Aspira Women's Health Inc (AWH) 2014 Q4 法說會逐字稿

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  • Operator

  • Good day, ladies and gentlemen, and welcome to the fourth-quarter 2014 Vermillion earnings conference call. My name is Derek and I will be your coordinator for the call today. With me today are Valerie Palmieri, President and Chief Executive Officer of Vermillion; Eric Schoen, the Company's Vice President of Finance and Chief Accounting Officer; and Dr. Donald Munroe, Senior Vice President and Chief Scientific Officer.

  • This morning they will recap their 2014 performance, discuss 2015 priorities, provide an update on their new Quest commercial agreement, review their FDA submission of OVA2, and issue Q1 2015 guidance.

  • 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 materially differ. 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, changes in government regulations, payer reimbursement, relationships with our strategic partners, and other factors described in the Vermillion 2013 Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K.

  • 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 - President and CEO

  • Thank you, Derek. Good morning, everyone, and thank you for joining us. I'd like to start the call by saying it has been an exciting first few months, and we'll be discussing on number of foundational milestones which have been completed, as well as those which are on the docket to complete this year.

  • First, I'd like to start with a review of our new mission and vision. Vermillion's new mission has expanded from ovarian cancer to driving care pathway solutions for all benign and malignant pelvic mass conditions. The estimated size of this market is 1 million patients in the US. Our primary mission is to improve patient outcomes, increase physician effectiveness, and thus reduce the cost of healthcare via proprietary technology and informatics.

  • Our initial focus starts with ovarian cancer, the cancer with the highest mortality rate of all gynecologic cancers. Our goal is to provide diagnostic solutions with our patented technology to determine the risk of malignancy, and thereby ensure patients receive optimal treatment in the shortest amount of time. Two patients die every hour from ovarian cancer. Currently the diagnosis for these patients frequently comes too late to change the outcome. We have the ability to change this.

  • Moving on to our overall vision, our vision is to be the global leader in personalized medical management of gynecologic health; to improve clinical outcomes for physicians, payers, and, most of all, their patients. We do not believe there's one silver bullet that solves the healthcare paradigms. It is the compilation of clinical data, other modalities and diagnostics that drive optimal care. In this healthcare paradigm of needing to work smarter, our bioanalytic products drive smart medicine.

  • Our mission and vision may be a tall order, but we have demonstrated we can do it. We have made core investments in our team, analytics, processes and partnerships, and have the know-how to do this and do it well. As mentioned on the prior earnings call, our strategic plan includes three phases: number one, our rebuild phase in late 2014/early 2015; number two, a transformation phase through 2015; and number three, a market expansion and growth phase through 2016.

  • I am now going to address our rebuild phase. This phase includes retooling of the management team and laying the foundation for the deployment of our new strategy. The rebuild phase is nearly complete and includes five major milestones. First and foremost is our new commercial relationship with Quest. Second is our team. We made conscious decisions to bolster our sales and customer experience leadership and operations leadership. Third is the conversion of our sales team from a contract salesforce to an employed salesforce. Fourth is implementing a new sales process called the Challenger model. It is a physician practice integration model focused on driving clinical solutions. And fifth is the implementation of a sales care pathway plan to drive commercialization.

  • I will review each of these items in detail. Regarding our new Quest agreement as of March 11, we have reached a settlement agreement for all claims related to our prior strategic and loan agreements. We are moving forward with a new Quest commercial agreement. In this agreement, Vermillion's wholly-owned subsidiary, ASPiRA LABS, will begin to offer OVA1 testing to Quest customers. Quest expects to transfer all OVA1 service to ASPiRA starting with 39 states this year, while continuing the blood draw and logistics support to transport specimens from its clients to ASPiRA LABS for testing.

  • Quest will also continue to offer OVA1 services through its own OVA1 performing labs in the remaining 11 states, until ASPiRA has the required state approvals to provide those services. Quest will receive a fee for collection and logistics support services provided. This commercial agreement will allow us to deliver additional proprietary technology to the Quest client base, based on a mutual agreement as well. Truly a partnership to continue to offer our OVA1 to Quest clients, as well as expand the offering on a mutually agreed basis.

