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Aspira Women's Health Provides Commercial, Reimbursement and Cash Guidance Updates

Aspira Women's Health Provides Commercial, Reimbursement and Cash Guidance Updates

aspira women's health提供商业、报销和现金指导更新
GlobeNewswire ·  06/13 08:00

Monthly OvaSuiteSM product volume grew by more than 26% in May compared to January

Monthly OvaSuiteSM与一月相比,5月份的产量增长了超过26%

Reimbursement momentum continued with expanded Anthem and Medicaid coverage for OvaSuite

OvaSuite的报销力度继续扩大,已获得Anthem和Medicaid的更多覆盖范围

Cash used in operations guidance for 2024 expected to be lowered

预测到2024年运营现金流会有所降低

AUSTIN, Texas, June 13, 2024 (GLOBE NEWSWIRE) -- Aspira Women's Health Inc. ("Aspira" or the "Company") (Nasdaq: AWH), a bio-analytical based women's health company focused on the development of gynecologic disease diagnostic tools, today provided interim commercial and operational updates for the second quarter of 2024.

2024年6月13日,德克萨斯州奥斯汀(GLOBE NEWSWIRE)——以生物分析为基础的妇女健康公司Aspira Women’s Health Inc.(“ Aspira ”或“ 公司 ”)(纳斯达克:AWH)今天为2024年第二季度提供了商业和业务更新

Product volume continued its sustained monthly gains, growing by more than 26% in May 2024 compared to January 2024. Year-over-year growth in monthly product volume per full-time sales representative grew to 569 for the five months ended May 2024 compared to 484 for the same period of 2023. This increase was achieved while also shifting resources to cost-effective inside sales reps that represent approximately 20% of the 19-person team as of May 2024. Year-to-date OvaWatch volume through the end of May 2024 is up by more than 88% compared to the same period in 2023.

2024年5月,产品成交量持续增长,较2024年1月增长超过26%。截至2024年5月底的五个月中,每位全职销售代表每月产品成交量同比增长至569,而2023年同期为484。在实现增长的同时,还将资源调整到成本效益高的内部销售代表身上。截至2024年5月,他们占据了19人团队的约20%,这一增长趋势无疑是具可持续性的。截至目前,OvaWatch在销售代表达到年满五个月时,每位全职销售代表的月度产量同比增长了569个,达到了2024年5月,与2023年同期相比,增长超过了88%

"We are excited to share highlights from across the organization," said Nicole Sandford, Aspira's CEO. "The momentum is truly undeniable. Product volume in May 2024 surpassed April continuing our monthly growth we have experienced all year. Importantly, we are reaching these new heights with a leaner, more professional sales team. Sales volume per full-time representative on a year-to-date basis continues to increase, proving that our focus on our sales team while deepening relationships with larger physician groups and channel partnerships is working. With our highly qualified representatives in our territories and an expanded inside sales capability, we expect to drive accelerated growth for the rest of the year."

“我们很高兴分享组织各方面的亮点,”Aspira公司CEO Nicole Sandford表示。“我们获得的势头确实不可否认。2024年5月的产品成交量超过4月,延续了我们全年一直经历的增长趋势。更重要的是,我们拥有了更精简、更专业的销售团队,每位全职代表的销售量在今年以来的基础上继续增加,在拓展与大型医生团体以及频道伙伴关系的同时,证明了我们对销售团队的关注是有效的。拥有高素质代表和一个扩大的内部销售能力,我们预计将在今年下半年实现加速增长。”

Ms. Sandford continued, "OvaWatch sales growth is a major leading indicator of our future growth. The addressable market for OvaWatch, which is now available to assist in the initial and ongoing assessment of malignancy risk for women with an adnexal mass, is estimated to be between 2 and 4 million tests a year. This is a more than 10-fold increase over the estimated Ova1Plus addressable market of approximately 200,000 tests per year. We believe we are well-positioned to capture a significant share of this larger market as a trusted provider of innovative gynecology diagnostics, especially with the expansion of the test for mass monitoring and the release of powerful new publications1,2 just a few weeks ago."

