Aspira Women's Health Inc.

Aspira Women's Health Inc.

$0.48
-0.1 (-16.8%)
NASDAQ Capital Market
USD, US
Medical - Diagnostics & Research

Aspira Women's Health Inc. (AWH) Q4 2018 Earnings Call Transcript

Published at 2019-03-28 23:28:07
Operator
Good afternoon, ladies and gentlemen, and welcome to Vermillion's Fourth Quarter 2018 Conference Call. My name is Jeremy, and I will be your coordinator for the call today. [Operator Instructions]. As a reminder, this conference is being recorded today. Leading the call today is Valerie Palmieri, President and Chief Executive Officer; and Bob Beechey, Chief Financial Officer. Valerie will provide a corporate update and Bob will summarize the company's financial results. After the prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to Vermillion's expected future performance, future business prospects or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. 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 forecasts due to the impact of many factors beyond the control of Vermillion. The company assumes no obligation to update or supplement any forward-looking statement whether as a result of new information, future events or otherwise. Participants are directed to the cautionary note set forth in today's press release as well as the risk factors set forth in Vermillion's annual report filed with the SEC for 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 Valerie Palmieri, President and Chief Executive Officer. Valerie?
Valerie Palmieri
Thank you, Jeremy. Good afternoon, everyone, and thank you for joining us today. This afternoon, we will be reviewing our Q4 accomplishments and financial performance as well as providing an update on Q1 developments and planned product introductions during 2019. Today, 39 women in the U.S. die each day of ovarian cancer, and we are working very hard to erase that number. Since launch of OVA1/Overa, we're having an impact on patients' lives. OVA1 specifically has made a difference in the lives of over 111,000 patients with 0 safety or efficacy issues. Currently, ovarian cancer is the only the sex-specific cancer with greater than a 50% mortality rate, and today 85% of all ovarian cancers are diagnosed when the cancer is beyond the ovaries or fallopian tubes. Our goal is to change that for all ages, stages and ethnicities. OVA1 is the only FDA-cleared ovarian cancer risk assessment solution, which is ACOG-endorsed with positive physician statements from NCCN and SGO, covered by Medicare and covered by Medicaid on a state-by-state basis. It is now covered and/or has positive medical policy with over 50% of the U.S. population as we now have 160 million covered lives. It is an exciting time for Vermillion in our journey to become the standard of care for ovarian cancer risk assessment. In Q4, we launched OVA1 plus, which cleared the gap of the first-generation technology by improving specificity and significantly reducing falsely elevated results while maintaining best-in-class sensitivity. In addition to the OVA1 plus technology launch, we also launched a universal global platform. This allows OVA1 to be performed on a global basis on a state-of-the-art instrument at the local level. We also quantified the inadequacy of CA125 in identifying risk of cancer in African-American women and presented at the Mid-Atlantic Gynecologic Society meeting, which will be -- we will also be presenting our latest abstract at the American Association for Cancer Research or better known as a AACR. In addition, we obtained our second national insurance carrier, Cigna, in January of 2019, the first one was HCSC. As many of you are aware, the company has successfully been integrating into guidelines obtained U.S. payer coverage for 167 million lives and obtained PAMA price of $897. The launching of OVA1 plus on a global platform provides a trigger in late 2018 for the expansion of our commercial team. We commenced our Phase I hiring in Q4 and recently completed our Phase II hiring plan in Q1. We ended 2018 with 12 sales reps and are entering Q1 2019 with 19 sales territories, with a total of 30 commercial FTEs, including sales, marketing, market access and customer service. Our Q4 growth was expected to be modest from a year-on-year perspective in the context of the timing of sales additions and having just launched our improved test during Q4. Despite this timing, our product revenue is up year-over-year at 21%. In terms of 2019, it is premature for us to make public projections, but we plan to provide guidance once we have 2 quarters of fully-trained salespeople in the field with the improved OVA1 plus product. I am happy to report that we are gaining traction in Q1 as our Q4 hires, who have been in the field for 60 to 90 days, we are seeing some early leading indicators. While we have three more receiving days in March, we are driving over 30% year-on-year volume growth for the first quarter 2019. This is the first time since the Quest transition we are growing double digits quarter-over-quarter and year-over-year, approximately 20% and 30%, respectively. We believe this growth is a direct reflection of the technology performance improvements and reducing falsely elevated risks, and in fact, we saw a 63% conversion