Aspira Women's Health Inc.

Aspira Women's Health Inc.

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Aspira Women's Health Inc. (AWH) Q3 2015 Earnings Call Transcript

Published at 2015-11-12 12:02:03
Executives
Valerie Palmieri - President and CEO Eric Schoen - VP, Finance and CAO Laura Miller - SVP, Sales and Customer Experience Donald Munroe - SVP, Business Development and CSO
Analysts
Mark Macarro - Canaccord Genuity
Operator
Good day, ladies and gentlemen and welcome to the Third Quarter 2015 Vermillion Earnings Conference Call. My name is Jenifer and I'll be your coordinator for the call today. With me today are Valerie Palmieri, President and Chief Executive Officer; Eric Schoen, Vice President of Finance and Chief Accounting Officer; Dr. Donald Munroe, Senior Vice President of Business Development and Chief Scientific Officer; and Laura Miller, Senior Vice President of Sales and Customer Experience. This morning they’ll recap their Q3 2015 performance and discuss progress on 2015 priorities. Before we get started, I would like to point out that there will be a replay of this conference available via telephone and Internet. Please refer to today’s press release for replay information. Some of the commentary and answers to today’s questions may contain forward-looking statements. 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. 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 environments, the speed of market adoption of Vermillion's products, Vermillion's ability to commercialize over to or outside the United States, changes in government regulations, Vermillion's ability to obtain and maintain required regulatory approvals, payer reimbursement and other factors as described in the Vermillion quarterly reports on Form 10-Q for the third quarter of 2015. Following the Vermillion team’s remarks, we will open up the call for your questions. Now I would like to turn the call over to Ms. Palmieri.
Valerie Palmieri
Good morning, everyone and welcome. Today we'll be discussing our Q3 milestones, which marked Vermillion's continued progress in 2015. These milestones include the following, an update on our overall strategic plan, a review of our Q3 financials and then update on the status of our OVA2 FDA regulatory submission. Let me first start with our strategic plan. As mentioned on prior earnings calls, our strategic plan has three phases. A rebuild phase, which starts in late 2014, continued through 2015 and is now complete, a transformation phase, which began this year and will continue through early 2016 and a market expansion in growth phase, which will demonstrate meaningful results in 2016 and beyond. Let me first address our rebuild phase, this phase lays the foundation for the deployment of our new strategy. The most significant milestone is transferring the book of business from Quest to ASPiRA. As you know, we transferred the business to our wholly subsidiary ASPiRA Labs as of August 10. We are 90 days post transition and we report in the progress in our commercialization update. Laura Miller, our Senior Vice President of Sales and Customer Experience will discuss this later in the call. Our second milestone is a completion and deployment of our ASPiRA commercialization team. We have spent the majority of the quarter developing partnerships with multiplier organizations increasing our penetration in specific markets, driving significant growth in new accounts and kit deliveries with the Quest transition. We'll also discuss our commercial progress later in the call. I'll now update you on the second phase of our strategy, the transformation phase. This phase changes our focus from solely a technology licensed company to a diagnostic service company through ASPiRA Labs. This phase includes five major milestones. Number one, the submission and clearance of our next generation product OVA2; number two, the continued development and publication of strong healthy economics peer review publication. Number three, the implementation of regional and national care pathway protocols including SGO and CCN and ACOG guidelines. Number four the initiation of our first in kind pelvic mass registry to develop our pelvic mass disease portfolio and finally planning for our international launch in 2016. In terms of the first milestone, the submission and clearance of our second generation OVA2 product, the FDA submission continues to pace to our targeted launch of OVA2 in the fourth quarter of 2015 or early 2016. We've been in active communication with the FDA and believe we have a path to clearance. Dr. Donald Munroe, our Chief Scientific Officer will go into more depth on the regulatory path of OVA2 in just a few