Vermillion Incorporated (NASDAQ:VRML)
Q2 2016 Earnings Conference Call
August 10, 2016 08:00 AM ET
Valerie Palmieri - President & CEO
Eric Schoen - VP, Finance & CAO
Donald Munroe - SVP, Business Development & CSO
Sam Slutsky - LifeSci Capital
Good morning, ladies and gentlemen and welcome to the Second Quarter 2016 Vermillion’s Earnings Conference Call. My name is Levy and I'll be your coordinator for the call today. With me today are Valerie Palmieri, President & Chief Executive Officer; Eric Schoen, Vice President of Finance & Chief Accounting Officer; This afternoon they’ll recap their second quarter 2016 performance and discuss key accomplishments and priorities in 2016.
Before we get started, I would like to point out that there will be a replay of this conference call available via telephone and Internet. Please refer to today’s press release for replay information. This presentation contains and answers to today’s questions may contain forward-looking statements. Including statements regarding Vermillion’s Research Trial Services business ASPiRA IVD, Vermillion’s plans to commercialize Overa, the anticipated use of proceeds for Vermillion’s loan from the State of Connecticut, anticipated test volumes in future periods, expected progress with respect to Vermillion’s strategic plan. Vermillion’s ability to recapture clients as part of its sales initiative and Vermillion’s ability to establish in the case of Overa and continue to improve in the case of OVA1, payer coverage for its test including though additional clinical utility and help economic publication. You are cautioned not to place undue reliance on forward-looking statements.
Vermillion is providing this information as of the date of this conference call and does not undertake any obligation to update any forward-looking statements contained on this call as a result of new information, future events or otherwise except as required by law. Forward-looking statements reflect management’s current estimates, projections, expectations or beliefs and involve risks and uncertainties that could cause actual results and outcomes to be materially different.
Risks and uncertainties that may affect the future results of the Company include, but are not limited to the competitive environment, the speed of market adoption of Vermillion’s products, Vermillion’s ability to commercialize Overa inside and outside of the United States, Vermillion’s ability to specifically enter into a new line of business with ASPiRA IDB Inc, Vermillion’s ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to those products, changes in government regulations, Vermillion’s ability to obtain and maintain required regulatory approvals, payer reimbursement and other factors as described in the Vermillion annual report on Form 10-K for 2015 and Vermillion’s quarterly report on the Form 10-Q for the first quarter ended June 30, 2016. Following the Vermillion’s teams remarks, we will open up the call for your questions.
Now I would like to turn the call over to Ms. Palmieri.
Thank you, Levy. Good afternoon everyone and welcome. Our update today will include a review of our progress on our strategic plan as well as a review of our second quarter 2016 financials. Let me first start with the recap of our strategic plan. For 2016 we have two phases to our plan. The two phases are, a transformation phase, which is focused on changing our business from slowly a technology license company through licensing plus to diagnostic service companies ASPiRA Lab and ASPiRA IVD. Second a domestic and international OVA1 and Overa market expansion and growth phase, which is designed to demonstrate meaningful results in 2016 and beyond.
Now I go into the first phase. The first phase is the transformation phase is underway there are five major objectives that I will update you on that will change our focus from slowly technology license company to a licensing plus to diagnostic service companies ASPiRA Lab and ASPiRA IVD. The transformation phase for 2016 includes five major objectives. First the diversification of our revenue channels as well as the optimization of our infrastructure. We will begin reporting Vermillion's revenues as two components, the first one being, ASPiRA Lab and the second ASPiRA IVD.
Our second objective is the continued development and publication of strong health economics and clinical utility studies to drive positive medical policy coverage as well as guidelines for our products. Number three is the creation of our direct-to-consumer channel better known as direct-to-women marketing with our OVA1 awareness team. Number four, the optimization and creation of pelvic mass specimen and data repository to support the development of new products, predictive analytics in ovarian cancer as well as a differential diagnosis of debilitating benign diseases that also present at pelvic masses. And lastly, the execution of our targeted launch program for Overa.
