Aspira Women's Health Inc (AWH) 2022 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to Aspira Women's Health, Inc. Fourth Quarter and Year-End 2022 Earnings Conference Call. (Operator Instructions) As a reminder, this call is being recorded. Leading the call today are Nicole Sandford, President and Chief Executive Officer; Marlene McLennan, Interim Chief Financial Officer; and Dr. Ryan Phan, Chief Scientific and Operating Officer.

女士們先生們，早上好，歡迎來到 Aspira Women's Health, Inc. 2022 年第四季度和年終收益電話會議。 （操作員說明）提醒一下，此通話正在錄音中。今天主持電話會議的是總裁兼首席執行官 Nicole Sandford；臨時首席財務官 Marlene McLennan；首席科學和運營官 Ryan Phan 博士。

Before we begin, I would like to remind everyone that forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995, will be made during this call, including statements relating to Aspira's expected future performance, future business prospects and future events or plans. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subjected to risks and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond the company's control.

在我們開始之前，我想提醒大家，根據 1995 年私人證券訴訟改革法案的定義，前瞻性陳述將在本次電話會議期間作出，包括與 Aspira 的預期未來業績、未來業務前景和未來事件或計劃。儘管公司認為此類前瞻性陳述中反映的預期是基於合理的假設，但實際結果和結果受到風險和不確定性的影響，並且由於公司無法控制的許多因素的影響，可能與預期存在重大差異。

The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Participants are directed to the cautionary notes set forth in today's press release, as well as the risk factors set forth in Aspira's most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the SEC for a description of factors that could actual -- that could cause actual results to differ materially from those anticipated in the forward-looking statements.

公司不承擔更新或補充任何前瞻性陳述的義務，無論是由於新信息、未來事件或其他原因，除非法律要求。請與會者閱讀今天新聞稿中提出的警示性說明，以及 Aspira 向美國證券交易委員會提交的 10-K 表格年度報告和 10-Q 表格季度報告中規定的風險因素，以說明風險因素這可能會導致實際結果與前瞻性陳述中預期的結果大相徑庭。

At this time, I'd like to turn the call over to Nicole Sandford, President and Chief Executive Officer. Please go ahead, ma'am.

在這個時候，我想把電話轉給總裁兼首席執行官妮可桑福德。請繼續，女士。

Thank you, operator, and good afternoon, everyone. It is my pleasure to welcome you to our 2022 year-end conference call.

謝謝接線員，大家下午好。很高興歡迎您參加我們的 2022 年年終電話會議。

Today, we plan to share with you highlights from a year of company-wide necessary change for Aspira Women's Health. Since stepping into the CEO role last year, I have said that achievement of our mission rested on focused execution in 3 areas: growth, innovation and operational excellence. I made a commitment to be transparent with our stakeholders and to earn your trust by clearly stating our intentions and then following through. I've also given my word that I would utilize our resources, your capital and our time, as effectively and efficiently as possible in pursuit of the long-term success of the company.

今天，我們計劃與您分享 Aspira Women's Health 一年來公司範圍內必要變革的亮點。自去年擔任首席執行官以來，我曾說過，我們使命的實現取決於三個領域的集中執行：增長、創新和卓越運營。我承諾對我們的利益相關者保持透明，並通過明確說明我們的意圖然後貫徹執行來贏得您的信任。我還承諾過，我會盡可能有效和高效地利用我們的資源、您的資金和我們的時間，以追求公司的長期成功。

While it has not been an easy year, I am proud of our progress and believe we have emerged stronger than ever before. I hope you will feel the same before this call is over.

雖然這不是輕鬆的一年，但我為我們的進步感到自豪，並相信我們比以往任何時候都更加強大。我希望在這次電話會議結束之前你也會有同樣的感覺。

Let me pause and introduce Dr. Ryan Phan, our Chief Scientific and Operating Officer; and Marlene McLennan, our Interim Chief Financial Officer. You will hear from each of them shortly with an update on our product portfolio and financial performance, respectively, before we open the call for questions. Let me start with an overview of our commercial progress in 2022.

讓我停下來介紹一下我們的首席科學和運營官 Ryan Phan 博士；和我們的臨時首席財務官 Marlene McLennan。在我們開始提問之前，您很快就會收到他們每個人的來信，分別介紹我們的產品組合和財務業績的最新情況。讓我首先概述一下我們在 2022 年的商業進展。

We grew product revenue last year to $8.2 million, a 20% increase over 2021. At the same time, we increased gross profit 8 percentage points and reduced sales and marketing expense by 13% on a full year basis. Test volumes increased to 21,423, a 23% increase, continuing the sequential and year-over-year growth trends that we have sustained for every quarter since I became CEO.

我們去年的產品收入增長到 820 萬美元，比 2021 年增長了 20%。與此同時，我們全年的毛利潤增長了 8 個百分點，銷售和營銷費用減少了 13%。測試量增加到 21,423，增加了 23%，延續了自我擔任 CEO 以來我們每個季度都保持的環比和同比增長趨勢。

OvaSuite test volumes have continued their upward momentum in the first quarter of 2023. Despite major weather events that caused weeks of delivery disruptions around the country, we saw a dramatic daily volume growth in both January and February. In 2022, we rebranded our ovarian cancer portfolio under the name OvaSuite. Our Ova1Plus test, which has now been ordered more than 60,000 times, continues to displace inferior, but deeply entrenched single biomarker test. With the successful launch of OvaWatch in December 2022, we now offer a noninvasive risk assessment test for all of the more than 1 million women a year that develop adnexal mass.