minutes. Our second and third milestones include the completion of several peer reviewed publications for [year] which include health economics, clinical utility and clinical and analytical validation for OVA2, which we expect not only to drive peer acceptance, but also drives support data for regional and national guidelines. Regarding guidelines, we have recently held meetings with the key regional professional society on updating the guidelines for pelvic mass diagnosis and management. As a result of these meetings, there is now positive momentum on a guideline revision to reflect recent technology improvements in clinical knowledge. We will keep you apprised as things progress. And finally, we have completed our first clinical utility study; the study met its primary objective of demonstrating OVA1 effectiveness and practice as a successful risk assessment tool for pelvic masses and improving overall patient outcome. The manuscript has been submitted for publication in a peer review journal. We look forward to sharing the positive results of the study post publication. In addition to this study we plan to continue our health economic value-based pricing margin with three publications, which include completing a cost effective study with our secondary generation product OVA2 in two value benchmarking studies with Kaiser Permanente and the renowned NPCN, Markey Cancer Centre, which we will be publishing mid-year 2016. Our fourth milestone in this phase is the initiation of a first of its kind pelvic mass registry, we expect the registry to develop enterprise assets not just for our present focus in ovarian cancer, but also allow us to address benign care pathway dilemmas for a very large potential market of 20 million patients, including women who have endometriosis, polycystic ovarian disease and other gynaecologic disease. We're finalizing the contract for the $7.5 million grant from the Cancer Prevention and Research Institute of Texas with MD Anderson as the primary investigator. As discussed in previous calls, this reward will help facilitate the establishment of the registry as well as allow us to use a portion of those funds we've previously allocated to the registry to support other areas of the business or reducing our overall burn rate. Please note the receipt of any CPRIT funds is subject to the successful negotiation of a contract between the parties and may include the payment of future royalties to CPRIT by Vermillion. The final milestone of our transformation phase is our international launch and we have three major updates, on October 26 we announced that OVA2 is now CE Marked. This occurred two months earlier than we had expected. OVA2 has been branded with the trademark name named OVARA derived from the Latin word [Protruche] [ph]. We’ll now refer to OVA2 as OVARA on a worldwide basis going forward. This CE Mark opens the entire European Union as a potential market for the Vermillion and OVARA having the ability to run the test locally on the Roche Cobas platform will make the commercialization barriers to enter in the EU markets much lower for OVARA compared to OVA1. Number two, OVARA's CE Mark has wider indications for use from the first generation FDA label for OVA1 in the U.S. This vital label is not limited to just those women with a public mass scheduled for surgery as it applies to all women with both cancer -- ovarian cancer symptoms and pelvic mass. In addition the vital label does not restrict, which type of physician orders OVARA as in the U.S. The majority of pelvic masses ex U.S. are diagnosed by primary care physicians or non- OBGYN specialist including emergency room physicians for this wider label is key. In addition to generating strong interest from EU entities the CE Mark carries weight worldwide even in markets that don’t accept the CE Mark from a regulatory standpoint. And lastly in terms of our international launch, this week Vermillion was pleased to announce that NICE which is a National Institute for Healthcare and Excellence has ended the MIB, which is Medtech Innovation Briefing pause on OVA1. Specifically NICE posted on their website NICE will not now produce an MIB on the OVA1 test, because the company plans to launch a successor test to the national health system. This decision by NICE in the light of OVARA CE Mark aligns well with Vermillion intent to market OVARA to the U.K. and beyond as its test can give women hope internationally in overcoming ovarian cancer. As a result this is important CE Mark in the next generation OVARA products Vermillion expect to see its first international volume in late 2016. 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 Q3 financials. Eric?
