Aspira Women's Health Inc
NASDAQ:AWH
Earnings Call Analysis
Q4-2023 Analysis
Aspira Women's Health Inc
The company is carefully considering its options for submitting a management manuscript to other journals and is currently awaiting a review. They have also seen improvement in reimbursements for their tests OvaWatch and Ova1, with OvaWatch quickly catching up to Ova1's pricing. Efforts to close the commercial gap in reimbursement and address holdouts on Ova1 are ongoing, and recent progress has been very encouraging for the company. They have not provided specific numbers regarding the average denial rate for appeals, suggesting an area for future clarification.
The company had a total of 17 sales representatives, including inside salespeople, showing significant impact. They are currently looking to fill three open roles, one due to turnover and others for new territories. Expansion into new territories is dependent on strong reimbursement and strategic relationships with physician groups and health systems. For instance, they are targeting a large health system in the Midwest, ensuring all the critical pieces like medical policy and reimbursement are in place before adding a representative in the area.
There is substantial interest from NIH in EndoCheck, and a grant application to support this development is nearing submission. The swift progress of another test, EndoMDx, raises questions about how the two tests will complement each other or which will launch. There’s a palpable excitement and awareness among the medical community, particularly for a non-invasive endometriosis test. This enthusiasm was evident from the positive reception at the SRI Conference, highlighting the unmet need in the current diagnostic landscape.
There are several existing treatments for endometriosis, mainly for pain management, with recent drugs from AbbVie and Myovant being notable additions. However, the current dependency on surgical diagnostic methods is a bottleneck for progress in therapy development. The company believes that creating a non-invasive diagnostic like EndoCheck will accelerate the development of new treatments.
The company’s executives express immense gratitude to shareholders and interest parties for their support. The company positions itself as well-poised in 2024, with eager anticipation to discuss the first quarter results shortly. The sentiment is hopeful and optimistic, reflecting confidence in the company's trajectory.
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Good morning, ladies and gentlemen, and welcome to Aspira Women's Health, Inc. Fourth Quarter and '23 Year-end Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded today. Leading the call today are Nicole Sandford, Chief Executive Officer; and Torsten Hombeck, Chief Financial Officer. [Operator Instructions]
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 turn the call over to Nicole Sandford, President and Chief Executive Officer. Please go ahead.
Thank you, operator, and welcome, everyone, to our fourth quarter and year-end 2023 earnings conference call. With me today is Torsten Hombeck, our Chief Financial Officer, who will provide a brief update on our financial performance after my prepared remarks. We'll then open the call for questions. Before I begin my update on our progress, I want to take a minute to discuss the incredible ground flow of support for more women's health research and better outcomes in the United States. We have worked with other advocates to raise awareness among both federal and state lawmakers about the challenges women face in securing adequate gynecologic care and the particular issues we face in accessing innovative life-saving tools like the biomarker test offered by Aspira. Some of you remember Aspira's patient spokesperson, Diane Powis, who spent some of her last months of life preparing for and delivering to Congress a briefing that led the introduction of new legislation. Perhaps a few people know about our ongoing effort to change state laws and coverage policies that impact women's health matters across the country. There's been a long exhausting process that has required focused determination and the support of exceptional advocates and shareholders, and it finally appears to be paying off. President Biden recently signed an executive order supporting women's health research that opened up access to $100 million in funding through the newly formed Advanced Research Projects Agency for Health, or ARPA-H. Moreover, state legislation is being introduced around the country to expand coverage for biomarker testing. Last week, the State of Delaware passed The Faith Deanna Johnson Act aimed at improving access to detection and intervention services for those with a family history of certain types of cancers. They joined 15 other states that have already passed broad biomarker testing legislation and nearly a dozen more with those under consideration. We've also seen unprecedented interest in women's health research from the National Institute of Health and the Department of Defense. The most exciting thing about the additional opportunities is that many are focused on funding projects that [ play ] into our strengths. Strong ties world-class academic and research centers have demonstrated the ability to launch and deliver tests in a commercial setting and a pipeline of near-term products are just a few of the advantages we see for Aspira. We intend to continue our long history of working with change makers in women's health to advocate for health equity and improve the outcomes for women. And we are certainly eager to take full advantage of the