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Executives

Bruce Allan Huebner - Interim Chief Executive Officer, Interim President and Director

Eric J. Schoen - Chief Accounting Officer

Donald G. Munroe - Chief Scientific Officer and Vice President of Research & Development

Analysts

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

Debjit Chattopadhyay

Vermillion (VRML) Q4 2012 Earnings Call February 20, 2013 4:30 PM ET

Operator

Good afternoon, everyone, and thank you for participating in today's conference call to discuss Vermillion's Fourth Quarter and Full Year Ended December 31, 2012. Joining us today are Bruce Huebner, the Interim Chief Executive Officer for Vermillion; and Eric Schoen, the company's Chief Accounting Officer. Following their remarks, we will open the call for your questions. Then before we conclude today's call, I'll provide the company's Safe Harbor statement and important cautions regarding forward-looking statements made during this call.

Before we begin, I would like to remind everyone that this call is being recorded and will be available for replay through March 6, 2013, starting later this evening via the link provided in today's press release as well as on the company's website. Now, I'd like to turn the call over to Mr. Huebner. Please go ahead.

Bruce Allan Huebner

Thank you, Edison. Good afternoon, everyone, and thank you for joining us. It's a pleasure to speak to all of you. Today, we'll talk about our operational successes from the past quarter and then turn to discussing our future growth opportunities. As part of this outlook discussion, I would like to present a new strategic direction for our business that has been evolving over the past year. But before I get into the specifics, I will turn the call over to our Chief Accounting Officer, Eric Schoen, who will take us through our fourth quarter and full year 2012 results.

Eric J. Schoen

Thanks, Bruce. We originally planned to release only preliminary results today. However, we received our annual true-up report from Quest Diagnostics ahead of schedule. Therefore, we are pleased to share complete fourth quarter and full year 2012 results.

Total revenue for the 3 months ended December 31, 2012, was $1.1 million, comprised of $1 million from products sales of OVA1 and $114,000 from license revenue. Product revenue in the fourth quarter of 2012 included 2 components. First, we received revenue of $213,000 from approximately 4,260 OVA1 test performed at the fixed $50 per test. In addition, revenue of $816,000 was recognized through the 33% royalty from the Quest Diagnostics true-up report. This represented approximately 13,700 OVA1 tests reported by Quest Diagnostics, which were resolved in 2012 at an average of $60 per test.

The resolved volume includes both reimbursed and unreimbursed tests for which Quest Diagnostics considers the payment status final as of December 31, 2012. Tests that do not yet have a final resolution for 2012 will be included in a future true-up report.

Total revenue for the full year 2012 increased 9% to $2.1 million compared to $1.9 million in 2011. Total revenue in 2012 included $1.6 million from product sales of OVA1 and $454,000 of license revenue.

Product sales of OVA1 in 2012 included $824,000 from approximately 16,460 tests performed at the fixed $50 per test, and $816,000 for the 33% royalty reported by Quest Diagnostics for 2012. By comparison, revenue in 2011 included $1.5 million from products sales of OVA1 and $454,000 of license revenue.

Product sales of OVA1 in 2011 was comprised of 3 components. The first component was $761,000 from approximately 15,225 tests performed at the fixed $50 per test. The next component was $549,000 for the 33% royalty reported by Quest Diagnostics for 2011. This represented approximately 11,700 tests resolved at an average of $47 per test. The last component was a $159,000 for the 33% royalty reported by Quest Diagnostics for 2010. The 2010 royalty was reported to the company and recorded in the first quarter of 2011.

