Vermillion, Inc. (NASDAQ:VRML)
Q3 2012 Earnings Call
November 12, 2012, 04:30 pm ET
Gail Page - President & CEO
Eric Schoen - Chief Accounting Officer
Donald Munroe - VP, Research & Development, Chief Scientific Officer
Scott Gleason - Stephens
Debjit Chattopadhyay - Emerging Growth Equities
Kevin Degeeter - Ladenburg
Good afternoon everyone and thank you for participating in today's conference call to discuss Vermillion’s Third Quarter ended September 30, 2012. Joining us today are, Gail Page, the President and Chief Executive Officer of Vermillion and Eric Schoen the company's Chief Accounting Officer. Following their remarks, we will open up the call for your questions. And before we conclude today's call, I'll provide the company's second half statement with 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 November 26, 2012 starting later this evening via the link provided in today's press release as well as on the company's website.
Now I would like to turn the call over to the President and CEO of Vermillion, Ms. Gail Page.
Thank you. Good afternoon everyone and thank you for joining us. Today, we will discuss the progress we've made with our ovarian cancer franchise and Vascular Medicine programs including the strategic foundation we have put in place to advance these programs. There was a lot of exciting news we announced during as well as after the quarter that we would like to delve into, but first I would like to turn the call over to our Chief Accounting Officer, Eric Schoen to take us through the quarter’s financial results. Following his remarks, I’ll discuss the operational highlights for the quarter, provide an update on some exciting recent developments and then present our outlook for the remainder of the year. We will then open up the call for your questions.
Now to Eric.
Thank you, Gail. Today we released our third quarter financial results and the press release and we will file our Form 10Q when the SEC reopens tomorrow. Both of these will be available for download via the investor section of our website at www.vermillion.com.
In Q3, the volume of OVA1 was in line with our forecast at approximately 4,100 tests. Total revenue for the three months ended September 30, 2012 was $319,000; $205,000 from product sales of OVA1 and $114,000 from license revenue. Total revenue for the nine months ended September 30, 2012 was $952,000; $611,000 from product sales of OVA1 and $341,000 from license revenue.
OVA1 revenue in the nine months ended September 30, 2012 included only the $50 fixed portion of revenue from each OVA1 test performed. The variable portion of OVA1 revenue is expected to be recognized in the fourth quarter of the year consistent with 2011.
Operating expenses for the three and nine months ended September 30, 2012, were approximately $2.6 million and $9 million respectively. Operating expenses included approximately $0.2 million of non-cash stock based compensation expense in the third quarter and $0.8 million in the nine months of 2012. This compares with operating expenses of $4.8 million and $15.5 million for the same three and nine month’s period in 2011. Operating expenses in the prior year included $0.4 million and $3 million of non-cash stock based compensation expense in the same three and nine month periods.
Along with non cash stock based compensation changes, the year-over-year decreases were due primarily to lower clinical trial costs, decreased legal fees and continuing cost containment with improved operational efficiency.
Total net loss for the third quarter was approximately $2 million or $0.13 per share on weighted average shares outstanding of 15.1 million. Total net loss for the nine months ended September 30, 2012, was approximately $5.8 million or $0.39 per share based on weighted average shares outstanding of 15 million.
Net loss for the three and nine months ended September 30, 2012, included a non-operating $50,000 and $1.8 million gain on sale of instrument business respectively from the release of the escrow account established in the sale of our tools business back in 2006. We recognized the final $50,000 gain upon the release of remaining Bio-Rad escrow funds to our balance sheet in September 2012.
Net loss for the three and nine months ended September 30, 2012, also included a non-operating $0.3 million and $0.7 million gain on litigation settlement respectively related to a favorable litigation settlement with Oppenheimer earlier in the year. We recognized the final $0.3 million gain upon receipt of the final schedule payment in August 2012.