  • Moving onto the second milestone, this milestone includes the additions to our senior management team, which include experts in diagnostic servers industries, including Laura Miller serving as Senior Vice President of Sales and Customer Experience; and Patrick Carpenter, GM of ASPiRA, both who have served in leadership roles and top companies such as LabCorp and DIANON.

  • Our next milestone includes the complete retooling of our sales capabilities. In 2014 we hired a contract salesforce. In late Q4 of 2014 we strategically decided to initiate an employee salesforce. The new salesforce was hired, and our training was completed in Q1 2015. This salesforce has been hired to specifically focus on the OB/GYN, GYN oncologist, plus regional hospital systems and networks. The sales teams' role include market development specialists, strategic account managers, and custom account managers, coupled with medical science liaisons who support all three roles in terms of physician education.

  • We are placing the sales team in specific regions based on the states we are licensed, the incident rate of pelvic mass procedures, and key opinion leader influence. With this investment in strategy and talent, we will expect to increase OVA1 utilization, positive medical policy coverage, and establish payer strategies with national and regional payers.

  • Moving on to our next milestone, this includes a significant investment in the how of the sales process. In terms of the design and development of our marketing collateral, we have rebuilt all materials based on a well-known Challenger sales model. The Challenger model has been shown to provide unique insights for customers and is ideal for specific, solutions-driven approach to complex healthcare pathways.

  • The last milestone of phase 1 is a change in the core battle plan to drive sales ramp and penetration via a care pathway process. The prior plan was built on commercialization from a single call point; that is, the OB/GYN. We are now building a plan to call point that now touches each part of the patient's care pathway. This new plan directly markets to GYN oncologists, better known as the gynecologic disease experts, ACOs and OB/GYNs. This approach utilizes high-touch and low-touch solutions. Each role in the sales team has a specific call point to manage relationships and education on OVA1.

  • These roles include the strategic account manager, who will focus on hospital systems and networks with coverage of KOLs, payers, plus integration of local guidelines within an institution; the market development specialists, who educate GYN oncologists and the respective referral base of OB/GYNs, KOLs, and payers; the customer account manager, who will cover the country with low-touch marketing campaigns; and, last but not least, a medical science liaison, who support our medical and sales team on KOL and speaker development, scientific messaging, plus physician education.

  • This multichannel approach will drive volume in the GYN oncologist referral base, increase exposure with payers, as well as assist in the creation of guidelines within large networks and systems. This approach, used in conjunction with the Challenger model, has been shown to be effective with recent examples including, most notably, Myriad Genetics.

  • We are now moving on to our second phase, which is the transformation phase, and has been initiated in 2015. This phase includes five milestones as well, and we are transitioning from solely being a technology license company to a high-performing diagnostics service company.

  • The five milestones are, number one, the submission and clearance of OVA2. Donald Munroe, our Chief Scientific Officer, will elaborate on this in detail later in the call. Number two, laying the foundation of health economics with the publishing of the OVA2 data and health economic studies, as well as initiating regional impact studies. Number three, working with key professional societies to initiate or update practice guidelines. Number four, initiating of an unparalleled pelvic mass registry. And number five, the bolstering of our US and international infrastructure.

  • In terms of the first milestone, the submission and clearance of our OVA2 product, I am happy to report that we have submitted a 510(k) for OVA2 on March 6, 2015. We anticipate feedback in the next 90 days, towards the goal of clearance in late Q3. Donald will review this process and next steps in greater detail in a few minutes.

  • The second milestone for 2015 will be the publication of health economic studies, initiating our regional impact studies, and publication of our OVA2 data by Q4 2015. In fact, we will soon issue a press release on the publication of OVA1 cost-effectiveness abstract, which will be presented as a poster at the American College of Medical Quality, or ACMQ, annual conference, which will be held this Friday, March 27. We are excited about this first health economic analysis of the OVA500 intended use trial data, which predicts OVA1 benefits and patient outcomes. Due to publication embargo rules, we cannot disclose the details at this point. But we invite you to watch for the forthcoming press release with study details.