OvaSuite 測試量在 2023 年第一季度繼續保持上升勢頭。儘管重大天氣事件導致全國各地的交付中斷數週，但我們在 1 月和 2 月看到了每日測試量的急劇增長。 2022 年，我們將卵巢癌產品組合更名為 OvaSuite。我們的 Ova1Plus 測試現已訂購超過 60,000 次，繼續取代劣質但根深蒂固的單一生物標誌物測試。隨著 OvaWatch 於 2022 年 12 月的成功推出，我們現在為每年超過 100 萬患有附件包塊的所有女性提供無創風險評估測試。

Our OvaSuite tests have the potential to replace fear with data when women and their healthcare providers make decisions about how, when or even if they remove a women's reproductive organs. With one of the most extensive ovarian cancer biobanks and decades of bioinformatics expertise, we believe there is no one better positioned to become the market leader in the development of the most advanced diagnostic tools for this devastating and deadly disease.

當女性及其醫療保健提供者決定如何、何時或什至是否切除女性的生殖器官時，我們的 OvaSuite 測試有可能用數據取代恐懼。憑藉最廣泛的卵巢癌生物庫之一和數十年的生物信息學專業知識，我們相信沒有人能更好地成為開發針對這種破壞性和致命疾病的最先進診斷工具的市場領導者。

Before moving on, I want to remind you that we face no competition in the market for OvaWatch. It is a completely new risk assessment blood test with a clinically validated 99% negative predictive value that can significantly reduce the number of indeterminate masses and provides a previously unattainable level of confidence in a physician's decision about the care of their patients.

在繼續之前，我想提醒您，我們在 OvaWatch 市場上沒有競爭。這是一種全新的風險評估血液測試，具有經過臨床驗證的 99% 的陰性預測值，可以顯著減少不確定腫塊的數量，並為醫生對患者護理的決定提供前所未有的信心。

We learned a great deal about our OvaSuite sales and marketing strategies in the last year. In addition to completely rebooting our marketing program, we reallocated funds to high-impact provider conferences, streamlined our KOL program, and reworked our incentive plans to drive behaviors that results in provider adoption. In 2023, we will engage in more market focused, high-impact media, starting with an interview on lifetime channels morning show, The Balancing Act in April.

去年，我們學到了很多關於 OvaSuite 銷售和營銷策略的知識。除了完全重新啟動我們的營銷計劃之外，我們還將資金重新分配給具有高影響力的供應商會議，簡化了我們的 KOL 計劃，並重新制定了激勵計劃以推動導致供應商採用的行為。 2023 年，我們將參與更多以市場為中心、具有高影響力的媒體，首先是在 4 月份的終生頻道早間節目 The Balancing Act 上接受采訪。

Last year, we announced an Ova1Plus co-marketing and distribution agreement with BioReference. Following an October launch, momentum among the joint sales teams has been lower than anticipated. However, we believe our partnership continues to be an important part of the women's healthcare program. We are working together to implement more effective sales incentives as part of a relaunch between the commercial team. We intend to make the most of this experience and the lessons learned, as we look towards the development of commercial partnerships for our other products, including OvaWatch.

去年，我們宣布了與 BioReference 的 Ova1Plus 聯合營銷和分銷協議。在 10 月發布後，聯合銷售團隊的勢頭低於預期。但是，我們相信我們的合作夥伴關係仍然是女性醫療保健計劃的重要組成部分。作為商業團隊重新啟動的一部分，我們正在共同努力實施更有效的銷售激勵措施。我們打算充分利用這一經驗和吸取的教訓，因為我們期待為我們的其他產品（包括 OvaWatch）發展商業合作夥伴關係。

On the reimbursement front, we are actively pursuing payer adoption and fair pricing for the OvaSuite test portfolio, hitting a number of important milestones in 2022. Starting with OvaWatch, the American Medical Association moved quickly to assign OvaWatch a unique PLA code, which will facilitate efficient coverage and reimbursement when it goes into effect in April of 2023. We also secured OvaWatch coverage from an industry-leading global payer just 2 months after our official launch and only weeks after the publication of our clinical validation study.

在報銷方面，我們正在積極尋求 OvaSuite 測試組合的付款人採用和公平定價，在 2022 年達到了一些重要的里程碑。從 OvaWatch 開始，美國醫學協會迅速採取行動為 OvaWatch 分配了一個獨特的 PLA 代碼，這將有助於2023 年 4 月生效時的有效覆蓋和報銷。在我們正式推出僅 2 個月後和臨床驗證研究發布僅幾週後，我們還獲得了行業領先的全球付款人的 OvaWatch 覆蓋。

Meanwhile, we continue to press hold out commercial payers on Ova1Plus coverage, adding [Sentinel] of Oklahoma and Molina of Ohio coverage in the first quarter of 2023. The OVA1 clinical utility study, which experienced significant COVID delays, has been completed and a manuscript has been submitted for publication.

與此同時，我們繼續敦促商業付款人不要使用 Ova1Plus 的覆蓋範圍，並在 2023 年第一季度增加俄克拉荷馬州的 [Sentinel] 和俄亥俄州的 Molina 覆蓋範圍。OVA1 臨床效用研究已經完成，該研究經歷了嚴重的 COVID 延遲，並且手稿已完成已提交出版。

On the Medicare front, we joined with ovarian cancer advocacy groups to educate Congress on the failures of single biomarker tests and the need for better diagnostic tools to save women's lives. Our combined efforts resulted in the call for national Medicare coverage for multi-marker ovarian cancer test the Omnibus spending bill passed late last year. While we continue to pursue the crosswalk of OvaWatch coverage via our Novitas OVA1 LCD, the implementation of this provision by CMS in 2023 would potentially provide a national coverage determination for all of our ovarian cancer testing portfolio.