from October 1 to December 1. In addition to the leading indicators, we are also laying the foundation for building our overall awareness at the physician level, including presence at trade shows in our overall key opinion network. We have exhibited at the Society of Gynecologic Oncology annual meeting and the American College of Osteopathic Obstetricians and Gynecologists annual conference in March. We will also be exhibiting at the American Association for Cancer Research in April and the American College of Obstetricians and Gynecologists annual meeting in May. At both SGO and ACOOG, we were -- there was a response from our attendees for a need for increased global awareness of ovarian cancer. Our attendance at SGO was well received to drive more awareness, and in fact, there was a community feeling of gratitude that ASPiRA is doing its part. In fact, during the SGO presidential address, Dr. Brown spoke about the lack of knowledge about women's cancers and treatments, pointing out the ethnic and racial differences that need to be observed more closely. Attending these meetings to promote our products and reach our current and new customers is an important pathway to educate and promote OVA1 plus to as many physicians and patients as possible. With the improvement in our technology, we have also been able to bolster our KOL support nationwide. A year ago, we had a handful of KOLs. And today, we have over 23 KOLs spread throughout the U.S. and more being added monthly. This increase in thought leader support was instrumental in driving OVA1 plus support and overall conversion. Dr. Charles Dutton [ph], our Clinical Medical Director, has been instrumental to the process. The second major accomplishment during Q4 is the launch of our new platform and evolving web service offering. We have generated significant interest in our decentralized model. We continue to have discussions with 20-plus partners and are working through the national sales cycle. As previously discussed on the Q3 call, these large deals have a 12 to 18-month sales cycle from prospecting to the contract phase. The contract phase is the last phase. We are in the final contracting phase of our 2 previously discussed partnerships. Each of these deals represents a large ordering base of more than 200 plus OB/GYN. We continue to work through the other partnerships, and we'll have more updates on future calls. We expect to see the volume increases from this newly launched decentralized model in the second half of 2019. We believe this model will drive wider adoption of OVA1 plus, and these partners will become influencers within the payer community as well. The decentralized model is also key to our international adoption. Today, we are primarily focused on studies to validate our OVA technology on specific populations in 2 select countries, the Philippines and Israel. In the Philippines, we are 18 months into a 2-year prospective ovarian study, with data on over 65% of the patients needed for the study. We believe this prospective outcome study will be a significant contributor towards payer coverage when it's published in 2020. The end goal of the Philippines study is threefold: the adoption of Overa into the Filipino healthcare system protocol, a prospective Overa outcome study which can be used worldwide and additional data on CA125 disparity in the Asian population. In Israel, our study with Clalit Health Services is ongoing. Clalit Health Services is Israel's largest HMO and health provider, with approximately 3.8 million insured members or about half of the insured population. Our technology is being studied on Israeli patients who are at high risk for a BRCA mutation to determine if earlier-stage disease can be diagnosed and if the time to treatment can be expedited for improved outcomes for patients with adnexal mass. In Israel, nearly 1/3 of the 8.5 million Jewish population is of Ashkenazi Jewish descent. The Ashkenazi Jewish population has a 1 in 40 or 2% chance of inheriting the BRCA1-2 mutation versus 1 in 400 in the U.S. The lifetime ovarian risk for women with a BRCA1 mutation is estimated to be between 35% and 70%. For the women with a BRCA2 mutation, the risk has been estimated to be between 10% and 30% by age 70. We believe OVA1, Overa and now OVA1 plus can actually have meaningful improvement to outcome and care for patients as well. Keep in mind, our ability to offer our testing on this platform is significant as we now have the ability to distribute an ACOG-endorsed technology on a globally-distributed platform. Our increased reach to patients through decentralization of the testing site will allow more of the population in the markets we serve to access OVA1 and eventually change the standard of care for pelvic mass management on a global basis. Beyond commercial expansion of our team in 2019, we also plan to expand the product extensions as well as our product portfolio in the second half of 2019. The basis of this expansion is the utilization of our one-of-a-kind pelvic mass data and specimen repository. I would like to report on a few updates. Number one, our CA125 ASPiRA data continues to be well received by payers and providers. As reported in the last earnings call, we presented the data