  • In this vein, we have also made significant progress in our endeavor to conduct regional impact studies to support coverage and reimbursement of OVA1 with targeted payers in our key markets. The regional impact studies are designed to leverage the approximately 17,000 OVA1 samples processed yearly from our key customers, which demonstrate clinical utility of OVA1 using actual data from our providers. We believe these studies will significantly bolster our position with health plans and garner acceptable reimbursement. Two studies will be initiated in second half of the year.

  • Our third milestone is a guideline plan. As you know, guidelines can take many years to achieve. With the introduction of OVA2, we seek an updated position from SGO and to establish guidelines within ACOG. Additionally, we will submit an updated package to NCCN.

  • Our fourth milestone is the initiation of an unparalleled pelvic mass registry, beginning patient enrollment by the end of 2015. Initial funding and plans are in place. What makes this registry unique is that it will follow the care pathway of women from the time of first presentation through diagnosis, treatment, and early outcomes. And rather than just focusing on ovarian cancer alone, the registry will deliver hard assets and insights into other benign and malignant diseases that present similarly and require differential diagnosis and early intervention. These examples include endometriosis, polycystic ovarian syndrome, and other gynecologic disease states. This study will shed light on the care pathway dilemmas of a very large potential market of 20 million patients. 20% of all women in the US age 20 to 70 years old have endometriosis, polycystic ovarian disease, or other gynecologic conditions today.

  • In addition, this study will be designed from input not only from nationally renowned physicians, but also from patient advocacy groups, health economists, and community practitioners. So we will have input from the entire care pathway so we can drive solutions which impact the patient, physician, and the payer, a common theme with our overall strategy.

  • The last milestone for 2015 includes the building of our informatics infrastructure, full lab licensure, and infrastructure to access the international market. Our goal is to build an informatics infrastructure which will serve all three customers -- physicians, payers, and, most of all, their patients. Patients, especially women, drive healthcare in the US, and we intend to deliver systems to ensure an optimized customer experience.

  • Regarding our licensure, we intend to obtain full national licensure by the second half of 2015, so we will be able to accept specimens from all 50 states.

  • In terms of our international foundation, Vermillion updated its quality systems to satisfy the EU Medical Device Directive, the Canadian medical device regulations, and ISO 13485. We received ISO 13485 certification on February 6, 2015. In addition, Vermillion registered OVA1 in the EU on March 6, 2015. Both of these elements are critical to our core international plan, which will begin to show fruit in 2016.

  • I would like to turn to Eric Schoen, our VP of Finance, for a rundown of our Q4 and fiscal 2014 financials. Eric?

  • Eric Schoen - VP of Finance and CAO

  • Thanks, Valerie. Today we filed our fourth-quarter and full-year 2014 financial results in a press release, which is available for download via the investor section of our website at www.Vermillion.com. Our Form 10-K will be filed with the Securities and Exchange Commission before the end of March.

  • Total revenue for the full-year 2014 was consistent with the prior year, at approximately $2.5 million. Total revenue in 2014 included $2.1 million from product sales of OVA1, and $454,000 of license revenue. The product sales of OVA1 in 2014 included $825,000 from approximately 16,839 tests performed, and included $1.2 million in the fourth quarter for the variable royalty reported by Quest Diagnostics for 2014. By comparison, 2013 included revenue for 17,004 tests performed, again flat year-over-year.

  • Total revenue in the fourth quarter of 2014 was $1.6 million, consistent with the same year-ago quarter. The OVA1 product revenue in both quarters includes an additional royalty component of revenue from Quest. With the new Quest commercial agreement executed on March 11, we will no longer be receiving an annual royalty report. Rather, we will recognize all revenue for OVA1 tests run through Quest Diagnostics at a contractually agreed-upon rate per test, in the period in which the tests are performed and during the transition period, until all tests are performed at ASPiRA LABS.

