Aspira Women's Health Inc.

Aspira Women's Health Inc.

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Medical - Diagnostics & Research

Aspira Women's Health Inc. (AWH) Q3 2014 Earnings Call Transcript

Published at 2014-11-13 22:16:08
Executives
James LaFrance – Chairman, President and CEO Eric Schoen – VP, Finance and Chief Accounting Officer Don Munroe – SVP and Chief Scientific Officer Valerie Palmieri – COO
Analysts
Adam Evertts – LifeSci Capital Jack Fraser – Seamark Capital Mike Cebek – Ladder 31 Investments
Operator
Good afternoon, everyone, and thank you for participating in today’s conference call to discuss Vermillion’s Third Quarter ended September 30, 2014. Joining us today are, Jim LaFrance, the Chairman, President and Chief Executive Officer of Vermillion; Eric Schoen, the Company’s Vice President of Finance and Chief Accounting Officer; and Donald Munroe, Senior Vice President/Chief Scientific Officer. Following their remarks, we will open up the call for your questions. Then before we conclude today’s call, I’ll provide the Company’s Safe Harbor 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 27, 2014 starting later this evening via the link provided in today’s press release as well as the Company’s website. I would now like to turn the call over to Mr. LaFrance.
James LaFrance
Thank you, Rockcie. Good afternoon, everyone and thank you for joining us. I would like to start provide a sense for where we are in our journey and we are headed. I want to give this by summarizing our new vision and then outline three distinct phases that span from now through 2016. The three phases are a rebuilt phase with is occurring now and the second half of 2014. A transformation phase which will span 2015 and the third phase, our market expansion and growth phase which will begin in 2016. In the last six month, Vermillion has been actively rebuilding its team energy growth strategy. Great progress has been made on both fronts. We’ve assessed market opportunities, we’ve assessed our capabilities, our strength and weaknesses and have developed a strategy in operation plan that we believe our result in difference making solutions for patients and customers and strong returns for our shareholders. Vermillion has begun the process of transforming itself into a bio-analytic solutions company focused on gynecologic disease. Today, Vermillion has focused narrowly on one leg of a clinical decisionary [ph ]that begins with hundreds of thousands of women presenting at their [indiscernible] office or primary care doctor with non-specific symptoms of pain or virginal bleeding. The issue due narrowly is which of these patients will require surgery with a suspicion of a ovarian cancer. The issue viewed more broadly is how do they slot line clinician are properly treat out of these women into effective and cost sufficient treatment pathways both malignant and benign gynecologic disease. The former hoping identify malignant ovarian cancer is where we are focused historically. The ladder aiding clinician in the differential diagnosis of women presenting with public masses and other gynecologic symptoms is our expanded market opportunity focus. This larger focus includes endometriosis, polycystic ovarian syndrome, fibroids and other gynecologic diseases. I said a minute ago that Vermillion was in the process of transforming itself into a bio-analytics company focused on gynecologic disease. I just spoke about the market expansion transformation but let me talk about the bio-analytics transformation and what that means. Today, we have a good set of tool, protein biomarkers and a multivariate algorithm. With a launch of our OVA2 product in 2015, this toolset should improve, but the toolbox needs to be expanded. To find and mind for both, you need a verity of tools. The find the gold, we are looking for predictive tools which identify and pass malignant and banine conditions, you will need a verity of new things in our Vermillion discovery toolbox. The challenge is both finding disease largely defined by sensitivity and separating one disease type from another largely defined by its efficacy. Biomarkers are very good at the first and challenged under ladder, particularly what prevalence is well. So when we plan to expand – fully planned to expand beyond biomarkers and pure diagnostic measurement to include other modalities such as imaging, clinical risk factors and patient data in our sodium calculus. This new range of tools should boost specificity allowing us to better sort patients to non-colorations and newly discovered ones. Vermillion also plans to build this own gynecologic disease sample and data registry. A data base will accelerate our innovation by allowing us to mind colorations retrospectively and validate new colorations prospectively. This patient data registry is a significant multiyear investment for the company, but we believe it will bear fruit multiple times in the years to come and several million apart as a women’s health leader, collaborator and innovator. This is our expanded company vision. Form ovarian cancer, the gynecologic disease and from biomarkers and then algorithm as a foundation to additional horsepower of added modalities, clinical risk factors and patient data to create differential diagnosis colorations. That’s the strategic side of what we have accomplished in the last three months. Let me now circle back to operational phases setting out how we will achieve our vision. Again there are three operational phases, rebuild, transplant and market expansion and growth. The first phase, the rebuild