at the Mid-Atlantic Gynecologic Oncology Society Meeting. I am also happy to report that we will be presenting the data at American Association of Cancer Research next week. We believe this data will allow reps to actively sell the OVA1 ethnicity benefit versus CA125 as well as ROMA. We also have two manuscripts awaiting publication. In addition, we anticipate we'll be launching a large multi-sized Disparity study on this very large population. The end goal is delivering an ethnicity-specific risk assessment. Moving on to our number two development. We also intend to leverage our previous research and development to expand the OVA family of products for wider indications. Such expansion is more developmental in nature as we optimize the algorithm for expanded indications. Specifically, we will introduce a watch and wait product, a third generation of OVA product to be formally announced in the second half of 2019. This will be in the form of an LDT, a laboratory developed test. The opportunity for this application is approximately 0.5 million to 1 million women in the U.S., and the basis of this product will be an algorithm based on 7 markers with the rule-in and rule-out algorithms. Due to this being an LDT, this algorithm will also be updated on a regular basis. We will be submitting our validation publication in the first half of 2019. Also in the second half of 2019, we will be launching a product extension of OVA1 plus, which is the Symptom Index tool. The tool was created by Dr. Barbara Goff, a key opinion leader in GYN oncology. Keep in mind, all these technologies will be launched via a universal platform and web service in time. I would like to now turn the call over to Bob for a review of our financial results.
Robert Beechey
Thank you, Valerie. Let me begin by addressing our NASDAQ listing status. As previously disclosed, we were notified by NASDAQ that we were not in compliance of listing standards, namely maintaining a bid-ask price closing over $1. To come back into compliance with listing standards, NASDAQ requires a stock to maintain a closing price over $1 for 10 consecutive days. On March 22, our stock closed above $1 for the 10th consecutive day, and we were formally notified by NASDAQ on March 26 that they have rescinded the deficiency notice. We are very pleased to be back in compliance with NASDAQ listing standards, obviously. Regarding our fourth quarter results, our product revenue in the fourth quarter of 2018 was $795,000, a 21% increase from 2017, driven by a 5% volume increase and improved pricing. Our price per test in the fourth quarter of 2018 was $398 compared to $344 in Q4 of 2017, a 15% increase. Our percent paid for third-party claims from payers was 45% in Q4 compared to 31% in Q4 of 2017, a 45% increase. In addition, within that number, our percent paid on Medicare advantage claims increased to 45% compared to 31% in Q4 of 2017, a 62% increase. Product volume was 1,996 OVA1 and OVA1 plus tests performed, representing a 5% increase year-on-year. Product costs are up 23% year-on-year. This was driven by one-time validation and costs incurred in switching our in-house testing to the Roche Cobas. In addition, we engaged Quest to dedicate a project manager to the Vermillion account to resolve some customer service issues. We anticipate maintaining that investment as we ramp up volume. Total operating expenses, which includes sales and marketing, R&D, as well as G&A expenses in the fourth quarter of 2018, were down 1% compared to the year-ago quarter. This was driven by decreases in consulting expenditures, offset by increases in sales. Our G&A expenses are down year-on-year as well due to severance expenses in 2017. Net loss attributable to common shareholders for the fourth quarter of 2018 was $2.8 million or $0.04 loss per share as compared to a net loss of $3 million or negative $0.05 per share in the same period of 2017. Cash and cash equivalents at December 31, 2018, were $9.4 million. The company utilized approximately $2.4 million in cash in the fourth quarter of 2018. We are redeploying research dollars to commercial to optimize our deployment of capital. As Valerie noted, most of the expenditures to develop our new product introductions are developmental in nature and don't require a lot of heavy original research. We expect Q1 cash utilization to increase modestly as we onboard and train the commercial team. As the commercial team gains traction, we naturally expect that short-term increase in cash utilization to decline and reverse as we gain adoption of our current and future products. It is important to note that our planned new products are all sold at the same call point, and we'll leverage our existing investment in marketing and sales. In addition, the new product introductions, as I noted, require minimal R&D spend. Consequently, we project Q1 as the high watermark in cash utilization. In addition, we have 2 existing sources of financing: a Connecticut state forgivable loan, which is primarily based on achievement of employment milestones, which we will hit within our current operating plan; and warrants to purchase our common stock at approximately $5 million exercise price at $1.81 per share. Now I'll turn it back to Valerie.