Eric Schoen
Thanks Valerie. Total product revenue in the third quarter of 2015, $330,000 compared to $209,000 in the same year ago period. Under our new commercial agreement with Quest Diagnostics, we recognized all product revenue the time in OVA1 test is performed by Quest Diagnostics rather than differing some revenue as in prior periods. Revenue for test performed by Quest Diagnostics was $190,000 during the three month ended September 30, 2015, representing test performed prior to the August 10 cutover. Revenue for spiral labs contractual plan is recognized OVA1 test is performed. All other ASPiRA revenue is being recognized on a cash basis thus non-contractual plan there is a lag period between performing a test, being able to recognize ASPiRA revenue for that test. ASPiRA contributed $140,000 to revenue for the third quarter of 2015 compared to $52,000 in the second quarter of 2015. Product revenue in the third quarter of 2015 derived from 3,183 OVA1 tests representing a 26% decrease compared to the 4,325 OVA1 test performed same year ago quarter. Volume in the third quarter of 2015 included 1,665 tests performed at ASPiRA lab, variable ASPiRA volume in the second quarter of 2015, 274 tests. The overall decrease in test, the volume loss, August 10 transaction from Quest, these results will be discussed in the sales section by Laura Miller. We convert from a licensing company to diagnostic services company or transitioning from receiving a small percent of net revenue per patient via licensing fee to receiving a 100% of the revenue ASPiRA is billing entity. However since we’re a new billing entity, we expect a greater than 180-day delay on receiving those payment parallel with building our contracted payor network. Payor contract did not come over with the Quest specimen, so ASPiRA is in the process of obtaining its own payor contract. Thus we will experience a timing issue with recognizing revenue. Offset revenue in the third quarter of 2015 increased to 757,000 compared to 606,000 in the prior year. The increase was related to cost for processing the full volume of test after the August 10 cutover. Operating expenses for the three months ended September 30, 2015, were approximately $4.7 million compared with operating expenses of $5.3 million for the same three month period in 2014. The year-over-year decrease was due primarily due to research and development cost related to OVARA not being repeated in 2015. Net loss for the third quarter was $5.1 million or $0.10 per share, weighted average shares outstanding of $50.3 million. This compares to a net loss of $5.6 million or $0.16 per share in the third quarter of 2014, 35.9 million shares outstanding. Cash and cash equivalents at September 30, 2015, $24 million including the net proceeds of $17.5 million on July 17 offering of common stock. The company utilized $4.4 million in cash third quarter of 2015. Now I’ll turn it back to Valerie.
Valerie Palmieri
Thanks Eric. I’d like to turn the call over to our Senior Vice President of Sales and Customer Experience, Laura Miller to review our sales and managed market activities. Laura?
Laura Miller
Thanks Valerie. Let me start with a review of our Q3 performance. Q3 volume was significantly down due to planned and unplanned attrition due to the volume transition. Total performance between Quest and ASPiRA Lab averaged about 50 patients per day in Q3 2015, compared to 68 per day in the prior year. Prior to the Quest notification there was an average of 63 patients per day, between ASPiRA and Quest. As of the August cutover, there about 50 per day. There was a 7% loss due to customer transition, 4% remains with Quest and a 13% loss due to low volume and ease of use. We anticipated a 15% loss due to the transition and as a result 10% was not planned. We have an active recapture program in place to regain key account. On a positive not our ASPiRA volume has had positive momentum with 490 new patients within 2015. Within the Quest ASPiRA managed account, we grew accounts on average by 60% Q2, 2015 versus Q3 2015. The ASPiRA Lab sales team established 218 new accounts in Q3 versus a 118 accounts in Q2. These new accounts contributed to an increase of 244 new OVA1 patients within Q3. Within the new accounts pending to ASPiRA in Q2 versus new account pending in Q3 there was an average of 41% increase in OVA1 utilization quarter-over-quarter. This also translated into an increase of kits released to 2,974 kits in Q3 versus 2,344 kits released in Q2, a 26% increase quarter-over-quarter. Of these kits released within year ASPiRA has achieved 28% return rate as over one patient. These key indicators of growth potential established positive trends within the ASPiRA book of business. Through Q3 there were 28 laboratory services agreements executed with regional reference laboratories and hospital systems. Some of these laboratory service agreements represent lobotomy draw service and our co-marketing agreement. In the months of September and October, the ASPiRA sales, marketing and managed market teams trained 179 regional reference labs as representatives focused on the OB/GYN call point. Home marketing agreements provide for OVA1 to be offered by the regional reference laboratories a differentiator in their OB/GYN relationships. The targeting efforts between ASPiRA sales and the co-marketing