.54 on the Nasdaq Global Market. The stock market in general has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. In addition to the factors discussed in Part II, Item 1A, “Risk Factors,” and elsewhere in this report, these factors include:
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The realization of any of the above risks or any of a broad range of other risks, including those described in this Part II, Item 1A, “Risk Factors,” could have a dramatic and adverse impact on the market price of our common stock.
In addition, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.
If securities or industry analysts do not publish research or publish unfavorable research about our business, our stock price and trading volume could decline.
The trading market for our common stock will rely in part on the research and reports that equity research analysts publish about us and our business. We will not have any control of the analysts or the content and opinions included in their reports. The price of our stock could decline if one or more equity research analysts downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease, which in turn could cause our stock price or trading volume to decline.
We do not know whether an active, liquid and orderly trading market will exist for our common stock or what the market price of our common stock will be and as a result it may be difficult for you to sell your shares of our common stock.
Our common stock is currently traded on Nasdaq Global Market, but we can provide no assurance that we will be able to maintain an active trading market on Nasdaq Global Market or any other exchange in the future. If an active trading market does not develop, or is not maintained, or if we fail to satisfy the continued listing standards of the Nasdaq Global Market or applicable SEC rules for any reason and our securities are delisted, you may have difficulty selling any of our shares of common stock that you buy. The lack of an active trading market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The lack of an active trading market may also reduce the fair market value of your shares. Furthermore, an inactive trading market may also impair our ability to raise capital by selling shares of our common stock and may impair our ability to enter into strategic collaborations or acquire companies, technologies or other assets by using our shares of common stock as consideration.
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock.
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As of September 30, 2024, we had 40,254,105 shares of common stock issued and outstanding. All of these shares are available for sale in the public market, subject to limitations under Rule 144 with respect to affiliates of our company.
We have filed registration statements on Form S-8 under the Securities Act registering the offer and sale of up to an aggregate of 10,660,797 shares of common stock pursuant to our Equity Plans and an aggregate of 757,694 shares of common stock pursuant to our 2021 ESPP. Our 2021 Plan and 2021 ESPP each contain an evergreen provision that may increase the number of shares available for issuance pursuant to such plans on the first day of each fiscal year. See Note 6 – Stock-Based Compensation Expense in the Notes to the unaudited condensed consolidated financial statements included in this report.
On May 8, 2024, we filed an automatic shelf registration statement on Form S-3ASR with the SEC that enables us to offer for sale, from time to time and as the capital markets permit, an unspecified amount of common stock, preferred stock, debt securities, warrants and units. The shelf registration statement became automatically effective upon filing and is valid for three years. Each time we offer to sell securities under the registration statement, we will provide a prospectus supplement that will contain specific information about the terms of that offering and the securities being offered. For example, on May 9, 2024, we filed a prospectus supplement for the offer and sale of up to 1,785,714 shares of our common stock in an underwritten public offering (the “Public Offering”). On May 13, 2024, we issued 2,053,571 shares of our common stock at a price to the public of $56.00 per share, which included the full exercise by the underwriters of their option to purchase up to 267,857 additional shares. Our net proceeds from the offering were $107.5 million, after deducting $6.9 in underwriting discounts and commissions and $0.6 million in other offering costs.
We cannot predict what effect, if any, sales of our shares in the public market or the availability of shares for sale will have on the market price of our common stock. However, future sales of substantial amounts of our common stock in the public market, or the perception that such sales may occur, could adversely affect the market price of our common stock.
In the future, we may issue additional shares of common stock or other equity or debt securities convertible into common stock in connection with a financing, acquisition, litigation settlement, and employee arrangements or otherwise. Any such issuance could result in substantial dilution to our existing stockholders and could cause our stock price to decline.
We have incurred increased costs as a result of operating as a public company, and our management devotes substantial time to new compliance initiatives and corporate governance practices. Additionally, if we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
As a public company we are incurring significant legal, accounting and other expenses and these expenses may increase since after December 31, 2023, we are no longer considered an “emerging growth company.” We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Protection Act, as well as rules adopted, and to be adopted, by the SEC and Nasdaq. Our management and other personnel will need to devote a substantial amount of time and effort to these compliance initiatives. Moreover, we expect these rules and regulations to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly, which will increase our operating expenses. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain sufficient coverage. We cannot accurately predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified employees and persons to serve on our Board of Directors, our board committees or as executive officers.