Operating expenses for the 3 months ended December 31 and the full year 2012 were $2.4 million and $11.4 million, respectively. Operating expenses included $0.5 million and $1.3 million in noncash stock-based compensation expense in the 3 and 12 months ended December 31, 2012, respectively. This compares with operating expenses of $3.9 million and $19.4 million for the same 3-month period and full fiscal year 2011. Operating expenses included $0.3 million and $3.3 million in noncash stock-based compensation expense in the 3 and 12 months ended December 31, 2011, respectively. The annual decrease was due primarily to lower clinical trial costs for the ongoing development of the company's ovarian cancer franchise and PAD program, as well as lower overall headcount and stock-based compensation charges compared to the prior year. Research and development expenses for the prior year also included $435,000 for the Correlogic asset acquisition.

Net loss for the fourth quarter was $1.4 million as compared to $3.1 million in the same year-ago quarter. Net loss for 2012 was $7.1 million as compared to $17.8 million in the prior year. The 2012 net loss included onetime gains of $1.8 million for the release of an escrow account related to the 2006 sale of our instrument business and a $0.7 million gain on our favorable Oppenheimer litigation settlement.

Our current shares outstanding are 15.2 million. Weighted average shares outstanding were 15.1 million for the fourth quarter of 2012 and 15 million for the 12 months ended December 31, 2012, for a net loss of $0.09 a share and $0.48 per share, respectively.

Cash and cash equivalents at December 31, 2012, were $8 million. The company utilized $2.4 million in cash in the fourth quarter in addition to the $5.9 million debt payment to Quest Diagnostics.

The company expects cash utilization of $2 million to $2.5 million in the first quarter of '13, and cash-based operating expenses of approximately $9.5 million to $10 million for the full year 2013, slightly less than the $10.1 million for 2012.

Now I'll turn it back to Bruce for a discussion on various corporate initiatives.

Bruce Allan Huebner

Thank you, Eric. Today, we have a lot to cover. The management team and I have been very busy for the last 3 months. The first thing I'd like to introduce is our new vision for Vermillion, which takes advantage of our unique position in the ovarian cancer market. This new vision simply stated is: To become a recognized leader in the advancement of women's health by providing innovative methods to detect, monitor and manage the treatment of gynecologic cancers and other related diseases.

OVA1 is clearly the foundation of our corporate vision. Based upon my recent discussion with various gynecologic oncologists, OB/GYNs, as well as feedback from our key opinion leaders, the acceptance of OVA1 is rapidly increasing. Since launch, nearly 38,000 tests have been ordered by 5,341 physicians, with over 1,600 new physicians ordering for the first time in 2012. These current customers represent a major opportunity to increase OVA1 reorder rates, which is a key focus for our growth strategy in 2013.

There are 3 elements to our 2013 marketing strategy: one, build upon the OVA500 study published in the February edition of Gynecologic Oncology; two, launch of the time campaign; and three, publication of follow-on manuscripts. The OVA500 study led by principal investigator Dr. Robert Bristow of UC Irvine confirmed an overall sensitivity of 96%, a negative predictive value of 98%, as well as the detection of a broad range of ovarian cancer subtypes among nearly 500 patients undergoing ovarian mass surgery. Of significance, OVA1 identified 83% of cancers missed by clinical assessment and 71% of cancers missed by CA125. This data strongly confirms the benefit of OVA1 brings to the detection of ovarian cancer.

In addition, we are targeting physicians with our time campaign, launched in late January, which builds on the fact that every 23 minutes, a woman is diagnosed with ovarian cancer. This is a multifaceted campaign targeting gynecologic surgeons who are the most likely to benefit from our 95% to 98% negative predictive value. We have selected a very specific target group based on geography, payer coverage and sales presence, and can rapidly expand this program based on Phase I success.

To further support our strong technical position, we plan to submit at least 3 abstracts to various scientific meetings and peer-reviewed journals over the next 2 quarters. Our collaborators are currently preparing the manuscripts for publication, which will further demonstrate the clinical utility of OVA1. We are very excited about these results' especially impressive performance we have observed in presurgical triage of early-stage ovarian cancer and premenopausal women. In our opinion, the new publications will offer solid evidence that tests like OVA1 should be considered as a standard of care in an update to the professional guidelines of groups such as SGO and ACOG. This will help press the case for medical necessity and broader coverage for OVA1.