teams of these regional referenced laboratories is to offer the test as a part of a pelvic mass workup to OB/GYN physicians in the joint coverage area. During the ASPiRA training for women's health sales team, teams were educated on the OVA1 test, clinical utility, positioning OVA1, selling the ASPiRA difference in the management of OVA1 and identifying key targets in their given geography. The targeting efforts are orchestrated and owned by the joint team. This forced multiplier should provide OVA1 to more physicians than what would have been achieved by the ASPiRA team alone in addition to educating these teams on a consultative sales process. The ASPiRA sales team will be the pelvic mass product specialist in the women's health environment. Within Q4 the ASPiRA sales team will continue to establish relationships with the previously Quest managed accounts and physician. The Q4 focus is on the top 10 accounts by market and our regional reference laboratory strategy for volume growth and increased utilization of OVA1. The team will provide tools to physicians to keep the OVA1 test top of mind through protocol integration training, expanded pelvic mass menu and collection instruction. We are anxiously awaiting the release of OVARA to improve the physician's management of pelvic mass patients. On the managed markets front, the commercial team plans to continue to leverage the positive medical policy coverage, it's key plan most recently CareFirst Blue Cross/Blue Shield of Maryland by realigning key sales resources to gain awareness of the coverage for OVA1. We also plan to continue to execute regional impact and clinical utility studies for OVARA. The efforts will focus on positive medical policy coverage for the payors in the given market. Communication with national payers has increased significantly and we continue to leverage and develop new and critical evidence. However, we did experience a setback with high mark Blue Cross/Blue Shield first previously positive coverage of OVA1 to negative. We will continue our effort to understand this decision and plan to provide the evidence necessary to have positive policy reinstated. I'll now turn it back to you Valerie.
Valerie Palmieri
Thanks Laura. Let's now review our regulatory progress on our second generation test of OVARA, I’m now going to turn it over to Donald Munroe, our Chief Scientific Officer. Donald?
Donald Munroe
Thanks Valerie. First I'll update you on our progress toward FDA clearance of our second generation product OVARA. Then I'll turn to our publication pipeline supporting OVARA launch, commercialization 2016. As we told you last quarter, we began a series of information exchanges in May, 510(k) submission as part of the FDA standard additional information request process also known as the AI request. The overall list included 18 items ranging from administrative significant technical questions. Eight satisfied 17 of the 18 questions. One item of technical and analytical detail under discussion. This involves technically complex but addressable questions, which have required extensive algorithmic simulations, analytical testing and data exchange. We remain confident of clearance, every line of evidence to date, what is the quality of our design, clear demonstration of enhanced clinical accuracy. Nevertheless, we recognize that OVARA will be the first multi-ovarian test number one to be cleared second generation test by FDA under the 510(k) clearance process. As such we appreciate the importance of fully addressing these technical questions. As the timeline technical feedback we received just a few days ago from the FDA has now pushed our November AI submission target back by about one month. We’re making every effort to conclude the last remaining technical exchanges by early December to preserve the possibility of clearance in calendar 2015. However January may be now more likely given the administrative process after the early December submission and holiday schedule. As always we must caution 510(k) process can never be taken for granted. Questions or requirements may arise at any point, which pose uncertainty to our clearance projections. We'll update you as new information becomes available. Into our publication pipeline, we're excited about our strong line up supporting OVARA commercialization. Almost a dozen peer reviewed articles are planned to have leading clinical collaborators covering three main areas. These are number one, OVARA performance validations; number two, combination of OVARA with imaging or symptoms to predict malignancy risk; number three, ways to measure healthcare value and the early detection of triage of women with ovarian cancer. About half of these were submitted as abstracts in September with deadline for 2016 posters and presentations, Annual Meetings of SGO for the Society of Gynecologic Oncology and ACOG, the American Congress of Obstetricians and Gynecologists. We’ll be able to share more on these exciting results after they are published. In addition our pivotal OVARA clinical validation has been submitted to a preeminent specialty journal but we away -- another study of OVARA was presented to the armed forces ACOG Meeting in Virginia last month ahead of publication. We manage to publish online will share exciting findings of these new submission. Now I'll turn it back to Valerie.