new opportunities that are available to us in 2024 and beyond. Now let's take a look at 2023. It was an exciting and dynamic year filled many changes and strong strategic execution. Throughout it all, we stayed true to our 3 touchstones for progress: growth, innovation and operational excellence. I'll begin with a review of our growth this year, followed by an update on developments on the innovation side. I will then cover operational execution highlights, including some exciting recent leadership announcements. Improving our commercial capabilities was the most important strategic growth priority for us in 2023. Aspira's commercially available assays are, without question, revolutionary tools with the potential to substantially improve health outcomes for women, despite steady volume growth and inflection point has remained elusive. At the beginning of 2023, we completed a comprehensive review of our commercial ecosystem, with the goal of identifying people, process and technology enhancements. The results we're telling, we needed to make sweeping changes throughout the organization to address competency gaps. In the summer of 2023, we launched a commercial refresh program based on the findings of our review to align our team and implement critically important changes aimed at ensuring our assays would reach their full potential. It's hard to overstate the comprehensive nature of the changes we made. We recruited new members to the leadership team, created several high-level strategic roles to focus on national accounts and alliances, redesigned our sales incentive compensation plan, eliminated unprofitable territories, replaced underperforming reps, in-sourced marketing with experienced health care and diagnostic professionals, created an inside sales function and expanded our data and targeting capabilities. We knew, though, that we would sacrifice some volume growth in the second half of the year by cutting on profitable territories in order to properly rebuild our team and implement new processes and protocols. While we did see some softness in the third and fourth quarters of 2023, we managed to achieve 15% year-over-year growth in OvaSuite revenues. OvaWatch, which we introduced at the end of 2022, grew throughout the year as physicians recognized its ability to fill an unmet need in the clinical management of adnexal masses. Importantly, we accomplished this growth while simultaneously decreasing our sales and marketing expenses by nearly 50%. We had a total of 17 full-time salespeople at the end of 2023, down from 24 at the beginning of the year. Thanks to a sales team that is more experienced than at any point in the company's history, the average full year OvaSuite test volume per full-time sales reps increased 50% from 779 in 2022 to 1,170 in 2023. We are approaching the end of the commercial refresh program and we'll be ready for the anticipated introduction of our new products. We expect to see more growth in 2024 as our improved sales team hit its stride and many of the important infrastructure improvements begin to make an impact. In fact, March has been a very strong month so far, even with several open commercial positions left to fill. Of course, the other critical component of revenue is price. The average unit price of our OvaSuite tests increased to $383, up from $372 in 2022. Driving the improvement in AUP was the improvement in our market access capabilities, including a new PLA code for OvaWatch, the approval of our CMS request to crosswalk the pricing of Ova1 to OvaWatch and numerous expansions of commercial and Medicaid coverage. Let's move now to an update on our innovation efforts, which we see as fundamental for the creation of long-term enterprise value. Fortunately, we are extremely well positioned to successfully develop novel AI-based assay to aid in the doses of gynecologic disease based on our extensive know-how and experience, designing and launching blood tests for ovarian cancer. This experience carries with it benefits like our biobank of over 110,000 patient samples and data from thousands more. This is, of course, the extremely valuable raw material from which we build our future products, including those already in development. In January, we were pleased to update you with exciting developments we have made in both our ovarian cancer and endometriosis portfolio. In ovarian cancer, we have been developing clinical data to expand the use of our OvaWatch test from a single-use test to a multiple use test for the monitoring of an adnexal mass. We believe many women can avoid the unnecessary or premature surgical removal of their ovaries, thereby avoiding lifelong side effects and a tremendous cost via health care system with the noninvasive monitoring of their masses. Surgery does not have to be the first step. However, proper assessment and clinical planning can only happen with the benefit of a reliable, clinically proven test that provides information on the map. OvaWatch is that critical tool. We have manuscripts currently under review by well-respected peer-reviewed journals. While we cannot predict when we will be accepted for publication, we believe the data clearly supports the monitoring of the mass to provide women with an alternative to premature or unnecessary surgical intervention. Also in ovarian cancer, we have spoken previously about OvaMDx, the next-generation noninvasive risk assessment tests that combine serum proteins, clinical data and microRNA. We are developing this test in collaboration with Dana-Farber Cancer Institute as part of a licensing agreement we signed in 2023. Based on initial research, OvaMDx