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Operator
Good morning, ladies and gentlemen, and welcome to the Aspira Women's Health Incorporated First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will open the call for your questions. As a reminder, this call is being recorded today. Before we begin, I would like to remind everyone that forward-looking statements as defined under the Private Security Litigation Reform Act of 1995 will be made during this call, including statements related 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 subject to risks and uncertainty that could cause results to differ materially from those anticipated due to the impact of many factors beyond the SPIRA Women's Health Control. 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 ASPIRE's most recent annual Form 10-K and quarterly report on Form 10-Q filed with the SEC for a description of factors that could cause actual results to differ materially from those anticipated in a forward-looking statement.
Nicole
At this time, I'd like to turn the call over to Nicole Sanford, Chief Executive Officer. Please go ahead.
Nicole Sanford
Thank you and welcome everyone to our first quarter 2024 earnings conference call. With me today are Dr. Sandy Milligan, our new president, and Torsten Holmbach, our chief financial officer. I will begin with an overview of our strategy, execution, and operation, followed by Sandy with an update on our development plans and Torsten with a review of our financials. We will then open the call for questions. Let me begin with our strategy and commercial execution this quarter. We were excited to see Overwatch grow by 114% to 1,052 in the first quarter of 2024 over the same period last year, representing approximately 18% of total test volume, which declined slightly to 5,829. This is important as we believe the largest opportunity for future growth rests with Overwatch now that we are offering it as a tool for the longitudinal monitoring of masses, creating an opportunity for repeat testing for the more than 1.2 million patients a year that develop an inexorable mass and potentially multiplying the total addressable market by more than two to three times that of a single-use test. Overwatch is designed to help physicians determine the risk of cancer for women with potentially benign or indeterminate masses, something for which there is no other non-invasive tool available. We believe the broad adoption of Overwatch will help women avoid unnecessary surgery for the benefit of patients, physicians, and payers. In fact, data published just last week in the peer-reviewed journal Frontiers in Medicine showed that physician accuracy in predicting malignancy would have improved by more than 400% had Overwatch been used for those patients. You'll hear more about the data shortly, but let's stop there for a minute and talk about the power of this paper. It clearly demonstrates Overwatch's utility for physicians to improve the accuracy of their assessment of malignancy risk and offers an incredible benefit to premenopausal women who may have resorted to surgery in the past. These women face the onset of surgical menopause if their ovaries are removed, causing a host of near and long-term health risks due to the abrupt drop in circulating hormones compared to women that experience menopause naturally and gradually. Surgical menopause has been found to increase women's long-term risk of cardiovascular disease, osteoporosis, Parkinson's disease, and dementia, to name a few. We believe this data will play a central role in driving adoption of Overwatch by both physicians and payers and are currently executing an aggressive campaign to share the paper and findings with our various stakeholders. We also saw the publication of data supporting periodic testing published in the peer-reviewed journal Gynecologic Oncology earlier this month. The validation of Overwatch as a reliable test in the monitoring of ovarian cancer risk in women with indeterminate or low-risk anexal masses especially in a prestigious journal for gynecologic oncology, is a major milestone. Data in this analysis of over 500 women supports the use of Overwatch for monitoring masses over time, offering women and physicians peace of mind if they choose to avoid surgery when malignancy risk is low. Turning now to our commercial activities, our team is more prepared than ever to take advantage of the expanded features of Overwatch. Our sales efficiency numbers continue to improve, with volume for full-time representative increasing 22% to 364 in the first quarter this year when compared to the first quarter of last year. In addition, March was the strongest month of the first quarter, and the momentum has carried into April, which was the second largest volume month in company history, despite two remaining open territories. Another key factor to growth is average unit pricing, or AUP, which was at $369 for the quarter, consistent with the first full quarter of last year. Importantly, the volatility we anticipated with the launch of Overwatch never materialized, and our gross margin remains strong at 56%. Moving to an update on innovation, we are aggressively seeking alternative sources of funding for our product development, including the pursuit of research grants under the leadership of our new president, Sandy Milligan. We submitted ARPA-H grants for OVA-MDX and ENDO-MDX last month to take advantage of the opportunity to obtain funds made available by the Biden administration to support women's health research. The ARPA-H grant process is expected to be condensed with funding decisions to be made as early as the fourth quarter. Other grant applications have been submitted for our portfolio, some of which have been submitted in partnership with collaborators. In addition to an NIH grant submitted by Dana-Farber Cancer Institute, our endo-check test was included in a third ARPA-H grant proposal submitted by a scientific researcher owns a patent that may be used in a promising drug therapy for the treatment of endometrioma. EndoCheck is the only non-invasive test that has been shown to accurately identify endometrioma, making it the perfect pairing for a combined solution and collaboration on clinical research. Positioning EndoCheck as a research test in this manner may generate income while simultaneously validating the algorithm. I continue to believe in the promise of EndoCheck as an inexpensive, non-invasive tool for women with suspected endometrioma, especially for women with comorbidities that create higher surgical risk, adolescents, and underinsured patients. However, we need to be smart about how we build the market to meet the needs of clinicians as well as patients. We are extraordinarily conscious of our spending, and while we would like to fully fund all of our programs, we must be thoughtful in deciding where our research dollars go. While we are pursuing alternative sources of funding for EndoCheck, we are focusing our attention on the MDX portfolio. Now it is my pleasure to turn the call over to Dr. Sandy Milligan, who joined us just a month ago. Her impact is already being felt throughout the organization, providing incredible insight, expertise, leadership, and relationships. Sandy brings a refreshing discipline from her years in the military, a depth of medical knowledge from training as a physician, and strategic clarity from her prior senior roles with a variety of market-leading life sciences companies. She has been a tremendous addition to the team. I will now turn the call over to her.
