Prosomnus Inc (OSA) 2023 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day and thank you for standing by. Welcome to the ProSomnus Q2 2023 investor update conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Mike Cavanaugh.

    美好的一天,感謝您的支持。歡迎參加 ProSomnus 2023 年第二季度投資者更新電話會議。 (操作員指示)請注意,今天的會議正在錄製中。我現在想把會議交給今天的發言人邁克·卡瓦諾 (Mike Cavanaugh)。

  • Mike Cavanaugh - IR

    Mike Cavanaugh - IR

  • Thank you and good morning. Welcome to the ProSomnus, Incorporated second-quarter investor update call. We thank you for joining us. Earlier today, ProSomnus issued a press release announcing our financial results for the quarter ended June 30, 2023, and describing the company's recent business highlights. You can access a copy of the announcement on the company's website at www.investors.prosomnus.com.

    謝謝你,早上好。歡迎參加 ProSomnus, Incorporated 第二季度投資者更新電話會議。我們感謝您加入我們。今天早些時候,ProSomnus 發布了一份新聞稿,公佈了截至 2023 年 6 月 30 日的季度財務業績,並描述了公司近期的業務亮點。您可以在公司網站 www.investors.prosomnus.com 上訪問該公告的副本。

  • With me on the call today are ProSomnus's Chief Executive, Len Liptak and Chief Financial Officer, Brian Dow. Len will begin the call discussing the quarter's business and operational highlights, Brian will then provide a review of financial results and our financial outlook for the remainder of 2023. And we will then conclude with a question-and-answer session.

    今天與我一起參加電話會議的是 ProSomnus 首席執行官 Len Liptak 和首席財務官 Brian Dow。 Len 將在電話會議開始時討論本季度的業務和運營亮點,然後 Brian 將回顧財務業績以及我們對 2023 年剩餘時間的財務前景。然後我們將以問答環節結束。

  • Before we begin, I would like to inform you that comments mentioned on today's call may be deemed to contain forward-looking statements and that actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in our Securities and Exchange Commission filings, including our most recent S-1 filed on May 30, 2023. Our SEC filings can be found through our company website at investors.prosumnus.com or at the SEC's website. Investors are cautioned not to place undue reliance on such forward-looking statements, and ProSomnus undertakes no obligation to publicly update or release any revisions to these forward-looking statements.

    在我們開始之前,我想通知您,今天電話會議中提到的評論可能被視為包含前瞻性陳述,並且由於某些風險和不確定性,實際結果可能與明示或暗示的結果存在重大差異。這些風險和不確定性在我們的證券交易委員會文件中詳細描述,包括我們於2023 年5 月30 日提交的最新S-1 文件。我們的SEC 文件可以通過我們公司網站Investors.prosumnus.com 或SEC的網站找到。網站。請投資者不要過分依賴此類前瞻性陳述,ProSomnus 不承擔公開更新或發布對這些前瞻性陳述的任何修訂的義務。

  • Please note that this conference call is being recorded and will be available for audio replay on our website at prosomnus.com in the News and Events section under our Investor Relations page shortly after the conclusion of this call. Today's press release and supplementary financial data tables have been posted to our website.

    請注意,本次電話會議正在錄音,並將在本次電話會議結束後不久在我們的網站 prosomnus.com 投資者關係頁面下的新聞和活動部分進行音頻重播。今天的新聞稿和補充財務數據表已發佈到我們的網站上。

  • And with that, I will turn it over to Len Liptak.

    接下來,我會將其交給 Len Liptak。

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • Thank you, Mike. Good day to everyone. Welcome to our second-quarter investor call. On behalf of every member of team ProSomnus, I am pleased to report record financial results, operational excellence, and strategic progress that exceeds expectations for Q2 2023.

    謝謝你,邁克。祝大家有美好的一天。歡迎參加我們第二季度的投資者電話會議。我代表 ProSomnus 團隊的每一位成員,很高興地報告創紀錄的財務業績、卓越的運營以及超出 2023 年第二季度預期的戰略進展。

  • Our vision is for ProSomnus devices to be the leading treatment for the 1 billion people worldwide suffering from obstructive sleep apnea. Our vision is based upon our assessment of the best available scientific data, feedback from expert clinicians, patient preference, medical guidelines, our technology development, and the belief that physicians, providers, payers, and patients will take a rational scientific approach to selecting and reimbursing the optimal treatment option for every patient.

    我們的願景是讓 ProSomnus 設備成為全球 10 億患有阻塞性睡眠呼吸暫停患者的領先治療方法。我們的願景基於我們對最佳可用科學數據的評估、專家臨床醫生的反饋、患者偏好、醫療指南、我們的技術開發,以及醫生、提供者、付款人和患者將採取合理的科學方法來選擇和治療的信念。為每位患者提供最佳治療方案的補償。

  • ProSomnus, as immediate opportunity, is to offer an effective, safe, and non-invasive treatment for the millions of people diagnosed with obstructive sleep apnea who have failed or refused continuous positive airway pressure, CPAP. We believe this immediate opportunity is estimated to be approximately 4 billion in the US alone, representing one of the largest opportunity for MedTech.

    ProSomnus 是一個迫在眉睫的機會,旨在為數百萬被診斷患有阻塞性睡眠呼吸暫停但失敗或拒絕持續氣道正壓通氣 (CPAP) 的患者提供有效、安全和非侵入性的治療。我們相信,僅在美國,這一直接機會估計就約為 40 億,是醫療科技領域最大的機會之一。

  • Treating OSA is also one of the most compelling opportunities in medicine. The consequences of untreated OSA are well established, including significantly higher rates of mortality, and an increased risk of heart attack and stroke, reduced cognitive function, impairment of everyday quality of life, and higher economic cost to payers and patients alike. We believe that our strong topline revenues, steady and leverageable gross margin, compelling data reported in the period, and on-plan progress of our strategic initiatives represent meaningful progress towards realizing our vision and validates our value proposition.

    治療 OSA 也是醫學領域最引人注目的機會之一。未經治療的阻塞性睡眠呼吸暫停的後果是眾所周知的,包括死亡率顯著升高、心髒病和中風的風險增加、認知功能下降、日常生活質量受損以及支付者和患者的經濟成本更高。我們相信,我們強勁的營收、穩定且可利用的毛利率、期內報告的令人信服的數據以及我們戰略舉措的按計劃進展代表了我們在實現願景方面取得的有意義的進展,並驗證了我們的價值主張。

  • During the second quarter of 2023, ProSomnus generated record revenues of $6.9 million, representing a 43% increase year over year from the second quarter of 2022 and 19% sequentially from what was a very strong first quarter of 2023. Looking at ProSomnus six months of 2023, we're reporting revenues of $12.7 million, a 48% year-over-year increase when compared to the same period of 2022. Relative to percentage growth, these results place ProSomnus within the upper echelon of publicly traded medical device companies in terms of revenue growth.