Now I go into detail on the first objective of our information phase, the launch of our new service within the ASPiRA channel strategy known as ASPiRA IVD. We formed ASPiRA IVD incorporated in April 2016. ASPiRA IVD is a specialized laboratory service provider dedicated to meeting the unique testing needs of IVD manufacturers and pharma commercializing high complexity assays. Through our new service offering we have started to offer IVD clinical trial services to third-party customers and have realized revenue in the second quarter of 2016.
Our goal for ASPiRA IVD is to become a leader in IVD trial services and to enhance our pipeline of future technologies by fostering relationships with IVD manufacturers as well as pharma companies that will use our services. We have made steady progress to-date including number one, the completion of our CLIA licensed Trumbull, Connecticut laboratory. Second, the completion of two new studies that generated $155,000 of revenue in Q2 more details will be shared in the financial update. And lastly, the completion of our study sponsored site audits for follow-on business. With the fully trained staff of technical and pathology experts, we're on track to start multiple IVD studies in the second half of 2016.
I am now moving onto our second objective, which is the publication of foundational peer reviewed papers for OVA1 and Overa peer dossier including clinical utility studies, a 360 degree review of health economics, our validation studies for Overa as well as several scientific and clinical publications. In May of 2016, at the American Congress of Obstetricians and Gynecologists, Dr. Lee Shulman, Chief of the Division of Obstetrics and Gynecology in Clinical Genetics at Northwestern University in Chicago, Illinois presented a comparison of Overa and ROMA algorithm. This study concluded that while Overa and ROMA detected more cancers than the widely used off-label diagnostic CA125. CA125 failed to detect 29% of all malignancies and 37% of all early stage cancers. But ROMA failed to detect 21% of all cancers and 39% of early stage cancers.
By comparison Overa detected 91% of all cancers with just 9% missed and 90% of all early study cancers. As you know with most cancers detecting early stage disease can significantly improve patient outcomes. With ovarian cancer, there is even more of an opportunity to make a difference. The five year survival rate is for early stage is 80% to 90% versus only 5% to 20% for late stage. We believe publications like this will be vital to expanding the use enactive to OVA1 and Overa versus ROMA and CA125 and they are key to our fundamental mission to improve outcomes for women at elevated risk for ovarian cancer. Our continued progress with their publications has led to several strategic positive medical policy and contracts for OVA1. I will cover that in detail during the commercialization update.
Moving on to our next objective, our third objective, it’s the creation of a new ASPiRA awareness channel. This channel fosters patient awareness and education through our OVA1 awareness team. This team includes Shannon Miller, the most decorated American Olympian Gymnast of all time and ovarian cancer survivor as well as a team of NASCAR Sprint Cup Driver, Martin Truex and his partner Sherry Pollex, an ovarian cancer survivor. The OVA1 awareness team has been featured in 40 news and media stories in our major market since March.
Some of the second quarter results are as follows. We have increased traffic to our ovarian cancer risk quiz approximately 20,000 women have completed the quiz through the first half of the year, 5,000 in Q1, 15,000 in Q2 approximately a threefold increase quarter over quarter. In celebration of Shannon’s five year cancer survivorship anniversary, we hosted a satellite media tour. The tour was broadcast in ASPiRA’s major markets and resulted in the reach of an additional 1 million viewers, totaled, appointed a news exposure statistics. In addition Shannon had two major opportunities to highlight OVA1, one on Thoughts & Friends and the other on people.com.
In June Martin Truex Junior and his life partner Sherry Pollex were also featured on Fox Sports to discuss their ovarian cancer journey, Sherry was also featured in several local outlets that discussed her work with OVA1 and sherrystrong.com. In total, we continue to gain momentum from their effort and have reached close to 6.8 million people, since February 2016. In Q1 we reached approximately 600,000 and in Q2 our reach extended to 6.2 million. This broadcast results, resulted in a total of 150,000 Web interactions to-date, we’re in the process of creating a tracking system to measure conversations on these multiple touch-points. With more to come in Q3 2016 update.
Moving on to our fourth objective which is the optimization and creation of a first in kind pelvic mass specimen bank and data repository to support the development of new products and predicting analytics in ovarian cancer as well as the differential diagnosis of debilitating benign conditions which is a larger market need and opportunity. There are two foundational elements of the pelvic mass repository which are underway. First the investment in our IT infrastructure to support large amounts of data in clinical informatics, and second the finalization of the assessment of the top clinical problems facing physicians, to manage pelvic masses today and the development of study protocol. These protocols will use specimens from our current bank, newly created IVD and collaborative banks as well as for prospective studies.