在 Medicare 方面，我們與卵巢癌倡導團體合作，就單一生物標誌物測試的失敗以及需要更好的診斷工具來挽救女性生命對國會進行教育。我們的共同努力導致呼籲國家醫療保險覆蓋多標記卵巢癌測試，去年年底通過了綜合支出法案。雖然我們繼續通過我們的 Novitas OVA1 LCD 追求 OvaWatch 覆蓋範圍的交叉路口，但 CMS 在 2023 年實施這一規定可能會為我們所有的卵巢癌檢測產品組合提供全國覆蓋範圍的確定。

On the Medicaid front, we became credentialed in a number of additional states in 2022 and are actively engaged with Medicaid decision-makers since launching OvaWatch in December.

在醫療補助方面，我們在 2022 年獲得了其他一些州的認證，並且自去年 12 月推出 OvaWatch 以來，我們積極與醫療補助決策者接觸。

Turning to our operational excellence initiatives, we have aggressively reduced back office and discretionary spending and reallocated funds to activities that drive our strategic goals. We are a smaller, more nimble organization today compared to a year ago. We eliminated nearly 30% of the workforce, creating significant payroll and payroll-related savings that we will see in 2023. While this has meant that the team that remains must do even more to support our success, I know each individual shares a passion for our mission to improve outcomes for women with gynecologic diseases.

談到我們的卓越運營計劃，我們積極減少後台和可自由支配的支出，並將資金重新分配給推動我們戰略目標的活動。與一年前相比，我們今天是一個更小、更靈活的組織。我們裁掉了近 30% 的員工，創造了大量的工資和工資相關的節省，我們將在 2023 年看到這一點。雖然這意味著留下來的團隊必須做更多的工作來支持我們的成功，但我知道每個人都對我們的使命是改善患有婦科疾病的女性的預後。

Last quarter, we used $7.1 million in cash, a meaningful step down from the trajectory we were on at the beginning of 2022. We will continue to streamline spending while growing top line revenue. In 2023, our cash usage for operations is expected to be between $16 million and $19 million. A significant reduction when compared to the $32.3 million of cash used in operations in 2022, while this is meaningful progress, we recognize that our cash needs exceed our year-end cash balance of $13.6 million. We are actively identifying additional sources of liquidity and in February, put a $12.5 million EPM in place with Cantor Fitzgerald. I'm confident in our ability to secure additional funding to meet our needs and in our ability to navigate these difficult market conditions without sacrificing revenue growth.

上個季度，我們使用了 710 萬美元的現金，與 2022 年初的軌跡相比邁出了有意義的一步。我們將繼續精簡支出，同時增加收入。到 2023 年，我們的運營現金使用量預計將在 1600 萬至 1900 萬美元之間。與 2022 年運營中使用的 3230 萬美元現金相比，這是一個顯著減少，雖然這是有意義的進步，但我們認識到我們的現金需求超過了年終現金餘額 1360 萬美元。我們正在積極尋找額外的流動資金來源，並在 2 月份與 Cantor Fitzgerald 建立了 1250 萬美元的 EPM。我相信我們有能力獲得額外的資金來滿足我們的需求，並且有能力在不犧牲收入增長的情況下應對這些困難的市場條件。

That being said, our cash needs will drive how quickly we can move some of our programs, products and activities forward.

話雖如此，我們的現金需求將推動我們推進某些計劃、產品和活動的速度。

Now I will turn the call over to Ryan for a closer look at our product development and innovation progress.

現在我將把電話轉給瑞安，讓他更仔細地了解我們的產品開發和創新進展。

Thank you, Nicole. I am proud to say that in spite of challenges, we have found opportunities and have made significant progress in our growth and innovation goals. I will spend the next few minutes updating you on our overall product development and pipeline progress.

謝謝你，妮可。我很自豪地說，儘管面臨挑戰，我們還是找到了機遇，並在我們的增長和創新目標方面取得了重大進展。在接下來的幾分鐘裡，我將向您介紹我們的整體產品開發和管道進展情況。

Let me start with OvaWatch, which we will launch in December. OvaWatch is the first and only of its kind noninvasive ovarian cancer reassessment test. It provides health care providers with a personalized result based on 7 biomarkers, age and menopausal status for women presenting with benign and indeterminate adnexal masses. Historically, patient might have chosen preventative surgery, potentially causing lifelong implication for women, who have their ovaries necessarily removed. With the launch of the OvaWatch, clinicians are able to make better informed care decisions for women than they were previously possible.

讓我從我們將於 12 月推出的 OvaWatch 開始。 OvaWatch 是同類中第一個也是唯一一個無創卵巢癌再評估測試。它為醫療保健提供者提供基於 7 種生物標誌物、年齡和絕經狀態的個性化結果，適用於患有良性和不確定附件腫塊的女性。從歷史上看，患者可能會選擇預防性手術，這可能會對必須切除卵巢的女性造成終生影響。隨著 OvaWatch 的推出，臨床醫生能夠為女性做出比以前更明智的護理決定。

I am also pleased to say that the OvaWatch clinical validation management will publish in the peer review journal of Frontiers in Medicine just a few weeks ago. This publication highlights real-world evidence to support the clinical usefulness of OvaWatch in the management of adnexal masses. It demonstrated OvaWatch's high negative predictive value across diverse data sets. And so its utility as an effective assessment tool for clinician to safely decrease premature or unnecessary surgery.