Valerie Palmieri
Thanks Donald. In closing Q3 was a historic quarter for Vermillion in transferring our technology from Quest to ASPiRA Labs. We’ve completed the rebuild phase and are driving through the transformation phase of 2015 as we had planned. Starting in 2016 we believe we are well positioned for our third phase, which is market expansion and growth. During 2016 we expect to complete the following. In the U.S. consistent commercial traction with OVARA with regional partners in large health organizations, conditioned on an FDA clearance of OVARA. Ex U.S. we'll initiate arrangements in key strategic countries aimed to maximize our ability to distribute OVARA via the Roche Cobas 6000. And lastly, the delivery of state-of-the-art informatics tools to the patient provider and payors. With these three core foundation blocks in place, we believe we’ll have the ability to be the disease management solution for public mass disease, which again impacts 20 million women in the U.S. and more than 300 million worldwide. In simple terms, our goal is to become the global diagnostics expert in pelvic mass disease while delivering the portfolio on a platform at point of care. That concludes our presentation and we’re ready to take question.
Operator
Thank you [Operator Instructions] And we’ll take our first question from Mark Macarro with Canaccord Genuity.
Mark Macarro
Hey guys, how are you, thanks for taking the question.
Valerie Palmieri
My pleasure.
Mark Macarro
Great. So the first question maybe either for Donald or Valerie, I think you called out specifics on the FDA submission for OVARA, can you just maybe provide a little bit more clarification, I think you called out 18 items, you satisfied 17, one being analytical or technical in nature. Can you provide a little bit more information about the piece that the FDA is still reviewing and the complexity of this and more precisely what you are doing to move this forward?
Donald Munroe
So, I'll take the question and thanks for asking. In the 18 questions as I mentioned, it ranged from administrative to questions about the algorithm some of the things that we have to do easily solved and were addressed quickly. Others required additional simulations and testing. We’re down to one item. We’ve had a highly interactive and collegial dialogue with the FDA, it's been a great relationship. At the same time we need to recognize that this is the first multi-ovarian test to be cleared under the 510K process by FDA. Though we’re working together on just resolving the last technical questions we have to address. We’ve a clear path to do it. But exactly what we need to do and when it will be done and we’ll exchange with the FDA and hopefully that will wrap it up. So as we said, we expect to that in early December, which could still lead to clearance in 2015, but may extend into January 2016.
Mark Macarro
Okay. And maybe a question for Laura or Valerie, you guys called out a small amount of unplanned volume stepping down. Want to just see if there is any step-down related to folks that might be expecting OVARAs launch in the U.S. and I am just trying to better understand the drivers of the volume dynamic that you called out?
Valerie Palmieri
Hey Mark, I think with regards to the transition with Quest, we’ve seen a shortfall with regards to volume as its transitioning. So there is basically of service change. Many of the organizations were under an EMR interface with the CARE360 through Quest and the opportunity there is the change in terms of manual methodology. So what we seen really in terms of transition is what we would expect with regards to the transition of volumes going from one laboratory to the next. And we’ve actually seen a pickup in volumes specific to post the transition I would say by the third week of September through this time period now in Q4. That’s so much related to the OVARA launch so.
Mark Macarro
Okay. Got it and for the new accounts that you picked up, can you guys maybe clarify the types of accounts you’re seeing? Any surprises -- is this mostly primary care, smaller clinics or are you getting adoption from some larger entities?
Valerie Palmieri
Yeah, that’s a great question Mark. So based on our work and our efforts and investment in our multiplayer’s are base business has been increasing on the larger OB/GYN group. Work still needs to be done in the hospital systems and networks in terms of protocol integration and acceptation of standard of care. Where we are seeing significant growth are those larger OB/GYN groups that are starting to add by physician within that referral group.
Mark Macarro
Excellent. And as we think about Q4 and Q1 and just maybe the first half '16, can you help us get a sober view on commercial health plan adoption and you had made comments about Care First Blue Cross, hoping maybe you could clarify the status of the Care First Blue Cross contract and then thoughts on other health plans into '16.
Valerie Palmieri
So Mark, I’ll take that this is Valerie. So as you know we received Care First. We now are actively I would sweating that positive medical policy coverage right now. As you know that’s a first step to go into contract. So we have a couple of contracts that we’re working on at the present. We do, the big kahuna is the Nationals. So we are actively pursuing a couple of national plans as the present. Can't go into details right now, but there is some nice momentum that we had on that front but the payors are definitely front in centers. So in terms of people that are focused on the payers, we have an east and a west director plus our VP of Managed Markets and that’s solely what they're doing. So 18 million lives right now, our goal is we want to grow this by leaps and bounds over the next year. But again its getting the volume within our four walls within Quest. So that transition in August has helped us -- is helping us make our case with the payors prior to getting that volume in our four wells are -- weren’t on the radar screen from the payor's standpoint. So we're making a lot more noise now and on the next call I’m sure we’ve got much more to present.