Sandford女士说:“OvaWatch的销售增长是未来增长的主导指标。目前可以使用OvaWatch来最初和持续评估女性怀疑有卵巢肿瘤的风险。据估计,市场潜力为每年200万到400万个测试。这相当于Ova1Plus潜在市场的10倍以上,Ova1Plus潜在市场大约为每年20万次测验。我们相信我们的市场定位和扩大套餐监控测试,结合最新发现的强大新公开销售数据,我们能够成为得到信任的妇科诊断创新提供商,并成功应对未来的新挑战。”这些血液测试为美国每年被诊断为卵巢肿块的120万妇女提供了唯一全面的卵巢癌筛查工具。 OvaWatch的阴性预测值为99%,可用作评估卵巢癌风险的指标,用于对具有不确定性或良性生长的卵巢肿块做出初次临床评测,以避免不必要的手术。Ova1Plus由两项FDA认证测试构成,是一种驳回策略。1,2几周前,刚刚发布的强大新公开销售数据已成为我们计划扩大OvaSuite产品范围,向全国各个医生组织扩大对产品的使用的转折点。

The Company's expansion into the Philippines is on track for a commercial launch of OvaWatch in the third quarter. Revenues from this agreement are expected to generate higher margins compared to margins achieved in the U.S. market as costs associated with providing the test are absorbed by the Company's laboratory partner in the Philippines. Aspira will receive a fee-per-test for access to its proprietary algorithm. Moreover, the Company's inside sales team will support physician adoption using third-party resources, local to the Philippines, that are already trained and supporting the U.S. sales team today.

公司进入菲律宾的扩展计划进展顺利,OvaWatch保健品将于第三季度在该地市场商用。与美国市场相比,此项协议的收入预计将获得更高的利润空间,同时与菲律宾的实验室合作伙伴共同承担提供测试所产生的成本。Aspira将收取每次测试的费用,以购买其专有算法的访问权限。此外,公司的内部销售团队还将支持第三方资源,当地已经接受了相关培训的销售团队,以支持医生的采用。这些销售团队也正在支持美国销售团队。

On the reimbursement front, the Company today announced that it has executed an OvaSuite contract with Anthem Plans of Connecticut, New Hampshire, and Maine, adding over 2 million covered lives under the umbrella agreement with Anthem. Aspira was nationally certified by Anthem earlier this year and the Company expects to add up to 16 million covered lives over the next few quarters as additional regions are added.

此外,公司还与康涅狄格州、新罕布什尔州和缅因州Anthem Plans签订了OvaSuite合同,该框架协议下又增加了超过200万人的覆盖范围。今年早些时候,Aspira已获得Anthem的国家认证,并期望在未来几个季度内增加高达1600万的覆盖范围。

Additionally, the states of Maryland and Kentucky each expanded their Medicaid coverage for OvaWatch adding the test to the fee schedule at $897 per test. With the addition of these two states, OvaSuite tests are now on the fee schedule in nine states, with reviews in progress on several more.

此外,马里兰州和肯塔基州还分别将Medicaid的覆盖范围扩大到OvaWatch,将测试添加到费用表中,费用为每个测试897美元。由于费用乘公司实验室合作伙伴在菲律宾承担的成本,该公司预计将在未来几个季度内增加高达1600万的覆盖范围。

Torsten Hombeck, Chief Financial Officer of Aspira added, "We are glad to see our relationship with Anthem expand to a second region within the Anthem family, bringing our total lives with Anthem to 9 million. We anticipate adding more regions representing an additional 16 million lives, including Ohio, Indiana, Missouri, Wisconsin, and Kentucky in the coming months. We are optimistic that other commercial payers will follow suit, given the strength of our published data in the peer-reviewed journal Frontiers in Medicine showing that OvaWatch can improve a physician's ability to predict malignancy by 431% and lower the number of unnecessary surgeries by 62%1. The publication served as a tipping point in the move by large physician groups to expand access to our OvaSuite of products to their physicians."

