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spk04: Good afternoon, ladies and gentlemen, and welcome to the Espira Women's Health Incorporated Third Quarter 2023 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. Leading the call today is Nicole Sanford, President and Chief Executive Officer. Joining her is Dr. Torsten Hombach, Chief Financial Officer. After the prepared remarks, we will open the call for Q&A. 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 the SBIR'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 subjects to risks and uncertainties and could 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 to 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 ESPERA's most recent annual report on Form 10-K and quarterly report on Form 10-Q, filed with the SEC for description of factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. At this time, I'd like to turn the call over to Nicole Sanford, President and Chief Executive Officer. Please go ahead.
spk07: Thank you, Operator, and good afternoon, everyone. I would like to welcome you to our third quarter 2023 conference call. We'll start the call with highlights from this quarter before handing it to our CFO, Torsten Holmbeck, to review our financial performance in more detail. As always, I'll start with growth. We were excited to see CMS's preliminary approval of our request to crosswalk pricing from Oval One to Overwatch in the 2024 preliminary laboratory test fee schedule. If approved as expected later this month, the pricing will apply to all Medicare beneficiaries beginning in January 2024. Elsewhere on the growth front, we welcome back Michelle Snyder as our Senior Vice President of Commercial Strategy and Operations. She rejoins Aspira following successful leadership roles at Sonic Laboratories and SEMA IV. Michelle and I have been collaborating closely on the execution of the next phase of our commercial refresh. including the development of a physician-focused omnichannel strategy, the reinvigoration of our inside sales organization, and the launch of several high-impact campaigns, including our recent physician-focused Overwatch KOL webinar that attracted over 400 participants. We also launched a point-of-care practice aid to help healthcare providers talk to their patients about anexal masses and how our non-invasive OvaSuite products can help assess their risk of cancer. We believe these efforts will continue to drive our Oversweet test into the patient care pathway and increase provider adoption. We have created a new vice president of business development role and recruited a talented executive with extensive healthcare relationships to accelerate our commercial expansion plan. Elsewhere in sales, we turned around several underperforming territories, further reinforcing a performance culture in the commercial organization. We implemented a new relationship with a contract sales organization to improve flexibility and have seen immediate improvements in many of those territories as a result. This quarter, we continue our track record of year-over-year growth for Oversuite since I became CEO. Product revenues for the third quarter were $2.2 million, representing growth of 9% compared to the third quarter of 2022. The number of Oversuite tests performed this quarter was 5,783, an increase of 5% compared to the third quarter of 2022, with Overwatch contributing nearly 20% of that volume. We performed 18,331 Oversuite tests in the first nine months of this year, an increase of 16% versus the same period of 2022. The volume growth was driven by a much leaner sales team, which demonstrates our commitment to eliminating unprofitable and underperforming territories and a renewed focus on partnerships to drive profitable growth that can sustain the company as we bring new and expanded product lines to market. Turning to our average unit price, I continue to be pleased with our progress. Since we began billing Overwatch under its unique PLA code on April 1st, our Overwatch AUP has shown a steady increase to $347, a 7% increase over the second quarter. Oversuite AUP declined to $383 from $396 in the second quarter. However, as Torsten will cover in more detail shortly, the ongoing focus on cost containment helped to hold gross margin at 59%. Operating expenses dropped again in the third quarter, returning to levels the company has not achieved since 2020, while simultaneously achieving growth in both product revenues and volumes. Let me now turn to innovation. This quarter, we welcome Dr. Jody Berry to our senior leadership team. Jody joined Aspira as chief scientific officer in September, following a distinguished academic and commercial career in biochemistry and diagnostics research and development. Most recently, Jody served as the chief scientific officer of Orisher Technologies, where he led the breakthrough discovery of the first integrated swab test for COVID-19. Not only is he a prolific and award-winning researcher, but he is also passionate about women's health. an interest that goes all the way back