Aspira Women’s Health Inc. (NASDAQ:AWH) Q1 2024 Earnings Call Transcript

Aspira Women’s Health Inc. (NASDAQ:AWH) Q1 2024 Earnings Call Transcript May 15, 2024

Aspira Women’s Health Inc. misses on earnings expectations. Reported EPS is $-0.39 EPS, expectations were $-0.36.

Operator: Good morning, ladies and gentlemen, and welcome to Aspira Women’s Health, Incorporated. First Quarter 2024 Earnings Conference Call. At this time, all participants are in listen-only mode. Following managements 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 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 subject to risks and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond Aspira Women’s Health’s 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 note 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 cause actual results to differ materially from those anticipated in the forward-looking statements. At this time, I would like to call the call over to Nicole Sandford, Chief Executive Officer. Please go ahead.

Nicole Sandford: 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 Hombeck, our Chief Financial Officer. I will begin with an overview of our strategy, execution and operations, 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 OvaWatch grow by 114% to 1,052 in the first quarter of 2024 over the same period last year, representing approximately 18% of total which declined slightly to 5,829. This is important as we believe the largest opportunity for future growth rests with OvaWatch 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 adnexal mass and potentially multiplying the total addressable market by more than 2x to 3x that of a single use test. OvaWatch 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 noninvasive tool available. We believe the broad adoption of OvaWatch 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 OvaWatch 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 OvaWatch’s utility for physicians to improve the accuracy of their assessment of malignancy risk and offers an incredible benefit to pre-menopausal 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 hormone 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 OvaWatch 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 OvaWatch as a reliable test in the monitoring of ovarian cancer risk in women with indeterminate or low risk anexcel 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 OvaWatch 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 OvaWatch. Our sales efficiency numbers continue to improve with volume per 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 OvaWatch 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 OvaMDx and EndoMDx 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 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 EndoCheck test was included in a third ARPA-H grant proposal submitted by a scientific researcher that owns a patent that may be used in a promising drug therapy for the treatment of endometrioma. EndoCheck is the only noninvasive 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 EndoTech, 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, time lines 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 develop an algorithm and trained it on our internal dataset composed of women with adnexal masses where this algorithm had high performance. We then applied the algorithm to an external dataset 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 OvaWatch focused manuscripts earlier this month. Collectively, the study supports the use of OvaWatch 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 OvaWatch could substantially reduce surgeries for low-risk patients performed out of concern for malignancy risk, especially for asymptomatic and pre-menopausal women. Indeed, OvaWatch may have reduced the number of surgeries in women with low risk of malignancy by 62% in all patients and 77% in pre-menopausal women. With the added feature of serial monitoring, OvaWatch 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 OvaMDx, 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 histological 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 miRNA and protein candidates as part of the ongoing test design. By the end of 2024, we expect to complete the assay and algorithm design input and begin the verification and validation procedures, leveraging our experience developing OvaMDx and confidence in the signature delivery 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 LVTs 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 OvaWatch. 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 timelines. 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.

With that, let me turn it over to Torsten for an update on our financials.

Torsten Hombeck: Thank you, Sandy. Let me begin with a review of our first quarter 2024 financial results. OvaSuite 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 strong 114% year-over-year growth of OvaWatch, but was offset by a decrease in our Ova1Plus 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 are now seeing a return to growth in test volume. As a matter of fact, our OvaSuite test volumes since January of 2024 have increased each month, both for Ova1Plus and OvaWatch, 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 Ova1Plus compared to this quarter where volume was closer to an 80-20 split between Ova1Plus and OvaWatch.

The stable AUP means the average price of OvaWatch is increasing and conforming with Ova1Plus 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 OvaSuite, like Ansemond, 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 and 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 disciplined spending throughout the organization.

