Aspira Women's Health Inc.

Aspira Women's Health Inc.

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

Aspira Women's Health Inc. (AWH) Q1 2019 Earnings Call Transcript

Published at 2019-05-14 19:48:08
Operator
Good afternoon, ladies and gentlemen, and welcome to Vermillion’s First Quarter 2019 Conference Call. My name is Sherry, and I will be your coordinator for today’s call. [Operator Instructions] As a reminder, this conference is being recorded today. Leading the call today is Valerie Palmieri, President and Chief Executive Officer; Bob Beechey, Chief Financial Officer; and Chris Goulart, Senior Vice President of Commercial Operations. After 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, Sherry. Good afternoon, everyone, and thank you for joining us today. This afternoon, we will be reviewing our Q1 accomplishments and financial performance as well as providing an update on Q2 developments and our planned product introductions during 2019. Before we go into the details, let me step back and reiterate our passion about improving the outcomes for women with ovarian cancer. Our goal is to globally transform women’s health, starting with ovarian cancer. Each day, 39 women die in the U.S. of ovarian cancer. We are working very hard to change that for all women of all ages, stages and ethnicities. Since our launch of OVA1 and Overa, we know we are having an impact on patients’ lives. OVA1 specifically has made a difference in the lives of over 113,000 patients with zero safety or efficacy issues. It is an exciting time at Vermillion as we continue our ramp into full commercialization mode. In the fourth quarter of last year, we launched our OVA1 plus product. We saw great responses from physicians, patients as well as the KOL community. We are truly on our way to becoming the standard of care for pelvic mass risk assessment. I would now like to provide color on some of the key highlights from the quarter. Number one. A key goal for Q1 was the completion of the hiring of our commercial team. We started this journey in Q3 2018 with the hiring of Chris Goulart, our Senior Vice President of Commercial Operations. Chris came to us with a track record in women’s health, with his last position leading the constellation program at Natera. At Natera, he led the initial U.S. commercialization of the technology transfer of their noninvasive prenatal testing product, which has become a fast- growing sector for Natera. This experience is a critical skill set to drive the OVA portfolio and its decentralized expansion. Our commericial investment is making meaningful progress. And you will be introduced to Chris shortly. Number two, another key goal was the addition of a second national payer. As we discussed in the last call, we received national coverage from Cigna. While this is the second national carrier to state that OVA1 is medically necessary and, therefore, giving a positive coverage, this was really a turning point in sentiment and has been very helpful in the overall commercialization efforts. We now have over 50% of the U.S. population covered, and this will continue to work on gaining additional support. And last but not least, our third goal was the publication of our CA125 disparity data. We are pleased to announce that our paper has just been accepted to Biomarkers in Cancer. This is our third CA125 disparity data product with two abstracts completed, and we also have another abstract – another manuscript in the queue Chris will discuss in detail later in the call. To recap, we are just getting started in a large market with a new enhanced product, CA125 disparity data and a strong commercial team coupled with solid payer coverage and pricing. We are looking forward to a breakout year for 2019. At this point, I’d like to introduce Chris Goulart, our Senior Vice President of Commercial Operations, and turn the call over to him. Chris?