  • Fourth-quarter 2014 product revenue was derived from 4,474 OVA1 tests performed, representing a 6% increase compared to 4,218 OVA1 tests in the year-ago quarter. This volume includes tests performed at ASPiRA LABS in 2014.

  • Volume in the fourth quarter included 257 OVA1 tests performed by ASPiRA LABS compared to 152 OVA1 tests performed in the third quarter of 2014. This represents a 69% increase in test volume, quarter over quarter. We expect OVA1 test volumes at ASPiRA LABS to increase significantly in the second quarter of 2015 as we transition existing Quest Diagnostics' customers to ASPiRA, as well as generate growth organically through our salesforce.

  • For ASPiRA LABS, we have not yet established sufficient payment history with insurance companies or private payers for the tests performed, and are thus recognizing revenue on a cash basis. There will also be a lag period between performing a test and ultimate cash collection, due to the denial and appeal process. Once we establish a reliable payment history, we plan to return to a normal accrual revenue recognition methodology.

  • With regard to the first quarter of 2015 volume guidance, and similar to the first quarter of 2014, we expect winter weather-related seasonality to adversely impact test volumes compared to the fourth quarter of 2014.

  • Cost of revenue for the three months ended December 31, 2014, and full-year 2014, totaled $500,000 and $1.2 million, respectively. This level of expense was due to the investment in ASPiRA LABS, which opened in June 2014. There was no comparable expense in the prior-year quarter or full-year 2013.

  • Operating expenses for the three months ended December 31, 2014, and the full-year 2014, were approximately $5.2 million and $20.5 million, respectively. Operating expenses included approximately $0.3 million of non-cash, stock-based compensation expense in the fourth quarter and $1.2 million for the full year 2014. This compares with operating expenses of $3.3 million and $11.3 million for the same three-month and full-year periods in 2013. Operating expenses in the prior year included $0.6 million and $0.9 million of non-cash, stock-based compensation expense in the same three-month and full-year 2013 periods.

  • The year-over-year increases are due to our continued investment in our salesforce, as well as research and development efforts to complete development and validation of our OVA2 tests. 2014 expense also includes the pre-opening costs to build out ASPiRA LABS.

  • Net loss for the fourth quarter was $4.1 million or $0.11 per share on weighted average shares outstanding of 36.7 million. Total net loss for the year ended December 31, 2014, was approximately $19.2 million or $0.53 per share, based on weighted average shares outstanding of 36.1 million. Our total shares outstanding at December 31, 2014, were 43.1 million.

  • Cash and cash equivalents at December 31, 2014, were $23 million, including the $10.5 million gross proceeds from our private placement of common stock and warrants in December 2014. The Company utilized $4.3 million in cash in the fourth quarter of 2014, and expects between $4.6 million and $4.9 million in cash outlay for operations during the first quarter of 2015. In addition, we made the final repayment of debt to Quest Diagnostics, totaling $1.1 million in the first quarter. We now have no debt on our balance sheet.

  • Now I will turn it back to Valerie.

  • Valerie Palmieri - President and CEO

  • Thanks, Eric. Let's now turn our attention to our OVA2 development progress. And let's discuss some of the achievements in the quarter.

  • I'm going to turn over to Donald Munroe, our Chief Scientific Officer. Donald?

  • Donald Munroe - SVP of Business Development and Chief Scientific Officer

  • Thanks, Valerie. Last quarter we updated you on the progress we made in our second-generation product, OVA2, completing the development and verification phases of product development. The redesign included swapping out two of the five OVA1 biomarkers and migrating the assay from outdated legacy instruments to the Roche cobas 6000, a state-of-the-art integrated clinical chemistry platform with thousands of placements worldwide. In fact, a total of 10,000 cobas 6000 systems have been placed worldwide, more than any other comparable platform.

  • Today we're pleased to announce the completion of the double-blinded validation of OVA2 with the help of three external clinical sites. The results will be presented at conferences and submitted for publication in peer-reviewed specialty journals. Therefore, I can't reveal details at this time, except that we and our medical advisors are very excited about the significant improvement in specificity and positive predictive value that was achieved. We look forward to sharing these data as they are published in the second half of the year.