Valerie Palmieri
Thank you, Bob. Before we open the call for Q&A, let me emphasize our optimism for building our company for success as we execute on our larger mission to help the 20 million women in the U.S., with both low and high-risk masses to get the right treatment from the right doctor at the right time. I would also like to thank my entire team for their tireless work in our unrelenting march to help women of all ethnicities to get the best care possible. OVA1 plus has been dramatically improved such that we expect it to become the standard of care in pelvic mass risk assessment for ovarian cancer. And looking back, prior to the Quest transition, our key gaps were specificity, platform and commercial investment. In the last 3 years, we methodically kicked down all barriers from specificity platform guidelines and payers. We have finally reached the moment to deliver an FDA-cleared guideline-supported technology that demonstrates the ability to detect the risk of cancer more effectively and earlier than existing 38-year-old standard of care tests. It is time that all women of every socioeconomic background receive the best care possible, and we are proud and excited to make this happen. Our end goal is to enhance shareholder value by saving lives and saving money for the overall healthcare system. We are now happy to answer your questions.
Operator
[Operator Instructions]. Our first question comes from the line of Michael Brcic from National Securities.
Michael Brcic
I missed your last trip to Chicago. I thought I'd caught you in the first time around. So hopefully, I'll get you again on the next one. I just have a question on the Cigna coverage. They added OVA1. Your new product is OVA1 plus. Do you have to go through a whole rigmarole to get that approved in their system? Or is it more of a technical change for them?
Valerie Palmieri
Yes -- no, there's no change. It's the same CPT code. What we've done with OVA1 and OVA1 plus is it's still the same CPT code. We've been able to incorporate our second-generation technology for intermediate risk, so we have a confirmatory test. So we've improved our specificity by 33% with the incorporation of our second technology. So there's no changes to the payers. OVA1 plus is also supported by the payers. So Cigna is stating that our tests is medically necessary, whether it's OVA1 or OVA1 plus. It stands -- basically it's equal. But from a clinical standpoint, this improvement in specificity has been tremendous in terms of it being received by the providers.
Michael Brcic
It's been a while, so can you sort of maybe talk about the total addressable market you have there and what you're competing against? Are you -- just those 2 things.
Valerie Palmieri
Sure. So the total addressable market and I'll kind of take it from 30,000 feet in terms of what the addressable market is. So there's 20 million women with masses. There are 22,000 women with ovarian cancer. The FDA indication of our test is those women that are planned for surgery, so that addressable market is anywhere from 200,000 to 300,000 women. There is wider use for our test, where doctors are utilizing the technology for low-risk patients and actually putting the patients more into a watch and wait. Because of the -- listening to our physicians, we actually are widening the market to 0.5 million, so taking that 300,000 and then adding to that, another 0.5 million to 1 million patients. And those are just the patients. With watch and wait patients, they can actually receive an OVA3 test anywhere from 2 to 4 times per year. So in listening to our customers, we have expanded our technology portfolio in terms of the care pathway for those low-risk patients, where they want to spare infertility. They want -- the mass is such that they do not want to proceed with surgery or there's comorbidity. So the market for the test that is commercialized today is 200 to 300, and then the test that we will be commercializing -- 200,000 to 300,000 -- and then the test that we will be commercializing in the back of the year is 0.5 million to 1 million patients. But keep in mind that 0.5 million to 1 million can have repeat events per year.