may provide higher specificity for all ovarian cancer and higher sensitivity for certain early-stage cancers when compared to existing technology, a major leap forward in diagnostic testing. We are in the process of completing our final test design, which includes completing the transfer of the test to an FDA-approved PCR system. We expect to complete this work along with the verification and validation of the assay by the end of 2024. Let's turn now to our endometriosis portfolio. Endometriosis is a significant problem for millions of women, up to 6.5 million women in the U.S. alone to be more precise. Based on a ground flow of advocacy, we expect the proliferation of therapeutics to treat this disease, increasing the need for an easy-to-use, reliable, noninvasive diagnostics. We are well positioned to meet this need. In December 2023, we announced the exciting news that our work can produce the first-ever protein biomarker test for the identification of endometriosis. Data from our studies clearly showed that EndoCheck accurately identifies ovarian endometriosis in endometrioma, one of the most common forms of endometriosis. We presented the data related to the performance of this test earlier this month at the Society for Reproductive Investigation Annual Scientific Conference. We were told by the reception and the level of excitement surrounding our work. We intend to finalize the manuscript for publication based on the data and complete an NIH grant application for additional funding for the remaining development and validation steps required for EndoCheck. We're currently evaluating the best commercial application and appropriate launch timeline for EndoCheck in light of the meaningful progress that has been made in the development of EndoMDx, our noninvasive test combining serum proteins, clinical data and microRNA for the identification of all endometriosis. Our successful sponsored research agreement with a consortium of world-class academic and clinical partners, led by Dana-Farber Cancer Institute, led to the development of a promising microRNA signature that is currently in the final test design stages. Much like our work with OvaMDx, the test will be transferred to an FDA-approved PCR system before finalizing the algorithm and verification of the signature in 2024. As you can see, we intend to lead the way in the creation of noninvasive AI-based tests to aid in the diagnosis of gynecologic diseases. On the operational side, we welcome Dr. Sandra Milligan as President, who joins an already strong leadership team. As a seasoned executive with women's health and product development expertise, Sandy is coming in to accelerate our launch plans and secure new innovation and commercialization partnership. She is an accomplished leader with a stellar reputation, and we are excited to have her join the team. We've come a long way, and I'm very proud of that, but we still have work to do to prepare for the much bigger opportunity in front of us. In the past 2 years, we have been methodically laying the foundation, brick by brick, for breakout growth. There is a growing optimism inside the company, a feeling that we are ready to reach our full potential, and this is a great way to start 2024. With that, let me turn it over to Torsten for an update on our financials. Torsten?
Thank you, Nicole. I will begin with a review of our fourth quarter results, followed by a review of our full year 2023 results. OvaSuite revenue for the fourth quarter of 2023 was $2.1 million, which was flat compared to the fourth quarter of 2022. Revenue in the fourth quarter of 2023 benefited by strong year-over-year growth of OvaWatch, which was offset by a decrease in our Ova1Plus tests volume. We also benefited somewhat from an increase in our overall average unit price, or AUP, which rose to $376 in the fourth quarter of 2023 compared to $369 in the same period of 2022. We have made headway in gaining additional reimbursement coverage for OvaWatch, which continues to improve our overall AUP. Research and development expenses for the fourth quarter of 2023 increased slightly, while G&A was essentially flat and sales and marketing expenses decreased by 40%. Moving to our full year 2023 results. OvaSuite revenues improved 15% to $9.2 million compared to $8 million in '22. Revenues benefited from our OvaWatch sales volume increases and our improving AUP, which increased to $382 for the full year compared to $376 (sic) [ $372 ] in 2022. OvaSuite volume increased by 12% in 2023 compared to 2022. Our gross margins for the full year improved to 57% compared to 52% in '22, benefiting from lower lab supply and shipping costs in '23 versus 2022. We made great improvements across the board last year in R&D, sales and marketing and G&A spending. Our R&D expenses last year decreased 32% compared to 2022. Sales and marketing expenses decreased 48%, and G&A expenses were down 16% compared to 2022. Overall, our cash used in operating activities in 2023 was $15.9 million, down 49% compared to cash used in operations of $31.1 million in 2022. Our cash as of December 31, '23, was $2.9 million, which was boosted by $5.5 million in gross proceeds raised in January 2024 as part of our registered direct offering. On our existing equity purchase agreement with Lincoln Park Capital, we have approximately $8.4 million remaining available to us. Additionally, we are pursuing a number of nondilutive sources of cash, including research grants. Our cash used in operating activities in '24 is expected to be between USD 15 million and USD 18 million. With that, I will now turn the call back over to Nicole. Nicole?