我也很高興地說，OvaWatch 臨床驗證管理將在幾週前發表在 Frontiers in Medicine 的同行評審期刊上。該出版物強調了支持 OvaWatch 在附件包塊管理中的臨床用途的真實世界證據。它展示了 OvaWatch 在不同數據集中的高陰性預測價值。因此，它可作為臨床醫生安全減少過早或不必要手術的有效評估工具。

Enrollment in the prospective OVA1 study has been committed. However, we continue to follow with end goal patients via additional periodic blood draws. As a result, we are collecting real-world evidence to support the second phase of the OvaWatch launch, a serial monitoring assay for women with adnexal masses who are not identified for surgical intervention.

已承諾參與前瞻性 OVA1 研究。然而，我們繼續通過額外的定期抽血來跟踪最終目標患者。因此，我們正在收集真實世界的證據來支持 OvaWatch 啟動的第二階段，這是一項針對患有附件腫塊但未確定需要手術干預的女性的系列監測分析。

Let's move on to EndoCheck, our in development test for the identification of endometriosis. You may recall that we expanded our development activity in 2022. The result of our internal development of a protein-based test was expanded to consider a multiomic noninvasive diagnostic tests via a sponsor agreement with a consortium of academic institutions led by Harvard Dana-Farber Cancer Institute. I will provide an update on each starting with the internal efforts.

讓我們繼續進行 EndoCheck，這是我們用於識別子宮內膜異位症的開發測試。您可能還記得我們在 2022 年擴大了我們的開發活動。我們內部開發的基於蛋白質的測試的結果通過與哈佛達納-法伯癌症研究所領導的學術機構聯盟的讚助協議擴展到考慮多組學無創診斷測試研究所。我將從內部努力開始提供每項更新。

While I'm pleased that we have made much progress on the development of an effective assay, the speed of development and commercialization of any endometriosis test will depend on the availability and cost of usable high-quality samples that align with our test's intended use. While we have recently succeeded in identifying and cataloging a lost number of patient samples from our own biobank. Additional samples from other sources will be needed to develop a commercially viable test.

雖然我很高興我們在開發有效檢測方面取得了很大進展，但任何子宮內膜異位症檢測的開發和商業化速度將取決於符合我們檢測預期用途的可用高質量樣本的可用性和成本。雖然我們最近成功地從我們自己的生物庫中識別和編目了丟失的患者樣本數量。需要來自其他來源的額外樣本來開發商業上可行的測試。

The surplus sufficient symbol continues, and we remain focused on the launch of the first-generation assay in the second half of the year.

盈餘充足的跡象仍在繼續，我們仍然專注於今年下半年第一代檢測的推出。

With respect to the small cell research agreement with Dana Farber, we are pleased to report that the development efforts with this group of scientists and collaborators are on track. Sufficient and highly qualified endometriosis patients and controlled cohorts were obtained for this study and the development efforts are well underway, utilizing a next-generation sequencing-based approach and proteomic analysis for the identification of microRNAs and proteins.

關於與 Dana Farber 的小細胞研究協議，我們很高興地報告，與這組科學家和合作者的開發工作正在按計劃進行。本研究獲得了足夠且高素質的子宮內膜異位症患者和對照隊列，開發工作正在順利進行，利用下一代基於測序的方法和蛋白質組學分析來鑑定 microRNA 和蛋白質。

We believe that the project of this collaborative effort will meet our expected development goals for 2023.

我們相信，這一合作項目將實現我們預期的 2023 年發展目標。

To support the development of endometriosis diagnosis assay, our multicenter clinical study for endometriosis were designed and is currently enrolling patients to confirm the clinical performance of EndoCheck as a noninvasive tool to aid the diagnosis of endometriosis. This is a prospective observational study. We are pleased with our enrollment upside and patients so far.

為了支持子宮內膜異位症診斷試驗的發展，我們設計了針對子宮內膜異位症的多中心臨床研究，目前正在招募患者以確認 EndoCheck 作為一種無創工具來幫助診斷子宮內膜異位症的臨床性能。這是一項前瞻性觀察研究。到目前為止，我們對我們的入學率和患者感到滿意。

We are closely monitoring progress and potentially competitive efforts, both in the U.S. and globally, but are optimistic about the competitive positioning of our EndoCheck test. We believe asking what gynecology diseases is and our ability to develop and validate the clinical assay in our clear laboratory setting offers an advantage over others.

我們正在密切關注美國和全球的進展和潛在的競爭努力，但對我們的 EndoCheck 測試的競爭定位持樂觀態度。我們相信，詢問什麼是婦科疾病以及我們在清晰的實驗室環境中開發和驗證臨床檢測的能力比其他人更有優勢。

The strategy and approach on EndoCheck launch will be discussed at an R&D Day that we plan to host on May 21. We will also highlight the potential for the 0 margin application of our OvaWatch test and our plans for growing the OvaSuite portfolio.

EndoCheck 發布的戰略和方法將在我們計劃於 5 月 21 日舉辦的研發日上進行討論。我們還將強調我們的 OvaWatch 測試的零保證金應用的潛力以及我們擴大 OvaSuite 產品組合的計劃。

It has indeed been a very dynamic and exciting time for Aspira. I've been with the company for less than a year and are focused on building momentum through the first phase along on OvaWatch and a steady progress in the development of EndoCheck. I am confident in the progress we made in the development of powerful products will help improve women's gynecology health.