Now I will go into details about of our milestone at this stage, which is the creation of our IT infrastructure. Besides the IT infrastructure will house our ASPiRA Labs and IVD services as well as informatics capabilities to point pelvic mass repository. We have completed the hardware portion of this goal in 2016 and now is in full use for ASPiRA Labs and ASPiRA IVD. We plan to build the current foundation with an expanding data engine for a deeper understanding about benign and malignant pelvic masses, which we believe will lay the foundation for future algorithms for early detection, simpler management, diagnosis and prognosis of gynecologic diseases. Planned input into this data bases will include patient-reported symptom surveys, physicians assessments, imaging information, current diagnostics as well as new biomarkers from a variety of sources or specimen type such as DNA, RNA, proteomic markers etcetera.
Regarding the foundation of the specimen repository and database, we have setback and are reviewing the following needs and questions with our key opinion leaders and specimen repository committee. They include one of the top clinical problems in managing benign and malignant conditions, what problems when solve d will truly change practice. Today we have close to 5,000 specimens with no pathology as well as a newly approved internal IRB directed bank of 7,000 plus specimens of which we are creating programs through patient consent. In addition to optimizing our specimen repository plan we are creating collaboration programs with top academic institutions. We truly want to create the largest malignant and benign pelvic mass bank.
Inclusive of a systematic, systematic one and the goal of the program problem will be the collaboration of sharing clinical, epidemiological, genetic and proteomic data on various types of pelvic masses. We anticipate that this repository may develop enterprise assets not just to our present focus in ovarian cancer, but also allow us to identify markers which may address benign care pathway dilemmas for a very large potential 20 million U.S. patients market, including women who have endometriosis, polycystic ovary syndrome and other pelvic gynecologic diseases. The cost to manage these diseases on a annual basis in the U.S. is over $28 billion. This may present a sizeable opportunity to improve healthcare patient fees and patient outcomes.
Regarding the financial aspect of the repository, as discussed we decided to utilize and build upon our existing specimen banks as well as take a more collaborative approach with partners, while we were awarded the $7.5 million CPRIT which is known as the Cancer Prevention and Research Institute of Texas grant. We ultimately should not come to mutually agreeable contractible terms. We decided this grant will not be in the best interest of our shareholders. We are also in the process of looking at alternative grant programs to supplement our approach but it is not critical to our success.
The fifth and last primary objective is the commercialization of Overa, our next generation OVA1 product. I'm happy to report that our Overa targeted launch program has been received well by the physician community. We rolled out Overa's use in a target of launch program practice at the American Congress of Obstetricians and Gynecologists Annual Meeting in May. Since then we have built the plan to commercialize Overa in select markets and systems, with the goal to provide broad coverage, value-based payment and enactive to an improved pelvic mass risk assessment tool.
The first stage of our plan to commercialize Overa is the targeted launch program over the next 12 to 18 months. Our targeted launch programs are better known TLP is focused on driving protocol and practice integration with select strategic customers and healthcare systems. The program has three primary goals. Number one to enhance our commercial opportunity and setting for OVA1 is not gaining traction or has not been commercialized yet, number two to pilot customized local practice protocols which may optimize care with Overa and number three to develop perspective evidence of Overa clinical utility targeted to demonstrating improved patient outcomes and more efficient research utilization to support national care endorsement.
The first goal would be tackled to commercialization effort focused on strategic accounts and healthcare systems. Through the second quarter we have qualified these accounts and are in the process of setting up. Once qualified these accounts would be categorized into two groups one for the Overa targeted of launch program and the second for active clinical utility data collection. For the targeted launch program we identified partners to help us customize care protocols that are measurable benefit for example by optimizing cost and minimizing the length of stay for low risk patients.
Sites have been selected based on commercial appeal and their willingness to both standardize to a successful care path including Overa. The second group will be used for Overa clinical utility studies. We are starting just like one to two healthcare systems with strong campaign, high patient volume and proven ability to manage physician participation and compliance. We anticipate that study outputs will support payer messaging and reinforce Overa’s value in the host healthcare system. This concludes my introduction. So let's now turn to the financials. I’ll hand the call over to Eric Schoen, our Chief Accounting Officer and Vice President of Finance for a review of our second quarter 2016 financials. Eric?