  • Although Vermillion has filed the OVA2 510(k) with the FDA on March 6, 2015, the clearance process can never be taken for granted. But we feel our package and data are exceptional, so we're still on track for product launch in Q3 2015, as we have previously projected.

  • I will turn it back to Valerie now.

  • Valerie Palmieri - President and CEO

  • Thanks, Donald. As we complete the transformation phase in 2015, we have set our sights on our third phase, which is market expansion and growth in 2016. By this time, we expect to have met all of the following prerequisites: number one, full national licensure of ASPiRA; number two, a track record for value-based pricing and payer acceptance; number three, fully exercised regional commercialization strategies with OVA2; and number four, initiation of our sample and patient registry, so we can mine for new disease care pathway patterns to feed and expand our product pipeline.

  • Keep in mind, we will be launching OVA2 with an already existing customer base, coupled with state-of-the-art instrumentation which will be deployed worldwide as well. In addition, our growth phase will be kicked off with a 25-plus strong salesforce, our strong medical science liaison team, and a potential market of over 1 million patients.

  • This concludes our question-and-answer session. I would now like to turn the call back over --. I'm sorry. Okay.

  • In addition, our timing is right. Women's health and ovarian cancer has taken on a different perspective in the marketplace. First, the mortality rate has not changed in 30 years. With the [intention] of our ovarian Dream Team in 2014 -- September 2014, from Stand Up To Cancer -- ovarian cancer is now at the forefront of national attention. Our technology has the potential to change the outcomes of ovarian cancer, not only in the US but worldwide, and [intend] will make significant impact on overall gynecologic health.

  • This concludes our presentation, and we're ready to take questions.

  • Operator

  • (Operator Instructions). Debjit Chattopadhyay, ROTH Capital Partners.

  • Debjit Chattopadhyay - Analyst

  • Congrats on the progress here. Just a couple of questions, first on the potential European launch for OVA1. So, are we presuming this launch for OVA1 is still on the older platform?

  • Valerie Palmieri - President and CEO

  • That is correct, yes.

  • Debjit Chattopadhyay - Analyst

  • And do you have plans to migrate OVA1 to the cobas 6000? Or would you just launch OVA2 once it gets approved in the US?

  • Valerie Palmieri - President and CEO

  • So let me step back on this. OVA1 is on two platforms today. We can launch OVA1, ex-US, immediately. OVA2 will be on this new Roche cobas platform, which will -- our goal is to have clearance by Q3. So we can start with OVA2 and then move to OVA2. But OVA2 will be replacing OVA1.

  • Debjit Chattopadhyay - Analyst

  • Now, could you walk us through the process of registering OVA2, ex-US? Do you have to go through a separate CE Mark?

  • Valerie Palmieri - President and CEO

  • No. No, we do not need to go through a separate CE Mark.

  • Debjit Chattopadhyay - Analyst

  • So, why would you then launch OVA1 right now? You're not planning to launch OVA1 anyway between now and the end of the year, right?

  • Valerie Palmieri - President and CEO

  • We have the capability. There is interest, but we have capability to do it. Could we wait till OVA2? Yes, we could, but we can also -- we have interest right now on OVA1.

  • Debjit Chattopadhyay - Analyst

  • And in terms of any potential showstoppers with the FDA, how have your conversations been with the Agency regarding the approval of OVA2?

  • Valerie Palmieri - President and CEO

  • The conversations have been very positive. We had a pre-submission conversation late last year, and overall it's been very positive. And as you know, this is a 510(k) and we are going for substantial equivalence.

  • Debjit Chattopadhyay - Analyst

  • And one last question on private payer reimbursement during the rest of the year. Do you have set milestones and targets for this year?

  • Valerie Palmieri - President and CEO

  • Yes. So, our milestones, we are going to start -- we are basically measuring this year with volume by -- we'd like to achieve one national payer and several regional payers by the end of the year. That is our goal.