對於 Aspira 來說，這確實是一個充滿活力和激動人心的時刻。我在公司工作不到一年，專注於通過 OvaWatch 的第一階段建立勢頭，並在 EndoCheck 的開發中取得穩步進展。我相信我們在開發功能強大的產品方面取得的進展將有助於改善女性的婦科健康。

I will now turn to Marlene for a discussion of our financial performance. Marlene?

我現在將請 Marlene 討論我們的財務業績。馬琳？

Thank you, Ryan. Total product revenue was $8.2 million for the year and $2.1 million for the quarter ended December 31, 2022, compared to $6.6 million and $1.9 million for the same period in 2021. The 20% full year and 16% fourth quarter revenue increases were due to an increase in Ova1Plus test volume compared to the prior year, partially offset by a lower average unit price of $372 for the year, and $369 for the fourth quarter of 2022 compared to $378 and $381 for the same period in 2021, respectively.

謝謝你，瑞安。全年產品總收入為 820 萬美元，截至 2022 年 12 月 31 日止季度為 210 萬美元，而 2021 年同期為 660 萬美元和 190 萬美元。全年收入增長 20%，第四季度收入增長 16%，原因是Ova1Plus 測試量與上一年相比有所增加，部分被較低的平均單價所抵消，全年平均單價為 372 美元，2022 年第四季度為 369 美元，而 2021 年同期分別為 378 美元和 381 美元。

The overall number of tests performed increased 23% for the year to 21,423, with the fourth quarter volume increasing 18% to 5,642 test. Gross profit margin for the year was 53% compared to 45% in 2021. For the fourth quarter, gross profit margin was 57% compared to 55% in the same period last year. Margin improvement is primarily attributed to targeted cost control measures in the laboratory and information technology spending.

全年進行的測試總數增加了 23%，達到 21,423 次，第四季度的測試量增加了 18%，達到 5,642 次測試。全年毛利率為 53%，而 2021 年為 45%。第四季度毛利率為 57%，而去年同期為 55%。利潤率的提高主要歸功於實驗室和信息技術支出方面的針對性成本控制措施。

Research and development expenses for the year increased 12% to $6 million, primarily due to costs related to our sponsored research collaboration agreements and increases in employment-related expenses, partially offset by decrease in costs attributed to clinical trials. R&D for the quarter decreased 29% over the same period last year, primarily due to personnel expenses.

本年度研發費用增加 12% 至 600 萬美元，這主要是由於與我們贊助的研究合作協議相關的費用以及與就業相關的費用增加，部分被臨床試驗費用的減少所抵消。本季度研發費用同比下降29%，主要是人員費用支出。

Sales and marketing expenses decreased 13% for the year to $14.9 million and 40% for the quarter to $2.9 million, primarily due to decreases in employment-related expenses, consulting expenses and other marketing expenses, offset by an increase in travel costs.

銷售和營銷費用全年下降 13% 至 1,490 萬美元，本季度下降 40% 至 290 萬美元，這主要是由於與就業相關的費用、諮詢費用和其他營銷費用的減少，被差旅費用的增加所抵消。

General and administrative expenses for the year increased 22% to $16.2 million, primarily due to legal costs, severance for role eliminations and incremental cost of the Executive Chairperson and costs related to our capital raise. For the quarter, G&A expenses decreased 21% to $2.9 million, primarily due to a decrease in outside legal expenses.

本年度的一般和行政費用增加了 22%，達到 1,620 萬美元，這主要是由於法律費用、職位取消的遣散費和執行主席的增量成本以及與我們的融資相關的成本。本季度，G&A 費用下降 21% 至 290 萬美元，這主要是由於外部法律費用的減少。

As of December 31, 2022, Aspira had $13.6 million in cash, and short-term investments. Cash used in operations for the year was $32.2 million compared to $27.4 million in 2021. We utilized $7.1 million in operating activities during the fourth quarter of 2022 compared to $7.6 million in the fourth quarter of 2021 and $8 million in the third quarter of 2022. Cash to be used in operations in 2023 is anticipated to be between $16 million and $19 million.

截至2022年12月31日，Aspira擁有1360萬美元的現金和短期投資。全年運營中使用的現金為 3220 萬美元，而 2021 年為 2740 萬美元。2022 年第四季度我們在運營活動中使用了 710 萬美元，而 2021 年第四季度為 760 萬美元，2022 年第三季度為 800 萬美元。預計 2023 年用於運營的現金將在 1600 萬至 1900 萬美元之間。

I will turn it back over to Nicole.

我會把它轉回給妮可。

Thank you, Marlene. In closing, we've come a long way since the beginning of 2022, and we have been through tremendous change as an organization. But the one thing that remains clear is the critical need for better ovarian cancer diagnostic tools for women and the resulting potential for our business. We're taking all the steps we believe are necessary to position ourselves for success and continue to be steadfastly focused on growth, innovation and operational excellence.

謝謝你，瑪琳。最後，自 2022 年初以來，我們已經取得了長足的進步，作為一個組織，我們經歷了巨大的變革。但仍然清楚的一件事是，迫切需要更好的女性卵巢癌診斷工具以及由此產生的我們業務的潛力。我們正在採取所有我們認為必要的步驟來為自己定位成功，並繼續堅定不移地專注於增長、創新和卓越運營。

With that, I would like to now open up the call for questions. Operator?

有了這個，我現在想打開問題的電話。操作員？

(Operator Instructions) Our first question comes from the line of Ross Osborn with Cantor Fitzgerald.