phase expanse the second half of this year 2014, in this phase, we have rebuilt the management team with a new Head of Sales and Managed Markets from PerkinElmer, a new Head of Marketing from Myriad, a new Head of Operations from DIANON, LabCorp and a new Chief Medical Officer from Banner MD Anderson. These new hires joined a strong core of leaders we’ve retained in technology, regulatory and finance. This new team rebuilt the strategy and vision as we discussed, rebuilt our commercial strategy, reestablished our medical and advisory support, rebuilt our patient efficacy strategy and established for the first time a billing system and payer strategy outside of the cost relationship. So much need foundational work has been achieved in the last quarter and into this quarter, this outputting on which to build the future. We also very importantly stayed on track with OVA2 development project. Most recently we pass the major milestone on this project, graduating from the internal verification phase to the external validation phase. We plan to summit to the FDA for 510(K) plans in January keeping us on course for a launch in the second half of 2015. Don Munroe, our Chief Scientific Officer will address our progress on OVA2 more completely in a minute. The second phase of our operation plan is the transformation phase which signifies that there are prerequisite that must before we go into the full growth state that we are anticipating. Let all those things they need to happen. The first prerequisite is four National licensure of the ASPiRA LABS. We currently serve the vast majority below 48 states, but some of the missing states are big ones including New York, Florida and Pennsylvania. These states collectively makeup a sizeable portion of our total OVA1 volume. Until we have full licensure, we expect to continue to use Quest Diagnostics as a producer and commercial partner for OVA1. It is largely guesswork to determine when the state of New York for example will approve our licensure that based on where we are in the process and their past history, we anticipate reaching four national licensures by mid-year 2015. The prerequisite of the transformation phase is establishing our own payer coverage. Up until ASPiRA launch, Quest with the sole source provider of OVA1 and largely the only contractor with payers for public and product, national and regional. And where Vermillion can ally a Medicare coverage under 81503 and a small number of positive medical policies OVA1 has received, we must dramatically buildup our medical policy in covered life base with newly established payer relationships and newly established price points. This is the large challenge that will take some time, but also is a major opportunity. Today, Vermillion on average yields $125 per touch from Quest, while Quest receives a net $330 for the test after all discounts and denials. So Vermillion has the opportunity to significantly increase its revenue protest upon conversion to ASPiRA from a $125 to $330 if we do as well Quest or better if we were able to make a better case to payers. And three prerequisite in a transformation stage is the launch of OVA2. OVA2 with a substantially enhanced performance should provide strong health economic arguments and new round of publications and the next ramp of customer uptake and acceptance in the marketplace. As mentioned OVA2 is tracking a submission with the FDA as planned. With their review period beginning in early 2013, our best production on clearance predicated on published averages for 510(K) submission is a 166 calendar days just short of six months. So when you line up these prerequisites, one, two and three national licensure for ASPiRA, establishing new payer contracting and OVA2 launch. Things start to align of our Q3 of 2015. We plan to be in a position to do a complete commercial re-launch and rebrand of the ASPiRA and/or over franchise at that time. Also by the end of 2015, we plan to demonstrate pure of concept for a lab develop test product series which we refer to internally as OVAx, the OVAx series is beyond biomarkers approach with additional elements like clinical risk factors and patient history data to boost productive value that I discussed in our strategy outline earlier. This rapid follow-on LDT offering brings into view how much we believe our innovation cycle can be spread up overtime. That hasn’t fall our historical path of launching an IVD product every four to five years, we plan to introduce an innovation cycle half of what it has been. The third phase of our commercial operational plan is market expansion and growth beginning in 2016. By this time, we expect a net all of our prerequisite, full national licensure of ASPiRA we expect to have established track record for price level and payer acceptance, we plan to fully exercise a regional commercial strategies and began scale them to a full national pasture, we have to have launched OVA2 and demonstrated OVAx proven concept with a LDT product, we plan to begin to build out our sample and patient data registry and begun mining for new disease correlation to speed and expand our product pipeline. To be clear, although I call for globe phase in 2016, we plan to have substantial revenue growth in 2015 but expect to region inflection point the following year. At 2016, we expect to have largely transformed ourselves into bio-analytic solutions company focuses on gynecologic disease and begun to reaping the benefits of this transformation. I will now like to turn to Eric Schoen, our VP of Finance for a rundown of our quarter three financials.