    2023 年第二季度,ProSomnus 創造了創紀錄的 690 萬美元收入,較 2022 年第二季度同比增長 43%,較 2023 年第一季度強勁增長 19%。看看 ProSomnus 六個月的收入到2023 年,我們報告的收入為1,270 萬美元,與2022 年同期相比,同比增長48%。相對於增長百分比,這些結果使ProSomnus 在上市醫療器械公司中處於領先地位收入增長。

  • Our strong results year to date are reflective of the clinicians and patients who, in increasing numbers, are trusting prescribing and ultimately utilizing ProSomnus devices to provide a safe, effective, and non-invasive treatment for OSA. During the second quarter of 2023, clinicians prescribe nearly twice as many ProSomnus devices as surgical alternatives, for example, ultimately selecting our therapy, which clinical studies suggest is more effective, significant, more economical for providers, patients and payers, and has fewer and less severe adverse events and side effects.

    我們今年迄今為止的強勁成果反映了越來越多的臨床醫生和患者相信處方並最終利用 ProSomnus 設備為 OSA 提供安全、有效和非侵入性的治療。例如,在2023 年第二季度,臨床醫生開出的ProSomnus 設備數量幾乎是手術替代方案的兩倍,最終選擇了我們的療法,臨床研究表明,這種療法對提供者、患者和付款人來說更有效、更重要、更經濟,而且需要更少和更經濟的方法。不太嚴重的不良事件和副作用。

  • Our EVO precision device family was a key driver of our growth in Q2 2023, representing 84% of sales volume. Post-market surveillance of 9,815 patients treated with ProSomnus EVO indicate 97% patient satisfaction and 97% clinical satisfaction. 99% of clinicians stated that they would recommend EVO and prescribe EVO again. We believe these levels of patient and clinician satisfaction indicate a growing validation of our differentiation.

    我們的 EVO 精密設備系列是我們 2023 年第二季度增長的關鍵驅動力,佔銷量的 84%。對 9,815 名接受 ProSomnus EVO 治療的患者進行的上市後監測表明,患者滿意度為 97%,臨床滿意度為 97%。 99%的臨床醫生表示他們會推薦EVO並再次開出EVO。我們相信,患者和臨床醫生的這些滿意度水平表明我們的差異化日益得到驗證。

  • In addition to the increasing clinical acceptance of our EVO precision devices, our revenue results for Q2 2023 and for the first six months of the year are also being driven by investments in our commercial capabilities. Based on the strong contributions from our excellent sales and manufacturing team members in North America and Europe, and an unprecedented opportunity to earn prescriptions from patients who have failed or refused CPAP, they invest in the expansion of our direct sales team at our targeted clinical marketing capabilities.

    除了我們的 EVO 精密設備的臨床接受度不斷提高之外,我們 2023 年第二季度和今年前六個月的收入結果也受到對商業能力的投資的推動。基於我們在北美和歐洲的優秀銷售和製造團隊成員的強大貢獻,以及從失敗或拒絕CPAP的患者那裡獲得前所未有的處方的機會,他們在我們有針對性的臨床營銷方面投資擴大了我們的直銷團隊能力。

  • Over the first half of 2023, we doubled our number of ProSomnus direct sales consultants from 13 to 26. We expect that each new rep will generate $400,000 in incremental revenue within the first year and will building carry on average a $2 million territory at maturity: a level our seasoned reps have demonstrated in the recent past. Once the territory reaches the maturity, we will subdivide based on procedure volumes to provide their locations with our current device offerings, labeling, and reimbursement rates.

    2023 年上半年,我們的ProSomnus 直銷顧問數量增加了一倍,從13 名增加到26 名。我們預計每位新代表將在第一年內產生40 萬美元的增量收入,並在成熟時平均建立200 萬美元的收益領域:我們經驗豐富的代表最近已經展示了這一水平。一旦該地區達到成熟,我們將根據手術量進行細分,為他們的地點提供我們當前的設備產品、標籤和報銷費率。

  • The objective for our sales consultants is to drive utilization rates at therapy providers who are primarily dentists trained in sleep medicine by originating and developing referral relationships with sleep-oriented physicians. Sales consultants accomplished this objective by clinical education, sharing data, and servicing, and fostering communications between sleep physicians and these therapy providers. We look forward to realizing additional revenue growth and leverage over the coming months from investments made in the first half of 2023 to expand our direct sales team.

    我們銷售顧問的目標是通過與以睡眠為導向的醫生建立和發展轉介關係來提高治療提供者的利用率,這些治療提供者主要是接受過睡眠醫學培訓的牙醫。銷售顧問通過臨床教育、共享數據和服務以及促進睡眠醫生和這些治療提供者之間的溝通來實現這一目標。我們期待在未來幾個月內通過 2023 年上半年為擴大我們的直銷團隊而進行的投資實現額外的收入增長和槓桿作用。

  • Looking forward, we have recently released and expect to have released additional data to further fuel growth as ProSomnus devices were featured in a scientific abstracts and podium presentations at seven scientific conferences in Q2 2023 alone. Preliminary data from the Front Line OSA Treatment Study, FLOSAT, was presented at the American Thoracic Society in May and the British Sleep Society in June.

    展望未來,我們最近發布並預計將發布更多數據,以進一步推動增長,因為僅 2023 年第二季度,ProSomnus 設備就出現在七場科學會議的科學摘要和講台演講中。前線 OSA 治療研究 FLOSAT 的初步數據分別於 5 月在美國胸科協會和 6 月在英國睡眠協會公佈。

  • FLOSAT is a head-to-head crossover trial comparing the efficacy of precision oral appliance therapy as frontline treatment versus CPAP for patients with moderate and severe OSA. The preliminary readout from FLOSAT indicates that ProSomnus devices are efficacious, safe and patient preferred as a frontline treatment relative to CPAP. Full results from FLOSAT are scheduled to be presented in August and also at the [Edbesma] conference in September and the World Sleep Congress in October.

    FLOSAT 是一項頭對頭交叉試驗,比較精準口腔矯治器治療作為一線治療與 CPAP 對中度和重度 OSA 患者的療效。 FLOSAT 的初步讀數表明,ProSomnus 設備有效、安全,是患者首選的相對於 CPAP 的一線治療方法。 FLOSAT 的完整結果計劃於 8 月公佈,並在 9 月的 [Edbesma] 會議和 10 月的世界睡眠大會上公佈。

  • A secondary observation from the preliminary FLOSAT data is that the treatment of severe OSA is directionally more effective than invasive implantable treatments. The preliminary FLOSAT data demonstrate that 79% of patients with severe OSA were successfully treated to an AHI of less than 20% and a 50% improvement.

