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Vermillion, Inc. (NASDAQ:VRML)

Q1 2014 Earnings Conference Call

May 15, 2014 4:30 pm ET

Executives

James T. LaFrance - Chairman, President and CEO

Eric Schoen - VP, Finance and CAO

Marian E. Sacco - SVP, Sales & Marketing, and Chief Commercial Officer

Donald G. Munroe - SVP, Business Development and Chief Scientific Officer

Carl Severinghaus - Director of Board

Analysts

Debjit Chattopadhyay - ROTH Capital Partners

Bruce Jackson - Lake Street Capital Markets

Operator

Good afternoon, everyone, and thank you for participating in today's conference call to discuss Vermillion's first quarter ended March 31, 2014. Joining us today are, Jim LaFrance, the Chairman, President and Chief Executive Officer of Vermillion, and Eric Schoen, Company's Vice President of Finance and Chief Accounting Officer. Following their remarks, we will open up the call for your questions.

Before we conclude today's call, I'll provide the Company's Safe Harbor statement with important cautions regarding forward-looking statements made during the call. Before we begin, I would like to remind everyone that this call is being recorded and will be available for replay through May 29, 2014 starting later this evening via the link provided in today's press release as well as on the Company's Web-site. (Operator Instructions)

I would now like to turn the call over to Mr. LaFrance. Please go ahead, sir.

James T. LaFrance

Thank you, Claudine. Good afternoon, everyone. Thank you for joining us. It's a pleasure to speak to all of you for the first time in this setting. As some of you are aware, I've been Chairman of the Board of Vermillion since December and assumed the role of President and CEO on April 23, just over three weeks ago. As you can expect, there's been a whirlwind since getting to know the team on a different basis and coming fully up to speed on Vermillion's opportunities and challenges. I've had a chance to meet face-to-face with majority of the Company and all have been very welcoming, but anxious to move on with the business at hand, building a great cancer diagnostic company in women's health.

Today we will talk about our accomplishments in the first quarter and how that sets the stage for the remainder of 2014. I will now turn the call over to our Vice President of Finance and Chief Accounting Officer, Eric Schoen, who will take us through our first quarter of 2014 results. Eric?

Eric Schoen

Thanks Jim. Today we filed our first quarter 2014 financial results in the press release and our Form 10-Q with the Securities and Exchange Commission. These are available for download via the Investors section of our Web-site at www.vermillion.com.

Total revenue for the first quarter of 2014 decreased to $305,000 compared to $328,000 in the first quarter of 2013. Total revenue in the first quarter of 2014 included $191,000 from product sales of OVA1 and $114,000 of license revenue. Product sales of OVA1 in the first quarter of 2014 included revenue from 3,817 tests performed. By comparison, revenue in the first quarter of 2013 was generated from 4,274 OVA1 tests performed. The 11% volume decrease was primarily due to the reorganization of sales staff in advance of the launch of ASPiRA LABS as well as the impact of having several open sales rep physicians in key territories in the first quarter.

OVA1 revenue in the first quarter of 2014 included only the $50 fixed portion of revenue per test from the OVA1 test performed. The OVA1 product revenue in both periods does not include the additional royalty component of revenue based on 33% of Quest Diagnostics gross margin. The Company recognizes this portion of revenue when reported by Quest Diagnostics via an annual true-up after the end of the calendar year.

Operating expenses for the three months ended March 31, 2014 were approximately $4.2 million. This compares with operating expenses of $2.9 million for the same three month period in 2013. The year-over-year increase was due primarily to increased efforts in the first quarter of 2014 associated with our collaboration with the Johns Hopkins University School of Medicine to advance our platform migration and next-generation diagnostic test.

In addition, we increased research and development headcount compared to the same period in 2013. Also, we incurred significant expenses in the establishment of ASPiRA LABS as well as increases in medical meeting and education activity in 2014 compared to the same period in 2013.

Net loss for the first quarter was $4 million, or $0.11 per share, on weighted average shares outstanding of 35.8 million. This compares to a net loss of $2.6 million, or $0.17 per share, in the first quarter 2013 on 52 million shares outstanding.