Eric Schoen
Thanks Jim. Today we filled our third quarter 2014 financial release and a press release and our from 10-Q with the Securities and Exchange Commission which is available for download via the Investor Section of our website at www.vermillion .com. Total revenue for the third quarter of 2014 was 323,000 comprised of 209,000 from sales of OVA1 and 114,000 from license revenue. Total revenue for the nine months ended September 30, 2014 was 952,000, 611,000 from product sales of OVA1 and 341,000 from license revenue. Third quarter 2014 product revenue was derived from 4,325 OVA1 test performed which is consistent with the year ago quarter. This volume includes tests performed at ASPiRA LABSs. We do expect to see a modest increase in test volumes in the fourth quarter of 2014 compared to third quarter level. OVA1 revenue in 2014 included only the $50 fixed portion of revenue for test from the OVA1 test performed by Quest Diagnostics. The OVA1 product revenue does not include the addition royalty component of revenue based upon 33% of Quest Diagnostics gross margin. The company recognizes this portion of revenue when reported by Quest Diagnostics be an annual to us after the end of the calendar year. For ASPiRA LABS, we have not yet established sufficient payment history with insurance companies of private payers for the test performed and are thus recognizing revenue on a cash basis. We also expect there will be a lengthy lag period between performance of the 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. ASPiRA test volume has been growing steadily month-over-month and we will begin the breakout test volume separately from the Quest Diagnostics volumes once levels become meaningful which is expected in the fourth quarter 2014. Cost of revenue for the three months ended September 30th 2014 totaled 606,000 of which 575,000 related to ASPiRA LABS. We estimate approximately 200,000 incurred for ASPiRA in the third quarter to the non-recurring cost which will diminish in the fourth quarter of 2014. In the third quarter, we made substantial investments in building our laboratory infrastructure. This investment should setup the organization for high margins and scalability. This investment included the integration of a versatile laboratory information system in implementing a cloud based billing system. The laboratory information system is planned to include a physician web portal for ordering and reviewing reports as well as a smart phone application in the near future. Our operating expenses for the three and nine months ended September 30, 2014 were approximately 5.3 million and 15.3 million respectively. Operating expenses included approximately 0.4 million of non-cash stock based compensation expense in the third quarter and 0.9 million in the first nine months of 2014. This compares with operating expenses of 2.6 million and 7.9 million for the same three and nine month period of 2013. Operating expenses in the prior year included just 0.1 million and 0.3 million of non-cash stock based compensation expense in the same three and nine month period. The year-over-year increases are due to our continued investments in our sales force as well as research and development effort to complete development of our OVA2 test. We are looking forward to realizing the benefit of some of these investments by hitting our near term milestones including our FDA submission planned for early January 2015 and release of the validation study data by mid-2015. We also remained committed to publishing initial heath economic data in the first half of 2015. Net loss for the second quarter was 5.6 million or $0.16 per share on weighted average shares outstanding of 35.9 million. Total net loss for the nine months ended September 30, 2014 was approximately 15.1 million or $0.42 per share based on weighted average shares outstanding for 35.9 million. Our total shares outstanding at September 30, 2014 was 36million. Cash and cash equivalents at September 30, 2014 were 16.8 million. The company utilized 5.4 million in cash in the third quarter are expected high watermark for cash utilization as previously disclosed. We expect 4.5 to 5 million of cash to be utilized in the fourth quarter of 2014 which still includes to the non-recurring ASPiRA LABS and other costs. Now, I’ll turn it back to Jim.