Aspira的首席财务官Torsten Hombeck补充说:“我们很高兴看到我们与Anthem的关系扩展到了Anthem家族的第二个地区,将我们与Anthem的总人数扩大到了900万。我们期望在未来几个季度内增加更多地区,包括俄亥俄州、印第安那州、密苏里州、威斯康星州和肯塔基州等地区的合作伙伴。我们乐观地认为,在同行审查期间,在同行评审期刊《医学前沿》中发表的数据显示,OvaWatch can improve a physician's ability to predict malignancy by 431% and lower the number of unnecessary surgeries by 62%(OvaWatch可以使医生预测恶性肿瘤的能力提高431%,并将不必要的手术数量降低62%)更多商业付款方也将效仿。”《医学前沿》是一个同行评审的期刊,该发表了一篇数据文章,称OvaWatch能够让医生预测恶性肿瘤的能力增加431%,并将不必要的手术数量降低62%这一刊物成为了更多大型医生集团扩大其OvaSuite产品使用范围的转折点1此刊物成为更多大型医生集团扩大其OvaSuite产品使用范围的转折点。

The Company anticipates providing a downward revision of the 2024 cash used in operations guidance during the second quarter 2024 earnings call.

公司预计将在2024年第二季度的业绩会上下调运营现金流的指导意见。

About Aspira Women's Health Inc.
Aspira Women's Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases.

关于Aspira Women's Health Inc.
Aspira Women's Health公司致力于发现、开发和商业化非侵入式人工智能诊断妇科疾病测试,共同提供全面的血液测试组合,用于检测卵巢癌,适用于120多万美国女性的卵附件肿块检测。OvaWatch提供了99%的阴性预测值,用于评估卵巢癌的风险,对于最初的临床评估显示肿块未定或良性的妇女,因此手术可能过早或不必要。Ova1Plus由两项经过FDA批准的测试Ova1和Overa组成,用于评估计划接受手术的妇女的卵巢恶性肿瘤风险。

OvaWatch and Ova1Plus are offered to clinicians as OvaSuiteSM. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer for the 1.2+ million American women diagnosed with an adnexal mass each year. OvaWatch provides a negative predictive value of 99% and is used to assess ovarian cancer risk for women where initial clinical assessment indicates the mass is indeterminate or benign, and thus surgery may be premature or unnecessary. Ova1Plus is a reflex process of two FDA-cleared tests, Ova1 and Overa, to assess the risk of ovarian malignancy in women planned for surgery.

OvaWatch和Ova1Plus作为OvaSuite提供给临床医生使用。它们共同提供了唯一的全面血液测试组合,用于为每年被诊断为附件肿块的超过120万名美国妇女检测卵巢癌。当初步临床评估发现肿块不确定或良性时,OvaWatch提供99%的负预测值,用于评估卵巢癌风险,因此手术可能是过早或不必要的。Ova1Plus是两种经FDA批准的测试方法——Ova1和Overa的联用,用于评估计划手术的女性患者的卵巢恶性风险。SM Aspira Women's Health Inc.(“ Aspira ”或“ 公司 ”)(纳斯达克:AWH)是一家以生物分析为基础的妇女健康公司,专注于妇科病诊断工具的开发。OvaWatch提供了99%的阴性预测值,用于评估卵巢癌风险,对于具有不确定性或良性生长的卵巢肿块进行早期临床评定将使手术避免成为一种先去方法。Ova1Plus是两个FDA认证测试的反射过程,用于检测卵巢癌的所有风险因素和 Overa,用于评估计划接受手术的妇女的卵巢恶性肿瘤风险。

Our in-development test pipeline is designed to expand our ovarian cancer portfolio and addresses the tremendous need for noninvasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, our OvaMDxSM risk assessment is designed to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests. In endometriosis, EndoCheckSM is the first-ever noninvasive test designed to identify endometriomas, one of the most commonly occurring forms of endometriosis. The EndoMDxSM test is designed to combine microRNA and protein biomarkers with patient data to identify all endometriosis.