Thanks, Valerie. Today, we furnished our second quarter 2016 financial results in a press release and filed our Form 10-Q with the Securities and Exchange Commission which is available for download via the Investors section of our Web site at www.vermillion.com.
Total revenue in the second quarter of 2016 was 709,000 compared to 535,000 in the same year ago quarter. The second quarter of 2016 revenue included 554,000 from product sales of OVA1 by ASPiRA LABS and 155,000 of service revenue from ASPiRA IVD. This marks the initial revenue from ASPiRA IVD and we're optimistic that revenue from this channel can grow during the balance of 2016 and beyond. As ASPiRA IVD began operations in the second quarter of 2016, there was no comparable service revenue in the prior year.
The second quarter revenue in 2015 was comprised of 483,000 in OVA1 product revenue from sales by Quest Diagnostics and 52,000 in OVA1 product revenue from ASPiRA LABS. Product revenue in the second quarter of 2016 was derived from 2,345 OVA1 tests performed by ASPiRA LABS. ASPiRA LABS performed a total of 274 tests in the second quarter of the prior year in addition to the 3,829 OVA1 tests performed at Quest Diagnostics. Revenue on a per test performed basis increased to $236 in the second quarter of 2016 compared to $130 in the second quarter of 2015 because billing through ASPiRA LABS allows us to recognize more revenue per test than the royalty rates we previously received from Quest Diagnostics.
Revenue for ASPiRA LABS’ contractual clients is recognized when the OVA1 test is performed. All other ASPiRA LABS revenue is being recognized on a cash basis and thus for non-contractual clients there was a lag period between performing the test and being able to recognize revenue for that test. Cost of OVA1 product revenue for the second quarter of 2016 totaled 527,000 and was consistent with the comparable prior year quarter. Cost of service revenue totaled 60,000 for ASPiRA IVD for the second quarter of 2016.
Total operating expenses in the second quarter of 2016 decreased to 3.9 million compared to 4.8 million in the same year ago quarter. The decrease was due primarily to lower sales personnel and personnel-related expenses following our February 2016 restructuring as well as lower research and development collaboration costs. These decreases were partially offset by costs related to establishing the laboratory for ASPiRA IVD. We are pleased to see that the decrease of our expense structure in February 2016 yielded the intended result of reducing our operating expenses by approximately 1 million per quarter.
Net loss for the second quarter of 2016 was 3.7 million or $0.07 per share on a weighted average shares outstanding of 52.2 million. This compares to a net loss of 4.8 million or $0.11 per share in the second quarter of 2015 on 43 million shares outstanding. Cash and cash equivalents at June 30, 2016, were $11.1 million. The Company utilized a net $2 million in cash in the second quarter of 2016 after receiving $2 million in proceeds from the loan of up 4 million from the State of Connecticut Department of Economics and Community Development in April of 2016. The remaining 2 million will be advanced if and when the Company achieves certain future milestone. The Company expects net cash utilization of 3.2 million to 3.7 million in the third quarter of 2016.
Now I will turn it back to Valerie.
Thanks, Eric. I would like to discuss our sales strategy and performance for Q2 2016. As reported on our Q1 earnings call, we believe that OVA1 testing volumes have now stabilized and are now moving in a positive trajectory. Our Q1volume was 2,265 while the volume in Q2 was 2,345 which is 4% growth over prior quarter. The stabilization is due to a new on-boarding program as well as continued focus on large accounts and recapture efforts. In addition to the client recapture program, our new sales analytic tools allow us to see real time volume changes as well as physician ordering pattern optimization opportunities, such as repeat volume senders and those not sending after their first specimen. This will continue to result in improved sales efficiency and test utilization overtime.
Some of the core metrics, we have seen positive traction on are as follows. We have seen traction with our 1820 customers, which are our large accounts. These customers comprise 80% of our total client base and 20% of our revenue. Comparing quarter over quarter, the total number of accounts has increased by 13% while the exceptions related to these accounts have increased by 12%. To conclude, we’re seeing improvement in the growth of large accounts as well as the volumes for these accounts. Although low double-digits we believe this may be a positive start with our new sales analytics tool.