  • Debjit Chattopadhyay - Analyst

  • And one other question about in the gap-fill status right now. Could you walk us through what you would need to demonstrate this year, so you'd get -- I mean, you will move away from the gap-fill status in 2016?

  • Valerie Palmieri - President and CEO

  • Do you want to do that, Eric, or do you want me to?

  • Eric Schoen - VP of Finance and CAO

  • Sure. With regards to gap-fill, we have coverage through Novitas. We will be getting our price from them as we submit claims. We are very cognizant of the gap-fill process and protecting our price. We expect that CMS will be looking at those data points during the year, and we're hopeful that that will set a price for us in early 2016. But in similar to 2015, CMS has been slow to price MAAA and other molecular codes, so there's no guarantees. But we do already have coverage from Novitas.

  • Debjit Chattopadhyay - Analyst

  • Well, thank you so much, and good luck.

  • Operator

  • (Operator Instructions). [George Caftercue].

  • George Caftercue

  • Congratulations on the progress. Can you just talk to guidelines? In your opening remarks, Valerie, you mentioned an SGO update you're working off of OVA2, and also [lead team's] ACOG. So can you talk a little bit more towards guidelines, please?

  • Valerie Palmieri - President and CEO

  • Sure. Sure, I'd be happy to. So, as you know, guidelines is a process with a capital P, so it does take time. We already have a physician statement from the SGO as of 2013. So our goal is to actually getting more impactful position statement from an SGO with OVA2; and then leveraging that, that renewed position statement, with ACOG. Because as you know, SGO are considered the gynecologic disease experts, and they have a lot of influence on ACOG. We are also going to be submitting a submission to NCCN as well. So we are initiating the process this year with our OVA2 product, and we are putting a dedicated team on this.

  • George Caftercue

  • And I assume that's different to prior. By inference, there wasn't a dedicated team prior to guidelines?

  • Valerie Palmieri - President and CEO

  • A dedicated team, and also team that has done it before; so I'd say those are two differences.

  • George Caftercue

  • Okay, thank you.

  • Operator

  • (Operator Instructions). John Grimley, TJW Capital.

  • John Grimley - Analyst

  • Congratulations on the progress you've made.

  • Valerie Palmieri - President and CEO

  • Thank you, John. Good morning.

  • John Grimley - Analyst

  • So I just want to better understand the agreement with Quest. You guys used to get $50 up front, and then a percentage of the collection. How should we think about pricing at ASPiRA? And then on tests going forward, obviously the economic arrangement is better, assuming you can collect for the tests you do. Can you just flesh that out a little bit more so we understand what the arrangement was, and what it looks like going forward? And then also tie in pricing as well, if you can.

  • Eric Schoen - VP of Finance and CAO

  • Sure. The previous agreement with Quest, we got -- as you mentioned -- the $50 fixed fee, plus one-third of their gross margin. That's going away. There will now be an agreed-upon, set price per test that we'll get to recognize up front. We have not disclosed, nor will we disclose, what that is, at this time. But you should think of that as that's the tailing off of the business. Because in the second half of 2015, we intend to get full licensure, and all testing should be performed at ASPiRA LABS by the end of the year.

  • So what you really want to focus on is -- what are the economics at ASPiRA LABS? So we will be billing and collecting those tests. At the outset, that's going to be on the cash basis, but now we have the ability to recognize the full value from those tests. There's going to be denials and appeals at the outset. Quest had all the contracts with the payers. ASPiRA LABS did not. That's what we're working on presently. And over time, we should see our average unit price increase as we get those contracts in place and make collections.

  • John Grimley - Analyst

  • And should we assume OVA2 is going to have a higher price than OVA1?

  • Valerie Palmieri - President and CEO

  • Yes.

  • John Grimley - Analyst

  • Okay.

  • Valerie Palmieri - President and CEO

  • And it's based on health economics.

  • John Grimley - Analyst

  • And is that the most important -- so, obviously, payers will drive -- will be really important for you guys. And I know it takes a long time. I know you've been working at it a long time. It sounds like we have several health economic studies coming out this year. Are those the key catalysts to put in front of the payers, to push them to move?