Mark Macarro
Okay, one for Eric and then I’ll get back in the queue. Eric, how should we think about cash burn in Q4 and its stepping up into 2016 with obviously you have a number of iron to the fire with ramping up sales and marketing and then on the development front. So can you just maybe quantify where we can see cash burn step up?
Eric Schoen
Sure Mark. First of all we did finish Q3 with $24 million in cash, so really strong cash position. Our base burn is about all in is about $5 million per quarter that you can expect to go into 2016. You'll see I’ll call it onetime expenses when we start up the registry. There is generally some startup cost per site. So it could pick up in certain quarters more towards $6 million, but think of $5 million as our good base loss going forward.
Mark Macarro
Great, thank you very much.
Valerie Palmieri
Thank you, Mark.
Operator
[Operator Instructions] And we’ll go back to Mark Macarro with Canaccord Genuity. Please proceed.
Mark Macarro
All right. Okay so international would love to hear your thoughts on -- I appreciate the commentary on the CE Marking before expected, Valerie can you explain to what and I think you -- you said that you expect international volumes in late '16, why is it late '16 and not early to mid 16?
Valerie Palmieri
So, I think there is a couple of things, one is we’re going to start with the private market. So in each market there is usually a government system. So, what you do is you just start in the private market and then you move to the I’ll call the national market. So will there be incremental volume growing over next year, but what I’m saying is what we’re going to see in terms of, what I consider that bolus it's almost like turning a switch will be later in 2016. We're actively Mark, looking distributors and partners there and we anticipate getting those started sooner, but in terms of what I call large accretive volume it will be later in 2016, just because of the time to get into the socialized medicine system.
Mark Macarro
Perfect, okay. And obviously Roche Cobas is a well known and well used platform, can you help me think about whether or not this will be a centralized testing play in other words hospitals that are already using the Cobas doing testing in house as oppose to physician office clinics that may be order in OVARA test but what you’d run it for them through a central lab.
Valerie Palmieri
So I think it’s a combination of both, I think its pending on the size of the hospital, they will have a Cobas system are just spending on the size, the clinics won’t have a Cobas system so I think it depends on the size of the hospital system but you’re absolutely correct. We are for us to as we’re building this platform for Ovarian cancer but moving towards pelvic mass which is $300 million worldwide, $20 million here in the U.S, the centralized platform will allow us to distribute on a much more rapid bases and actually bring disease management protocol in care pathways to the local level. So, that will be plan for us to not only in the ex U.S. but also a plan in the U.S. as well.
Mark Macarro
Okay, great and then I might have missed it what was the average selling price in the quarter and I know there is there is one for Quest and one for ASPiRA but how should we think about that creeping up in the out quarters here.
Eric Schoen
Yeah, Mark Quest is at $125, that’s been consistent. We had a given an average selling price for ASPiRA simply because got all those tests that are in process and there is a lag between when we run the test, when we collect the cash and can recognize revenue. So it's going to be another quarter at least until we get a good handle on what we collect for test.
Mark Macarro
Okay. And I know you guys called out a 180 delay I believe this is on the payer contract side, can you clarify that comment is well and I think you’re referring to the time that takes to sign up commercial payers and it’s a reasonable to think that, that will shorten as you add commercial payers on.
Eric Schoen
Well really Mark, what that's referring to is the cycle time between sort of running what I’d call your average patient test. You bill a payer that’s at least 30 days until you get a response unless it's with a payer that we have positive medical policy, we do expect to get similar to most diagnostic labs that are in our same position lots to denials and we go through level one of appeals, level two of appeals. Eventually we will win a percentage of those appeals and that’s one of the ways you get that coverage creating that noise with the payors, but that process time of submitting the claim, getting it now, going through the appeals process can talk about a 180 days and that’s what I talk about the lag time between running a test and being able to recognize revenue for that same test.