Because we no longer qualify as an “emerging growth company” we will incur additional expenses and management’s time may be diverted in an effort to comply with compliance-related activities to comply with the increased documentation and reporting requirements under Section 404(b) of the Sarbanes-Oxley Act of 2002. The Sarbanes-Oxley Act requires, among other things, that we assess the effectiveness of our internal control over financial reporting annually and the effectiveness of our disclosure controls and procedures quarterly. In addition, our independent registered public accounting firm will have to attest to the effectiveness of our internal control over financial reporting under Section 404(b). We have implemented improved processes for documenting and evaluating our system of internal controls required under Section 404(b) however, the rules governing the standards
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that must be met for management to assess our internal control over financial reporting are complex and require significant judgment, documentation, testing and possible remediation to meet the detailed standards. During the course of documenting, evaluating and testing our internal control over financial reporting, our management may identify significant deficiencies or material weaknesses which may not be remedied in time to meet the deadline imposed by the Sarbanes-Oxley Act.
Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.
If we are unable to comply with the requirements of Section 404(b) of the Sarbanes-Oxley Act effectively and if management identifies one or more significant deficiencies or material weaknesses, or if our independent registered public accounting firm is unable to attest that our management’s report is fairly stated or if they are unable to express an opinion on the effectiveness of our internal controls or if we are unable to maintain proper and effective internal controls, we may not be able to produce timely and accurate financial statements any of which could result in a loss of investor confidence or negative investor perceptions. If any of the above were to happen, the market price of our stock could decline significantly and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.
We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
We have never declared or paid any cash dividends on our common stock. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to any appreciation in the value of their stock.
Provisions in our certificate of incorporation, bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our common stock.
Our certificate of incorporation and bylaws contain provisions that could depress the market price of our common stock by acting to discourage, delay or prevent a change in control of our company or changes in our management that the stockholders of our company may deem advantageous. These provisions, among other things:
In addition, Section 203 of the General Corporation Law of the State of Delaware, (“DGCL”), prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns, or within the last three years has owned, 15% of our
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voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.
Any provision of our amended and restated certificate of incorporation, amended and restated bylaws or Delaware law that has the effect of delaying or preventing a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock and could also affect the price that some investors are willing to pay for our common stock.
Our bylaws provide that, unless the company consents in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, another State court in Delaware or the federal district court for the District of Delaware) is the exclusive forum for:
This Delaware forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that the stockholder finds favorable for disputes with us or our directors, officers or other employees, which may discourage lawsuits against us and our directors, officers and other employees. Any person or entity purchasing or otherwise acquiring any interest in any of our securities shall be deemed to have notice of and consented to this provision. If a court were to find this Delaware forum provision to be inapplicable or unenforceable in an action, we may incur additional costs associated with litigating such disputes in multiple and/or other jurisdictions, which could seriously harm our business.
Our bylaws provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933, as amended against any person in connection with any offering of the Company’s securities, including but not limited to any auditor, underwriter, expert, control person, or other defendant. This federal forum provision may limit a stockholder’s ability to bring a Securities Act claim in a judicial forum that the stockholder finds favorable, which may discourage lawsuits against us and our directors, officers and other employees. Any person purchasing or otherwise acquiring any interest in any of our securities shall be deemed to have notice of and consented to this provision. While the Delaware Supreme Court has held such provisions to be facially valid as a matter of Delaware law and several state trial courts have enforced such provisions and required that suits asserting Securities Act claims be filed in federal court, there is no guarantee that courts of appeal will affirm the enforceability of such provisions. If a court were to find this federal forum provision to be inapplicable or unenforceable in an action, we may incur additional costs associated with litigating Securities Act claims in state court, or both state and federal court, which could seriously harm our business.
This Delaware forum provision does not apply to actions arising under the Securities Exchange Act of 1934 because the federal courts have exclusive jurisdiction over such claims.
Taxing authorities may successfully assert that we should have collected or in the future should collect sales and use, value added or similar taxes, and we could be subject to liability with respect to past or future sales, which could adversely affect our results of operations.
We rely on third party software for state and local tax rates, updated whenever tax rates change. We also rely on state exemptions, when applicable, for medical devices and services, which are determined by management’s review of each state’s sales tax laws and regulations concerning prescribed medical treatments. However, as laws and regulations change from time to time, these exemptions may or may not continue to apply to our products in the various taxing jurisdictions. Certain jurisdictions in which we do not collect such taxes on sales of our products may later assert that such taxes are applicable, which could result in tax assessments, penalties and interest, and we may
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be required to collect such taxes in the future. Such tax assessments, penalties and interest or future requirements may adversely affect the results of our operations.
Our Board of Directors are authorized to issue and designate shares of our preferred stock in additional series without stockholder approval under our charter documents and Delaware law.
