Vermillion, Inc. (NASDAQ:VRML)
Q2 2017 Earnings Conference Call
August 8, 2017 4:30 PM ET
Valerie Palmieri – President and CEO
Marra Francis – CMO
Eric Schoen – SVP, Finance and CAO
George Kafkarkou – Private Investor
Unidentified Analyst –
Good afternoon, ladies and gentlemen. And welcome to the Second Quarter 2017 Vermillion Earnings Conference Call. My name is Stephney and I’ll be your coordinator for the call today.
With me today are, President and Chief Executive Officer; Dr. Marra Francis, Chief Medical Officer; and Eric Schoen, Senior Vice President of Finance and Chief Accounting Officer. This afternoon, they’ll discuss Vermillion’s Q2 2017 performance.
Before we get started, I’d like to point out that there will be a replay of this conference call available via telephone and internet. Please refer to today’s press release for replay information. This presentation contains, and answers to today’s questions may contain forward-looking statements including statements regarding our business plans, plans and expectations with respect to ASPiRA IVD, our pelvic mass data repository, our cloud web service platform and international commercialization and repeated test volume, our ability to expand payer coverage for our test and financial impact and scientific publications and study outcomes, anticipated cash utilization and anticipated revenue and the timing of the recognition thereof.
You are cautions not to place on undue reliance on forward looking statement. Vermillion is providing this information as 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 except as required by law. 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 factors as described in the Vermillion’ annual report on Form 10-K for 2016 and quarterly report on Form 10-Q for the first quarter of 2017.
Following the Vermillion teams’ remarks, we will open-up the call for your questions.
Now I’d like to turn the call over to Ms. Palmieri. Please go ahead.
Thank you, Stephney. Good afternoon, everyone and thanks for joining us today. This afternoon I’ll provide you with highlights of the quarter, our review of the progress we’ve made towards implementing our strategy. Vermillion has had a milestone organic growth quarter highlighted by year-over-year revenue growth of 55% improvement. Year-over-year average per day volume increased 19% in territories with sales coverage. In addition, year-over-year gross margin improved from 5% to 50%. These improvements are direct relationship to the strategic investments that we’ve made to enhance customer value through deeper customer relationship as well as focus sales effort. Personalized patient efficacy and a revenue cycle management improvement and capability.
This afternoon we’ll discuss the details of our second quarter performance, the large market opportunity that remains for OVA1 and Overa and the investments we are making in the business to maximize our ability to capture that opportunity as well as progress on our strategic plan. We are very proud of the impact of OVA1 and Overa are having on patients’ lives. Since OVA1 launched in 2010, OVA1 has impacted over 90,000 women with zero safety or efficacy issues. And as we build our patients outcome program, we should be able to better understand the number of cancers detected even in early stage as well as the percentage of women with ovarian cancer who actually get to gynecologic oncologist. Keep in mind over 60% of ovarian cancer is diagnosed late stage and close to 66% of primary ovarian cancer patients do not have their initial surgery performed by gynecology oncologist.
In addition to the majority of patient being benign, understanding the low risk management care pathway is critical for a patient’s peace of mind. Today, OVA1 is FDA cleared, covered by Medicare and included in a major society guideline; it is covered or has positive medical policy for close to 30% of the population. And during the second quarter of 2017, we received payment and over 54% of the time versus less than 17% of the time in second quarter of 2016 for a non-patient pay volume that would include Medicare, Medicaid commercial insurance and client bill.
During Q2, we achieved a trajectory change in the business in terms of revenue volume and cash collection and we are confident in our prospects for long-term growth of the business. In spite of these gains, we did recently received notice of a significant client bill account which is no longer referring OVA1 to us and as a result we’ve begun servicing a portion of these customers directly. Eric will review the details in a few minutes.
Our goal is to change the standard of care by managing the 1 million plus women with pelvic mass. This will take time and require further investments in our people and our infrastructure. To discuss or second quarter financial review, I’d like to introduce Eric Schoen, our Senior Vice President of Finance and Chief Accounting Officer.
Thanks, Valerie. Today we press released our second quarter 2017 financial results which are also available for download via the Investor section of our Web site at www.vermillion.com. We’ll also file our Form 10-Q with a Securities and Exchange Commission by August 14.