（操作員說明）我們的第一個問題來自 Ross Osborn 和 Cantor Fitzgerald 的台詞。

Congrats on the progress. I thought we'd start off on ASP this year. There's a lot of moving dynamics. So maybe focused on OvaWatch initially. How should we think about ASP following your ability to sign a national payer? And then as a follow-up, when looking at the corporate ASP, can we just walk through the change in payer mix there and how that should evolve over this year?

祝賀進步。我以為我們今年會開始使用 ASP。有很多動態變化。所以最初可能專注於 OvaWatch。根據您簽署國家付款人的能力，我們應該如何考慮 ASP？然後作為後續行動，在查看公司 ASP 時，我們能否僅介紹那裡付款人組合的變化以及今年應該如何發展？

Sure. Well, on the OvaWatch side, as you know, it does take some time to get those payer relationships lined up. We were very pleased with the progress that we've made so far. But of course, the business is -- or the test market is really divided in a number of parts, including Medicare, which is really important for an ovarian cancer test, as women are at higher risk as they age. So we continue to be optimistic about the crosswalk of the Novitas LCD and as I mentioned in my earlier remarks, we are looking at a potential NCD for multi-market ovarian cancer blood test based on the provision in omnibus bill. So still work to do there, of course, but ultimately, we expect in reasonably short order, sometime towards the end of the year to start to see the OvaWatch, ASP start to line up with the Ova1Plus price.

當然。好吧，在 OvaWatch 方面，如您所知，確實需要一些時間來協調這些付款人關係。我們對迄今為止取得的進展感到非常滿意。但是，當然，業務是 - 或者測試市場實際上分為許多部分，包括醫療保險，這對於卵巢癌測試非常重要，因為女性隨著年齡的增長面臨更高的風險。因此，我們繼續對 Novitas LCD 的人行橫道持樂觀態度，正如我在之前的發言中提到的那樣，我們正在尋找一種潛在的 NCD，用於根據綜合法案的規定進行多市場卵巢癌血液檢測。因此，當然，仍然需要在那裡做，但最終，我們預計在相當短的時間內，在年底的某個時候開始看到 OvaWatch，ASP 開始與 Ova1Plus 價格保持一致。

And to your point around the changes -- I'm sorry, Rob, I think you were asking around OVA1Plus average selling price, what to make of that in the mix. It is true. It had additional Medicaid sales this year and that mix has sort of resulted in a little bit of erosion on the sales price. But on the upside, that gives us a great platform to go back to those states, which we have been doing aggressively in the last several weeks to go back to states and say, your patients -- your Medicaid patients are benefiting from this test. They've been ordered frequently. We've been able to provide statistics and have had very positive conversations with a number of state Medicaid administrators, to make them see that the test is useful and is being used for the population and to encourage them to accelerate, adding over plus to the fee schedule.

至於你關於變化的觀點——對不起，Rob，我想你是在詢問 OVA1Plus 的平均售價，在組合中如何考慮。是真的。它今年有額外的醫療補助銷售，這種組合在某種程度上導致了銷售價格的下降。但從好的方面來看，這為我們提供了一個很好的平台來回到那些州，我們在過去幾週一直在積極地回到這些州並說，你的病人——你的醫療補助病人正在從這項測試中受益。他們經常被訂購。我們已經能夠提供統計數據，並與許多州醫療補助管理人員進行了非常積極的對話，讓他們看到該測試是有用的並且正在用於人口，並鼓勵他們加快速度，增加 over plus收費表。

Okay. Great. And juggling a couple of calls, I may have missed this, but how are conversations going with potential partners for co-marketing distribution agreement for OvaWatch? Any idea on the time line there?

好的。偉大的。打了幾個電話，我可能錯過了這個，但與潛在合作夥伴就 OvaWatch 的聯合營銷分銷協議進行的對話進展如何？那裡的時間線有什麼想法嗎？

So as you probably know, the important issue that people are looking to is very similar to the question you already asked, which is what does the reimbursement look like for this test, because that is an important risk factor for any potential partner on a commercial partnership for OvaWatch. So every time we have an announcement, which we've had many in the last couple of months, which is great, we get a more captive audience with people to talk about, the market potential for the test. No time line here to -- no time line here to announce. Believe me, we'll be happy to tell you when there's something there.

因此，您可能知道，人們正在尋找的重要問題與您已經提出的問題非常相似，即該測試的報銷情況如何，因為這對於任何潛在的商業合作夥伴來說都是一個重要的風險因素OvaWatch 的合作夥伴關係。因此，每次我們發佈公告時，我們在過去幾個月裡發布了很多公告，這很棒，我們會吸引更多的觀眾來討論測試的市場潛力。這裡沒有時間線——這裡沒有要宣布的時間線。相信我，我們很樂意在有消息時告訴您。

Okay. Got it. And then maybe on your cash burn, does a signing of a potential partner for OvaWatch, does that include in your cash burn guidance positive or negatively?

好的。知道了。然後也許在您的現金消耗方面，是否為 OvaWatch 簽署了一個潛在的合作夥伴，這是否包括在您的現金消耗指導中是積極的還是消極的？

No. We have not included anything relative to cash for OvaWatch partnership.

沒有。我們沒有為 OvaWatch 合作夥伴關係包括任何與現金相關的內容。

Okay. Great. And then lastly on -- nice reiteration for your plan to launch on that test. So I guess between now and launch, what needs to happen from both a development and regulatory perspective?

好的。偉大的。然後最後 - 很好地重申了您在該測試中啟動的計劃。所以我想從現在到發布之間，從開發和監管的角度來看需要發生什麼？

So we've mentioned in the past that we are pursuing a number of different potential paths for the launch of an endometriosis test, which could include an FDA path or an LDT. So we're not ruling either out at this point or remove them all in, I guess, I would say. So from a regulatory standpoint, that's still sort of developing as we continue to think about what makes the most sense from a launch perspective.