  • Valerie Palmieri - President and CEO

  • Yes, you are correct. That is absolutely the key catalysts.

  • John Grimley - Analyst

  • And how much does women's health -- it just seems like women's health is a big focus in the overall healthcare community. Are there payers that are more focused on women's health that give you an upper hand, potentially? Or am I wrong to make that assumption?

  • Valerie Palmieri - President and CEO

  • No, I think you're onto something. I think certain payers actually have women's health divisions, and see themselves as the woman's health organization. So I do think that it is not a common theme yet, but I do see it as something that is growing. Women control 85% of the healthcare decisions in the country, not only themselves but their families, so it's a big push.

  • John Grimley - Analyst

  • And then just last, Valerie, you've been there for a short time, but clearly have been working hard and accomplished a lot. What is your biggest negative surprise? And what has you most excited about the next 12 to 24 months? What are you most excited about?

  • Valerie Palmieri - President and CEO

  • What I'm most excited about -- and this is going to sound like something that is outside of our control, but it's in our control -- is the timing. The fact that Stand Up For Cancer acknowledged an ovarian Dream Team, and you saw the -- even just yesterday, the buzz with Angelina Jolie. I think the timing is right for ovarian cancer. Ovarian cancer has been seen as a rare disease, and the mortality rate has not changed in the last 30 years. So I think that having this technology that I considered have been coveted and almost kept in a box through this commercialization process in the past.

  • We now have the opportunity to commercialize a very robust technology, manage the timing of the marketplace, and make difference in terms of managing ovarian cancer and changing patients' lives. So that's what keeps me up at night, and that's what we're driving towards.

  • John Grimley - Analyst

  • Great. Thanks a lot.

  • Operator

  • Adam Evertts, LifeSci Capital.

  • Adam Evertts - Analyst

  • Just want to get a better idea of the transition from selling OVA1 to OVA2. By the time you launch OVA2, will you have established the necessary relationships with physicians and KOLs, and simply swap out the product that you're offering? Essentially how much will the process of selling OVA1 help you launch OVA2?

  • Valerie Palmieri - President and CEO

  • Absolutely. So, we are basically -- as we transition from OVA1 to OVA2, we have an existing customer base, which is an ASPiRA customer base and the Quest customer base. We're also changing the way we're positioning that sale. As I mentioned earlier, we are selling through the entire patient journey. So from a GYN oncologist, which is a gynecologic disease expert, to the hospital systems or regional health networks, to the OB/GYN. In the past, we were only selling direct to GYNs, and now we really have a triad approach.

  • And we're also supporting that process with also medical science liaisons. So, we're going on the existing base, and we are bolstering the existing base with hitting it from several sides. So I do believe the uptake and ramp with OVA2 will be significant.

  • Adam Evertts - Analyst

  • Great, thank you.

  • Operator

  • This concludes our question-and-answer session.

  • I would now like to turn the call back over to Ms. Palmieri. Ms. Palmieri, please proceed.

  • Valerie Palmieri - President and CEO

  • Thank you, Derek. To conclude, we have a planned and methodical mission to change the course of gynecologic health in the US, and worldwide in time. In terms of the strategy, we have three primary objectives to meet in 2015. First and foremost is the successful implementation of our new commercial relationship with Quest. Second is the performance-driven deployment of our sales care pathway team and our new Challenger model to drive sales ramp penetration with our current, as well as new, customers. Third is compelling these health economics publications to drive value-based pricing.

  • As we expand our markets, we will be building upon our existing bioanalytics platform solutions to change not only the way ovarian cancer is managed, but moving near-term into pelvic mass care pathways while setting our sights on bioanalytic management of the larger disease paradigm, which impacts one out of every five women.

  • We appreciate you attending our call and your continued support. Thank you.

  • Operator

  • Again, I would like to remind everyone that this call will be available for replay through April 8, 2015, 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 website.

  • Thank you, ladies and gentlemen, for joining us today for our presentation. You may now disconnect.