Sandy Milligan
Thank you, Nicole, and it is truly my pleasure to be part of the Aspira team. It has been an exhilarating ride so far, and I see tremendous potential in our science and technical expertise to forward our vision of transforming gynecological health. Since joining, my focus has been on understanding our programs and strategies to accelerate product development by confirming our priorities, timelines, and capabilities to accelerate our progress without sacrificing scientific or technical rigor. Building on what Nicole has already shared about EndoCheck, we have continued to make strides with the scientific and clinical support for the test. From our previous work with ovarian cancer, We saw potential correlation between some protein biomarkers and endometriosis. We utilized AI to develop an algorithm and trained it on our internal data set composed of women with adnexal masses where this algorithm had high performance. We then applied the algorithm to an external data set that included both patients with and without adnexal masses. In this cohort, we found that the signature had superior performance in the presence of endometriomas and superficial ovarian endometriosis, representing subtypes that are present in up to 40% of women diagnosed with endometriosis. We presented data related to the performance of EndoCheck for the identification of endometrioma at the Society of Reproductive Investigation annual scientific meeting in February, where there was a great deal of excitement about EndoCheck from clinical, academic, and other attendees for its potential contribution to a test with a broader application and the insights it offers to improve the understanding of this devastating and complex disease. Also, as Nicole mentioned, we announced the publication of two Overwatch-focused manuscripts earlier this month, Collectively, the studies support the use of Overwatch as a repeat ovarian cancer risk assessment tool and demonstrated the potential for significantly improved triaging of malignancies for surgery and clinical impression alone. Our published data demonstrates that Overwatch could substantially reduce surgeries for low-risk patients performed out of concern for malignancy risk, especially for asymptomatic and premenopausal women. Indeed, OvalWatch may have reduced the number of surgeries in women with low risk of malignancy by 62% in all patients and 77% in premenopausal women. With the added feature of serial monitoring, OvalWatch can be drawn at provider-prescribed intervals for active surveillance of an adnexal mass determined by initial clinical assessment as indeterminate or low risk. This is the strongest clinical support for OvaWatch and its value proposition for physicians and patients to date. Moving on to OVA-MDX, which is being developed in collaboration with the Dana-Farber Cancer Institute, we have completed assay analytical feasibility on an FDA-approved PCR system and are nearing completion of our initial test design. This is a major innovation and a critical step in the development of our next-generation test for ovarian cancer risk. We believe that the performance of the miRNAs we have licensed from Dana-Farber will lead to the development of a commercial application. As we have shared previously, we believe this test will have the power to improve sensitivity for early-stage ovarian cancer as well as specificity for histiological subtypes solidifying our position as the leader in non-invasive ovarian cancer testing for women with adnexal masses. Primarily leveraging samples from our existing biobank, we expect to complete the design and assay verification by the end of 2024. EndoMDX is also being developed in collaboration with Dana-Farber. We will begin establishing analytical feasibility and down-selecting of MI, RNA, and protein candidates as part of the ongoing test design. By the end of 2024, we expect to complete the assay and algorithm design inputs and begin the verification and validation procedures leveraging our experience developing OVA-MDX and confidence in the signature delivered by Dana-Farber. On the regulatory front, earlier this month, FDA finalized its rule to regulate lab-developed tests. It is worth noting that unlike earlier proposals, it included provisions that may allow existing LDTs to be exempted from additional oversight provisions. We do not anticipate the new rule to have any impact on our ability to offer existing products, including the longitudinal testing feature of Overwatch. We are still assessing the impact of the final rule on the regulatory strategy for products in our pipeline. However, we do not currently anticipate this regulation to cause significant extension of our prior development or launch timeline. I want to thank everyone in the company for the reception I have received since joining. It is clear that everyone here is committed to the success of the company and to making a difference in women's health, and I am honored to be working alongside our talented crew. The passion for leading the way in women's health with non-invasive AI-enabled tests to aid in the diagnosis of gynecological diseases is unwavering and truly inspiring.