Our cash used in operating activities in the first quarter of 2023 was $4.4 million down 23% compared to cash used in 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 Lincoln Park Capital and we’ve 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 used in operations guidance for 2024 to be between $15 million 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 was the publication of our two papers Nicole and Sandy talked about earlier and the expansion of OvaWatch 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 Sandford: Thank you, Torsten. Aspira remains statistically focused on its mission to improve health outcomes for millions of women, while positioning ourselves for long-term success. We have the only blood test on the market for the accurate assessment of the risk of malignancy for all patients that have been diagnosed with an adnexal mass and we are leading the way in the development of non-invasive test for endometriosis. With the launch of the longitudinal monitoring feature of OvaWatch complete, the return of volume growth at the end of the first quarter and into the start of the second quarter, I’m 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. Operator?

Q&A Session

Operator: [Operator Instructions] Our first question is from Ross Osborn with Cantor Fitzgerald.

Ross Osborn : So starting off, would you remind us to the extent that OvaWatch LM will cannibalize the single monitoring offering?

Nicole Sandford: Sure. So, hey, Ross. Thanks for joining. It 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 interval for running additional tests. This is a multiplier. It’s not really a divider, let’s say. Is that is that helpful?

Ross Osborn : 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 Sandford: Sure. Well, a few things. I think we’ve talked, in the past about our commercial refresh. We’ve completed most of that, 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 are 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 at 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 longitudinal monitoring test, which we believe is the largest opportunity for the company and the company’s history, frankly for growth.

Ross Osborn : 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 Sandford: It’s a little early for us to be a 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’ll take any modification 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.

Operator: Our next question is from Andrew Brackmann with William Blair.

Maggie Boeye: This is Maggie Boeye on for Andrew today. Maybe one just to start on OvaWatch growth. Can you talk about how much of the growth in the quarter from OvaWatch 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 Sandford: 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 physicians. So I’m not really prepared to give any additional color about that. And it’s 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 OvaWatch Longitude 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 adnexal mass.

And so it will just become part of the standard procedure that physician views when they have a patient with an adnexal mass 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 an a follow-up ultrasound. We believe over time, the ultrasound and the OvaWatch test will be ordered at the same time for the follow-up.

Maggie Boeye: 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 Sandford: Sure. Torsten, do you want me to cover that or are you able to comment?

Torsten Hombeck: Yes. 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 Sandford: 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, it really has 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’ve we’re credentialed now, and it’s for OvaSuite, which is 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.

Operator: [Operator Instructions] Our next question is from Do Kim with Water Tower Research.

Do Kim : First question on for the longitudinal monitoring of OvaWatch, 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?

Nicole Sandford: Good morning, Do. 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 health care 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 a ultrasound, which was somewhere between three and six months. So that’s going to be up to the physician. Of course, a lot of things can change between that first draw. So, we’re going to, we’re 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. And I’m sorry, Do. Can you repeat the second part of your question?

Do Kim : Are there any limitations from insurance payers on the frequency of the number of testing allowed?

Nicole Sandford: Okay. No. We don’t have anything in any of their existing contracts that would restrict that.

Do Kim : And how do you plan to use these publications, and congrats on getting those studies published, as an effective marketing tool?

Nicole Sandford: A few different ways. We’ve already trained the sales team on the, 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 OvaWatch 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 round tables and KOL events.

Do 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, the level of undiagnosed patients still out there? And how much overlap is there between your OvaSuite marketing efforts, your sales force versus the endometriosis population?

Nicole Sandford: 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 OvaWatch tech. So, it’s the same physician typically. A gynecologist, a nurse practitioner, someone in a OBGYN office will be most likely to be the first to identify, the potential for all of these masks related and pain driven disease diagnosis. 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 driving them to the physician’s office. And so, 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 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 Sandford: I’ll add one thing to that. Thank you, Sandy. Do, 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 4 or 5 that had more than 100,000 members. So, this awareness is a really important part of our strategy when we roll out our first endometriosis test. There’s a 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.

Do Kim : Absolutely agree. We’re excited about your progress. Congrats on the quarter and thanks for taking our questions.

Operator: At this time, there are no further questions in the queue. I will now turn it back to Nicole Sandford for closing remarks.

Nicole Sandford: 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.

Operator: This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.