Another key metrics which we focus on, is the direct impact on our growth, is the growth of repeat ordering account and their volumes. We have had a 16% increase in physicians reordering OVA1 quarter over quarter as well as a 7% increase in volume from these accounts. Both of these improvements have had a major, a direct impact on our sales efficiency and profitability of our sales comp.
Lastly we would like to report on some significant updates on three sales adoption drivers, which include payer coverage, regional commercialization of partners and international expansion. On the nearest care front, we’re happy to report that we now have full contracts with Priority Health of Michigan, IMS of Texas, and Central Valley Health doing business as the Duluth Foundation in California. These contracts are the results of our campaign to pursue unit care coverage agreements throughout 2016. These contacts may allow us to get coverage for Overa as an existing in network provider for OVA1 as well. We continue to execute on our campaign, we hope to expand OVA1 test adoptions further building our data depository and expanding our clinical studies to demonstrate the total cost of care benefit of OVA1 to healthcare systems.
Moving on to our second adoption, sales adoption driver. We are finalizing our strategic regional lab agreements for OVA1 which would differentiate their offering within their current OBGYN practices. The goal of this agreement is to maximize our distribution efforts through strategic sales teams, the goal of ASPiRA Lab sales team and the Lab’s commercial sales team is to tag team the integration of OVA1 as part of the physician assessment protocol and if successful this should rapidly expand our current base of physicians. As part of our arrangements we will be implementing specialized training programs designed to train these commercial teams to become pelvic mass product experts.
The last adoption driver which we are in the process of finalizing and implementing, our partnership is focused international distribution network. As we continue to see strong interest for international partners, we are rolling out two new Overa international models one is centralized and one is decentralized designed to meeting the unique needs of the international market. We are happy to add Pro-Genetics of Israel and MacroHealth of the Philippines to our previously announced agreement with the Southern South Korea distributer Biomedical Science.
MacroHealth is our first decentralized Overa agreement, while the near impact of these contracts will be minimal as we work through market regulatory and peer issues in the local jurisdictions we look forward to seeing positive impact to our volume and revenue in 2017 and beyond. We believe that Overa is proven diagnostic technology running on the Roche cobas 6,000 platform which has more than 10,000 active systems installed worldwide lays a solid foundation for global commercialization so women worldwide can more easily benefit from our technology. Keep in mind that about 90% of the Ovarian cancers worldwide are outside of the U.S. and we have just started to enter that market.
So, in closing we believe that the second quarter of 2016 has built a solid foundation for continued success throughout the remainder of the year. We believe we are well positioned to enter the market expansion and growth phase of our strategy. This next phase of our strategy has four core foundation blocks. Number one in the U.S. implementing the Overa targeted launch program with regional partners and large health organizations, while maintaining constant commercial traction and expanded peer coverage for OVA1.
Number two. Outside the U.S. we plan to continue our efforts to develop key strategic relationships in specific countries aimed to maximize our ability to distribute Overa via the Roche cobas 6,000 platform. Number three. The delivery of state of the art informatics tools to the patients, providers and payers. And lastly diversifying our revenue channels and leveraging our relationships with IVD and pharma companies through our informatics, service and repository capabilities via ASPiRA IVD.
Once these four core foundation blocks are in place, we believe we will have the ability to provide solutions for disease effecting women that could lead to a pelvic mass. Keep in mind the pelvic masses impacted 20 million women in the U.S. and more than 300 million women worldwide. In simple terms, our vision and primary goal is to be the global diagnostics leader in advancing women's health, coupling information and new technologies. We are starting with the needle in the haystack Ovarian cancer and we are well on our way to launching software and diagnostic solutions that we believe may truly change the outcomes of Ovarian cancer and pelvic mass management worldwide.
That concludes our presentation and we are now ready to take questions.
Thank you. [Operator Instructions] And we'll take our first question from Sam Slutsky with LifeSci Capital.
In terms of Overa what's the timing of the initial launch for it?