Mark Macarro
Okay, great and can you remind us Valerie where you're at with the sales and marketing team in the U.S. and then secondly, when you can expect to potentially announce distributor partners in Europe?
Valerie Palmieri
Okay. So number one, in terms of sales and marketing in the U.S. say about 20 people in the field right now. We also has in the U.S. added our multiplier, so women’s health boutique, referenced laboratories that are adding another 179. So in the U.S. about 199, 200 consultative sales reps in the U.S. and then actually launched in September and October of this year. In terms of ex U.S. we are very close on a couple of partnerships right now, so we are in term sheet discussions right now.
Mark Macarro
Okay. Great, and we love to hear a little bit more about the Kaiser Permanente discussions, can you explain to me what the -- I believe that's the cost aspect in the study on OVARA. I think you said 2016, could you give a little more clarity on what exactly they will be doing for you? Whether this is designing a model and when we can expect to see this become relevant in their business.
Valerie Palmieri
Yes Mark, I am going to hand the call over to Donald. So he can go through the details with the three part process.
Donald Munroe
Sure Mark. So I think one thing that we did to recognize is that ovarian cancer is a low prevalence disease and that often the different parts and pieces are disconnected. Kaiser is an example of an organization where everything is integrated under one roof from primary care to specials referrals. So that partnership is very important for us in terms of being able to look at the big picture and put together data on the care pathways that are being used today. As we go forward, we're going to publish on a retrospective look-back on the patients that they dealt with over the past eight or so years in the Southern California network. We're going to look where there was opportunity to do things better, faster to ensure that there was appropriate referral of the patients of ovarian cancer, so they could get the best care. In the literature that says that results and better outcomes in terms of survival and immediate outcome for the patients. And then going forward, on a put together proposed care path that would include OVARA and this will be something that could eventually turn into clinical utility studies or other such studies, now the fact that they're interested in working with us definitely the idea that even for an advanced integrated network like Kaiser, our technology may bring value and we want to be able to take this to the other stations around the country where they have care pathways or where they need care pathways in order to do a better job or triaging them with potential ovarian cancer.
Mark Macarro
Okay. Wonderful. And final question for me and thanks for all the time, any competitive dynamics whatsoever as it relates to ROMA or CA125 in the quarter? I know it's been a brief period of time, but any changes there?
Valerie Palmieri
No Mark, nothing at all. I think that with our findings with OVARA, you will see that it will stand head and shoulders above CA125 or ROMA. So not that OVA1 did not do that. We believe that OVARA is going to really take it to another dimension. So no, there has been no competitive pressure. Really it's an awareness issue in terms of us getting awareness out there and ensuring how the doctors are integrating into their protocol. And we're really using the Myriad approach to that in terms of integration.
Mark Macarro
Excellent. Thanks very much.
Valerie Palmieri
Thank you.
Operator
And at this time, there are no further questions. This concludes our question-and-answer session. I would now like to turn the call back over to Ms. Palmieri. Please proceed.
Valerie Palmieri
Thank you, Jenifer. To conclude we have a steadfast methodical mission to change the course of pelvic mass disease in the U.S. and worldwide. We have completed one of two major strategies phases, our rebuild. We're now focusing on completing our transformation phase. The three key elements are, the successful deployment of our new commercialization strategy based on strong science and health economics to drive sales ramp and payor coverage. Number two rolling out a true pelvic mass disease management offering with a portfolio of test. And number three setting the stage for guidelines for OVARA to become a standard of care for early detection of high risk patients. As we expand our markets, we will be building upon our existing bio-analytics solutions platform to not only change the way ovarian cancer is managed but by pushing early detection upstream and building our proprietary portfolio to manage pelvic mass disease, which impact one out of every five women in the US. Our end goal is to serve a global market with strong proprietary science coupled with a platform, which 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.
Operator
Again I would like to remind everyone that this call will be available for replay through November 26 starting later this evening via the link provided in today's press release as well as available in the Investor section of the company's website. Thank you, ladies and gentlemen for joining us today for our presentation. You may now disconnect.