    FLOSAT 初步數據的第二個觀察結果是,嚴重 OSA 的治療在定向上比侵入性植入治療更有效。初步 FLOSAT 數據表明,79% 的嚴重 OSA 患者得到了成功治療,AHI 低於 20%,改善了 50%。

  • [HNS] clinical studies routinely report success in the 65% range for moderate to severe OSA patients using the same success criteria but excluding concentric collapse patients due to a contraindication. Based on the FLOSAT observations, we've begun designing a randomized, controlled trial comparing precision oral appliance therapy and HNS for the treatment of severe OSA patients. The primary objective for this study is to provide physicians with the data to support optimal treatment selection for each and every patient.

    [HNS] 臨床研究通常報告,使用相同的成功標準,中度至重度 OSA 患者的成功率在 65% 範圍內,但由於禁忌症而排除同心塌陷患者。根據 FLOSAT 觀察結果,我們開始設計一項隨機對照試驗,比較精準口腔矯治器療法和 HNS 對嚴重 OSA 患者的治療效果。這項研究的主要目的是為醫生提供數據,以支持每位患者的最佳治療選擇。

  • I'm also pleased to report progress on our severe OSA study known as the SOS study. The objective of our SOS study is to demonstrate the safety and effectiveness of treating severe OSA patients with ProSomnus EVO. This data will be used to petition the FDA for expanding our label to include severe OSA. Severe OSA represents one-third of all patients carries high perceived value amongst physicians and has also opportunities for elevated reimbursement amounts.

    我還很高興地報告我們的嚴重 OSA 研究(稱為 SOS 研究)的進展。我們 SOS 研究的目的是證明 ProSomnus EVO 治療嚴重 OSA 患者的安全性和有效性。這些數據將用於向 FDA 申請擴大我們的標籤範圍,將嚴重的 OSA 納入其中。嚴重 OSA 佔所有患者的三分之一,在醫生中具有很高的認知價值,並且也有機會獲得更高的報銷金額。

  • All six SOS investigational centers are fully online, with five centers enrolling patients, and the sixth center expected to begin enrolling patients in Q3 2023. We anticipate full enrollment by the end of 2023 and a report on preliminary data in early 2024.

    所有六個SOS 研究中心均已全面上線,其中五個中心正在招募患者,第六個中心預計將於2023 年第三季度開始招募患者。我們預計將於2023 年底完成全面招募,並於2024 年初發布初步數據報告。

  • One other notable data stream is the utilization of the sleep apnea-specific hypoxic burden metrics. As you may know, the apnea hypopnea index counts sleep disordered breathing events. However, research indicates that AHI is not predictive of health risk. Alternatively, research has demonstrated that the sleep apnea hypoxic burden, a measure of hypoxia caused by a sleep apnea event, is predictive of all-cause mortality and cardiovascular risk.

    另一個值得注意的數據流是睡眠呼吸暫停特定的低氧負擔指標的利用。如您所知,呼吸暫停低通氣指數統計睡眠呼吸障礙事件。然而,研究表明 AHI 並不能預測健康風險。另外,研究表明,睡眠呼吸暫停缺氧負擔(睡眠呼吸暫停事件引起的缺氧的衡量標準)可以預測全因死亡率和心血管風險。

  • A scientific abstract presented at the American Thoracic Society in May 2023 demonstrated that treatment with ProSomnus precision medical devices successfully improved the sleep apnea-specific hypoxic burden for 91% of the 109 study participants, which included 36 milds, 35 moderates, and 38 patients with severe OSA. This result suggests that ProSomnus is well positioned as the field of sleep medicine shifts to sleep apnea-specific hypoxic burden as a key metric for treatment planning and disease management.

    2023 年5 月在美國胸科學會提交的一份科學摘要表明,使用ProSomnus 精密醫療設備進行治療成功改善了109 名研究參與者中91% 的睡眠呼吸暫停特異性缺氧負擔,其中包括36 名輕度患者、35 名中度患者和38 名重度睡眠呼吸暫停患者。嚴重的阻塞性睡眠呼吸暫停。這一結果表明,隨著睡眠醫學領域轉向將睡眠呼吸暫停特異性低氧負擔作為治療計劃和疾病管理的關鍵指標,ProSomnus 處於有利地位。

  • Our R&D team continues to make healthy progress on our RPMO2 project, our next-generation sensor embedded device. The purpose of our RPMO2 sensor embedded device is to enable the remote monitoring of patients' physiologic metrics such as heart rate variability and sleep apnea-specific hypoxic burden that are predictive of OSA-related health risks.

    我們的研發團隊在下一代傳感器嵌入式設備 RPMO2 項目上繼續取得健康進展。我們的 RPMO2 傳感器嵌入式設備的目的是能夠遠程監測患者的生理指標,例如心率變異性和睡眠呼吸暫停特定的低氧負擔,這些指標可預測 OSA 相關的健康風險。

  • While our device treats the patient's OSA, the sensor embedded in our RPMO2 device will monitor the patient's physiologic response to the treatment. Data will be transmitted from the RPMO2 device to the patient's smartphone via Bluetooth and then uploaded from the smartphone to the healthcare providers portal.

    當我們的設備治療患者的 OSA 時,嵌入 RPMO2 設備中的傳感器將監測患者對治療的生理反應。數據將通過藍牙從 RPMO2 設備傳輸到患者的智能手機,然後從智能手機上傳到醫療保健提供商門戶。

  • This medically important physiologic data will enable healthcare providers and their patients to actively and remotely manage OSA, enabling more evidence-driven treatment planning, reducing office visits and hospitalizations, and ultimately lower overall cost of care. In sum, our next-generation sensor device will beat the OSA, with continuous glucose monitoring is for diabetes. This program remains on track for first commercial use by the end of 2023.

    這些醫學上重要的生理數據將使醫療保健提供者及其患者能夠主動遠程管理 OSA,從而實現更多證據驅動的治療計劃,減少就診和住院治療,並最終降低總體護理成本。總而言之,我們的下一代傳感器設備將擊敗 OSA,針對糖尿病進行連續血糖監測。該程序仍有望在 2023 年底前首次投入商業使用。

  • With that, I'd like to turn the call over to Brian Dow, our Chief Financial Officer, for a review of our financials. Brian?

    說到這裡,我想將電話轉給我們的首席財務官 Brian Dow,以審查我們的財務狀況。布萊恩?

  • Brian Dow - CFO

    Brian Dow - CFO

  • Great. Thanks, Len, and thanks, everyone, for making time to join us today. As Len discussed a few moments ago, the second quarter of 2023 was another top-line, record-breaking quarter, with revenues totaling $6.9 million, representing an increase of 43% from the second quarter of 2022, a 19% increase sequentially from the first quarter of 2023. And for the first six months of 2023, revenue totaled $12.7 million, reflecting a 48% increase compared to the first six months of 2022.