因此，我們過去曾提到，我們正在尋求多種不同的潛在路徑來啟動子宮內膜異位症測試，其中可能包括 FDA 路徑或 LDT。所以我們不排除在這一點上或將它們全部刪除，我想，我會說。因此，從監管的角度來看，隨著我們繼續從發布的角度考慮什麼最有意義，這仍在發展中。

What needs to happen, as Ryan mentioned, the biggest barrier to a completed test is in remains, the availability of acceptable samples for the validation of the test. That has been a challenge, and it continues to be a challenge. It doesn't do us with any good whatsoever to try to validate or continue development with samples that are not high quality and that don't line up exactly with the test that we're developing. So that is a challenge. So we continue to seek out additional sources and as we said in the remarks earlier, we were very pleased to see that we were able to identify a number of additional samples in our own biobank as we continue to refine the test and the requirements.

正如 Ryan 提到的，需要發生的事情是，完成測試的最大障礙仍然存在，即用於驗證測試的可接受樣本的可用性。這一直是一個挑戰，而且仍然是一個挑戰。嘗試使用質量不高且與我們正在開發的測試不完全一致的樣本來驗證或繼續開發對我們沒有任何好處。所以這是一個挑戰。因此，我們繼續尋找更多來源，正如我們之前在評論中所說，我們很高興看到隨著我們繼續完善測試和要求，我們能夠在我們自己的生物樣本庫中識別出更多的樣本。

Our next question comes from the line of Andrew Brackmann with William Blair.

我們的下一個問題來自 Andrew Brackmann 和 William Blair 的對話。

This is Griffin, on for Andrew. Thank you taking our questions. Maybe just to start on OvaWatch, can you talk a little bit about the stock feedback that you're getting on OvaWatch? Are you seeing an expanded ordering population that you have that expanded label? And then I think there was some expectation for some cannibalization of OVA1Plus, has that played out as sort of expected so far?

這是格里芬，安德魯。感謝您回答我們的問題。也許只是從 OvaWatch 開始，你能談談你在 OvaWatch 上獲得的股票反饋嗎？您是否看到擁有該擴展標籤的擴展訂購人群？然後我認為對 OVA1Plus 的一些蠶食有一些期望，到目前為止，這是否像預期的那樣發揮作用？

Thanks for the question. I'll say on the cannibalization side, we have not seen that. We've continued to see growth in OVA1Plus. We were really thoughtful about how we presented the test to the physicians and the intended each very, very clear. We've found that they've been able to understand very easily which test is appropriate given the intended use. So happy to say that has not materialized as of yet. Of course, it's early days.

謝謝你的問題。我會說在蠶食方面，我們還沒有看到。我們繼續看到 OVA1Plus 的增長。我們非常仔細地考慮了我們如何向醫生介紹測試，並且每個人的意圖都非常非常清楚。我們發現他們能夠很容易地理解哪種測試適合預期用途。很高興地說這還沒有實現。當然，現在還為時過早。

And in terms of physician response, so far, it's been overwhelmingly positive. As you know, it takes a while to get the word out on a new test. So we continue to go out in the field and also as a company, we're investing in a lot of additional physician conferences and higher impact at the conferences were attending to get the word out. But people seem to be really open to the intended use and they understand the value of taking what turns out is a pretty significant number of masses that sort of fall into the indeterminant category, which frankly, means they really don't have a good sense of what to do with that patient. And it's a large percentage.

就醫生的反應而言，到目前為止，它是非常積極的。如您所知，要在新測試中廣為人知需要一段時間。因此，我們繼續在該領域走出去，作為一家公司，我們正在投資舉辦許多額外的醫師會議，並且在會議上產生更大的影響力，以宣傳。但人們似乎真的對預期用途持開放態度，他們理解採用結果的價值是相當多的質量，這些質量屬於不確定類別，坦率地說，這意味著他們真的沒有很好的感覺如何處理那個病人。而且比例很大。

Having a tool that helps them to reduce that number or to just have better insight into that number of patients is incredibly valuable. We've heard that time and again. So as they've learned how the test works, and the value of being able to isolate the patients that really do need additional scrutiny or additional clinical intervention and rule out to some extent, the women that are in that indeterminate category has been very, very valuable.

擁有一種工具可以幫助他們減少這個數字，或者只是更好地了解那個病人的數量，這是非常有價值的。我們聽過一次又一次。因此，當他們了解測試的工作原理，以及能夠隔離真正需要額外檢查或額外臨床干預並在一定程度上排除的患者的價值時，屬於不確定類別的女性一直非常，非常有價值。

Okay. And that corporate deck, I think, has a potential of watches $300 million to $420 million. Obviously, serial monitoring is really a big part of that. Can you just go in a little bit more detail on the time line for the serial launch indication? I know you talked about a prospective study that's enrolling, but any sense of time lines for launch there?

好的。我認為，那套公司的手錶有 3 億到 4.2 億美元的潛力。顯然，串行監控確實是其中的重要組成部分。您能否更詳細地說明串行啟動指示的時間線？我知道你談到了一項正在招募的前瞻性研究，但有什麼關於在那裡啟動的時間表嗎？

Yes. Yes. So I'll start and then Ryan can add any color to the study. The study is actually -- the study that we're using for the serial monitoring test is actually an extension of the OvaWatch, clinical validation study, which is frauds, we continue to take draws and monitor those patients through additional drugs. Our commitment has been to launch that serial monitoring test in the second half of 2023. Ryan, anything else you'd like to add?