So Overa is in a targeted launch program. We are launching Overa actually this month and it is going to be launched in specific healthcare systems or very large practices. And the goal of this is to focus on those practices, obtain the clinical utility study information, get that to publication and call, process and outline in place and basically have more of a focused launch through 2016 early 2017.
Okay. And then with the distribution agreements in Israel and the Philippine what are the market opportunities in these territories?
So in Israel, especially I would say is the -- it's a number one is just because of the Jewish population and the prevalence of BRCA positive women, one out of five women fought BRCA positive in Israel on Jewish population in Israel and then also ovarian cancer prevalence with the BRCA population. So there is a I call a very demographic specific population within Israel that we're targeting. In the Philippines, two things, one is English speaking and we're working with a distributor who has access to these few exporting or importing western technology. So those two markets are small, if you look at a total end, but they are what I call specific focused markets that we want to learn from and then expand through wider markets in time.
Okay got it. And then lastly with ASPiRA IVD, what are your expectations for this program going forward in terms of revenue potential?
So ASPiRA IVD is a couple of things, one is, it is a -- we just started just in Q2 of this year so the goal is to get our lab up and moving and that's where leveraging not only our lab in Connecticut but also our lab in Texas through ASPiRA IVD testing services. And so the goal is, is that 2016 will be a build year so the latter half of this year will be a build year. But in 2017 now that we've got the foundation built the people in place, we also have completed our site qualification business, so very important would be our partners whether IVD or pharma they have to qualify you site, so we have some major visits site qualification inspections behind us, we anticipate growth in the second half and then really I'd say putting on the jet fuel in 2017.
[Operator Instructions] We'll take our next question from George Cafocaru with Private Investor.
How you guys think about the CPT code process, how long did it take I mean do you have any -- how do you guys think about that?
Sure, thank you George there is a couple of things and I think, there is more to come on this because, let me talk about the current CPT code process and the new one that is coming in place. So the current CPT code process, we have a CPT code for OVA1, it’s 81503. We have already applied to the AMA in terms of the process rolled out, it will be a new CPT code process, but it tends to be and vaccination of the TAMA Act which is protecting access to Medicare, for Medicare patients. There is a possibility that actually that process becomes more streamlined, so instead of waiting for the technical cycle for AMA to review codes, there could be, what we consider quarterly reviews on codes.
In addition to that with TAMA there is the opportunity with OVA1 since it was an existing test, we will be placed in early 2017 based on our 2016 January through June timeframe, so there is -- so I do think the CPT code process might have some improvements to the process than in the past because it’s very time consuming and labor intensive and I offer things that where OVA1 sits today laying the foundation for Overa, there could be some positive in terms of pricing as well. So but what it is it’s very, we’re really this coding playbook is being written as we speak and it is changing fluidly the work should I say.
How do you guys think of the cash position we have at Vermillion, I mean I’ve clearly, quarterly expenses are reducing, which is could be very positive, tests are increasing which is another and revenues are increasing, which is another important dynamic but, we are projecting between 3.2 million-3.7 million expense in Q3, we have 11.1 cash in equivalents, how do you guys think of the cash position at Vermillion?
And this is Eric, we are always closely monitoring our cash position, you’re exactly right, we got 11.1 million at the end of June. We consciously reduced our burn rate in the first part of the year and in the second part of the year we intend for expenses to continue to stay lower and possibly go even little lower while our revenue increases. So we consciously made sure that we can go the balance of ’16 without needing to raise cash, if you do opportunistic and
If the market is right we might and we’re being open that at some point in the future we will go out and raise more cash via some vehicle.
And just a couple of quick questions, national and regional lab, potential agreements, my sense is that, is there another dialog going on and it’s all about striking the right deal, in fact how do you guys think about that and?
Unidentified Company Representative
Yes so, a couple of things as we started this process last year with OVA1 right and much to our -- we got our plans of Overa everyone wants the Chinese toy right so we are in the process of we acquired a few partners at the table right now and everyone wants a piece. So we are in the process really looking at what is the best is the specific markets or specific opportunities that would be better suited for certain partners but I can tell you that we have quite a few opportunities at the table of choosing how we want to work with them and we are very close. So I would presume that on the next earnings call we are going to have some new news in terms of who those specific partners are, but if any -- I actually think that that is taking our time a little bit and this has held to our advantage. And it has also allowed us to figure out the recipe of getting OVA1 and documented into physician practices since we are owning their sales team so now we kind of figured out the recipe. So I think actually we are sitting in a good position to take the best partner who gets stronger salesforce and to have the most efficient sales comp and really the most profitable sales process that we could put in place.