Cash and cash equivalents at September 30, 2012, were $16.3 million. We utilized $2.3 million in cash during the third quarter offset by the $0.3 million payment received on litigation settlement. We expect $2 million to $2.5 million of cash utilization during the fourth quarter of 2012 excluding approximately $5.9 million paid to Quest Diagnostics under the Secured Line of Credit Agreement in October 2012.
Now with that, I'll turn the call back over to Gail.
Thanks, Eric. Beyond the numbers, it was a very exciting quarter for Vermillion for both our ovarian cancer franchise and Vascular Medicine program. First, as many of you know, we reported favorable results from the OVA500 study, our second perspective clinical trial of OVA1. We are pleased to report that the principal investigator Dr. Robert Bristow of UC Irvine has now submitted a manuscript of the OVA500 study for publication. The study showed an overall sensitivity of 96%, a negative predicted value of 98% and detection of a broad range of ovarian cancer subtype. These findings are important since doctors, payers and professional societies make their decisions, in part, on the publication of multiple independent clinical studies.
As Dr. Bristow stated, we are especially excited that the sensitive detection of ovarian cancer was paired with the classification of most benign masses as low-risk, and greater than 95% confidence that a negative test will result in a benign pathology finding. The study also found a 91% detection of early stage malignancies; combining the results of both pivotal studies, OVA1 correctly identified 78 out of 84 early stage ovarian malignancies on more than 1,000 total patients evaluated.
This represents the combined risk ratification or standalone sensitivity of about 93%. This high percentage reaffirms the unrivaled sensitivity of OVA1 for early stage ovarian malignancies which is the least diagnosed and the most curable form of ovarian cancer and is underscores how OVA1 may aid primary physicians and the pre-search for detection, referral and optimal management of this often deadly disease.
I would also like to update you on publication and data from our Peripheral Artery Disease multi-marker clinical feasibility study. This study, and this study led by Dr. Will Hiatt, from the University of Colorado concentrated on validating three Vermillion biomarkers and their utility in an algorithm to access the risk of Peripheral Artery Disease. We are pleased to report that the manuscript was published online this month in the peer-review journal, Vascular Medicine; it will also be appearing in hard copy in the near future. This is a premier international journal featuring peer-reviewed research articles and reviews on vascular disease, diagnosis and treatments.
As we previously announced, the 1000 plus patient study identified 85% of PAD patients missed by the Framingham Risk Score’s high-risk cutoff. These results paved the way for the development phase of this program. The potential value of the test is bringing the detection of PAD to the primary care physician and an easy-to-use reliable in a foldable format for at-risk patient assessment. Unlike the ankle-brachial index text, our simple blood test would require no specialized training, equipment or allocation of precious examiner form and staffing.
In order to advance our PAD program, we are currently evaluating commercial partners, who could bring the necessary primary care physician reach along with the Vascular Medicine credentials to accelerate FDA clearance and drive market penetration.
In October, we achieved an important milestone with the repayment of outstanding development amount to Quest Diagnostics at maturity. This repayment helped delever our balance sheet and brings to a successful conclusion the development phase of our alliance with Quest diagnostics. Contrary to what has been portrayed in some non-Vermillion material, our repayment of the Quest loan is not a result of a lack of interest by Quest in OVA1, but rather an ordinary course payment of liabilities as they come due. With the repayment of the Quest loan, those parties announced assets on the broader commercialization of OVA1. So it’s been an exciting three months and the outlook remains positive. But before we go further, I would like to step back a bit and share a few thoughts and perspectives of who we are and how far we've come.
As we've announced, our board has continued its effort to recruit a CEO and remain committed to that path. So I'll soon be turning the reins over to a new CEO who will be taking Vermillion to its next level of accomplishments. As a pioneer in the diagnostics industry and it’s just more than two years for making this transition from product discovery to commercialization.
Few companies in our states have made such rapid progress over such a short span of time. Through it all, we have demonstrated tremendous perseverance and this perseverance has generated a groundbreaking record of accomplishments particularly in the development and the commercialization of multi-marker diagnostics. This includes the first ever FDA clearance of a proteomic-based IVDMIA.
