Aspira Women's Health Q1 2024 Earnings Call Transcript

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May 15, 2024

There are 7 speakers on the call.

Operator

Good morning, ladies and gentlemen, and welcome to the Aspyrra 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 Securities Litigation Reform Act of 1995 will be made during this call, including statements related to Aspire's expected future performance, future business prospects and future events or plans.

Operator

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 that could cause results to differ materially from those anticipated due to the impact of many factors beyond ASPIRO 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 note set forth in today's press release as well as the risk factors set forth in Aspire's most recent annual Form 10 ks and quarterly report on Form 10 Q filed with the SEC for a description of factors that could cause actual results to differ from those anticipated in the forward looking statements. At this time, I'd like to turn the call over to Nicole Sanford, Chief Executive Officer. Please go ahead.

Speaker 1

Thank you, and welcome, everyone, to our Q1 2024 earnings conference call. With me today are Doctor. Sandy Milligan, our new President and Torsten Hombach, 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.

Speaker 1

Let me begin with our strategy and commercial execution this quarter. We were excited to see Overwatch grow by 114% to 1052 in the Q1 of 2024 over the same period last year, representing approximately 18% of total pets volume, which declined slightly to 5,829. This is important as we believe the largest opportunity for future growth rests with that develop an index of mass and potentially multiplying the total addressable market by more than 2 to 3 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.

Speaker 1

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.

Speaker 1

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 is 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 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.

Speaker 1

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 per full time representative increasing 22% to 364 in the Q1 this year when compared to the Q1 of last year. In addition, March was the strongest month of the Q1 and the momentum has carried into April, which was the 2nd largest volume month in company history despite 2 remaining open territories. Another key factor to growth is average unit pricing or AUP, which was at $3.69 for the quarter, consistent with the 1st 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%.

Speaker 1

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 Q4. Other grant applications have been submitted for our portfolio, some of which have been submitted in partnership with collaborators.

Speaker 1

In addition to an NIH grant submitted by Dana Farber Cancer Institute, our EndoCheck test was included in a 3rd 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 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.

Speaker 1

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 Doctor. Sandy Milligan, who joined us just a month ago.

Speaker 1

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.

Speaker 2

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.

Speaker 2

We utilized AI to 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 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 2 Overwatch focused manuscripts earlier this month.

Speaker 2

Collectively, the study 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, Overwatch 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, Overwatch 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 OVA Watch and its value proposition for physicians and patients to date.

Speaker 2

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.

Speaker 2

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 inputs 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 LDTs to be exempted from additional oversight provisions.

Speaker 2

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 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.

Speaker 2

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 Thorsten for an update on our financials.

Speaker 3

Thank you, Sandy. Let me begin with a review of our Q1 2024 financial results. Oversuite revenue for the Q1 of 2024 was $2,200,000 which was a slight decline from the $2,300,000 in the same period last year, but an increase of approximately $100,000 from the $2,100,000 from the Q4 of 2023. Revenue in the quarter benefited by strong 114% year over year growth of Overwatch, but was offset by a decrease in our OVA1 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.

Speaker 3

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 OvisSuite test volumes since January of 2024 have increased each month, both for OVA1 plus 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.

Speaker 3

Our overall average unit price was stable at $3.69 for the Q1 of 2024 compared to $3.70 in the Q1 of last year. However, the AUP number alone doesn't tell the whole story. Last year's Q1 was almost all related to OVA1 plus compared to this quarter where volume was closer to an eightytwenty split between OVER1 plus and OVERWATCH. The stable AUP means the average price of OVERWATCH is increasing and conforming with OVA1 plus 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.

Speaker 3

With the recent announcement of commercial reimbursement wins for Overstreet, like Ansemond, California, we believe our AUP will improve steadily. Our gross margins for the Q1 of 2024 improved to 56.3% compared to 51.2% in the Q1 of 2023. Our operating expenses all showed significant improvement this quarter compared to the Q1 of 2023. Research and development expenses for the quarter decreased by 28% and sales and marketing expenses decreased by 27%, while G and A decreased 13% as a result of our continued focus on disciplined spending throughout the organization. Our cash used in operating activities in the Q1 of 2023 was $4,400,000 down 23% compared to cash used in operating activities of $5,700,000 in the Q1 of 2023.