Chris Goulart
Thank you, Valerie. I’m very pleased to be here to provide an update on our commercialization effort. As you know, we have a two-pronged approach with the decentralized platform channel and the direct sales channel. Starting with our decentralized approach. We have a focus list of large hospital networks and OB/GYN super gross, which we are in dialogue with to adopt our technology and perform it locally. As you know, we had two contracts in the red line process, but we are adapting those contracts to include our wider portfolio as our genetics offering is ahead of schedule, which I will discuss shortly. These arrangements will help to drive test adoption as well as we are integrated into the care pathway of the respective institutions and super groups. Keep in mind though the normal lead time on these type of complex transactions takes roughly 12 to 18 months. We have a building pipeline of potential partnerships with these super groups, which could be very meaningful to Vermillion. We continue to work through these partnerships, and we’ll have more updates on future calls. We believe that this model will drive wider adoption of OVA1 plus and our expanded portfolio. Also, keep in mind these partners will become strong influencers within the payer community as well. Now let me move on to our direct sales channel update. We commenced the first phase hiring in Q4 and have recently completed the second phase of our hiring plan in Q1. We currently stand at 20 sales territories, having just recently added the last territory. Our total commercial team is 30 FTEs, including leadership, marketing, managed care and customer experience. We now have in place the sales foundation to drive our overall portfolio. With our sales territories fully staffed, we are seeing sales volumes gaining considerable traction as representatives get up the learning curve in their territory. As reported, Q1 2019 volume increased nearly 30%. And I’m pleased to report Q2 volume continues to gain strength with April volume up over 60% year-over-year And we are seeing our growth rate accelerate in May of 2019. Please note, the learning curve for a new sales representative takes approximately one to two quarters to be fully effective. At the end of the first quarter, only 40% of our sales representatives were with us six months or more. Also, keep in mind these volume growth rates include no decentralized deals, which we expect to accelerate the growth rate as we add partners. We are also monitoring new physician additions. The average number of physicians who ordered on a monthly basis in Q4 of 2018 was 463. The number increased to 573 in Q1. And during the month of April 2019, I’m pleased to announce we’ve increased to 668. In addition to the leading indicators, we are also laying the foundation and building overall awareness at the physician level, including presence at all key trade shows, including, SGO, ACOOG, AACR and ACOG. At ACOG, we engaged in many discussions with OB/GYNs across the United States. And I’m happy to report on a number of topics with physicians, including: our newly launched OVA1 plus test has reduced the overall falsely elevated rate by 50%; our ethnic-specific data is compelling to clinicians, who feel that CA125 does not adequately perform well for patients in the African-American community. We plan to exhibit at future events and continue to drive physician adoption of the OVA family of tests. We are also building a top- caliber, key opinion leader network to drive education peer to peer. Our improvement in our technology and disparity data has really fueled nationwide KOL support. A year ago, we were in the early stages of building our KOL network. We have grown from 23 at the end of March to 28 KOLs at the end of April. This increase in thought leader support was instrumental in driving OVA1 plus support. Dr. Charles Dunton, our Clinical Medical Director, has been instrumental in this process. As part of our building our global leadership position in pelvic mass management, we are building an ovarian cancer 350 portfolio, which we refer to as Overa 350. This will incorporate current product extensions in an expanded portfolio. I would like to report on a few updates. Number one. The first products we’ll be rolling out is the incorporation of genetic testing into our pelvic mass risk assessment management portfolio. Approximately 15% of ovarian cancer is due to a genetic predisposition. This offering will include a hereditary breast ovarian cancer panel as well as a prenatal carrier screening panel. We originally planned to launch this product in the second half of 2019, but we are now moving it up to June of 2019. Keep in mind, this complementary product offering will be at the same call point as OVA1 plus, and testing results will be reported in a combined report with OVA1 plus later this year. Also, the learning curve will be minimal as the majority of our sales force has genetic testing experience. Number two, the second product launch is for our pelvic mass patients further upstream. It will provide a solution for pelvic mass patients who do not move forward with surgery. Today, approximately 0.5 million to 1 million women in the U.S. have a pelvic mass which is monitored for a period of time prior to surgery or the patient does not move forward with surgery. We have developed an algorithm based on seven protein markers which rule out and rule in algorithms. Our goal is to launch this in the second half of the year. In preparation for this launch, we recently submitted an abstract to the European Society of Gynaecological Oncology. And we are in the process of submitting our validation manuscript to a top journal based on retrospective data. The foundation of this product will be a laboratory-developed test. The algorithm can be refined on an ongoing basis. But the initial prospective study will be designed with an FDA clearance foundation in the future. Number three. Finally, as Valerie discussed, we are happy to announce the acceptance of our first of several studies on CA125 disparity data. This paper is a direct byproduct of our pelvic mass data and specimen repository. Last night, we press released the acceptance of our paper entitled Multivariate Index Assay is Superior to CA125 and HE4 Testing in Detection of Ovarian Malignancy in African American Women to the journal of Biomarkers in Cancer. The paper reviews data from our previous prospective studies that demonstrate that OVA2 has superior sensitivity to CA125 and HE4, otherwise known as ROMA, in detecting ovarian malignancy risk in all populations with marked improvement in detecting ovarian cancer in the African-American population. The paper revealed that OVA1 detected ovarian malignancies in African-American women 79% of the time compared to only 54% of time when using ROMA, a 45% improvement. OVA1 was superior in Caucasian women as well, detecting ovarian cancer 33% of the time compared to only 83% of the time using ROMA, approximately a 12% improvement. Our data is very compelling and indicates the current standard of care. CA125 plus ROMA is ineffective in the African-American population. In addition, we will be commencing a large multicenter study starting with Einstein Medical Center in Philadelphia, Pennsylvania. The IRB has been submitted and is awaiting approval. Our end goal is the creation of an ethnic-specific risk assessment, starting with the African-American population. Our bioinformaticists are also exploring the data in other non-Caucasian populations. We believe this data will allow our reps to actively position our OVA1 plus test as the best-in-class for all women in time. I would like to turn the call over to Bob for a review of our financial results. Bob?