    偉大的。謝謝萊恩,也謝謝大家今天抽出時間來參加我們的活動。正如 Len 剛才討論的那樣,2023 年第二季度又是一個營收破紀錄的季度,收入總計 690 萬美元,較 2022 年第二季度增長 43%,較 2022 年第二季度增長 19%。 2023 年第一季度。2023 年前6 個月,收入總計1,270 萬美元,較2022 年前6 個月增長48%。

  • To reiterate a bit of what Len covered, the strong topline results reported for the quarter and year to date reflect the growing clinical adoption of our precision oral appliances combined with the investments we have been making in our direct sales force during the first half of 2023 designed to capture this opportunity.

    重申一下 Len 所介紹的內容,本季度和本年度迄今為止報告的強勁營收結果反映了我們的精密口腔矯治器的臨床應用不斷增長,以及我們在 2023 年上半年對直銷隊伍進行的投資旨在抓住這個機會。

  • Gross margin during the quarter remained consistent with prior periods at 54% compared to 52% for the same period a year ago and 53% for the first quarter of 2023. Looking below the numbers, cost of revenue includes materials and manufacturing personnel as well as indirect costs, including our new manufacturing facility in Pleasanton.

    本季度的毛利率與前期保持一致,為 54%,而去年同期為 52%,2023 年第一季度為 53%。從數字下方看,收入成本包括材料和製造人員以及間接成本,包括我們在普萊森頓的新製造工廠。

  • The second quarter was the first full quarter operating with the additional overhead of our new facility, and we are already seeing leverage. In that, we increased our production capacity 4x with only modest margin pressure during the first quarter and modest improvement in the second quarter when comparing to last year. We expect that with the continued growth of our business and additional cost-out initiatives, margins will continue to improve.

    第二季度是我們新設施產生額外管理費用的第一個完整季度,我們已經看到了槓桿作用。因此,我們的產能增加了 4 倍,第一季度的利潤率壓力不大,第二季度與去年相比略有改善。我們預計,隨著業務的持續增長和額外的成本削減計劃,利潤率將繼續提高。

  • Operating expenses for the quarter were $9.5 million compared to $4 million for the same period a year ago. The increase in operating expense was driven first by planned investments made in our direct sales organization, development of our RPMO2 sensor enabled device, and conducting our FLOSAT head-to-head study versus CPAP, and severe OSA indication label expansion study. Secondarily, the increase was driven by G&A expenses stemming from increased public company expenses, including additional headcount, contract labor, professional services, and trailing expenses from the listing in December.

    本季度運營費用為 950 萬美元,而去年同期運營費用為 400 萬美元。運營費用的增加首先是由於對我們的直銷組織進行的計劃投資、開發我們的 RPMO2 傳感器設備、進行我們的 FLOSAT 與 CPAP 的頭對頭研究以及嚴格的 OSA 適應症標籤擴展研究。其次,這一增長是由於上市公司費用增加而導致的一般管理費用,包括額外的員工人數、合同工、專業服務以及 12 月份上市後的跟踪費用。

  • Taking a moment to drill down on the income statement. Sales and marketing expense increased to $3.6 million for the second quarter, reflecting an increase of $1.6 million or 81% compared to the second quarter of 2022, and an increase of $800,000 or 29% sequentially compared to the first quarter of 2023. Year-to-date sales and marketing expense totaled $6.5 million an increase of $2.3 million or 57% for the same period in 2022. The increase in sales and marketing expense reflects the increase in direct sales reps domestically and in Europe that Len discussed a few moments ago.

    花點時間深入研究損益表。第二季度銷售和營銷費用增加至 360 萬美元,較 2022 年第二季度增加 160 萬美元,即 81%,較 2023 年第一季度增加 80 萬美元,即 29%。截至目前,銷售和營銷費用總計650 萬美元,與2022 年同期相比增加了230 萬美元,即57%。銷售和營銷費用的增加反映了Len 剛才討論的國內和歐洲直銷代表的增加。

  • We currently stand at 26 direct sales personnel, and it is our expectation that our field representatives will reach productivity during their first year and then build overtime to an average book of $2 million per year, depending on geography. We expect to end 2023 roughly where we are today on sales headcount. And as planned, we expect to leverage the existing investment with incremental expenses, reflecting increased commissions.

    我們目前有 26 名直銷人員,我們期望我們的現場代表能夠在第一年達到生產力,然後加班到每年平均 200 萬美元,具體取決於地理位置。我們預計到 2023 年底,銷售人員數量將大致與目前的水平相同。按照計劃,我們預計將利用現有投資來增加支出,反映出佣金的增加。

  • Research and development expenses increased to $1.4 million for the second quarter, reflecting an increase of $700,000 or roughly twice the $700,000 expense recognized for the second quarter of 2022, and an increase of $350,000 or 35% sequentially compared to the first quarter of 2023. Year-to-date research and development expenses totaled $2.4 million, an increase of $1.2 million from an increase of $1.2 million for the same period during 2022.

    第二季度研發費用增加至140 萬美元,增加了70 萬美元,大約是2022 年第二季度確認的70 萬美元費用的兩倍,與2023 年第一季度相比,連續增加了35 萬美元,即35%。 -迄今為止的研發費用總計240萬美元,比2022年同期的120萬美元增加了120萬美元。

  • Consistent with our discussions on prior calls, R&D expenditures represent the planned investments in three major programs. First, the RPMO2 sensor enabled device. The RPMO2 sensor device is the principal driver of the year-over-year increase in R&D during the second quarter and the first half of 2023 compared to the same periods during 2022, as we have incurred incremental expenses associated with adding personnel with key skills to our development team and outside development services to develop the mobile app with which the RPMO2 communicates and transfers data to the cloud.

    與我們之前電話會議的討論一致,研發支出代表了三個主要項目的計劃投資。首先,RPMO2 傳感器啟用設備。與 2022 年同期相比,RPMO2 傳感器設備是 2023 年第二季度和上半年研發同比增長的主要驅動力,因為我們因增加具有關鍵技能的人員而產生了增量費用我們的開發團隊和外部開發服務來開發移動應用程序,RPMO2 通過該應用程序進行通信並將數據傳輸到雲。

  • Certain development elements have been completed at this point and will be replaced by testing regulatory and commercial readiness expenses during the remainder of the year. Thus, the current run rate will hold or modestly taper relative to the RPMO2.

    目前,某些開發要素已經完成,並將在今年剩餘時間內被測試監管和商業準備費用所取代。因此,當前的運行速度將保持不變或相對於 RPMO2 略有下降。

  • Next, during the first half of 2023, we were very active in the development of clinical data, sponsoring two key studies are FLOSAT and SOS studies. During the second quarter, our clinical study costs were comprised principally of site initiation expenses for our SOS study.