We then achieved Medicare coverage within weeks after the launch of OVA1 and we have extended this coverage to nearly 100 million lives across the US. And now we are among the first class of MAAA algorithmic assets to achieve a Category 1 CPT code by the American Medical Association. This means we can realize the value we established as a result of the gap-fill decision granted by CMS earlier this month.
While Vermillion has clearly set the standard in developing and commercializing proteomic-based algorithmic IVD tests. We also possess an impressive portfolio of uncommercialized biomarker (inaudible). This includes the ovarian, endometrial and breast cancer biomarkers as well as cardiovascular and Alzheimer’s disease. Our acquisition of assets and Correlogic further strengthened our leading position in diagnostics for ovarian cancer.
The repayment of the Quest Diagnostics development loan allows us the broadest range of strategic options to monetize these assets and expand our product portfolio. With these building blocks in place, our focus is on establishing the clinical relationships that would drive publications and leverage these assets into a broader product portfolio.
Fortunately, the early success in clinical revenues of OVA1 have led to an extensive roster of supporting key opinion leaders. These relationships have enabled a new series of clinical collaborations with some of the nation’s most respected teaching hospitals and medical centers. These studies are focused on pre and post surgical monitoring of high risk patients as well as developing tools to aid and the difference of biomedicines and management of gynecologic cancers.
We referred to this on our last call as an ovarian cancer franchise. Unfortunately, some took those words to mean a setback from our commitment to the Next Gen OVA2 program. Nothing could be further from the truth. In fact, this has continued our biomarker distributor collaboration with Dr. Dan Chan and coworkers at Johns Hopkins.
We expect these collaborations to result in even more opportunities for deployment of current and new biomarker combinations. Our successes along with these unique opportunities make Vermillion an attractive partner for IVD platform players or when Vermillion’s diagnostic franchises considering biomarker based products. For example, MAAA test can bring the opportunity for a high ROI to an otherwise parity driven gynecologic IVD testing or they can help women’ health companies or providers differentiate themselves in a crowded or commoditized marketplace.
Such partnership can offer the potential and return to accelerate Vermillion’s R&D program, expand our sales efforts, gain entry into the hospital testing market and expand our presence beyond the US. For example, the interest in OVA1 has grown to a point that major hospitals and cancer centers are considering adding OVA1 to their standard of care. As a result, it remains, form the potential of implementing over OVA1 testing in selected hospital labs. This part of program is of strategic importance as it could expand our [basic] account from a broader access to OVA1 and more of a positive impact on our profitability.
This product program is in its early stages and we will keep you up-to-date on our progress. But for now, I would like to turn back to provide some operational improvements we have made with OVA1.
As many of you know, the three common challenges inherent in the commercialization of any new diagnostic test or reimbursement, physician adoption and market education. So let’s discuss the steps our management team is taking to address these challenges.
In terms of reimbursement, on November 6, the clinical (inaudible) committee announced that CPT code test with an MAAA such as our test will be (inaudible), representing a two-year process of establishing long-term pricing.
In anticipation of this process, during the early stage of the OVA1, we secured approval for reimbursement from Medicare at $516.25 per test, which is a common benchmark for reimbursement of a new diagnostic. We also established another benchmark with our Department of Defense at the stated list at $650 per test.
Therefore, we're very pleased to establish this range of pricing ahead of receiving our Category 1 CPT code. We now have the ability to drive the reimbursement at these price levels during the gap-fill process and having a CPT code (inaudible) to OVA1 will streamline claims processing and strengthen our reimbursement position.
These developments provide us new information to engage [payers] in continued dialog. These discussions will revolve around an executive summary of the OVA500 study, the new Category 1 CPT code and have the pricing for over one should move forward in 2013.
We anticipate this for enhance payer recognition, contribute to more successful clients being processed as well as begin to resolve the lumpiness associated with claims build under our miscellaneous code. On previous calls, we had discussed our physician reorder rates to address if we had created a new program based on two key initiatives.