Cash and cash equivalents at March 31, 2014 were $26 million. The Company utilized $3.5 million in cash in the first quarter and we expect $3.3 million to $3.8 million of cash to be utilized in the second quarter of 2014.

With regards to the 2014 expense outlook, we have significantly increased our sales force and research and development headcount as well as our R&D collaboration activity. In addition, we are spending significant amounts in preparation of the ASPiRA LABS opening and will have moderate ongoing expenses thereafter. Thus, we anticipate our operating expenses to be between $4 million and $5 million per quarter for the remaining quarters of 2014.

With regards to test volumes, we roughly tripled our field sales presence at the beginning of the second quarter. We know from past experience that it takes a new field sales rep approximately one quarter to begin impacting test volumes as they build relationships and advance customers through the sales cycle. Thus, we do not expect to see the benefit of our increased field presence until the third quarter of 2014.

Now I'll turn it back to Jim.

James T. LaFrance

Thank you, Eric. During quarter one, we began the implementation of our strategy to develop CLIA laboratory for Vermillion. We received our CLIA certification in late March and formally announced ASPiRA LABS at the annual ACOG Meeting in April. We expect the lab to be fully operational this summer.

Our decision to develop a CLIA laboratory is driven by our desire to completely control the entire sales cycle and the entire customer experience, allowing us to both drive greater growth and realize the appropriate value of our tests with healthcare providers and payers. Quest Diagnostics will continue to be an important commercial partner of ours alongside our own ASPiRA LABS. We will also seek new commercial lab partners where appropriate to extend our commercial coverage and reach.

ASPiRA LABS is located in the Austin, Texas area. The Medical Director of the lab will be Dr. Herbert Fritsche. Dr. Fritsche has an extensive resume of work in the development and clinical use of cancer tests from his 40 years of experience as Head of the Clinical Chemistry Laboratory at M.D. Anderson Cancer Center.

Now I'd like to move on to our commercial expansion activities. During the first quarter of 2014, we expanded our Vermillion sales team, roughly tripling our dedicated sales force. We've established a focused 20-city plan managed by five district managers reporting to our Head of Sales. The majority of our expanded sales organization have extensive women's health sales experience and existing relationships with our call points in their respective geographies. Their objective is to help educate on the challenges of the ovarian cancer triage process, gain adoption of our proprietary OVA1 test, and build advocates for changing existing paradigms in the management of ovarian cancer patients.

In addition to the dedicated sales team calling on OB-GYN and GYN oncologist, we have a team of reimbursement specialists whose role is to drive coverage and reimbursement level decisions by both national and regional private payers. Today, we have a total of 56 million covered lives. Our goal is to significantly improve our payer coverage in 2014. We expect that our expanded sales force and the opening of ASPiRA LABS will begin to yield an appreciable increase in OVA1 order volume in quarter three.

On May 8, we announced an exciting new sponsored research collaboration with Moffitt Cancer Center in Tampa, Florida. Moffitt is a nationally renowned center of excellence in cancer research and treatment as well as a member of the National Comprehensive Cancer Network. Moffitt is considered by many to be the number one cancer hospital in Florida and is listed in U.S. News & World Report as one of America's best hospitals for cancer since 1999.

The collaboration will be led by Dr. Johnathan Lancaster, President of the Moffitt Medical Group, an expert on personalized medicine in gynecologic oncology. Together, we plan to examine the quality and cost of ovarian cancer care as it relates to patients coming into Moffitt from their community.

The first objective is a retrospective analysis of first surgeries on ovarian cancer and to what extent appropriate referral and treatment is administered. Such studies are critical to establishing the appropriate value of improved ovarian cancer triage in the minds of payers. Moffitt is one of three current health economic studies in progress which will aid Vermillion in establishing the clinical and economic benefits for payers, which will help propel coverage and payment level decisions.

Lastly, I would like to provide an update on our platform migration program. This program is important to put our current and future tests into a more sustainable, scalable and cost-effective solution. We completed our 510(k) pre-submission step with FDA during this quarter. Pre-submission meetings are intended to provide companies with an opportunity to obtain FDA feedback on future applications prior to their formal submission.