我们正在开发的测试管线旨在扩展我们的卵巢癌产品组合,并满足迫切需要为影响全球数百万女性的疾病——子宫内膜异位症开发非侵入式的诊断工具。在卵巢癌中,我们的OvaMDx风险评估旨在将微小RNA和蛋白生物标志物与患者数据相结合,进一步提高我们当前测试的灵敏度和特异性。在子宫内膜异位症中,EndoCheck是首个非侵入式的测试,旨在识别内膜异位囊肿,它是最常见的子宫内膜异位症形式之一。EndoMDx测试旨在将微小RNA和蛋白质生物标志物与患者数据相结合,以识别所有子宫内膜异位症。SM我们正在开发中的OvaMDx风险评估旨在将微小RNA和蛋白质生物标志物与患者数据相结合,进一步提高我们当前测试的灵敏度和特异性。SMEndoCheck是首个旨在非侵入性地检测和识别子宫内膜异位囊肿的测试。SMtest的设计是将microRNA和蛋白质生物标志物与患者数据相结合,以识别所有子宫内膜异位症。

Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve a number of risks and uncertainties. Such forward-looking statements include statements regarding, among other things, the timing and completion of any products in the pipeline development and other statements that are predictive in nature. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as "designed to," "expect," "plan," "anticipate," "could," "may," "intend," "will," "continue," "future," other words of similar meaning and the use of future dates. Forward-looking statements in this press release and other factors that may cause such differences include the satisfaction of customary closing conditions related to the offering and the expected timing of the closing of the offering. These and additional risks and uncertainties are described more fully in the company's filings with the SEC, including those factors identified as "Risk Factors" in our most recent Annual Report on Form 10-K, for the fiscal year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Aspira presently does not know, or that Aspira currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Aspira's expectations, plans, or forecasts of future events and views as of the date of this press release. Subsequent events and developments may cause the Company's assessments to change. However, while Aspira may elect to update these forward-looking statements at some point in the future, Aspira expressly disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Aspira's assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

前瞻性声明
本新闻稿包含前瞻性声明,如1995年《私人证券诉讼改革法》所定义。前瞻性声明涉及多种风险和不确定性。这些前瞻性声明包括关于正在开发流程中的任何产品的时间和完成情况、其他具有预测性质的声明等。因已知和未知的风险、不确定性和其他因素,实际结果可能会有所不同。这些前瞻性声明通常可以通过使用“设计为”、“预计”、“计划”、“期待”、“可能”、“意图”、“将”、“持续”、“未来”、“其他相似含义的词语和使用将来日期的方式来识别。本新闻稿中的前瞻性声明和其他可能导致此类差异的因素包括满足与该发售有关的惯常收盘条件以及该发售的预计结束时间。这些和其他风险和不确定性在公司提交给美国证券交易委员会的文件中更详尽地描述,包括我们最近的年度报告(表格10-K),截至2023年12月31日的财年,和随后的季度报告(表格10-Q)中标识为“风险因素”的因素。如果这些风险中的任何一个成为现实,或者我们的假设证明是错误的,实际结果可能会与这些前瞻性声明所暗示的结果有所不同。Aspira目前可能不知道或认为不重要的其他风险也可能导致实际结果与前瞻性声明中包含的结果不同。此外,前瞻性声明反映了Aspira对未来事件和观点的期望、计划或预测,截至本新闻稿的日期。随后发生的事件和发展可能会导致公司的评估发生变化。然而,虽然Aspira可能会在未来某个时候选择更新这些前瞻性声明,但Aspira特此声明不承担任何更新前瞻性声明的义务,除非法律要求。这些前瞻性声明不应被视为Aspira对本新闻稿后的任何日期的评估。因此,不应过度依赖这些前瞻性声明。

Investor Relations Contact:
Torsten Hombeck, Ph.D.
Chief Financial Officer
Aspira Women's Health
Investors@aspirawh.com

投资者关系联系人:
Torsten Hombeck,博士
致富金融(临时代码) - 首席财务官
Aspira Women's Health
Investors@aspirawh.com

1 Frontiers | Ovarian Cancer surgical consideration is markedly improved by the neural network powered-MIA3G multivariate index assay (frontiersin.org)

1Frontiers | 神经网络驱动的MIA3G多元指数检测明显提高了卵巢癌手术考虑 (frontiersin.org)

2 Neural network-derived multivariate index assay demonstrates effective clinical performance in longitudinal monitoring of ovarian cancer risk – Gynecologic Oncology

2神经网络衍生的多元指数检测表现良好,对卵巢癌风险的纵向监测 - 妇科肿瘤学


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