James LaFrance
Thank Eric. On our third quarter performance specifically the lack of anticipated growth versus the prior quarter, we said in prior calls that we had anticipated growth in the third quarter on OVA1 sales based on having the expanded sales force in place. We did not achieve our internal goals but there were somehow point of learning on how to approach the market going forward. Let me address some of those. Payer strategy, sales and payer strategies need to be highly coordinated and ultimately need to get medical policy coverage at a fair price but clinician need to comfortable and often participate with your peels process and with your Patient A program via working on coverage with insurers. These processes are in place or not fully in place in quarter three. Call point, we are still appraising the optimal call point with a fragmented OBG land market of 35,000 clinicians, you cannot call on everyone if you have a very large sales force. Going forward, we plan to focus on a limited number of markets where we have identified opportunities to leverage key opinion leaders, payers and a broader network of informators and ACOs and health system. Consistency of approach and messaging that only you need talented sales team director the more influential customer, you need an effective sales process which positions our products appropriately and ultimately changes current clinical practice by including over one on a routine basis. Our new marketing team started in early September, we look forward to their endpoint on our sales teams and sales processes beginning with the fourth quarter. Finally, I briefly wish to address out transition status with Quest Diagnostics. We’ve been in active discussions with them for some time and both settling out our old contract and creating a new go forward relationship. We are hopeful that we will the negotiated settlement by year-end. Let’s not turn our attention to our development progress and discuss some of our achievement in the quarter. I’m going to turn it over to Don Munroe, our Chief Scientific Officer. Don?
Don Munroe
Thank Jim. I’m to update, we successfully completed development last quarter looking the design for subsequent verification and validation. The revise test design includes three of the five OVA1 biomarkers along with two new substitutions. We plan to disclose the biomarker over two panel in a future publication tell us not to compromise rules. The changes were designed to improve specificity and positive predicted value of PPV relative to OVA1 without given up key advantages of OVA1. It’s very high sensitivity, negative predicted value or NPV plus early stage performance at broad range of sub [ph] detected. With this design in hand, we also undertook and completed verification of OVA2. The exercise ran the new product through a wide verity of performance tests. To rigorously assess every aspect of the design prior to undertaking validation with help from external lab partners. The data from this exercise generated over 200 tables and figures and successfully map all the criteria for advancement. As a result the team received a green light to move forward into product validation which should begin this month. While the nature of validation means we cannot predict success with certainty, we are optimistic based on verification results. Work at the external lab should be completed in the next months, followed by submission of our 510(K) package to FDA early in 2015 targeting OVA2 product launch in the second half of 2015. We also expect to present and publish several pieces of refer and the design validation and independent evaluation of OVA2 in 2015. As these publications progress, we look forward to sharing more information about the changes to the biomarker panel and the design and important – their performance improvement we’ve been able to achieve. Back to you Jim.
James LaFrance
Thanks Don. That concludes our presentation and we’re ready to take your questions.
Operator
(Operator Instructions) We’ll hear first from Adam Evertts with LifeSci Capital. Adam Evertts – LifeSci Capital: Thank you. I just have two questions regarding ASPiRA LBS. The first is, what is the current turnaround time from sample collection to results and how does that compare to what’s been done with Quest?
Valerie Palmieri
Hi, this is Valerie Palmieri. The current turnaround time from collection to results is 24 to 48 hours, it’s about 24 hours improvement over the current class standard. Adam Evertts – LifeSci Capital: Great. Second question is given all of the changes in the business and plan to launch OVA2 in 2015, do you see any need for additional investment in order to handle the projected volume increases?
Valerie Palmieri
No, actually the majority of the investment occurred in 2014, so in 2015 and 2016 we will be leveraging our fixed and variable costs an addition to that increase in operating efficiency we also have invested in a truly personalized service and experience for the physician, repair and most importantly the patients. Adam Evertts – LifeSci Capital: Great, thank you.
Valerie Palmieri
You are welcome.
Operator
(Operator Instructions) We’ll hear next from Jack Fraser with Seamark Capital. Jack Fraser – Seamark Capital: Hi. I am wondering if you could still outsource or give us some recent sense or the volume that was held on specifically by ASPiRA LABS and then with regard to the received and collection cycle, if you could give us a sense of where we are in the agent of those account thus far and what your initial assumptions are about why could you do the experiments for accounts receivable leaving to collections. Thanks.