    接下來,在 2023 年上半年,我們非常積極地開發臨床數據,贊助了兩項關鍵研究:FLOSAT 和 SOS 研究。第二季度,我們的臨床研究成本主要包括 SOS 研究的場地啟動費用。

  • Turning now to general and administrative expenses. G&A expenses increased to $4.5 million for the quarter, reflecting an increase of $3.2 million compared to $1.3 million for the second quarter of 2022, and an increase of $1.1 million or 34% sequentially compared to the first quarter of 2023. Year-to-date general and administrative expenses totaled $7.8 million compared to $2.6 million for the same period during 2022. The increase in G&A can be grouped into three major categories: public company and post-listing transitional amounts, compensation, and facility related expenses.

    現在轉向一般和行政費用。本季度的一般管理費用增加至 450 萬美元,與 2022 年第二季度的 130 萬美元相比增加了 320 萬美元,與 2023 年第一季度相比增加了 110 萬美元,增幅為 34%。一般和行政費用總計780 萬美元,而2022 年同期為260 萬美元。一般和行政費用的增加可分為三大類:上市公司和上市後過渡金額、薪酬和設施相關費用。

  • Starting with public company and post listing transitional amounts not incurred during the first half of 2022 totaled $2.4 million included audit, legal and filing services relating to the 28 substantive SEC filings during the period, comprised of multiple registration statements, 10-K's, Q's, 8-K's proxies, and so on.

    從2022 年上半年未發生的上市公司和上市後過渡金額開始,總計240 萬美元,包括與該期間28 份實質性SEC 備案相關的審計、法律和備案服務,包括多個註冊聲明、10-K 、Q、 8-K的代理等等。

  • Public company insurance and a variety of smaller costs that when combined impacted period, including director fees, trailing transaction fees, and listing fees. Many of the professional services expenses will track downward in the back half of 2023 as the requisite registrations and filings directly related to our listing in December have been completed and will not recur on a go-forward basis. We will, however, remain above 2022 expenses going forward.

    上市公司保險和各種較小的成本綜合起來會影響期間,包括董事費、追踪交易費和上市費。由於與我們 12 月上市直接相關的必要註冊和備案工作已經完成,許多專業服務費用將在 2023 年下半年下降,並且不會再發生。然而,我們未來的支出將保持在 2022 年以上。

  • Compensation contributed to the increase for the first half of 2023 compared to the first half of '22, including approximately $400,000 of increased stock-based compensation. The increase in compensation is comprised of additional professional headcount within the accounting finance and human resource function, severance related to my predecessor, temporary contract labor to bridge between public company, and hiring of full-time staff. We expect compensation to moderate during the second half of the year as we transition to -- from more expensive contract support to full-time staff, and certain non-recurring expenses will not recur.

    與 2022 年上半年相比,2023 年上半年的薪酬增長有所貢獻,其中基於股票的薪酬增加了約 40 萬美元。薪酬的增加包括會計財務和人力資源職能部門增加專業人員、與我的前任相關的遣散費、上市公司之間的臨時合同工以及僱用全職員工。我們預計,隨著我們從更昂貴的合同支持過渡到全職員工,薪酬將在下半年有所放緩,並且某些非經常性費用將不會再次出現。

  • Finally, in G&A, as we've discussed previously, during the first quarter of 2023, we moved into our new facility in Pleasanton, California. This move was necessary to secure the needed space to meet production demands of our rapidly growing commercial volumes. In addition, the space provides ample space for administrative services. During the first half of 2023, facilities expense increased roughly $500,000.

    最後,在 G&A 方面,正如我們之前討論的那樣,我們於 2023 年第一季度搬進了位於加利福尼亞州普萊森頓的新工廠。這一舉措對於確保所需的空間來滿足我們快速增長的商業量的生產需求是必要的。此外,該空間還為行政服務提供了充足的空間。 2023 年上半年,設施費用增加了約 50 萬美元。

  • Looking at other income and expense items, we have three basic elements: interest expense relating to our convertible notes, non-cash accounting adjustments related to items on the balance sheet that are carried at fair value, and other small de minimis operating expenses.

    看看其他收入和費用項目,我們有三個基本要素:與可轉換票據相關的利息費用、與以公允價值計量的資產負債表項目相關的非現金會計調整以及其他小額最低運營費用。

  • Turning to the balance sheet for a moment, we ended the quarter with $6.2 million in cash. As we have discussed on prior calls, we remain well aware of the capital position and look forward to providing an update on that front in the near future.

    看看資產負債表,本季度結束時我們有 620 萬美元的現金。正如我們在之前的電話會議中所討論的那樣,我們仍然清楚地了解資本狀況,並期待在不久的將來提供這方面的最新信息。

  • Taking a look forward toward the remainder of 2023. We previously provided guidance that year-over-year topline revenue growth would be 35%, landing 2023 revenue just over $26 million. Based on the strong fundamental execution of our business reflected in the record topline revenue results reported today, I am updating our outlook for 2023. We are increasing our expectations for 2023 and now expect topline revenue growth of 40%, landing 2023 revenue just over $27 million.

    展望 2023 年剩餘時間。我們之前提供的指引是,營收同比增長將為 35%,2023 年收入略高於 2600 萬美元。基於今天報告的創紀錄的營收業績所反映的我們業務強勁的基本執行力,我正在更新我們對2023 年的展望。我們正在提高對2023 年的預期,現在預計營收增長40%,2023 年收入略高於27 美元百萬。

  • With that, I'd like to begin the question-and-answer portion of the call. Operator, please open the call for questions.

    接下來,我想開始通話的問答部分。接線員,請打開電話提問。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Scott Henry, ROTH Capital.

    斯科特·亨利,羅斯資本。

  • Scott Henry - Analyst

    Scott Henry - Analyst

  • Thank you and good morning.

    謝謝你,早上好。

  • Brian Dow - CFO

    Brian Dow - CFO

  • Good morning, Scott.

    早上好,斯科特。

  • Scott Henry - Analyst

    Scott Henry - Analyst

  • Really strong revenues. When we think about second half, should we expect any trends between Q3 and Q4? Or should we think about consistent growth throughout?

    收入確實強勁。當我們考慮下半年時,我們是否應該預期第三季度和第四季度之間的趨勢?或者我們應該考慮自始至終的持續增長?

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • Yeah. So Scott, thanks for your question and good to talk to you. Traditionally, what we see is a trend of seasonality between Q3 and Q4. This is largely driven by deductibles and people managing their out-of-pocket expenses. And so you normally see a little bit of a suppression in Q1 and uplift in Q4, and we expect that seasonality to repeat itself.