Dana - Farber
With that, let me turn it over to Torsten for an update on our financials.
spk00
Thank you, Sandy. Let me begin with a review of our first quarter 2024 financial results. Oversweet revenue for the first quarter of 2024 was $2.2 million, which was a slight decline from the $2.3 million in the same period last year, but an increase of approximately $100,000 from the $2.1 million, from the fourth quarter of 2023. Revenue in the quarter benefited by a strong 114% year-over-year growth of Overwatch, but was offset by a decrease in our Overwatch 1 Plus test volume that had been contributed by unprofitable territories eliminated as part of the refresh of our commercial strategy in 2023. Looking more closely at our sales trend this year, I'm very pleased to see our commercial refresh having a positive impact that we anticipated it would. We completed the refresh towards the end of last year, and importantly, we're now seeing a return to growth in test volume. As a matter of fact, our Oversweet test volumes since January of 2024 have increased each month, both for Overwatch and Overwatch. and we have seen that positive trend continue into April. I do not normally comment on the monthly trends, and we won't provide monthly updates in the future, but I felt it was important this quarter to demonstrate the reversal of the prior trends, which are now pointing again towards positive growth. Our overall average unit price was stable at $369 for the first quarter of 2024 compared to $370 in the first quarter of last year. However, the AUP number alone doesn't tell the whole story. Last year's first quarter was almost all related to over one plus compared to this quarter where volume was closer to an 80-20 split between Overwatch and Overwatch. The stable AUP means the average price of Overwatch is increasing and conforming with Overwatch faster than we had originally anticipated. We have seen no dilution in the price as a result of the change in product mix, which is normally expected with the launch of a new test. With the recent announcement of commercial reimbursement wins for Overwatch, like Anthem in California, we believe our AUP will improve steadily. Our gross margins for the first quarter of 2024 improved to 56.3% compared to 51.2% in the first quarter of 2023. Our operating expenses all showed significant improvement this quarter compared to the first quarter of 2023. Research development expenses for the quarter decreased by 28%, and sales and marketing expenses decreased by 27%, while G&A decreased 13% as a result of our continued focus on discipline spending throughout the organization. Our cash use and operating activities in the first quarter of 2023 was $4.4 million, down 23% compared to cash use and operating activities of $5.7 million in the first quarter of 2023. Cash and restricted cash as of March 31, 2024 was $3.7 million, up from $2.9 million as of December 31, 2023. To date, we have used $2 million from our existing equity line of credit with Nickel Park Capital, and we have approximately $2.8 million remaining available to us. Additionally, we are pursuing various dilutive and non-dilutive sources of funding, including research grants. We reiterate our cash use in operations guidance for 2024 to be between $15 and $18 million. On a macro level, we see a clear resurgence of interest in women's health, including and maybe especially with respect to advanced diagnostic tools. I believe this, with the publication of our two papers Nicole and Sandy talked about earlier, and the expansion of Overwatch and its potential to provide a source of recurring revenue, has strengthened our positioning in the market and with potential commercial partners. While conditions continue to be less than optimal for small cap companies, I'm encouraged by the conversations we are having with various parties, including potential investors about the company. With that, I will now turn the call back over to Nicole for our closing remarks.
Nicole
Nicole?
Dana - Farber
Thank you, Torsten.
Nicole Sanford
Aspire remains steadfastly focused on its mission to improve health outcomes for millions of women. while positioning ourselves for long-term success. We have the only blood tests on the market for the accurate assessment of the risk of malignancy for all patients that have been diagnosed with an anexal mass, and we are leading the way in the development of non-invasive tests for endometriosis. With the launch of the longitudinal monitoring feature of Overwatch Complete, the return of volume growth at the end of the first quarter and into the start of the second quarter, I am more bullish than ever about our ability to scale the business. Despite the ongoing challenges in the market, we have kept our promises to patients, physicians, and our shareholders to the best of our ability. Spirits in the company are high, and we remain deeply committed to realizing the opportunities in front of us. With that, I would like to open the call for questions.
Nicole
Operator? Thank you. We will now be conducting a question and answer session.
Operator
If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key.