First, the Quest Diagnostics have initiated a joint program focusing on six key state, one important element of the program is to identify physicians who are not reordering at a consistent rate and address their concerns and to reestablish OVA1 at top of mind as it means improved the use of everyone in their practice. We foresee the publication of the other 500 study to be a key catalyst in this program.
Second, we’ve rolled out a claims assistance program designed to renew physicians’ interest and reordering of OVA1 cases where patient bills will initiate. This program proactively assists a physician in [pill] and patient bills and thereby restores their confidence in ordering OVA1. We expect these two new initiatives to drive more consistent order impact and resulting in the OVA1 annuity which is the long-term goal.
Finally, with [physicians] in creating a top position continues to be a challenge with more practices adopting a no fee policy and fewer physicians travelling to industry meeting. So to assist we have our client surrounded by campaign along with our recently launched educational webinar series that is available on-demand on the OVA1 website along with OVA1 case study.
This provides the physicians the freedom to learn that their convenience. Quest Diagnostic is also launching a similar OVA1 webinar program later this month. These webinars are a cost effective evolution to our marketing program that will reach more physician especially those in the academic and those key facilities as well as those located in rural areas.
These programs that support [coding] clients processing and physician adoptions further strengthen our OVA1 commercialization efforts. However, we don’t expect to begin realizing the full impact of these programs until after the CPT code goes into effect early next year. So for the fourth quarter, we expect stable to slightly growing use of OVA1 ranging from 4,100 to 4,400 tests to be performed. This also takes into account a fewer number of business days in the quarter due to holiday and the recent weather events affecting the North Eastern state.
In closing, I would like to note that in addition to grow organically these efforts or strategies, programs and initiatives, we have kept an eye to possible M&A transactions. We always consider opportunities that have merit and compliment our business, keeping in mind our ultimate goal of creating shareholder value.
We strongly believe that we are leader in the multi-market diagnostic space, we are confident that given time and the support of our shareholders, our potential will be realized in market leadership growth and ultimately profitability.
Now with that, I would like to open up the call to questions.
(Operator Instructions) And our first question comes from the line of Scott Gleason with Stephens.
Scott Gleason - Stephens
Gail congratulations first on kind of titrating down the operating expenses here and mitigating the cash burn. I guess when we look at where that translates to, can you talk through a little bit where your current sales force stands and whether you guys have seen a turnover, whether its company directed or individual directed.
Well, right now we have [employed] between about eight and 10 people in the field. You always have the, what I would call, just in the normal course of business. We had one cell for it that was I think broken leg and on occasion you'll get one that has a family issue. So we sort of try to keep around eight to 10 out in the field at any given time. Our focus right now is not to continue to build that force but to rather make it become more efficient. We are firmly of the opinion right now that our focus should be on continuing to really secure this reimbursement, secure the things that are the foundation that which you would build a sales force upon. So we feel that we have the proper amount out there to really continue to do the market development at this point in time, and we look to expand that till after we really get things moving here into early 2013.
Scott Gleason - Stephens, Inc.
Gail that sounds like you guys are increasingly optimistic on potentially having some success on the private pair side following the establishment of the category 1 CBT code. Can you just give us some maybe a little bit of indication on how those discussions are progressing now that you guys have the category 1 CBT code in place, and also maybe just talk a little bit about how you expect the gap-fill process to play out?
Sure, but first let's talk about our strategy. Well, as you know from day one, we've been very aggressive in looking at this reimbursement because we all know that you can have the best tests in the world but unless you get it reimbursed, it really doesn't mean anything. So I think if you look back over to the course of the past two years and you sort of compare that to other tests, it’s done quite well in getting coverage decisions.