Bob Beechey
Thank you, Chris, and it’s great to have you on the call. Product revenue in the first quarter of 2019 was $779,000 a 27% increase from 2018. Revenue on a per test performed basis was $337 in the first quarter of 2019, which was flat compared to the prior year quarter. This was driven by an increase in patient pay as a percent of total expressions and an increase in patient paying out of pocket due to high deductibles in the first quarter, which is typical. The direct patient pay is a bridging strategy until we achieve comprehensive insurance coverage. It assures physicians that patients will not receive a surprise out-of-pocket – out-of-network bill. For the first quarter, when we were paid through third-party commercial insurance, we received on average $648 per test, and we received $806 per test on average from Medicare. In addition, we have not yet received a price from Cigna, so the Cigna claims were not being reimbursed during the first quarter. The number of OVA1 plus tests performed during the first quarter of 2019 increased 27% to 2,313 compared to the prior year period. Our gross profit in the first quarter was $109,000 compared to a negative number in the prior year. We naturally expect our gross margin to expand as we ramp volume and achieve scale. Total operating expenses for the first quarter of 2019 were $3.83 million compared to $2.68 million in the prior year period. The increase is primarily driven by the expansion of the commercialization team as well as onetime spending on data to support clinical evidence. Net loss attributable to common shareholders for the first quarter of 2019 was $3.72 million as compared to a net loss of $2.85 million per – in the same year period. Cash and cash equivalents at March 31, 2019, were $6.2 million compared to $9.4 million at December 31, 2018. The company utilized approximately $3.18 million in cash in the first quarter of 2019. Now that the majority of our basic research is completed for our portfolio, we are redeploying our research dollars to commercial – to optimize our deployment of capital. As the commercial team gains traction, we naturally expect our cash utilization to decline as sales increase. It is important to note that our planned new product introductions are all sold at the same call point and will leverage our existing commercial investment. In addition, the new product introductions require minimal R&D. I’ll now turn it back to Valerie.
Valerie Palmieri
Thank you, Bob. Before we open the call for Q&A, let me reiterate our optimism for building our company for success as we execute on a larger mission to help the 20 million women in the U.S., with both low- and high-risk masses, get treatment from the right doctor at the right time. We’ve set out with three major goals for the first half of the year. Number one, the completion of our commercial team build. Number two, a national payer; and number three, CA125 disparity paper acceptance. We accomplished all three. We are also ahead of our planned launch of our OVA360 portfolio, including genetics and soon-to-be Symptom Index and ethnic-specific risk assessment. We believe OVA1 plus, coupled with our new disparity data, will become the standard of care in pelvic mass risk assessment for ovarian cancer. It is now time that all women of every ethnicity receive the best care possible, and we are proud and excited to make that happen. We are now happy to answer your questions.
Operator
There are no questions at this time. I would like to turn the conference back over to management for closing remarks.
Valerie Palmieri
Thank you, Sherry. In closing, we believe we have a strong commercial foundation in place, and we are excited about our future. With a sizable commercial footprint, a guideline-endorsed and differentiated test, a deeper product portfolio within the same call points and over 50% of the lives under coverage, we believe we are in a position to support growth for the long-term. Our end goal is to serve a large global pelvic mass market and overall women’s health market with a platform coupled with proprietary science and data tools, which will drive better health and well-being to each patient we serve. Thank you for joining us today, and we appreciate your support and interest in Vermillion.
Operator
Thank you. This concludes today’s conference. You may disconnect your lines at this time, and thank you for your participation.