是的。是的。所以我會開始，然後 Ryan 可以為研究添加任何顏色。這項研究實際上是——我們用於連續監測測試的研究實際上是 OvaWatch 臨床驗證研究的延伸，這是欺詐，我們繼續抽取並通過其他藥物監測這些患者。我們的承諾是在 2023 年下半年啟動該系列監控測試。瑞安，你還有什麼想補充的嗎？

No, I think that Nicole mentioned everything needed, (inaudible) ask that question. You answered right. I think the OvaWatch serial monitoring assay is going to be key for the patient and the physician as well, particularly for this particular population, many of them was either by selection or by clinically makes sense, but not selected for surgical intervention. So they need a tool to follow up and OvaWatch is serving that purpose. The great news is our clinical study has come late, but we continue to follow those enrolled patients. So we know exactly what the a (inaudible) going to be. So those data are going to help us to set the stage for what the time line and also at the dosage, if you will. If you think therapeutically, how did this frequently how the woman should see the OvaWatch we may have those information when near to the time that we can launch the test, which we intended -- we remain intended for the second half of the year.

不，我認為 Nicole 提到了所有需要的東西，（聽不清）問那個問題。你回答對了。我認為 OvaWatch 連續監測分析對於患者和醫生來說也將是關鍵，特別是對於這個特定人群，他們中的許多人要么是通過選擇，要么是臨床上有意義，但沒有被選擇用於手術干預。因此，他們需要一種工具來跟進，而 OvaWatch 正是為這個目的服務的。好消息是我們的臨床研究來得晚了，但我們會繼續跟踪那些登記的患者。所以我們確切地知道 a（聽不清）會是什麼。因此，如果您願意，這些數據將幫助我們確定時間表和劑量。如果你從治療的角度考慮，女性應該如何頻繁地看到 OvaWatch，我們可能會在接近我們可以啟動測試的時間時獲得這些信息，這是我們打算的——我們仍然打算在今年下半年進行。

Okay. And then -- sorry.

好的。然後——抱歉。

Sorry, let me just say one thing. We understand that in the market that we are in right now, but the market conditions being what they are, investors, both current and potential investors, are hyper focused on companies with revenue. We continue to believe that the OvaWatch serial monitoring test is going to drive material revenue for the company and has been really put to the top of the list in terms of things we think about every day. And we do believe that our revenue estimates that we've talked about in the past are very, very realistic for a serial monitoring test.

抱歉，我只說一件事。我們知道，在我們現在所處的市場中，但市場條件是這樣的，投資者，無論是現有投資者還是潛在投資者，都非常關注有收入的公司。我們仍然相信，OvaWatch 系列監測測試將推動公司的物質收入，並且確實在我們每天思考的事情方面名列前茅。我們確實相信，我們過去談到的收入估算對於串行監控測試來說是非常非常現實的。

Okay. And then last one, maybe for you, Marlene, on just burn $16 million and $19 million for the year. Anything on how do you think about pacing, first half, second half split? And then I know you had previously sized the reduction forces being maybe something a little over $6 million year-over-year savings in 2023. Is that sort of still how you're thinking about that?

好的。最後一個，也許對你來說，瑪琳，今年只燒掉了 1600 萬美元和 1900 萬美元。關於節奏、上半場、下半場的劃分，你有什麼看法嗎？然後我知道你之前已經估計到 2023 年減少的力量可能會比去年同期節省超過 600 萬美元。你仍然是這樣想的嗎？

We are definitely on target for that and monitoring it very closely. It's pretty evenly spread over the quarters. Most of our savings will be realized towards second quarter going forward, because they were just initiated in first quarter. But overall, we are on target for $16 million to $19 million.

我們肯定會為此目標並密切監視它。它相當均勻地分佈在四分之一區。我們的大部分儲蓄將在未來第二季度實現，因為它們是在第一季度才開始的。但總的來說，我們的目標是 1600 萬到 1900 萬美元。

Ladies and gentlemen, there are no further questions at this time. I'd like to turn the call back to Nicole Sandford for any closing remarks.

女士們，先生們，現在沒有其他問題了。我想將電話轉回 Nicole Sandford 以聽取任何結束語。

Thank you so much, and thanks for the questions. We appreciate the attendance today and the continued support and interest in the company. We've been through an awful lot of change this year, as I said, but I'm more optimistic than I've ever been. I've said before, and I'll say it again that as companies that are further away from commercialization of their product, are really going to struggle. And as we see the fallout of that happening all around us, I believe that we're going to be comparatively a very, very attractive investment, especially as we kind of move through the year, and we continue to deliver on all of the things that we've promised.

非常感謝，也感謝提問。我們感謝今天的出席以及對公司的持續支持和興趣。正如我所說，今年我們經歷了很多變化，但我比以往任何時候都更加樂觀。我以前說過，現在我要再說一遍，作為離產品商業化更遠的公司，真的會陷入困境。當我們看到我們周圍發生的這種情況的後果時，我相信我們將成為一項相對非常非常有吸引力的投資，尤其是當我們經歷了這一年，我們將繼續實現所有目標我們已經承諾過。

So I appreciate your time today and look forward to continuing to bring you additional news and insight as the year goes on. Thank you so much.

因此，感謝您今天抽出寶貴時間，並期待在新的一年繼續為您帶來更多新聞和見解。太感謝了。

Thanks, everyone.

感謝大家。

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great evening.

今天的會議到此結束。此時您可以斷開線路。感謝您的參與，祝您度過一個愉快的夜晚。