Thank you, Torsten. We've come a long way this year, one that was punctuated by macroeconomic and geopolitical uncertainty and an overall softness in the diagnostics sector. The clear need for better tools for noninvasive gynecologic disease detection is increasingly being recognized by our national and state leaders, and this creates unprecedented opportunities for our business. We're taking all the steps we believe are necessary to position ourselves for success, and we'll continue to be steadfastly focused on growth, innovation and operational excellence. The energy in the company is fantastic now that we've done much of the hard work associated with rightsizing the business and upgrading our talent. Now we are in the exciting part of building it up and realizing our potential. With that, I'd like to now open the call for questions. Operator?
[Operator Instructions] Our first question is from the line of Ross Osborn with Cantor Fitzgerald.
So starting off with OvaWatch LM. Can you walk through the hurdles to getting your manuscript out? Is there another journal that could publish? And is publication a requirement for commercialization? And if not, why not go ahead and get the test to the market given it's been delayed already?
Sure. Ross, thanks for the question. Yes, there are certainly other journals that we could submit the management too. When you do that, of course, we set the clock. So as long as the journal is reviewing the manuscript, we've made the decision to wait it out. We have gotten some comments. So encouraging there. And the answer is no. It's not required necessarily to have the manuscript. Ultimately, the decision to launch the test is in the hands of our lab director. So that really is the path that we are on at this juncture.
Okay. Understood. And then maybe switching to pricing. How do you see price evolving throughout the year? And could you provide some color on where you stand on reimbursement efforts by each test?
Sure. So we've continued to see reimbursement improve for both tests. It's important to remember that as people adopt OvaWatch in place of potentially using Ova1 off-label, that is good for 2 -- for lots of obvious reasons. We couldn't build that Ova1 test. It was used off label. So now that OvaWatch is there to meet that need, it is encouraging physicians to use OvaWatch instead of off-label use of Ova1, which clearly we don't recommend or promote in any way, right? So that helps both the Ova1 price because we're collecting a higher percentage of those tests and OvaWatch, which has really surpassed our expectations in terms of how quickly it has trended up to meet the Ova1 pricing. In terms of the broader reimbursement, we've brought in a whole new team, really experienced team that is focused on, first and foremost, the commercial -- closing the commercial gap, aggressively going back to any holdouts on Ova1 and then pressing forward with OvaWatch for anyone who's covering Ova1. So we've seen some really great progress in that area we had a release earlier this year. So we're feeling really good about that.
Okay. Got it. Are you able to provide like an average denial rate in your success so far on appeals?
I don't have that information at the tip of my fingers here, Ross. But that's something we can look at in the future.
Okay. Great. And then last one for me, and I'll jump back in the queue. So you resized your territories at the beginning of last year. After 2 quarters, how are you thinking about your territories and headcount given we're [indiscernible]?