    是的。斯科特,謝謝你的問題,很高興與你交談。傳統上,我們看到的是第三季度和第四季度之間的季節性趨勢。這主要是由免賠額和人們管理自付費用驅動的。因此,您通常會看到第一季度出現一些抑制,第四季度出現一些上升,我們預計這種季節性會重演。

  • We are seeing some differences coming out of COVID and seasonality with people taking different vacations at different times. So it's not perfectly representing, let's say, pre-COVID seasonality. But we do expect in the large part for that seasonality pattern to hold true.

    我們發現,由於新冠疫情和季節性因素,人們在不同時間享受不同的假期,從而產生了一些差異。因此,它並不能完美地代表新冠疫情之前的季節性。但我們確實預計這種季節性模式在很大程度上會成立。

  • Scott Henry - Analyst

    Scott Henry - Analyst

  • Okay, great. And then just reflecting on a lot of the prepared remarks, the revenue is growing very strong, gaining market share much faster than the category. At some point, I would expect the business to hit an inflection point where the operating burn starts to decrease quarter over quarter as expenses trail revenue growth and leverage hits the bottom line. At what point do you think we should hit that inflection point perhaps very soon?

    好的,太好了。然後,只要反思一下許多準備好的評論,收入增長就非常強勁,獲得市場份額的速度比該類別快得多。在某個時候,我預計該業務將達到一個拐點,隨著支出落後於收入增長且槓桿觸及底線,運營消耗開始逐季下降。您認為我們應該在什麼時候很快達到這個拐點?

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • Yeah. I'll say a few words, and Brian will add a few comments to that, too. But we expect to begin seeing leverage right away. We incurred some public company costs that ultimately are going to be remain somewhat fixed. So as we continue to grow revenues, we'll see leverage over those fixed costs.

    是的。我會說幾句話,布萊恩也會對此添加一些評論。但我們預計會立即開始看到槓桿作用。我們產生了一些上市公司成本,這些成本最終將保持一定程度的固定。因此,隨著我們收入的不斷增長,我們將看到對這些固定成本的槓桿作用。

  • We moved into our new facility, which dramatically expanded our manufacturing capacity and manufacturing efficiency. So as those fixed costs get utilized over higher revenue levels, we expect to see leverage right away from that as well.

    我們搬進了新工廠,這極大地擴大了我們的製造能力和製造效率。因此,隨著這些固定成本在更高的收入水平上得到利用,我們預計也會立即看到槓桿作用。

  • So we -- pre-COVID and pre-taking the company public, we were absolutely seeing the business respond in terms of leverage as we grow the business. We expect that pattern to return as we put the public company transaction, our rearview mirror, and drive revenue over this new cost structure.

    因此,在新冠疫情發生之前以及在公司上市之前,我們絕對看到隨著我們業務的發展,業務在槓桿方面做出了反應。我們預計,當我們將上市公司交易作為我們的後視鏡並通過這種新的成本結構推動收入時,這種模式將會回歸。

  • Brian? And if you want to add to that?

    布萊恩?如果你想補充一下?

  • Brian Dow - CFO

    Brian Dow - CFO

  • Yeah. Scott, just one thing that I'll point out. There's a little bit of a stair step function that happened as we came into 2023. We made a pretty heavy investment as we talked about in our remarks, adding -- basically doubling the number of direct salespeople, for example.

    是的。斯科特,我只想指出一件事。當我們進入 2023 年時,出現了一些階梯函數。正如我們在評論中談到的那樣,我們進行了相當大的投資,例如,基本上將直銷人員的數量增加了一倍。

  • And we don't expect to do that in the back half of the year. We took the step forward. We're going to let those -- the new additions develop and leverage those for the remainder of the year and for the first half of next year. And then again, we will evaluate as the business grows on making the incremental additions to the sales team.

    我們預計不會在今年下半年做到這一點。我們向前邁出了一步。我們將讓這些——新增加的內容在今年剩餘時間和明年上半年得到開發和利用。然後,隨著業務的增長,我們將再次評估如何增加銷售團隊。

  • From the R&D side of the house, there was an increase year over year simply because we had the opportunity to drive the investment to bring the RPMO2 sensor enabled device forward into 2023. We are initiating the label expansion for SOS.

    從研發方面來看,同比增長只是因為我們有機會推動投資,將 RPMO2 傳感器設備提前到 2023 年。我們正在啟動 SOS 的標籤擴展。

  • And as we go forward, we again took the step up, but we do not expect to take similar steps like that for the remainder of '23 and for the first half of '24. Then obviously, becoming a public company and just getting everything squared away in the first quarter was the G&A side of the house with public company expenses and wrapping up what was left over from the transaction listing from December.

    隨著我們的前進,我們再次採取了步驟,但我們預計不會在 23 年剩餘時間和 24 年上半年採取類似的步驟。顯然,成為一家上市公司並在第一季度把一切都搞定是公司的一般行政費用,包括上市公司的費用,並完成 12 月份交易上市剩餘的費用。

  • So we've flat -- we believe that we have hit -- made the investments. And now it is time to start leveraging those. And that is what you will see as we go forward through the rest of this year.

    所以我們已經進行了投資——我們相信我們已經成功了。現在是時候開始利用這些了。這就是我們今年剩餘時間裡將會看到的情況。

  • Scott Henry - Analyst

    Scott Henry - Analyst

  • Okay, great. Final question. The O -- the sensor technology, I think, is really exciting. It could be a game changer for the appliance category.

    好的,太好了。最後一個問題。我認為 O——傳感器技術確實令人興奮。它可能會改變家電類別的遊戲規則。

  • When we think about that Q4 launch of this year, what are the risks of that getting delayed? Just trying to get an idea of how comfortable we should be in that Q4 target.

    當我們考慮今年第四季度的發佈時,推遲發布的風險是什麼?只是想知道我們在第四季度的目標中應該有多舒服。

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • Yeah. Great question, Scott, and it's exciting when you call it a game changer. It's also exciting when we do focus groups and interviews with KOLs, and they call it a game changer. And we believe that that in fact, absolutely, we have the potential to be a game changer for our field.

    是的。斯科特,這是一個很好的問題,當你稱它為遊戲規則改變者時,這真是令人興奮。當我們進行焦點小組和對 KOL 的採訪時,這也很令人興奮,他們稱之為遊戲規則改變者。我們相信,事實上,我們絕對有潛力成為我們領域的遊戲規則改變者。

  • It's an R&D project. So they're always the normal risks with R&D projects. In terms of the speed, it takes to finally validate the technology, and then also to get the final FDA clearance. So there, sometimes you have entities that are outside of our control and those things can always affect the timeline.

    這是一個研發項目。因此,它們始終是研發項目的正常風險。就速度而言,需要最終驗證該技術,然後還要獲得 FDA 的最終許可。因此,有時你會遇到一些超出我們控制範圍的實體,而這些事情總是會影響時間線。

  • But historically, we have an excellent track record with FDA clearances. We have a very professional team that has a lot of experience with FDA clearances. And so when we look back at those processes and apply those lessons learned to the RPMO2, we feel comfortable with the timeline that we've let out.