Michael Brcic
Now what about the insurance coverage for that 0.5 million to 1 million people?
Valerie Palmieri
So there's -- it probably -- if you go into it in detail, so the way you work insurance coverage is you -- there's 2 ways to do it: either you do a stacked code or you go to AMA and you actually get a PLA code. This will be a stacked code for the -- I would say, for the interim. And then as we define this, because I also think OVA3 can have -- there could be an OVA3.1 and an OVA3.2. So if we start with a stacked code and move to a specific code, that can happen in time. But that going to specific code out of the gate is a longer trajectory in terms of obtaining reimbursement, as the example of OVA1.
Michael Brcic
Sure. Finally, on the Israeli coverage, it's covered under the I'll call it premium plan or whatever.
Valerie Palmieri
That's correct.
Michael Brcic
Do you see that being -- at some point being part of the standard package? And I don't know how many -- I don't know what percentage of people that pay for the premium is as far as the covered lives over there.
Valerie Palmieri
Yes. So I would say that starting off with the premium, and let me kind of go into it in twofold. We started off with the study, to be honest with you, Michael. And the study in every country that we are looking at, they want to study on their own population. United States is very heterogeneous. These countries are more homogeneous. So we started up with the study. But to be very frank, that study moved into coverage on a quick basis. And so we're starting off with the premium coverage. We do anticipate once the study is completed, then we will have another shot to, I want to say, the overall coverage. But just having a payer like Clalit in terms of legitimizing our technology because right now they're using the 38-year-old standard of care, which is CA125, really taken on as an entity that they will pay for in parallel to doing the study. So the study is not done yet. I want to make sure that you understand that. The study is not done yet. The study is moving faster than we thought. We're adding more sites on a quicker basis. But first, they validate it on the population and then they offer it. And then actually, that offering goes really well. We do anticipate because the ratio of BRCA women in Israel is 1 in 40. And to give you just a -- walk you through that from a female perspective, those women prophylactically have oophorectomy. So at 35 years old, they are in menopause, which there's changes to blood pressure, weight, hormones. They really age 20 years. So it's truly a -- I would say a public health policy crisis right now in Israel.
Michael Brcic
Got it. And I assume you'll be looking at other ethnic groups and doing studies on that as well, right?
Valerie Palmieri
That is correct. So in the Philippines, we're focusing on the Asian population, and I would say too, and this ties back to our Disparity data, CA125 was a technology -- who had access to care 30 years ago? It was Caucasian women. So when it was developed, it was developed for the cohort of patients who had access to care. 38 years to where we are today, we are seeing CA125 listing 7 out of 10 cancers with African-American women, and that's the data that we will be publishing at AACR.
Operator
[Operator Instructions]. There are no further questions at this time, so I'd like to hand the call back to management for closing remarks.
Valerie Palmieri
Thank you, Jeremy. In closing, we believe we have laid a strong organic commercial foundation in late 2018 and Q1 of 2019. We are ready to leverage our guideline inclusion, 50% of the U.S. population under coverage, our improved technology with our decentralized data platform, and we've created an engine and a portfolio platform which can truly serve the end user directly and allow real-time impact to patient care. Our end goal is to serve a large global pelvic mass in women's health market, with a platform coupled with proprietary science, data tools and local impact, which will drive better health and well-being to each patient we serve and overall profitability and shareholder value. Thank you for joining us today, and we appreciate your support and interest in Vermillion.
Operator
This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.