to his earliest work in pelvic inflammatory disease and HIV. We made great progress in our effort to expand our OVA Suite portfolio, tests that use machine learning to provide a personalized risk of malignancy score for patients with a maxillomasses. Overwatch was designed to be commercially launched in two stages. The first stage was a point-in-time application for initial clinical assessment. which has now been ordered by physicians 2,440 times, with more than 40% of those tests coming in just this last quarter. I'm pleased to report that we have completed a critical step towards the second stage launch of Overwatch as a longitudinal monitoring application. Our clinical study of the real-world use of Overwatch as a tool for monitoring low-risk patients has been completed, and we have submitted the resulting paper for peer review and publication. We're in the process of completing final launch activities and expect to begin offering the longitudinal monitoring test by the end of the year as planned. Looking beyond Overwatch, we are excited about adding other modalities to expand our Oversuite portfolio. As we recently announced, Dr. Kevin Elias, Director of the Gynecologic Oncology Laboratory at Brigham and Women's Hospital, an Assistant Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School, recently presented a poster related to an in-development microRNA-based ovarian cancer test at the American Association of Cancer Research Special Conference for Ovarian Cancer. Dr. Elias highlighted data showing microRNA's potential to improve the diagnostic accuracy of noninvasive blood tests for women with anexal masses based on his extensive ovarian cancer research. The study combines serum protein and patient clinical information from Aspire's ovarian cancer clinical studies with microRNA identified by the Elias Laboratory in collaboration with a consortium of world-renowned academic researchers. Among other findings, the presentation concluded that the combination of microRNAs, proteins, and metadata identified 90% of early-stage and 100% of late-stage ovarian cancers in the study population. This research formed the basis of OVA-MDX, which is expected to become part of the company's OVA Suite portfolio under a previously announced licensing agreement. We are currently finalizing an advisory agreement with an experienced lab to assist our team with platform migration and test validation, which we expect will significantly accelerate the development, validation, and launch of a commercial product. Work under this agreement will begin shortly with the support and collaboration of Dr. Elias. Moving now to EndoCheck, our first-generation non-invasive protein-based blood test to aid in the detection of endometriosis. We continue our verification and validation of the test, utilizing samples acquired from both our EndoCheck study sites and the University of Oxford through a material transfer agreement. Upon validation, we will follow a similar launch strategy as was utilized for Overwatch, with a small-scale rollout to clinicians who have been involved in the development of the test, to be followed by a broader commercial launch upon publication of peer-reviewed data. We continue to develop EndoMDX in parallel with the protein-based EndoCheck test. EndoMDX, which will combine proteins and microRNA for a higher-performing test, is being developed through our sponsored research collaboration with a consortium of academic institutions led by Dana-Farber Cancer Institute. We made a second milestone payment of $125,000 in July following the delivery of the signature. We are now working closely with the collaborators to finalize the platform migration and validation strategy for a commercial test. Finally, we established a new clinical advisory board as an element of the company's overall mission to develop and commercialize high-impact diagnostic tools for gynecologic disease. The clinical advisory board will provide clinical input and guidance throughout the development of the company's portfolio of products and will be chaired by Aspira's Director of Medical Affairs, Dr. Leo Twiggs. Our three members include Dr. Levi Downs, medical director for gynecologic oncology with Park Nicollet Health System at Methodist Hospital, Dr. Nisha Garg, gynecologic surgeon with Arizona Gynecology Consultants, and Dr. Tamika See, the founder and owner of Advanced Women's Care Center. Turning now to operational excellence, we have once again decreased cash used in operations to 3.3 million in the third quarter, representing a 56% reduction when compared to the prior year. while still showing sustained growth. We strengthened our balance sheet with a recent equity raise to support our long-term strategic vision. We have a team that is determined to set a new standard of care in gynecologic health while setting an industry standard for prudent, high-impact capital deployment. Now, I would like to turn the call over to Torsten for a review of our financial performance. Torsten?
spk02: Thank you, Nicole, and good afternoon, everyone.