    但從歷史上看,我們在 FDA 許可方面擁有良好的記錄。我們擁有一支非常專業的團隊,在 FDA 審批方面擁有豐富的經驗。因此,當我們回顧這些流程並將這些經驗教訓應用到 RPMO2 時,我們對我們公佈的時間表感到滿意。

  • Scott Henry - Analyst

    Scott Henry - Analyst

  • Okay, great. Thank you for taking the question.

    好的,太好了。感謝您提出問題。

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • Yeah, Scott. Thank you.

    是的,斯科特。謝謝。

  • Brian Dow - CFO

    Brian Dow - CFO

  • Thanks, Scott.

    謝謝,斯科特。

  • Operator

    Operator

  • Alex Nowak, Craig-Hallum.

    亞歷克斯·諾瓦克,克雷格·哈勒姆。

  • Alex Nowak - Analyst

    Alex Nowak - Analyst

  • All right. Great. Good morning, everyone.

    好的。偉大的。大家,早安。

  • I just want to put a point on Henry's second question there, just around the cash burn. Is it fair to assume that the cash burn this quarter is really going to be the peak there, especially as we start to trail off a little bit on the new head count, revenue growth continues to ramp nicely, is that a fair point? And then just current thoughts on how to adjust the cash and the balance sheet right now.

    我只想就亨利的第二個問題提出一個觀點,即關於現金消耗的問題。可以公平地假設本季度的現金消耗確實將達到峰值,特別是當我們開始在新員工數量上有所減少時,收入增長繼續良好地增長,這是一個公平的觀點嗎?然後是目前關於如何調整現金和資產負債表的想法。

  • Brian Dow - CFO

    Brian Dow - CFO

  • Yeah, taking that in order. You're spot on. That is -- we do believe that we've hit the inflection point. Going forward, it will -- we're going to be able to leverage the investments that we've made in the first half of the year. And we just had to get the public company things behind us.

    是的,按順序進行。你說得對。也就是說,我們確實相信我們已經達到了拐點。展望未來,我們將能夠利用我們在今年上半年進行的投資。我們只需要把上市公司的事情拋在腦後。

  • So yes, we expect the tapering for the remainder of '23 and then to be able to continue leverage going forward. And as we've indicated, we intended and will remain opportunistic with respect to capital raising and fund raising. We obviously pay very close attention to that on a daily basis. And as I indicated in my comments, we look forward to providing an update in the near future.

    所以,是的,我們預計在 23 年剩餘時間內縮減規模,然後能夠繼續發揮槓桿作用。正如我們所指出的,我們打算並將在融資和籌資方面保持機會主義態度。顯然我們每天都非常密切關注這一點。正如我在評論中指出的那樣,我們期待在不久的將來提供更新。

  • Alex Nowak - Analyst

    Alex Nowak - Analyst

  • Okay. No, that's great.

    好的。不,那太好了。

  • The sales growth this quarter, really strong. Can you help break down the contribution throughout the quarter? I'm just curious, can you say how much is from the expanding sales force, how much is coming from just having more clinical data out there? And perhaps, any changes to the sleep apnea market just given that Philips are undergoing recall?

    本季度的銷售增長確實強勁。您能幫忙分解整個季度的貢獻嗎?我只是很好奇,你能說一下有多少來自於不斷擴大的銷售隊伍,有多少來自於更多的臨床數據嗎?考慮到飛利浦正在進行召回,睡眠呼吸暫停市場可能會發生什麼變化?

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • Yeah. Let me take a couple of those then -- and turn over to Brian for some additional comments if he has any.

    是的。那麼讓我來談談其中的一些——如果他有任何補充意見,請轉交給布萊恩。

  • But yeah. So the main feature we're seeing, Alex, is our sales team going out and driving utilization rates of our existing therapy providers, reaching out to sleep physicians, and creating referral relationships between those sleep physicians and the therapy providers. And that model is working very well.

    但是是的。因此,亞歷克斯,我們看到的主要特點是我們的銷售團隊走出去,提高現有治療提供者的利用率,接觸睡眠醫生,並在這些睡眠醫生和治療提供者之間建立推薦關係。這個模型運行得很好。

  • We are seeing some changes in the sleep market. I think anyone who has attended the battery of conferences over the past several months has been very pleasantly surprised to the extent to which sleep physicians are actively seeking CPAP alternatives.

    我們看到睡眠市場發生了一些變化。我認為過去幾個月參加過一系列會議的人都會對睡眠醫生積極尋求 CPAP 替代品的程度感到非常驚喜。

  • A year ago, let alone two years ago, there was not a whole lot of openness to that type of discussion. Today, sleep physicians are very much looking for a CPAP alternatives. And so we think that that's a very nice tailwind in conjunction with our efforts to expand our sales team, meet with those sleep physicians, make it easy for them to refer patients to a local, qualified dental therapy provider, dental sleep medicine therapy providers who are fluent in prescribing our devices.

    一年前,更不用說兩年前,這種類型的討論還沒有太多的開放性。如今,睡眠醫生正在積極尋找 CPAP 的替代品。因此,我們認為這是一個非常好的順風,再加上我們努力擴大我們的銷售團隊,與那些睡眠醫生會面,使他們能夠輕鬆地將患者轉介給當地合格的牙科治療提供者,牙科睡眠藥物治療提供者能夠熟練地開具我們的設備處方。

  • (multiple speakers)

    (多個發言者)

  • Alex Nowak - Analyst

    Alex Nowak - Analyst

  • Go ahead, Brian.

    繼續吧,布萊恩。

  • Brian Dow - CFO

    Brian Dow - CFO

  • To add to that, with respect to the segments that are moving, we're moving the football down the field in a fairly linear fashion. We're seeing growth within existing accounts. We're seeing new accounts come in and begin to mature.

    除此之外,對於正在移動的部分,我們正在以相當線性的方式將足球移動到球場上。我們看到現有賬戶的增長。我們看到新客戶不斷湧入並開始成熟。

  • And with that, tying back to clinical data, we continue to add clinical data to the portfolio. It gives the field reps the opportunity to field additional question that every clinician is going to have, and every clinician looks at it a little bit differently. And with the robust portfolio we have, we can address those issues and put them to bed. But again, we're seeing development and strong progress in basically all three of those verticals that we discussed.

    這樣,結合臨床數據,我們繼續將臨床數據添加到產品組合中。它使現場代表有機會回答每個臨床醫生都會遇到的其他問題,並且每個臨床醫生對這個問題的看法都略有不同。憑藉我們強大的產品組合,我們可以解決這些問題並解決它們。但我們再次看到,我們討論的所有三個垂直領域都取得了發展和強勁進展。

  • Alex Nowak - Analyst

    Alex Nowak - Analyst

  • That's good to hear because, obviously, oral appliances have always gotten less focus than seep out in the market. And ProSomnus is obviously changing that gear. So the other question that I have is how important is the SOS study and also the FLOSAT study to get access to that severe market? Or is the bigger benefit really going to be -- you'll be the only oral appliance out there? EVO specifically can now treat severe disease, and essentially, you're going to leapfrog every other oral appliance out there.