Okay, very good. You mentioned towards the end of your prepared remarks. Diversification of channels Valerie and you included to some pharma companies is that and just for giving especially as a reach but in a hypothetical. I'm sure you are aware of the developments at Tesaro we've had. Is that what you mean by diversification of channels teaming up with developments like Tesaro for example or how do you think of diversification in terms of other pharma?
So when you look at a couple of things is when we sit back and look at our company we have core strengths in device, we have core strengths in laboratory services running high scale, highly profitable services with very-very high quality. So our standards are very high so in IVD services division we are servicing both pharma companies and we are servicing both IVD companies, who are building assay to even service pharma. So the pharma relationship without going into a lot of detail is a -- with our specimen repository would be really a call the unmet needs in Ovarian cancer diagnostics and therapeutics there are opportunities for us to partner with pharma potentially. And also partner with IVD services companies because of our niche within pelvic mass with our pelvic mass repository. So it is a service lab servicing all specimens but is a service lab also which is leveraging our repository bank and working with pharma and looking at the potential opportunity, is there partnership opportunity for our companion diagnostics opportunity out there. So that's really leveraging our operating infrastructure, leveraging our knowhow, leveraging our asset and really trying to get ahead of the curve versus waiting for someone else to kind of figure it out. So, it's also fostering those relationships we're involved with discovery work early in the process.
Okay, all right and the final question for now. I have many but I'll just ask one which I ask on every call so I apologize.
How do you guys think about progress in terms of guidelines local, regional, nationwide how do you report back the status on that?
Well let me tap into two areas, national and regional, so the most important guideline for us to crack the code on is ACOG by far. When we set back and we look at where patients are coming into the system, it's at the primary care and the GYN level. So the ACOG guideline is extremely important. At the same time, we realize that is a tall order and it can take us -- we got to get Overa in these healthcare systems. We got to publish and then go for guidelines. But needless to say what we have found is there is some significant regional guideline societies that are very-very powerful and could be a huge opportunity for us to -- because they believe that even though Overa just got cleared the time is now to update their guideline. So we will have further updates on that, we're making progress on the regional side and we'll have some I believe some updates by the end of the year on that note. And it's important and we believe these regionals will have a rating effect on the nationals as well.
And that's all the time we have budgeted for today’s call. I would now like to hand the call back to Ms. Palmieri. Ms. Palmieri, please proceed.
Thank you, Levy. To conclude, we have a steadfast execution plan to change the course of pelvic mass patient management in the U.S. and worldwide. We have now completed one of three major strategy phases, our rebuild phase and we're now focusing on completing our transformation phase. The four key elements of the transformation phase are as follows. First, the successful deployment of our commercialization strategy based on focused clinical utility, health economics to drive sales, payer coverage, as well as guidelines for both OVA1 and Overa. Second, the rolling out of comprehensive pelvic mass diagnostic offerings with a portfolio of test in conjunction with our strategic lab partners' sales team. Third, delivering key results from our new distribution channels including direct-to-women, international and our ASPiRA IVD service.
And finally, laying the foundation for our one of a kind pelvic mass repository, which is intended to be the core of our big data engine and pelvic mass portfolio. As we build that database, we plan to build upon our existing platforms to not only change the way ovarian cancer is managed, but to literally push early detection upstream and build the proprietary portfolio to manage pelvic mass conditions, which impacts one out of every five women in the U.S. Our end goal is to serve a global market with strong proprietary science, coupled with a platform that will drive profitability and overall shareholder value. Thank you for joining us today and thank you for your interest in Vermillion. We look forward to seeing you at the upcoming medical meetings and investor conferences.
Again, I’d like to remind everyone this call will be available for replay through August 25th starting later this evening via the link provided in today’s press release, as well as available in the Investors section of the Company’s Web site. Thank you, ladies and gentlemen for joining us for our presentation. You may now disconnect.
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