Our certificate of incorporation authorizes our Board of Directors, without the approval of our stockholders, to issue shares of our preferred stock, subject to limitations prescribed by applicable law, rules and regulations and the provisions of our amended and restated certificate of incorporation, as shares of preferred stock in series, to establish from time to time the number of shares to be included in each such series and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations or restrictions thereof. The powers, preferences and rights of these additional series of preferred stock may be senior to or on parity with our common stock, which may reduce its value.
Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
The Tax Act enacted many significant changes to the U.S. tax laws, the consequences of which have not yet been fully determined. Changes in corporate tax rates, the realization of net deferred tax assets relating to our U.S. operations, the taxation of foreign earnings and the deductibility of expenses contained in the Tax Act or other tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges in the current or future taxable years and could increase our future U.S. tax expense. As an example, for taxable years beginning during or after 2022, the Tax Act eliminated the option to immediately deduct research and development expenditures currently and required taxpayers to capitalize and amortize them over five or fifteen years pursuant to Section 174 of the Code, which may impact our effective tax rate and our cash tax liability. However, recently proposed tax legislation, if enacted, would restore the ability to deduct currently domestic research and development expenditures through 2025 and would retroactively restore this benefit for 2022 and 2023. Regulatory or legislative developments may arise from various U.S. tax reform proposals, some of which include proposed changes to the U.S. tax law, which, if adopted, could result in increased taxation of our business operations. There is uncertainty regarding what changes, if any, will be enacted and the effect on our business and financial results. The foregoing items, as well as any future changes in tax laws, could have a material adverse effect on our business, cash flow, financial condition or results of operations. We will also continue to monitor and assess the impact of international tax reform, including but not limited to the 15% global minimal tax proposed by the Organisation for Economic Co-operation and Development. Finally, the Inflation Reduction Act of 2022 (the “IRA”) was effective beginning in fiscal year 2023. We do not currently expect that the IRA will have a material impact on our income tax liability.
General risk factors
Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
To succeed, we must recruit, retain, manage and motivate qualified executives as we build out the management team, and we face significant competition for experienced personnel. We are highly dependent on the principal members of our management and need to add executives with operational and commercialization experience as we plan for commercialization of our current and future products and build out a leadership team that can manage our operations as a public company. If we do not succeed in attracting and retaining qualified personnel, particularly at the management level, it could adversely affect our ability to execute our business plan and harm our operating results. In particular, the loss of one or more of our executive officers could be detrimental to us if we cannot recruit suitable replacements in a timely manner. The competition for qualified personnel in the medical device and ophthalmology field is intense and as a result, we may be unable to continue to attract and retain qualified personnel necessary for the future success of our business. We could in the future have difficulty attracting experienced personnel to our company and may be required to expend significant financial resources in our employee recruitment and retention efforts.
Many of the other medical device and biotechnology companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better prospects for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what we have to offer. If we are unable to continue to attract and retain high-quality personnel, the rate and success at which we can discover, develop and
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commercialize our current and future products will be limited and the potential for successfully growing our business will be harmed.
Our business and operations would suffer in the event of system failures or security breaches or incidents.
Our computer systems, as well as those of our contractors and other third parties with whom we do business, are vulnerable to damage from computer viruses, ransomware and other malicious code, unauthorized access, natural disasters (including hurricanes), terrorism, war and telecommunication and electrical failures. Any disruption or interruption in our systems, or those of our contractors or other third parties with whom we do business, whether from these or other causes, could cause interruptions in our operations, result in a material disruption of the commercialization of our RxSight system and our future products, and result in significant legal and financial exposure and reputational damages that could potentially have an adverse effect on our business. For example, the loss, corruption, or unavailability of preclinical study or clinical trial data from completed, ongoing, or planned trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Any disruption or security breach or incident resulting in, or believed or perceived to have reported in, the loss or unavailability of or damage to our data or applications, or inappropriate disclosure or other processing of personal, confidential or proprietary information, could cause us to incur liability and cause the commercialization of our RxSight system and the further development of our current and future products to be delayed.
The secure processing, maintenance, and transmission of this information is critical to our operations. Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers, internal bad actors, or others, or breached due to technical vulnerabilities, employee error, malfeasance, or other disruptions. Although, to our knowledge, we have not experienced any such material security breach to date, any security breach or security incident could compromise our systems and networks and the information stored or otherwise processed on them could be accessed, publicly disclosed, lost, stolen, rendered unavailable, modified, or otherwise processed without authorization. Any such actual or perceived access, disclosure, or other security breach or incident, loss, or unauthorized processing of information (whether affecting us or one of our third-party service providers or other third parties with whom we do business) could result in legal claims and proceedings, regulatory investigations, and other proceedings and liability under laws that protect the privacy of personal information, significant regulatory penalties or other fines or remedies, and such an event could disrupt our operations, damage our reputation, and cause a loss of confidence in us and our ability to commercialize our products and conduct clinical trials, which could adversely affect our reputation and delay the commercialization of our RxSight system and clinical development of our current and future products.