    很高興聽到這個消息,因為顯然,口腔矯治器在市場上的關注度始終低於其滲透率。 ProSomnus 顯然正在改變這一現狀。所以我的另一個問題是 SOS 研究和 FLOSAT 研究對於進入這個嚴峻的市場有多重要?或者更大的好處真的是——你將成為唯一的口腔矯治器嗎? EVO 現在可以專門治療嚴重的疾病,從本質上講,您將超越所有其他口腔矯治器。

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • Yeah, all of the above. I think the main thing, Alex, to keep in mind is that one of the -- let's say, your known limitations of sleep medicine is that there have been an inconsistent use of study end points and not a lot of head-to-head studies. And so what we're doing with our clinical affairs is trying to put medical grade data in front of physicians that help simplify their ability to select the optimal pay -- optimal therapy for the patient that's before them.

    是的,以上都是。亞歷克斯,我認為最重要的是要記住,睡眠醫學的已知局限性之一是研究終點的使用不一致,並且沒有進行大量的面對面研究學習。因此,我們在臨床事務方面所做的就是嘗試將醫療級數據提供給醫生,幫助他們簡化選擇最佳薪酬的能力,即為面前的患者提供最佳治療。

  • FLOSAT study does an incredibly important job of comparing ProSomnus devices with CPAP and demonstrating to physicians that our devices are safe and efficacious as frontline treatment for patients. And that goes a long way towards our sales reps, helping to educate sleep physicians and earning those referrals for patients who have refused or failed CPAP or potentially also frontline therapy for the right patients. And so we think FLOSAT goes a long way towards fitting into our plan here.

    FLOSAT 研究非常重要,它將 ProSomnus 設備與 CPAP 進行比較,並向醫生證明我們的設備作為患者的一線治療是安全有效的。這對我們的銷售代表大有幫助,幫助教育睡眠醫生,並為那些拒絕或失敗 CPAP 的患者贏得推薦,或者也可能為合適的患者提供一線治療。因此,我們認為 FLOSAT 在融入我們的計劃方面大有幫助。

  • And then also the SOS study, there's, let's say, a very practical benefit to the SOSA. But then there's also, let's say, a broader strategic and branding benefit to SOS. The practical is that one-third of all patients have severe OSA. And as you say, Alex, we'll be the only oral device that has a severe clearance that gives us an immediate advantage in the market.

    還有 SOS 研究,可以說,SOSA 有非常實際的好處。但比如說,SOS 還可以獲得更廣泛的戰略和品牌效益。實際上,三分之一的患者患有嚴重的 OSA。正如您所說,亞歷克斯,我們將成為唯一獲得嚴格許可的口腔設備,這使我們能夠在市場上立即獲得優勢。

  • The second is that severe has a high perceived value for all the right reasons. The morbidity-mortality curves show that severe patients have -- are much higher risks than moderate and mild patients. And so physicians really latch on to severe as being extremely important to their practices. And so being able to demonstrate that our devices are safe and efficacious for that severe patient population goes a long way towards making them also feel comfortable prescribing our therapy for moderate to mild and as frontline treatment as well.

    其次,出於所有正確的原因,“嚴重”具有很高的感知價值。發病率-死亡率曲線顯示,重症患者的風險比中度和輕度患者高得多。因此,醫生們確實認為重症對他們的實踐極其重要。因此,能夠證明我們的設備對於重症患者群體是安全有效的,這對於讓他們也放心地為中度至輕度患者開出我們的療法以及作為一線治療大有幫助。

  • Alex Nowak - Analyst

    Alex Nowak - Analyst

  • That's great. And maybe just last question just on that point, an update on which clinical trials to expect and when. I think SOS is coming out here pretty soon. When we should expect the FLOSAT study to be published, and any other clinical trial update?

    那太棒了。也許這只是關於這一點的最後一個問題,即預期進行哪些臨床試驗以及何時進行的最新信息。我認為 SOS 很快就會推出。我們什麼時候應該期待 FLOSAT 研究以及任何其他臨床試驗的更新?

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • Yeah, great question. So FLOSAT preliminary, final data will be presented in August at our ProSleep conference here in San Francisco, but then presented in a scientific forum at the Edbesma conference in October and then again at the World Sleep Congress in October. Edbesma is in September, World Sleep Congress is in October. SOS study, we expect to preliminary readout at the end of the year or early Q1 of next year rather and with a full data set following shortly thereafter.

    是的,很好的問題。因此,FLOSAT 的初步、最終數據將於 8 月在舊金山舉行的 ProSleep 會議上公佈,然後在 10 月的 Edbesma 會議的科學論壇上公佈,然後在 10 月的世界睡眠大會上再次公佈。 Edbesma 是九月,世界睡眠大會是十月。 SOS 研究,我們預計將在今年年底或明年第一季度初公佈初步數據,並在此後不久提供完整的數據集。

  • Alex Nowak - Analyst

    Alex Nowak - Analyst

  • All right. Excellent. Appreciate the update. Thank you.

    好的。出色的。感謝更新。謝謝。

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • Thanks, Alex.

    謝謝,亞歷克斯。

  • Brian Dow - CFO

    Brian Dow - CFO

  • Thanks, Alex.

    謝謝,亞歷克斯。

  • Operator

    Operator

  • This conclude -- sorry. That's all the time we have for questions, I would like to now turn the conference back to Len Liptak for closing remarks.

    這就是結論——抱歉。我們的提問時間就到此為止,我現在想將會議轉回由 Len Liptak 作總結髮言。

  • Len Liptak - Co-Founder & CEO

    Len Liptak - Co-Founder & CEO

  • First and foremost, I like to thank everyone for joining today's call. Thank you for supporting ProSomnus. I would also like to thank team members from ProSomnus, who are doing an incredible job focusing on the utilization of our precision devices to create exceptional treatment experiences for physicians, providers, and their patients.

    首先,我要感謝大家參加今天的電話會議。感謝您對 ProSomnus 的支持。我還要感謝 ProSomnus 的團隊成員,他們做了出色的工作,專注於利用我們的精密設備為醫生、提供者及其患者創造卓越的治療體驗。

  • We believe the continued strong topline growth demonstrates the financial strength of our business and operations, and we look forward to providing you further updates at our next investor call. Have a good rest of your day.

    我們相信,持續強勁的營收增長證明了我們業務和運營的財務實力,我們期待在下一次投資者電話會議上為您提供進一步的最新信息。祝你這一天好好休息。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。