Our choice of platform, which will be announced next quarter, transitions OVA1 to a modern, integrated and world-class instrument family. It will support a higher degree of automation for ASPiRA LABS and opens options for international market expansion at a later date. We remain optimistic that development can be completed in calendar 2014, targeting launch of OVA1 on the new platform in early 2015.

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

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from the line of Debjit Chattopadhyay with ROTH Capital Partners. Please proceed.

Debjit Chattopadhyay - ROTH Capital Partners

I'm just looking at the test volume growth here, so the test volumes that you reported for the first quarter of this year at this point lower than it was during the first quarter of 2013. Could you help us understand what the sales force composition was during 2014 first quarter versus 2013 first quarter?

James T. LaFrance

Sure, Debjit. So the first thing to note is, our expansion of the sales force didn't occur until the very start of the second quarter. So there was no impact in the first quarter. The rough number of salespeople in the field in the first quarter of 2013 was somewhere in like eight to nine range. In the first quarter of 2014, we had two open territories as well as three people that were transitioning to manager roles for ASPiRA LABS. So effectively we only had roughly five people focused on field sales during the quarter.

Debjit Chattopadhyay - ROTH Capital Partners

And how does that compare with the fourth quarter of last year? I believe there were like eight sales reps and one territory, which was Florida I believe, that was left open.

James T. LaFrance

Yes, that's roughly correct, Debjit.

Debjit Chattopadhyay - ROTH Capital Partners

So in the territories that the Vermillion reps were the primary lead, how was the performance compared to the fourth quarter of last year in terms of volume growth?

James T. LaFrance

Marian, do you want to address that?

Marian E. Sacco

So when we have a Vermillion rep in a field sales, they are actually growing volume through Quest at about 10% to 13% over areas where we do not have a Vermillion rep. So, I think your question is, if we have eight of them out there, we're seeing them consistently grow those areas. In the first quarter where we had some openings, we did see those areas decrease.

Debjit Chattopadhyay - ROTH Capital Partners

Alright, and the comment regarding significant potential expansion during the third quarter once most of the rep, the 23, 24 reps are up and running, so where do you see volume growth at during the third quarter of this year?

James T. LaFrance

Debjit, we don't project, we don't give those numbers or their projections. Clearly we have internal numbers but it just wouldn't be prudent to lay them out at this point.

Debjit Chattopadhyay - ROTH Capital Partners

Okay. And one last question. There was a study underway the Department of Defense, kind of similar outline like that you are proposing with [Moffitt] (ph), I mean just could you update us on the status of that and when can we expect a publication? Thank you so much for taking my questions.

Donald G. Munroe

Certainly. It's Donald Munroe here. So we had a little bit of a hiatus due to an organisational change within the DoD structure, and so we believe that it will be able to resume in the second half of the year but it basically led to kind of a six months time-out on that program, again external to Vermillion.

Operator

(Operator Instructions) We have a question from the line of Bruce Jackson with Lake Street Capital Markets. Please proceed.

Bruce Jackson - Lake Street Capital Markets

So with the sales force, so the old territory structure was nine territories. Do you have any plans to change the territory structures, how many reps do you think you're ultimately going to have out in the field by the end of the year?

James T. LaFrance

Marian?

Marian E. Sacco

Bruce, let me take that. So the old structure really had many of our reps but very thin, over two or three states, and what they were doing is staying at a very high level and gaining as much exposure as we can for OVA1. In our new organisational structure, we have 20 cities specifically designed in a territory that our reps will go very deep in those cities and get a lot of return to the doctors over and over again as well as build relationships with the hospitals. So I do see a very big difference in the new structure as we're moving forward and developing it commercially right now. Does that answer your question?

Bruce Jackson - Lake Street Capital Markets

It does. So each district manager is going to have roughly four cities?

Marian E. Sacco

Four reps.

Bruce Jackson - Lake Street Capital Markets

Four reps, okay.

Marian E. Sacco

Yes, and then each district manager is responsible for all the revenue for that district. So they will actually also implement out activities with hospital organisations or things like that. They will be the organiser of that district.

Bruce Jackson - Lake Street Capital Markets

Okay. And are you still in the process of hiring your reps?

Marian E. Sacco

Actually we are sold, except for one city at this point.