Now let's turn to our efforts with the insurance payers in 2013. We are currently engaged in discussions with the top 5 national payers such as Humana, Aetna, WellPoint, Anthem, as well as various regional payers. We expect to add at least 2 national payers and several regional payers by the end of the year. The value proposition to these payers is the better utilization of health care resources by getting the cancer patient to the right physician earlier where they can receive optimal care and improved outcomes.

Our long anticipated CPT code became effective in January, with the test priced in the first year by CMS, using their gap-fill process. CMS uses this process when no comparable test results exists -- or test exists, excuse me. Medicare currently reimburses OVA1 at $516 per test and our test list price is $650 per test. We now have the ability to drive reimbursement at these price levels during the gap-fill process. Having a CPT code unique to OVA1 streamlines the processing of claims and strengthens our reimbursement position. This will help add other payers at a price comparable to these existing price points.

We have analyzed recent data and now better understand physician habits and changes at the physician level. As a result, we have developed and implemented a new sales compensation plan. This plan was designed to reorient our sales efforts, specifically over -- excuse me, specifically, our goal to gain new accounts, improve reorder rates and cement the sales with extensive customer follow-ups.

Another area of our 2013 sales efforts will be targeting hospital accounts where we received a growing amount of interest. Growth in this market segment is dependent upon the local site having FDA approved instrumentation to perform OVA1. We are assessing the potential of this market opportunity and plan to initiate a focused effort to those facilities that meet the necessary criteria.

Finally, we are also evaluating international partners for OVA1 in the global market. We plan to meet with potential partners during the AACC, American Association for Clinical Chemistry meeting in July, with the goal to discuss partnering opportunities.

Now I'd like to discuss our action plan with Quest Diagnostics. We plan to discuss a sales action plan for Quest Diagnostics women's health specialists supporting the follow-up process for all existing physicians. Our data confirms that growing OVA1 usage among the existing physician base will significantly increase the revenues of both organizations. The programs and steps Vermillion is pursuing with payers, professional societies and with additional clinical publications will increase the likelihood of our mutual success.

Another key topic for discussion with Quest Diagnostics is the implementation of a plan to improve reimbursement. With the new CPT code in place and a proactive response to denials, I believe we should be able to show a marked improvement in reimbursement levels and frequency for OVA1 on a routine basis.

We also plan to continue the Vermillion Claims Assistance Program that was initiated last quarter. This program proactively assists the physicians in appealing patient bills and helps to maintain their ordering patterns.

So that wraps up our discussion of current OVA1 commercialization plans, our reimbursement efforts and the Quest partnership actions.

This brings me to a brief discussion of how we plan to address the product portfolio of the corporate vision. As we said, Vermillion will focus on the gynecologic oncology space moving forward. In this effort, we are aided by the many medical experts whose support we have gained with OVA1. As a result, we see many additional diagnostic testing opportunities which can be divided into 3 topics. Let me give you a brief overview. First, I will outline steps we're taking to explore expanded claims for OVA1. Secondly, I will give you a glimpse into the progress we made on a next generation OVA1 with substantially higher specificity, previously referred to in previous calls as OVA2. And third, I will talk about opportunities for line extension within our ovarian franchise and in other gynecologic cancers and diseases.

So let's start with the expansion of OVA1 claims. We have at least 3 new publications in the works to follow up on the OVA500 study just published. Based on the strong performance in both pivotal studies, a logical step is to submit new labeling claims to the FDA. We feel that our current data strongly supports detection of early-stage ovarian cancer prior to surgery for an adnexal mass. This has obvious implications for improving patient outcomes.

We expect this effort to become clearer in the next quarter as we move through the peer-review process and consider various business and regulatory factors.