spk01: It is my pleasure to be here today to provide you with an update on our financial performance. Product revenue for the three months ended September 30, 2023 was $2.2 million, an increase of 9% compared to $2 million for the same period in 2022. The increase in revenue was driven by an increase in over three tests performed during the quarter. which increased 5% to $5,783 compared to $5,524 for the same period in 2022. Revenue per oversweet test performed for the three months ended September 30, 2023 increased 4% to $383 compared to $369 for the same period in 2022. Total gross profit margin for the three months ended September 30, 2023 was 59% compared to 55.8% for the same period last year. Research and development expenses for the three months ended September 30, 2023 were $1 million compared to $2.2 million for the same period in 2022. The decrease of 54% was primarily due to decreases in collaboration and consulting costs. Sales and marketing expenses for three months ended September 30, 2023, were $1.7 million compared to $4 million, a decrease of 57% versus the same period last year. The decrease was primarily due to decreased personnel costs due to our focus of eliminating unprofitable territories and improving bottom line results. General administrative expenses for the three months ended September 30, 2023 with $2.7 million compared to $3.6 million, a decrease of 25% versus the same period last year. This decrease was primarily due to a decrease in personnel expenses and outside legal costs. Total cash, cash equivalents and restricted cash as of September 30, 2023 was approximately $5.4 million. Cash used in operations for the three months ended September 30, 2023 was $3.3 million compared to $7.5 million in the same period of last year and $3.4 million in the second quarter of this year. Our cash balance this quarter benefited from the registered direct offering we completed in July, where we raised $4.2 million in net proceeds. The company reiterates its operating cash utilization guidance for the second half of 2023 to between $6 million and $8 million.
spk02: I will now turn it back over to Nicole. Nicole?
spk07: Thank you, Torsten. My goal has been to be very clear with our investors about our plan and then focus on execution to meet those goals. We've taken many important steps this quarter. While we experienced some moderate seasonal impacts in the third quarter, we grew both volume and revenue with a leaner and more efficient sales team. The submission of the Overwatch Longitudinal Monitoring Paper is a significant achievement, which will expand the addressable market for our OVA Suite test portfolio. Exciting progress was made in the development of our other near-term products, including OVA MDX, EndoCheck, and EndoMDX. In addition, we remain committed to our operational excellence goals and are spending less to achieve more as a result. We are excited to move into 2024 from a position of strength. With that, I would like to now open the call for questions. Operator?
spk04: Thank you. Ladies and gentlemen, at this time, we will be conducting a question and answer session. If you'd like to ask a question, you may 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 would 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. Our first question comes from the line of Ben Hainer with Alliance Global Partners. Please proceed with your question.
spk06: Good afternoon, guys. Thanks for taking the questions. Just first off for me, on the clinical laboratory fee schedule, Medicare reimbursement, congrats on that development. Just wondering how quickly do you anticipate that will sort of diffuse out to other payers?
spk07: Hey, Ben. Thanks for the question. Really challenging to answer that, to be honest with you. It does take some time. We are in the process of a full-scale blitz to any holdouts that we have, both with OVA-1 and with Overwatch, with an updated set of materials, including when approved, it will also include the CMS pricing decision and the crosswalk. But the process is a little difficult to predict.
spk06: Yeah, I know it's a difficult question, but I thought I'd see if there are any grand insights there.
spk07: I wish I could give you a more satisfying answer, but I'm sure you're not surprised that it's just a little challenging to get there with the environment the way it is.
spk06: Yeah, yeah, completely understandable. And then on, you know, the folks that were using Oval One Plus kind of, you know, off-label, if you will, Do you think that the kind of cannibalization that's happened with Overwatch has kind of run its course now, or are folks still doing it the previous way?
spk07: Well, I think that we're going to continue to see people choose the test that's best for each situation. For us, we consider that we don't really think about it in terms of cannibalization because as you're not, as you would imagine, we don't use of over one. So, um, you know, it's really, it's, it's revenue regardless, right? It's revenue. We wouldn't have recognized if they were using, um, over one off label, even with contracted, um, payers, we didn't, we wouldn't get paid. So, um, every, uh, every tax that we run for overwatch is, um, is, is an improvement over the off-label use of OVA-1. However, we are seeing both tests are growing independently of one another. So, you know, I do think that we've seen probably the experimentation is behind us. Okay.
spk06: Fair enough. It makes sense. And then I think you gave the number on the Q2 call and kind of the test volume per field representative. Do you have that handy by any chance?
spk07: I do. I'm going to go pull it from Ernie's release because I believe it was in there.
spk05: Oh, sorry. I must have missed that. It wasn't in there. I don't have it handy.
spk07: I should have it handy. I apologize for that, but let me see what I can do to find it before we drop it.