So originally our thought was you go after the low hanging fruit, then you go after the middle majority, because you cannot really approach the payers that you have enough demand out there and you start to really have clinical evidence. But as we've indicated, we have been knocking on the doors of the larger payers, and I would say that those conversations have gone very well. They are being very attentive and with the publication of over 500 we expect other meetings to occur around that event, having the CPT protest really calls people to pay attention. So I would say that all of that is on track and its moving in a positive direction, and I think you had a second part to the question, sorry.
Scott Gleason - Stephens, Inc.
Yeah, I was just asking about gap-fill, how do you expect that process to play out. I think there's a pretty close [therapy] in terms of what you guys get paid today but if you could talk a little bit about your thoughts that would be great.
Unidentified Company Representative
Yeah, I think we believe that we are in a good position for gap-fill, because we do have the Medicare as a benchmark and we have the DOD and we have players in between. So I think having those as benchmark and having the CPT code gives us the ability to go out now and work and play in that value proposition to really take our health economic data in all the studies we’ve got and the payers that are existing and now really focus on helping people see the value that the test brings. So that's what I would say, we are very focused around those particular benchmarks. Did that answer your question Scott?
We do have another question coming from the line of Debjit Chattopadhyay from Emerging Growth Equities. Your line is now open.
Debjit Chattopadhyay - Emerging Growth Equities
I was just wondering given where OVA1 is in it's product life cycle, do you have any sense of history parallels between OVA1 and any other product that have been launched in the OBGYN community. We can model on 2013 especially when you potentially land big players like Aetna?
Well, off the top of my head, I think about year-to-date that I personally spend at (inaudible) and the iterations of products like (inaudible), fetal fibronectin, a lot of other products in the women’s healthcare space and I think about (inaudible) I know, I don’t know if my date is exactly right but it's been a while and I know that in the late 90s, they actually did a relaunch of that product because it came out and had some problems and they actually had to redo their clinical trials and they had to relaunch and I know that you know, for a couple of years they were relatively flat.
We were one of the first labs to work with them, but after about a couple of years when they also went to a gap-fill process and once they landed, I believe they viewed at their back double checking, but I believe they landed Aetna and then it seemed like once they got their reimbursement situated, they would started to land the big plants. It's just really their ability to dominate the market really took off in that regard.
So we look at products like that and go back. We looked at HPV, we looked at other test to say, what were the key trigger points that really got the market to fully accept it, so that they could become the standard of care because that’s what dropped the hockey stick and we believe that we're on track to do that whereby just clicking off these milestones.
Debjit Chattopadhyay - Emerging Growth Equities
Do you mention standard of care, could you if possible give us a little bit more color on these studies that are being planned out with some of your key thought leaders and how that might impact OVA1 or the subsequent OVA2 to be in becoming the standard of care? And thank you so much.
Sure, so what are the things has been very instrumental for us over the last I would say three to six months is bringing on a person to lead these efforts with the background of Dr. Munroe and he has been very successful in getting out there and having a dialogue with these thought leaders to start to plan out what these clinical collaborations may look like and which one from a marketing perspective at the end of the day as we engage with them do they address the questions that we are being asked out there, and do they further our programs, do they create new products or new uses for our products? So with that may be I will ask Donald just to speak briefly about some of the folks that he is targeting and just on a high level what those studies might look like.
Sure, thanks Gail. I think we mentioned on the previous call that we had a meeting at SGL Focus Group around unmet needs in ovarian cancer diagnostics. I think that one reason why we got very good attendance at that focus group is because of what OVA1 has been able to accomplish both the products with the strong performance at OVA1 has clinically and then just the track record. A lot of people talk about biomarkers, OVA1 can demonstrate that it’s achieved this track record in getting FDA approval, getting Medicare coverage CPT code and so on. So we have probably about four or five new collaborations that are in the works. I really can’t disclose names we will have press releases as we have signed deals with people, but they are name, institutes, and for example of New York, India, North West and other places, and we expect to work on things as we said high risk of monitoring, potential new indications or broader labeling of OVA1, and other types of cancer such as [Anemometro] cancer.
(Operator Instructions) next question comes from line of Kevin Degeeter with Ladenburg. Your line is open.