The techniques and sophistication used to conduct cyber-attacks and security breaches or other incidents, including of information technology systems, as well as the sources and targets of these attacks, may take many forms (including phishing, social engineering, denial or degradation of service attacks, sim swaps, ransomware, malware or other malicious code), change frequently and are often not recognized until such attacks are launched or have been in place for a period of time. In addition, our employees, contractors, or third parties with whom we do business may attempt to circumvent our security measures in order to misappropriate information, including confidential, personal, or otherwise regulated or protected information, and may purposefully or inadvertently cause a breach or incident involving, or compromise of, such information. Third parties may have the technology or know-how to breach the security of the information collected, stored, or transmitted by us, our contractors, third-party service providers, or other third parties with whom we do business, and our respective security measures, as well as those of our respective third-party service providers, may not effectively prohibit others from obtaining improper access to this information. Advances in computer and software capabilities and encryption technology, new tools, geopolitical tensions and conflicts, and other developments may increase the risk of such a breach, incident, or compromise. There is no assurance that any security procedures or controls that we, our contractors, or our third-party service providers or other third parties with whom we do business have implemented will be sufficient to prevent data-security related incidents from occurring.
We may be required to expend significant capital and other resources to protect against, respond to, and recover from any potential, attempted or existing security breaches, incidents, or failures and their consequences. As data security-related threats continue to evolve, we may be required to expend significant additional resources to continue to modify or enhance our protective measures or to investigate and remediate any information security vulnerabilities. We could be forced to expend significant financial and operational resources in responding to a security breach or incident, including investigating and remediating any information security vulnerabilities, defending against and resolving legal and regulatory claims and complying with notification obligations, all of
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which could divert resources and the attention of our management and key personnel away from our business operations and adversely affect our business, financial condition and results of operations. In addition, our remediation efforts may not be successful, and we could be unable to implement, maintain and upgrade adequate safeguards.
Our insurance policies may not be adequate to compensate us for the potential losses arising from any such disruption, failure, or security breach of, or security incident of or impacting, our systems or third-party systems where information important to our business operations or commercial development is stored or otherwise processed. In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, our insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.
Economic conditions may adversely affect our business.
Global economic, political and market conditions, armed conflict, including in Eastern Europe and the Middle East, and general economic downturns, may negatively impact our business. Challenging or uncertain economic conditions including those related to global epidemics, pandemics, or contagious diseases, geopolitical turmoil, and macroeconomic conditions, inflation, fluctuations in foreign exchange rates, instability in the global banking system, disruptions in supply chains and interest rates, could make it difficult for our customers and potential customers to accurately forecast and plan future business activities and may cause our customers and potential customers to slow or reduce spending, or vary order frequency, on our products. Furthermore, during challenging or uncertain economic times, our customers may face difficulties gaining timely access to sufficient credit and experience decreasing cash flow, which could impact their willingness to make purchases and their ability to make timely payments to us. Global economic conditions could have an adverse effect on demand for our products, including on our ability to predict future operating results and on our financial condition and operating results. If global economic conditions remain uncertain or deteriorate, it may materially impact our business, operating results and financial condition.
For example, we and other key international economies are currently operating in a period of economic uncertainty and the United States has recently experienced historically high levels of inflation and rising interest rates, which has led to increased costs of labor, capital, employee compensation and other similar effects. If unfavorable conditions in the national and global economy persist, or worsen, our current and potential customers’ operating costs will likely increase, which could result in reduced operating budgets. Our revenue may be disproportionately affected by delays or reductions in spending.
The present conditions and state of the U.S. and global economies make it difficult to predict whether, when and to what extent a recession has occurred or will occur in the near future. We cannot predict the timing, strength or duration of any economic slowdown, instability or recovery, generally or within any particular industry. If the economic conditions of the general economy or markets in which we operate do not improve, or worsen from present levels, our business, results of operations, and financial condition could be adversely affected.
Additionally, adverse worldwide economic conditions may also adversely impact our suppliers’ ability to provide us with materials and components, cause them to limit or place burdensome conditions upon future transactions with us, or affect their ability to fulfill their respective contractual obligations to us, which could have a material adverse effect on our business, financial condition and results of operations.