spk06: Okay. I got it. And lastly for me, you mentioned in the press release the revenue per test is expected to be volatile during 2023. Upside, downside, magnitude, what's the right way to kind of think of the volatile terminology there?
spk07: So it's another challenging question to answer because some of it depends a little bit on timing of collections because you're kind of working on enrolling quarters. Torsten, anything in addition to that that you'd add? I mean, by definition, volatile is challenging to predict, right? But we can see various collections. Our team has been doing a great job all year. So every dollar of revenue that's available to us, they're capturing it.
spk05: Got it. I think that's all I had today. Thanks a lot, guys. Thanks, Ben. As a reminder, it is star one to ask a question.
spk04: Our next question comes from the line of Andrew Brackman with William Blair. Please proceed with your question.
spk03: Hey, everyone. This is Dustin on the line for Andrew. Thanks for taking our questions. First on EndoCheck, good to hear. Yeah, hi, how are you? On EndoCheck, good to hear progress going on there. Just wondering what the updated timeline is for the launch. I think you said previously the fourth quarter. And then when that's launched, just what metrics are you guys going to use to see that this launch, you know, has been successful and what kind of goals are you laying out for yourselves there?
spk07: Sure. So we're not changing any of the timeline today. Our goal has been and continues to be the launch of a test for commercial use by the end of the year. We're still focused on that provided we're able to fully validate the test and have a rollout similar to what we did for Overwatch where we had a period of time where Overwatch was primarily being offered to physicians who were familiar with the development of the technology, we're planning on doing the same thing. That's really been the playbook we planned on following with a much broader commercial launch of the first-generation test in the first quarter of next year.
spk05: Understood.
spk03: And then on OvaCheck, great to see you guys got the proposed rule there with CMS. How confident are you guys in that being finalized? And then how would that actually influence the longitudinal monitoring product, if at all, in terms of pricing there?
spk07: So we don't expect there to be any impact on longitudinal monitoring. We believe that the test will be reversed at the same level. The likelihood that the crosswalk that was preliminarily approved becomes final, I would rate it at high. However, you know, CMS, ultimately holds the pen. The comment period is behind us. We submitted a comment. We were very, very confident in the case that we put forward for the crosswalk. I mean, there's almost every factor that they look at for a crosswalk request was in our favor in terms of the process, the platform, the analyze, you name it. So the case was as strong as it could possibly be We did submit a comment letter, and the final is expected in the next several weeks.
spk05: Understood. Thank you.
spk03: And then maybe looking out to 24, just any high-level thoughts on volumes and ASP growth? I know you're going to have a couple new tests launching at different price points, but anything high-level you can give us there and how that compares to the third quarter results?
spk07: Yeah, we're not really in a position to give any 2024 guidance at this point, Dustin, but thanks for trying.
spk03: Yep, thought I'd give it a shot. And, yeah, just one more. You know, spending in burn, any color on how you guys are thinking about runway, and obviously a lot's been done across the organization to help extend that, but just how are you thinking about that? Thank you.
spk01: Yeah, this is Thorsten. So in terms of runway, we have reiterated our cash burn guidance to use cash in operations in the second half of this year to be between 6 and 8 million US dollars. We have cash in the bank as of September 30 of a total of 5.4 million. That includes cash and restricted cash. And our cash burn for the third quarter was $3.3 million after $3.4 million in the second quarter and $5.7 million in the first quarter. So what you can see is that we continue to be very focused on controlling our cash burn, bringing that further down going forward on a quarter-to-quarter basis. And as any other biotech company, definitely public biotech company, we're constantly looking into dilutive and non-dilutive funding mechanisms to fund the company going forward. We do have, as a reminder, two ATM or equity line of credits. One is with Cantor and the other one is with Lincoln Park that are available to us. These are not true funding instruments. They definitely help the company on high trading volume days to draw certain dollars from that very line. So it's a safety net that we have, and we continue to look into various ways to continue to fund the company going forward.
spk05: Okay, great. Appreciate that. That's it from us. Thank you. Thank you. There are no further questions in the queue.
spk04: I'd like to hand the call back to Nicole Sanford for closing remarks.
spk07: Thank you, Doug, and thank you to all of our participants for joining today. I wish all of you a wonderful Thanksgiving holiday and look forward to connecting again in the new year.
spk04: Thank you. Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.
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