Eric Schoen
Hey Jack, this is Eric Schoen, so what I’d said in the prepared remarks is, we are going to disclose exactly buyer volumes at this point, but you can get the general sense that they are below 5% of our total volume. We expect that if we go above 5% next quarter and will begin to break that out, so people will be able to take metrics and growth rates from it. The volume has been growing month-over-month but in tellers side a meaningful level giving percentage is just – thing for anybody. We’ve began billing first buyer, we began collecting money but there is a lag time because without significant payer contracts or medical policy, we anticipate getting denials and having to appeal those denials. So the most thing – the piece that I will say at this point is that it will be a several month lag between running a test and collecting for a test. And again our revenue recognition is on the cash basis at this point. Jack Fraser – Seamark Capital: Okay, good, that sounds good. And one other quick question, in your – envisioned timeline for OVA2, should we to be thinking that OVA1 will effectively migrate us of the offering menu of the company at that time?
James LaFrance
Yes. Jack Fraser – Seamark Capital: So years from today offerings being equal and things to according the plan, this is going to be purely – that piece of the business will be purely over to franchise.
James LaFrance
Correct, but as we try to layout, the future will look different, I mean that we will with the introduction of and emphasis on LDT products after OVA2, after the approval, OVA2 with the introduction of the OVAx series will have multiple products going forward and in year you us introduce things beyond sort of the ovarian care path on to endometriosis and other offering. But definitely in the mid-term, we’ll beyond being a single product company. Jack Fraser – Seamark Capital: That’s helpful, thanks very much.
Operator
And we’ll move next to Mike Cebek with Ladder 31 Investments. Mike Cebek – Ladder 31 Investments: Hell everyone. Thanks for the update on the call. I was wondering if you could basically give a little more color or expand on the expectation for the fourth quarter volume improvements, now that you’ve had an expanded sales force in place and have a little better understanding of how to approach the markets?
Eric Schoen
Yeah Mike, we said in the prepared remarks that we do expect a modest increase, so certainly above Q3 levels and the year-ago Q4 levels, but we’re not at this point giving specific guidance. Mike Cebek – Ladder 31 Investments: Okay.
Eric Schoen
We are – I think we also said that during some of comments that we’re in the process of sort of changing our coverage model a bit to be more regional in emphasis, so more of a concentrated approach, so we’re – there is a bit that going on, that will be going on in the fourth quarter and be completed in the first quarter, so we have a bit above shuffling of rules and geography concentration if you will going on over the next quarter. But that said, we still anticipate a modest increase in OVA1 test volume. Mike Cebek – Ladder 31 Investments: Okay, I was wondering could you maybe even give me a little more information about how much regional activity you plan to have going through the fourth quarter and then into the start of next year? How many more sales people, how many more regions, I know a lot of work you probably doing out in the field is to support areas we have approval for ASPiRA LABS? Would it make sense?
James LaFrance
The overall level of sales people will not change, it will remain roughly in the – I think we’ve said before in the mid-20s, but the – what will change is sort of the some of our rules will change, we’re sort of I would say elevating our cover points to call on more of at ACO level that help level and trying to frankly gain the leverage on the market place as we try to install OVA1 into care pathways as they get established by organization to manage the business in that way, manage risk in that way. So we have sort of a rotation of lows and elevation of low. So the overall number is not changing but sort of the maybe the type of sales person and the skill set we are employing in the field are through our learning we’re elevating them. Mike Cebek – Ladder 31 Investments: Fair enough, thank you very much.
Operator
This concludes our question-and-answer session. I would like to now turn the conference back over to Mr. LaFrance. Mr. LaFrance, please proceed.
James LaFrance
Thanks Rockcie. To conclude, we are on a journey every million. We have our eyesight on establishing ourselves as a leader in bio-analytic solutions focused on gynecologic disease. Strategically, we plan to expand our market beyond the ovarian cancer pathway to a broader set of gynecologic diseases and we plan to expand our mining capabilities to a broader set of information and broader set of coloration tool. Operationally, we have three near-term focuses building out our pair base for ASPiRA and establishing a high value price point for the over product line, continuing to hold sales and marketing approach to drive uptake and acceptance of our products. And lastly transitioning the Quest volume to ASPiRA in the first half 2015 to prepare for our corporate re-launch in the second half of 2015 with our OVA2 product. Thank you.
Operator
Therefore we conclude today’s call. I would take a moment to read the Company 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 November 27, 2014 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.