Litigation and other legal proceedings may adversely affect our business.
From time to time we may become involved in legal proceedings relating to patent and other intellectual property matters, product liability claims, employee claims, tort or contract claims, federal regulatory investigations, securities class action and other legal proceedings or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. Litigation is inherently unpredictable and can result in excessive or unanticipated verdicts and/or injunctive relief that affect how we operate our business. We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change the way we operate our business, or both. There may be an increase in the scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could have a material adverse effect on our business, financial condition and results of operations. Adverse publicity about regulatory or legal action against us could damage our reputation and brand image, undermine our customers’ confidence and reduce long-term demand for our products, even if the regulatory or legal action is unfounded or not material to our operations.
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Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
Our operations could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, severe weather conditions, medical epidemics and other natural or man-made disasters or business interruptions, for which we are predominantly self-insured. We rely on third-party manufacturers to produce our products. Our ability to obtain clinical supplies of our products could be disrupted if the operations of these suppliers were affected by a man-made or natural disaster or other business interruption. In addition, our corporate headquarters is located in Aliso Viejo, California, near major earthquake faults and fire zones, and the ultimate impact on us for being located near major earthquake faults and fire zones and being consolidated in a certain geographical area is unknown. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.
Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
We seek to maintain sufficient levels of inventory in order to protect ourselves from supply interruptions, but due to the expansion of global lead times, particularly in Europe and Asia, has resulted in the lack of availability of raw materials, including semiconductors, computers, monitors electronic parts, metals, packaging, adhesives, chemicals, resins and subcontract painted components, limiting our ability to maintain as much inventory of components, sub-assemblies, materials and finished products on hand as would be ideal under normal circumstances. To ensure adequate inventory supply and manage our operations with our third-party manufacturers and suppliers, we forecast anticipated materials requirements and demand for our products in order to predict inventory needs and then place orders with our suppliers based on these predictions. Our ability to accurately forecast demand for our products could be negatively affected by many factors, including our limited historical commercial experience, rapid growth, failure to accurately manage our expansion strategy, the expansion of global lead times, product introductions by competitors, an increase or decrease in customer demand for our products, our failure to accurately forecast customer acceptance of new products, unanticipated changes in general market conditions or regulatory matters and weakening of economic conditions or consumer confidence in future economic conditions.
Inventory levels in excess of customer demand, including as a result of our introduction of product enhancements, may result in a portion of our inventory becoming obsolete or expiring, as well as inventory write-downs or write-offs, which could have a material adverse effect on our business, financial condition and results of operations. Conversely, if we underestimate customer demand for our products or our own requirements for components, subassemblies and materials, our third-party manufacturers and suppliers may not be able to deliver components, sub-assemblies and materials to meet our requirements, which could result in inadequate inventory levels or interruptions, delays or cancellations of deliveries to our customers, any of which would damage our reputation, customer relationships and business. In addition, several components, sub-assemblies and materials incorporated into our products require lengthy order lead times, and additional supplies or materials may not be available when required on terms that are acceptable to us, or at all, and our third-party manufacturers and suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements, any of which could have an adverse effect on our ability to meet customer demand for our products and our business, financial condition and results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
(a) Recent Sales of Unregistered Securities
None
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(b) Use of Proceeds from Registered Securities
None
(c) Issuer Purchases of Equity Securities
None
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
None.
Item 5. Other Information.
Rule 10b5-1 Trading Arrangements
On
On
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Item 6. Exhibits.
The following exhibits are filed as part of, or incorporated by reference into, this report unless otherwise stated.
EXHIBIT INDEX
Exhibit |
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Incorporated by Reference |
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Number |
Description |
Form |
File No. |
Exhibit |
Filing Date |
10.1* |
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31.1* |
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31.2* |
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32.1† |
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32.2† |
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101.INS |
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
Inline XBRL Taxonomy Extension Schema with embedded linkbase documents. |
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Cover page Interactive Data File (embedded with the Inline XBRL document). |
* Filed herewith
† The certifications attached as Exhibit 32.1 and 32.2 that accompany this report are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of RxSight Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this report, irrespective of any general incorporation language contained in such filing.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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RxSight, Inc. |
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Date: November 7, 2024 |
By: |
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/s/ Ron Kurtz, M.D. |
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Ron Kurtz, M.D. |
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Chief Executive Officer and President |
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(Principal Executive Officer) |
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Date: November 7, 2024 |
By: |
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/s/ Shelley Thunen |
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Shelley Thunen |
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Co- President and Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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