Nicole
One moment, please, while we poll for questions. Thank you. Our first question is from Ross Osborne with Cantor Fitzgerald.
Operator
Please proceed with your question.
spk04
Hi, good morning. Congrats on the progress. Thanks for taking our questions. So starting off, would you remind us to the extent that Overwatch LM will cannibalize the single monitoring offering?
Dana - Farber
Sure. So, hey, Ross, thanks for joining.
Nicole Sanford
It's really not a question of cannibalizing because this is extending the usage. So the single-use test will continue to be, and again, just a reminder to all that this is an additional feature. The test itself hasn't changed, so it's the same test. Okay, just to be perfectly clear. It's a new feature that is supported by some pretty powerful clinical data that will encourage physicians to run the test multiple times for the same patient over time. So that first test will still be the first test, just like always. And now the physicians will be encouraged or will be able to select their own intervals for running additional tests. So this is a multiplier. It's not really a divider, let's say. Is that helpful?
spk04
Yes, understood. And then moving on to volume, you mentioned March being the strongest month of the quarter with momentum carrying into April. Would you just provide some more color on what's driving growth?
Nicole Sanford
Sure. Well, a few things. I think we've talked in the past about our commercial refresh. We completed most of that work at this time, and that included improving our messaging, providing additional tools to the team, creating a new marketing team. We added some folks who were focused on driving pull-through with national accounts. We added some new people internally for inside sales. So there were a lot of different things that we've done over the course of the last year to improve the performance of the team. We also added a few roles in December. So we were close to a full team for the majority of the first quarter. So we're really starting to see the momentum that we expected to see as a result of the changes that we made. So the downward trajectory in the second half of last year was a conscious decision to conserve cash by eliminating unprofitable territories while we refreshed the entire commercial team. in preparation for the launch of the longitudinal monitoring test, which we believe is the largest opportunity for the company and the company's history, frankly, for growth.
spk04
Great. And then lastly for us, on the LDT proposal, are there any updates you'll need to do to your facilities to become compliant with the EA oversight?
Nicole Sanford
It's a little early for us to be 100% clear on the provisions, but Sandy, anything you want to comment there?
Sandy Milligan
Yes, certainly. I think there's some phase-in responsibilities that we will have, but I don't think it will take any modifications to our already CLIA-certified facilities. So there are some expected responsibilities around labeling, documentation, but nothing extraordinary and nothing that we're not prepared to do already.
Nicole
Okay, great. Thanks for taking our questions. Thanks, Ross. Thank you. Our next question is from Andrew Brackman with William Blair. Please proceed with your question.
Andrew Brackman
Hey, everyone. This is Maggie Bowie on for Andrew today. Maybe one just to start on Overwatch growth. Can you talk about how much of the growth in the quarter from Overwatch came from new accounts versus driving utilization in existing accounts? And then while I can appreciate it's still early, what are you seeing in terms of new versus existing accounts with the recent longitudinal monitoring launch?
Nicole Sanford
Hey, Maggie. Thanks for joining. I don't think we've ever talked about, or at least in recent history, we haven't talked about new versus existing positions. So I'm not really prepared to give any additional color about that. and it is very early. In fact, it's less than a week since we launched the longitudinal monitoring application, so definitely too early to give too much color. I want to tell you, though, this is, to me, is an important development, not just for the fact of driving recurring revenue, but we think that the Overwatch longitudinal monitoring test is going to help to create stickiness with our existing providers. What's important is that we have tests now that will be appropriate for assessing malignancy risk for every single patient that comes in the door with an anexal mask. And so it will just become part of the standard procedure that physicians use when they have a patient with an anexal mask. And having that continuous ability to monitor it is a big part of driving adoption. Doctors really like to see those patients back periodically. They will often have them come back and have a follow-up ultrasound. We believe over time, the ultrasound and the Overwatch test will be ordered at the same time for the follow-up.
Andrew Brackman
Okay, great. Thank you. And then could you expand on the recent Anthem update and then provide some more color on what you're expecting in terms of timing of potential coverage and contracts to come through?
Nicole Sanford
Torsten, do you want me to cover that, or are you able to comment?
spk00
Yeah, so with Anthem, we signed the first agreement which covered the Blue Crosses of California, which added approximately 6 million covered lives to our portfolio. We are in the process of credentialing with Anthem for additional territories, and we would expect the next step to be seen in the next few weeks.
Nicole Sanford
The plan there is to continue to add contracts. Oh, sorry, Maggie. So the plan will be to continue to add contracts. The way that Anthem works is you really have to kind of go region by region, contract by contract. But our plan is to do what we can to focus our energies on areas of the country where we have volumes so that we can get the most bang for the buck in terms of those those additional contracts. But one of the main keys is that we're credentialed now, and it's for OVA suite, which is the first time that we've been able to say that we have credentialing and contracting for the entire suite versus a single test.