Sure. So we were at 17 sales people at the end of the year. That included a number of inside sales people. It was the first year that we were able to add those folks into the mix, and they have made a pretty significant impact right out of the gate, which was great. We have 3 roles that we're looking to fill immediately. Those are open right now, one based on turnover and the other are just additional roles that we're looking to add to new territories or expanded territories. What's really important is if we're going to add a new territory, we have to do it in the context of strong reimbursement and in the context of creating more opportunity through strategic relationships with physician groups and health systems. So for example, for some time, we've been targeting a large health system in Midwest. I'm not ready quite to announce who it is, but targeting that health system there. And before we add a rep to that area, we want to lock in all of those critical pieces, including the medical policy, reimbursement, et cetera, et cetera. So we're really confident in the territories and the reps that we have now. But we're going to be thoughtful if we're going to add more in the future. It's going to be built around success in the building up that will make that rep successful.
Our next question is from the line of Sally Yanchus with Water Tower Research.
Yes. I don't know if you can -- can you comment on the status of EndoCheck? Is it possible that it could launch this year? Or when will you have a better idea of when it could hit the market?
Sure. Thanks, Sally. So EndoCheck, we are really taking a hard look at how to best launch that test in the marketplace, as I mentioned in my remarks. I will say there has been a very, very high level of interest in that test in particular by NIH. And one of program managers has strongly encouraged us to submit a grant application for the development of the test, which we are in the final stages of completing that application. So in the next week or so, I think that will be submitted. But there's a lot of excitement around that as part of a broader panel for understanding the nature of an adnexal mass. So I'm very encouraged by that and also encouraged by the thought that we can get a big piece of that funded by NIH through a grant. So fingers crossed on that. But the other piece is really understanding the rapid development process for EndoMDx, which is going much faster than I think we had anticipated, and thinking about how does the protein R&D that we've done so far for EndoCheck locked into EndoMDx and how do we look at those 2 as complementary and/or making a decision about which to launch and how. So it's great to have options, I guess, is the way I would characterize it.
Okay. And is there a lot of interest among the clinicians that your salesforce targets? I mean, are they aware of this type of tests of, I guess, how much interest and awareness is there among the physicians?
Yes, there's a lot of awareness and a lot of excitement for an endometriosis test. And our simple advisory board that we put together in 2023 has been really helpful in helping us to understand the need for, and then we [indiscernible] this quite candidly, what we hear over and over again is there's nothing currently, and so anything is really helpful, right? The only way to diagnose endometriosis today is through laparoscopic surgery, which is not ideal for anybody, but it's certainly even less ideal when you're talking about a pediatric patient, women with other comorbidities like obesity. These are people who are not good candidates for any surgery. So there's a lot of excitement and interest in the fact that we have now launched the first-ever protein-based blood test or completed the design [indiscernible], but completed the design of them and verified the performance of a noninvasive test for endometriosis and endometrioma being the first target for EndoCheck. So a lot of excitement there. Our poster at the SRI Conference related to the EndoCheck was the most -- one of the most popular poster presentations there. So I think it tells us a lot about the excitement that's happening.
That's great to hear. And are there currently therapies on the market to treat endometriosis? And what's the [indiscernible] there?
Yes. There's 2 -- well, there's several that have been around for a long time, and then there's 2 that are more recent additions to the field. Both are indicated for pain management for endometriosis. AbbVie has a drug on the market. And Myovant, which is now part of [ Sumitovant ], also has a drug on the market. But when you look forward into the future, there are many therapies in development and the need for a noninvasive or nonsurgical diagnostic is one of the things that's holding our progress. So we see that the creation of an effective diagnostic will help accelerate the development of the drug therapies as well.
[Operator Instructions] At this time, there are no further questions in the queue. I will now turn it back to Nicole Sandford for closing remarks.
Great. Thank you, operator, and thank you, everyone, for joining us. We really appreciate the support of our shareholders. We really appreciate all of you joining us today. Hopefully, you're hearing the excitement in my voice and Torsten's voice. The company is really well positioned in 2024, and we're excited to get back to you in just a few short weeks for our first quarter call. So thanks again, and enjoy a quiet day tomorrow.
The conference of Aspira Women's Health has now concluded. Thank you for your participation. You may now disconnect your lines.