Speaker 3

Cash and restricted cash as of March 31, 2024 was $3,700,000 up from $2,900,000 as of December 31, 2023. To date, we have used $2,000,000 from our existing equity line of credit with Lincoln Park Capital, and we have approximately 2 point $8,000,000 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 $15,000,000 $18,000,000 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 2 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 partners.

Speaker 3

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?

Speaker 1

Thank you, Thorsten. ASPIDER 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 test on the market for the accurate assessment of the risk of malignancy for all patients that have been diagnosed within the Nexo 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 Q1 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.

Speaker 1

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?

Operator

Thank you. We will now be conducting a question and answer session. Our first question is from Ross Osborne with Cantor Fitzgerald. Please proceed with your question.

Speaker 4

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?

Speaker 1

Sure. So, hey Ross, thanks for joining. 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.

Speaker 1

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.

Speaker 1

It's not really a divider, let's say. Is that helpful?

Speaker 4

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?

Speaker 1

Sure. Well, a few things. I think we've talked in the past about our commercial refresh. We've 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 are focused on driving pull through with national accounts.

Speaker 1

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 Q1. So we're really starting to see the momentum that we expected to see as a result of the changes that we made.

Speaker 1

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.

Speaker 4

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?

Speaker 1

It's a little early for us to be 100% clear on the provisions. But Sandy, anything you want to comment there?

Speaker 2

Yes, certainly. I think there's some phase in responsibilities that we will have, but I 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.

Speaker 4

Okay, great. Thanks for taking our questions.

Speaker 1

Thanks Ross.

Operator

Thank you. Our next question is from Andrew Brackmann with William Blair. Please proceed with your question.

Speaker 5

Hey, everyone. This is Maggie Bui 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?

Speaker 1

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 is very early.

Speaker 1

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 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 Anexo mask. And so it will just become part of the standard procedure that physicians use when they have a patient with an Anexo mask and having that continuous ability to monitor it is a big part of driving adoption.

Speaker 1

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.

Speaker 5

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?

Speaker 1

Sure. Thorsten, do you want me to cover that or are you able to comment?

Speaker 3

Yes. So with Anthem, we signed the first agreement, which covered the Blue Crosses of California, which added approximately 6,000,000 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?

Speaker 1

The plan there is to continue to add contracts. 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 additional contracts.

Speaker 1

But one of the main keys is that we are credentialed now And it's for Ovisuite, which is the first time that we've been able to say that we have credentialing and contracting for the entire suite versus a

Speaker 5

single test. Makes sense. Thanks so much for taking our questions today.

Speaker 1

Sure. Thanks Maggie.

Operator

Thanks Maggie. Our next question is from Do Kim with Water Tower Research. Please proceed with your question.

Speaker 6

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, testing, optimal time between tests or is it dependent on the patient? And, does the reimbursement coverage have limitations in the number of testing?

Speaker 1

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 a ultrasound, which was somewhere between 3 6 months. So that's going to be up to the physician. Of course, a lot of things can change between that first draw.

Speaker 1

So 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?

Speaker 6

Are there any limitations from insurance payers on the frequency or the number of testing allowed?

Speaker 1

Okay. No, we don't have anything in any their existing contracts that would restrict that.

Speaker 6

Okay, great. And how do you plan to use these publications and congrats on getting those studies published as an effective marketing tool?

Speaker 1

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.

Speaker 1

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.

Speaker 6

Great. 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 OVA suite marketing efforts, your sales force versus the endometriosis

Operator

population?

Speaker 1

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 tech. So it's the same physician typically, a gynecologist, a nurse practitioner, someone in OBGYN office will be most likely to be the first to identify the potential for all of these mass related 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.

Speaker 2

Yes, I agree with you, Nicole. I think it's a great question. 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 hopefully over time, we'll see that that standard accepted figure of 7 to 10 years of diagnosis starts to come down.

Speaker 2

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 invasive 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.

Speaker 1

I'll add one thing to that. Thank you, Sandy. Dough, 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 1000 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.

Speaker 1

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.

Speaker 6

Absolutely agree. We're excited about your progress. Congrats on the quarter and thanks for taking our questions. Thank you, Do.

Operator

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

Speaker 1

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.

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Aspira Women's Health Q1 2024
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