Bruce Jackson - Lake Street Capital Markets

Okay. And then with the lab, do you have it all built out yet, when do you think you're going to be actually generating reportable results?

Marian E. Sacco

Eric, would you like to answer that or you'd like me to answer that?

Eric Schoen

You could take it, Marian.

Marian E. Sacco

So obviously the structure of the lab has to be a full customer experience from sales straight on to the physician level. So we are really looking at sometime within this summer, end of Q2, to be fully functional with the lab.

Bruce Jackson - Lake Street Capital Markets

Okay. And then, in addition to OVA1, do you envision running, for example doing CA 125 testing for the follow-up treatment tests, that's the first question, and then might you at some point in time expand your menu out even further?

Marian E. Sacco

So at the first launch of our lab, we would like to be talking about both OVA1 and what we call longitudinal CA-125, so that again a patient who starts with an OVA1 at her OB-GYN can continue through our lab experience. And at this point, I can't comment to anything beyond those two tests at this point.

Bruce Jackson - Lake Street Capital Markets

Okay. Then moving over to the platform migration project, is this something where you're going to select one platform to move onto and then it's going to be exclusive or might you open it up to some other platforms over time?

Donald G. Munroe

It's Donald here again. There's certainly nothing limiting us to one platform, but since from an FDA perspective each platform is a new submission, it makes sense to start with one, and that's kind of the path that we're taking. Does that answer your question?

Bruce Jackson - Lake Street Capital Markets

It does, thank you. And then last one is on OVA2, can you just give us a little bit of an update on where that project is right now and are there any milestones we should be looking forward to?

Donald G. Munroe

Sure, and just to be precise, we prefer the next-gen term in terms of mollified panel which can support improved performance, just like you got other immunoassay that are next-generation, and they also provide potentially the basis for additional filings, line extensions or expanded claims. So, we've been continuing on the biomarker research work that we had undertaken with Johns Hopkins. On our previous call, we talked about a poster which published at ASCO last year which demonstrated a proof of concept that we can achieve higher specificity without sacrificing sensitivity. And so now we're working on the design of a potential commercial offering which would not be along the lines of those kinds of research immunoassay kits. Those are not really reliable enough to be used in a clinical setting. So that work is ongoing and that's about all that I could tell you about it at this point.

Bruce Jackson - Lake Street Capital Markets

Okay, great. Actually I was thinking I do have one more question. With CMS and the reimbursement going after the national coverage decision, when might we hear something about that?

Carl Severinghaus

This is Carl. Pursuing the national coverage decision will probably stay with local coverage decisions based on location of our lab which gives us sole source provider status, and all claims process through that lab in that jurisdiction.

Bruce Jackson - Lake Street Capital Markets

Okay, so that would be like going through an OVA test?

Carl Severinghaus

Yes, correct.

Bruce Jackson - Lake Street Capital Markets

Okay, okay. Great, that's it for me. Thank you.

Operator

Ladies and gentlemen, this concludes our question-and-answer session. If there are any further questions, please contact Company's Investor Relations or Ron Both at the Company's Investor Relations firm, Liolios Group, at 949-574-3860 or by e-mail at VRML@liolios.com. I would now like to turn the call back over to Mr. LaFrance. Please go ahead, sir.

James T. LaFrance

Thank you, Claudine. In closing, thank you for your time today. Vermillion is in a better place today than it was one year ago. It will hopefully be far ahead of today one year from now. This is a journey and we are entering a critical juncture with the significant change in our commercial strategy that we hope will yield strong results. We believe this change is necessary to deliver an outstanding experience to our customers and their patients. We also believe this change will result in greater growth, appropriate pricing in the marketplace and long-term shareholder value. We look forward to sharing our progress in the quarters ahead. Thank you.

Operator

Ladies and gentlemen, before we conclude today's call, I'd like to 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 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 environment, the speed of market adoption, changes in government regulations, payer reimbursement, relationships with our strategic partners, and other factors as described in the Vermillion 2013 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 May 29 starting later this evening via the link provided in today's press release, as well as available in the Investors section of the Company's Web-site. Thank you, ladies and gentlemen, for joining us today for our presentation. You may now disconnect.

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