Second, let's turn to prospects for a next-generation OVA1 version with higher specificity. This gen 2 OVA1 upgrade will allow doctors who retain a substantial higher fraction of benign cases without sacrificing the features and benefits of OVA1. Recently, we completed our Phase I discovery effort to substantially improve specificity. Together with our collaborators at Johns Hopkins Center for Biomarker Research (sic) [Center for Biomarker Discover], we are pleased to report that several design options were identified which achieve this goal.

Appropriate patent filings are in place to protect our breakthrough achievements. We expect some of this work to be presented at a cancer biomarker conference later this year, and of course, the manuscripts will also be submitted for publication in appropriate scientific journal.

Looking ahead, we are evaluating all options to further accelerate this work. These options include further design optimization, fast-track clinical validation and new partnering opportunities which are made possible by this important work.

The third and final topic is line extension, ovarian cancer and other gynecologic cancers. Within the ovarian cancer franchise, we see many market opportunities, examples that includes the monitoring of high risk patients using the next gen OVA1 as an aid in diagnosis and a selection in postsurgical monitoring of therapy. Additionally, some of these opportunities require repeated testing of the same patient. So through a line extension of OVA1 or the development or in line with other test, we can address a broader range of needs and drive significant growth.

In addition, many of our clinical collaborations and biomarker assets could readily be deployed against other gynecologic cancers such as cervical, vaginal and endometrial. It's interesting to note that both OVA1 clinical studies showed that OVA1 detected 90% or more of all metastatic adnexal cancers that did not originate in the ovary. So we may already have a great head start and be able to reuse existing OVA1 markers in the development of other gynecologic cancer test.

So once again, this demonstrates the unique position that Vermillion enjoys today. We have IP, field-leading clinical collaborators, an established playbook for commercialization of cancer diagnostics. We also have an ever-expanding list of physicians who would be receptive to these new offerings.

As part of our new product strategy, we are pleased to announce that we have extended our research agreement with Johns Hopkins University for another 3 years. Together with our pioneering collaborators, Dr. Daniel Chan and Dr. Zhang Zhang, few industry academic biomarker partnerships have proved as effective and productive as ours. It's a winning formula and one that we plan to continue and expand in the coming years.

Now I'd like to take this opportunity to discuss our peripheral artery disease program. In light of our strategic -- new strategic vision, we have decided to pursue further development of our PAD program by engaging a commercial partner. The ideal partner will have an established position in, in vitro diagnostic cardiology testing market. The positive results from our recent intended-use study and the continued backing from our key opinion leaders will support our discussions. We can plan to continue a dialogue with potential partners with the objective to find an agreement -- to finalize an agreement by year-end.

And that brings me to one personnel announcement that will facilitate our business development and partnering strategy. Dr. Donald Munroe will assume an expanded role as Senior Vice President of Business Development and Chief Scientific Officer, effective March 1. With Dr. Monroe's extensive background in IVD products, technology development and portfolio management, we feel there's a point where we'll bring new creative options and dealmaking to accelerate our growth and strengthen our footprint in women's health care.

One more topic, the next topic I would like to comment about is our ongoing CEO search. We have identified several highly qualified candidates, and are now entering into the next phase of the search process.

Finally, I would like to comment on our Q1 outlook for 2013. We expect to grow our OVA1 testing volume in the range from 4,250 to 4,550 tests performed.

In closing, with our new direction and vision, we plan to make significant progress in the ovarian cancer market in 2013 and address opportunities within gynecologic cancer and women's health. We will explore every opportunity that adds value and positive performance to the bottom line. Vermillion's management team, the board and our employees are all excited about the opportunities that lie ahead. We will stay focused and execute our plan, and I'm confident in future earnings calls, we will bring additional positive developments about your company.

Operator, this concludes our remarks and we are ready for questions.

Question-and-Answer Session

Operator

[Operator Instructions] And we do have a question from the line of Kevin DeGeeter from Ladenburg.