Kevin Degeeter - Ladenburg
Just one or two things; you mentioned the potential partnering for the PAD program. Can you talk about the opportunities there in the context of the right that Quest had previously or has to commercialize that program; has the structure of agreement with Quest been modified or it need to be modified to fully take advantage of any partnering discussions for the PAD program?
So the first part of your question would be, I think the key for the PAD program. As we indicated, the more we learned about that product, the development and the more that we learn about that market necessitates that really ought to be in the hands of like the primary care physicians. So what we really tries to do with the detail out in our mind, OVA2 might be a good partner for that because obviously our sales force and all the things that we have created have been very focused on the oncology markets.
So we wouldn’t want to set duplicity there but we do want to bring that program far enough along and find the right partnership for us so we can realize the value of it. Certainly as we move forward, any company that might want to work with us, all companies would like to have Quest and other clinical labs offer that product, so depending upon what product is generated out of that work that would be up to that company how they might want to work with Quest going forward. So certainly, Quest is a good partner and they certainly have a big sales force in the hospital market. So those things we just have to be determined in the future.
Kevin Degeeter - Ladenburg
But maybe if I could just personally find or point out it, previously, Quest had exercised the right for commercial rights CPT program in certain distribution channels and certain geographic markets, is that still in effect or does that, that changed in the last quarter or maybe in part related to repayment of the term loan?
Yeah, with the repayment of the loan that took care and we repaid for that development program and then there was a third one that Quest never elected. So that returns that intellectual property back to Vermillion.
Kevin Degeeter - Ladenburg
And Page maybe one other if I may, you mentioned in the prepared comments the pilot program with regard to the OVA1 testing and then the hospital settings, it sounds actually potentially quite exciting. Can you maybe talk a little bit more about the genesis of that program and you assuming the pilot hits the metrics that you are looking for, next step behind that pilot program?
Sure, as you know and I don't know Kevin you've covered some other companies that are somewhat similar, we are always, I think all molecular diagnostic companies are always thankful for the big lapse because they really help you get out there and start to leverage their system towards your product. And when you take a test like OVA1 you have to create demand in the market before hospitals want to bring it close in-house, and mostly what we've seen of late and our focus early on with the resources we had with working with Quest and we continue to work with them and they have been a good partner and we will continue to work with them. But as any test grows, any market grows, generally you will see demand to decentralize in certain areas and in our particular case we've had several organizations contact us that they feel like that they have enough volume. Now they may want to consider bringing it in, and how and may be they have a (inaudible) OBGYN population.
So we are being very careful to make sure that it’s the right location, it’s one that can support the volume, it’s the one that we can support and it’s meaningful to the company, because we have to make sure that every resource we send, is in a place where there is significant return, and shortly that it’s not in consonant with our arrangement with Quest.
Kevin Degeeter - Ladenburg
That’s sure is very helpful. May be just one more housekeeping question from me. You provide a cash burn guidance for the fourth quarter which is very helpful. Can you just walk us through a little bit more granularity what the underlying assumptions are with regard to the operating cost structure? We do have I believe the true-up payment from (inaudible) during the quarter. So it’s a little more challenging to appreciate what’s sort of assume within that cash burn guidance.
Sure. At the beginning of the year we announced that we planned on cash operating expenses of about $12 million and we are on target to meet or beat that target. We really think now we’ve approached, given our current level of operations currently what I would call a steady state. Q3 is very indicative of what you will see going forward.
This concludes our question-and-answer session. I would now like to turn the call back over to Ms. Page. Ms. Page please proceed.
In closing and on behalf of our management team; we appreciate your interest in Vermillion. We look forward to continuing to provide pioneering molecular diagnostics and bearing values for you as our shareholders. Thank you again for joining us today.
Before we conclude today’s call, I would 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. Vermilion 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 the 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, payout reimbursement, relationships with our strategic partners and other factors as described in the Vermilion 2010 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 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.
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