Andrew Brackman
Makes sense. Thanks so much for taking our questions today.
Nicole
Sure. Thanks, Maggie. Thanks, Maggie. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question is from Doe Kim with Water Tower Research. Please proceed with your question.
Doe Kim
Hi, good morning. Thanks for taking our questions. First question on for the longitudinal monitoring of Overwatch. How often or is there an expected frequency of repeat testing, optimal time between tests, or is it dependent on the patient? And does the reimbursement coverage have limitations in the number of testing?
Dana - Farber
Good morning, Joe.
Nicole Sanford
Thanks for the question. So, we made a very conscious decision not to prescribe a certain interval. What we found in our research was that individual physicians and healthcare providers have sort of their own judgment that they apply to how often they want to see those patients. We did see in the research that the most frequently selected interval was timed with an ultrasound, which was somewhere between three and six months. So that's that's going to be up to the physician. Of course, a lot of things can change between that first draw. So, you know, we're going to continue to study, but doctors were very clear to us that they didn't want to be told how often they ought to be drawing the test. They wanted that judgment to be in their hands as well. I'm sorry, Joe, can you repeat the second part of your question?
Doe Kim
Are there any limitations from insurance payers on the frequency of the number of testing allowed?
Nicole Sanford
Oh, okay. No, we don't have anything in any of their existing contracts that would restrict that.
Doe Kim
Okay, great. And how do you plan to use these publications and congrats on getting those studies published as an effective marketing tool?
Nicole Sanford
A few different ways, we've already trained the sales team on the outcomes of the studies. We've provided them with summaries of the studies and the full papers. They are out there talking to their existing ordering providers. We're also having our inside sales team reach out to physicians that have already used Overwatch to let them know that this feature is now available. So we're pretty aggressively going out there with that marketing side of things. and also plan on hosting some virtual roundtables and KOL events.
Nicole
Great.
Doe Kim
And one last question shifting over to the endometriosis testing. Do you have any updated thoughts on how the diagnosis of endometriosis is improving? Is the level of undiagnosed patients still out there? And how much overlap is there between your oversweet marketing efforts, your sales force versus the endometriosis population?
Nicole Sanford
Well, I'll comment on that piece and then I'll ask Sandy if she has anything to add on the diagnosis landscape for endometriosis. Just the overlap is significant. Most of the physicians that will see patients that have pelvic pain or sort of consistent symptoms with things that drive them to use an Overwatch test. So, you know, it's the same physician, typically a gynecologist, a nurse practitioner, someone in an OBGYN office will be most likely to be the first to identify the potential for all of these masks related and the and pain-driven disease diagnoses. And Sandy, you can comment, but I would say that without our test, there really hasn't been any major innovation that's helping women to be diagnosed with endometriosis sooner at this point.
Sandy Milligan
Yes, I agree with you, Nicole. I think it's a great question. I do think the one area that we've seen an uptake is the additional conversation and awareness. So I think that patients are more generally aware of what their symptomatology could be, driving them to the physician's office. And so, you know, hopefully over time we'll see that that standard accepted figure of 7 to 10 years of diagnosis starts to come down. However, as Nicole has pointed out, there isn't anything currently on the market, whether it's a diagnostic or an imaging study that has been qualified and certified or cleared that for the diagnosis of endometriosis. So as it stands, the gold standard for the diagnosis of endometriosis is still an evasive laparoscopic surgery. So we're still moving towards better diagnostic capabilities. And of course, we're hoping that we will remain the front runner in that area.
Nicole Sanford
I'll add one thing to that. Thank you, Sandy. Doe, just one thing that we did recently in our marketing team, we went out and we took a look at the social media footprint for endometriosis-focused groups, and particularly on Facebook and on Instagram. And we found a dozen that had literally thousands. And we had more than four or five that had more than 100,000 members. So, you know, this awareness is a really important part of our strategy when we roll out our first endometriosis test. There's an aggressive pull from the market for better diagnosis in endometriosis that I think could be incredibly valuable to us as we launch those tests.
Nicole
Absolutely agree. We're excited about your progress throughout the quarter, and thanks for taking our questions. Thank you, Joe. At this time, there are no further questions in the queue. I will now turn it back to Nicole Sanford for closing remarks.
Nicole Sanford
Well, thank you everyone for joining us today. We look forward to continuing the progress of our execution and providing another update on our next quarterly earnings call. Thanks everyone.
Nicole
This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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