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

A couple of questions here. A lot of interesting stuff on this call. I want to better appreciate the elements that give you a high level of confidence with regard to adding a couple of national payers and some regional payers. And should we look for specific additional publications as being key to pushing that discussions forward? Or can you just kind of frame for us what gives you that confidence? Because I...

Bruce Allan Huebner

Kevin, thanks for the question. In a typical process to gain payers, a lot of it's based on net technical support information. The OVA500 paper has been very well received by the KOLs, by the gyn-oncs that are leading the area, leading in this particular area, and they are quickly getting on -- pardon the expression, the bandwagon, to help support us as we did go talk to the payers. And as you're aware, there is typically a medical group with these large payers that do address and assess these particular areas, and with those type of support vehicles, we do feel confident that we're going to make strides with the national payers in 2013.

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

Terrific. And can you talk just -- and maybe in a little bit more granularity in terms of the type of data we should be looking for in the -- your upcoming presentations and eventual publications?

Bruce Allan Huebner

Kevin, I'm going to turn that over to Donald Munroe or Dr. Monroe regarding that. He's got a good handle on that.

Donald G. Munroe

So I think the first thing to keep in mind is that, now we have these 2 studies, each of which had 27 sites across the country. But actually, there was only an overlap of 10 sites between the 2 studies. So that's a total of 44 centers with about 1,110 surgery patients that were included, and well over 200 or 250 malignancies. So that's really a very good evidence base. And again then, knowing that, we were able to repeat the sensitivity, for example, exactly identical at 96%. So this is where you get into evidence levels, independent evidence from more than one study that says the same thing.

Now to quickly answer your question, I don't want to give away the punchline of the papers for fear of jeopardizing publication, but obvious areas of interest. First of all, detection of early-stage cancer is a biggest opportunity to do good. When you get that early-stage cancer patient into the hands of the right surgeon, chances of a complete cure are as high as 95%. Whereas if they're operated by the wrong surgeon, they could be upstaged merely by rupturing the cyst. So that's an example. Another would be how could this be combined in a standardized referral, since that doesn't happen today, there is no real standardized referral. And another is really what does the gynecologic oncologist make of the score. And so we think there's kind of new science there that we could kind of cut our teeth on which would help to better describe what that means. Now I'll pause there. Does that make sense?

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

It does. That's very helpful. And maybe just one or 2 housekeeping questions on the financial side, then I'll get back in the queue. Should we think of the fourth quarter, your operating expense lines, G&A and R&D as being representative of the run rate going forward? Or directionally, should we think of those having some movement. I guess, because they can really only go up at this point. And just -- and lastly, how should we think about the timeline or the potential for the transition over to accrual accounting on the revenue side?

Eric J. Schoen

Sure thing. This is Eric Schoen. I think the expense line for Q4 is probably a little higher than our run rate that we're expecting for 2013. I think you will probably see a little bit more expense in our R&D function and probably a little bit less in our G&A function, but it is fairly indicative.

Bruce Allan Huebner

And then, Kevin, one other thing, we have tightened down on our marketing expense from the advertising standpoint. So where we're spending money this year is direct face-to-face customer inputs and contact. So that has been reduced from last year as well.

Eric J. Schoen

The second part of your question?

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

With regard to discussions with your auditors about the potential for transitioning from cash revenue recognition to an accrual structure?

Eric J. Schoen

Sure. It certainly is an eventual goal of ours, but at this point in our product lifecycle, it's not going to be able to happen any time soon. It's just -- as we change, we expect our reimbursement rates to improve, and because of that improvement, impossible to predict accrual revenue at this point.

Operator

[Operator Instructions] The next question comes from the line of Debjit Chattopadhyay from the Emerging Growth Equities.

Debjit Chattopadhyay

Just wondering, in terms of the OVA2, so the big differentiator between OVA1 and OVA2, is it just going to be limited to specificity or are you thinking of something much broader with OVA2? I mean with the [indiscernible] 50% specificity with OVA1?

Donald G. Munroe

Yes, good question. So I tend to think in terms of technology platforms and then applications. And so improving a technology platform very often brings different applications into view, which were not feasible when you have a lower level of performance. So I think, one thing that will be common to many of the new applications of OVA1, for example, repeated testing potentially of women prior to surgery, that they were being monitored by a doctor would be having a higher level of specificity, so that you don't have as much potential for a referral. So that's just an example. But in talking to the doctors, they actually identified many different niche opportunities and some of them bigger ones which can include repeat testing. And that's what I would call applications. For example, maybe there's one way that we look at a woman with genetic susceptibility due to BRCA genes, may be another way when you're trying to preserve fertility and your watching a cyst that continues to change over time. Does that give you an idea?

Debjit Chattopadhyay

Yes, it does. Now in terms of publications that you spoke about, have these already been submitted or are they still in process of being submitted?

Donald G. Munroe

Well, kind of yes and yes. Because there's more than 1 -- at least 1 of then has been submitted. Some are in abstract form so they're really are the result of kind of going over our data, of both what we have from the 2 clinical studies and what we've been doing with Johns Hopkins. And so it's really quite a lot of work just pooling them together but they're in various stages.

Debjit Chattopadhyay

Now in terms of the timeline of talking to the FDA, I'm just trying to correlate your publication plan. Talking to the FDA and insurance coverage in the second half of the year, I mean, is that the way we should look at it? You need the publications before you can talk to the insurance companies?

Bruce Allan Huebner

No, Debjit, I think we've got a growing list of KOLs that are really in our camp, along with the OVA500 paper, puts us in a much stronger position to talk to all our payers. So the additional papers, the additional technical data is giving us fuel to be able to discuss with the FDA the ability to get expanded claims. So they're kind of 2 different things, although always additional technical information supports our reimbursement position as well.

Debjit Chattopadhyay

So in terms of the label expansion for the OVA1 then, we're talking to the FDA, when do you expect that to happen? And what kind of supporting information do you need to get in front of the agency?

Donald G. Munroe

Well, I think it really starts with a peer-reviewed publication. So there's no point in going to them to talk about the significance of the findings until we have those, not only analyzed, but accepted by, through the peer-reviewed process, which is today's best quality control for clinical science. And I don't really have a timeline for it. I think that we've got to look at a number of factors including business factors and partnering factors, not just the technical achievement.

Bruce Allan Huebner

And, Debjit, this is a priority for us so we're going to push it along as hard as we can so we can get that package pulled together. Because the sooner we can talk to the FDA and start showing the kind of results that we're seeing, the better off we're going to be. And I think that the better off the end-point patient's going to be because it's going to result in much better care.

Debjit Chattopadhyay

And one question, one last question, in terms of -- it's almost halfway through the first quarter. Do you see any direct follow through benefits of having CPT code and it's gap-fill in terms of ordering and reordering rates?

Bruce Allan Huebner

Debjit, that a good question. We're assessing it. It's early yet in the quarter. We haven't seen any significant impact on it yet, but we are going to be in monitoring that as very closely so that as we go forward, we can either tweak and adjust our sales and make sure we're driving in the right direction so we can see benefit from that.

Operator

[Operator Instructions] So this concludes our question-and-answer session. I would now like to turn the call over to Mr. Huebner. Mr. Huebner, please proceed.

Bruce Allan Huebner

Thank you, Edison. In closing and in behalf of our management team, we appreciate your interest in Vermillion. We look forward to continue to provide pioneering ovarian cancer diagnostics and building value for you as our shareholders. Thank you.

Operator

Before we conclude today's call, I would now take a moment to read the company's Safe Harbor statement. Some of the commentary and answers to today's questions may contain forward-looking statements. You're 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 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 parters and other factors described in the Vermillion 2001 Form 10-K, quarterly reports on form 10-Q and current reports on Form 8-K.

Now again, I would like to remind everyone that this call will be available for replay through March 6 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 your line.

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