Product revenue in the second quarter of 2017 totaled $860,000 compared to $554,000 in the prior year quarter, representing a 55% year-over-year increase. ASPiRA IVD service revenue in the second quarter of 2017 totaled $38,000 compared to $155,000 in the prior year quarter and will vary from quarter-to-quarter based on the size of ongoing customer project. Total revenue in the second quarter of 2017 was $898,000 compared to $709,000 in the same year ago quarter representing an increase of 27%. There were 2,418 OVA1 test performed during the second quarter of 2017 compared to 2,345 OVA1 test performed in the prior year quarter, or a 3% increase.
We’ll discuss the breakout volume between covered and non covered territory in the sales review of section of this call. However, in addition revenue on a third test performed basis increased to $356 in the second quarter of 2017, compared to $236 in the second quarter of 2016, repressing a 51% increase. This number compared to $296 in the first quarter of 2017 or 20% increase sequentially. Despite this strong metrics in the second quarter we do note that we expect test volume and to a lesser extent product revenue to decrease in the third quarter of 2017 due to the loss of one client bill customer.
We expect the direct volume loss from the client build customer to be between 5% and 10% in the third quarter relative to volume in the second quarter of 2017. We also expect some additional volume loss due to summer seasonality and the July holiday calendar. We are working to mitigate the losses and have already begun to partially replace the volume loss with direct arrangements with hospital systems and group.
Cost to product revenue for the second quarter of 2017 totaled $428,000 representing a 19% decrease from the prior year quarter due to lower consulting and personnel cost. Cost of ASPiRA IVD service revenue was $266,000 for the second quarter of 2017 compared to $60,000 for the same period in 2016. ASPiRA IVD does not commence operations until June 2016 and that’s included only one month of expense in 2016 compared to a full quarter of expense in 2017.
Total operating expenses in the second quarter of 2017 decreased to $2.6 million compared to $3.9 million in the same year-ago quarter, representing a decrease of 34%. The decrease was primarily due to commercial operating efficiencies as well as lower research and development costs following expiration of our collaboration agreement with the Johns Hopkins University School of Medicine and the clearance of Overa in March 2016.
Net loss for the second quarter of 2017 was $2.4 million or $0.04 per share compared to a net loss of $3.7 million or $0.07 per share in the same year-ago quarter.
Cash and cash equivalents at June 30, 2017 were $6 million; The Company utilized $1.7 million in cash in the second quarter of 2017 after deducting the final payment related to expenses for the February 2017 common stock offering. We plan for cash utilization to remain under $2 million per quarter over the balance of 2017.
I’ll now turn back to Valerie.
Thanks Eric. We will now review our core strategy. Our strategy had three phases: a rebuild phase, a transformation phase and a growth phase. We’ve completed the rebuild and transformation phase. In 2017, we’ve begun our growth phase with focusing on regional specific sales efficiency, key payer publications in coverage, and overall growth through our revenue diversification.
The three key objectives of the growth phase are as follows: first, the successful deployment of our domestic and international commercialization strategy based on focused clinical utility and health economics to drive sales, payer coverage, as well as continued momentum with guidelines.
Second is delivering key results from our new revenue channels, including international partnership and ASPiRA IVD. And third, laying the foundation for our one-of-a-kind pelvic mass repository which is intended to be the core of our big data engine and pelvic mass portfolio.
We will now review our first objective, which is the publication of foundational peer reviewed papers to support payer and guideline adoption.
I’d like to hand the call over to Dr. Marra Francis, our Chief Medical Officer to provide this update.
Thank you, Valerie. We continue to strive to maximize test coverage and clinical adoption. And this is directly driven by our core clinical utility and health economic publication. Currently we have one study accepted for publication that is scheduled to be published in Q4 and one in review. Both address the benefits of choosing a Multivariate Index Assay, such as OVA1 and Overa.
I’ll start with the paper that is currently in review. We’ve evaluated the benefit of our high negative predictive or NPV for the management of low risk OVA1 patients with adnexal masses. It is well established that an elevated OVA1 score benefits patients by having them either referred to or manage in consultation with a gynecology oncologist. While we know ovarian cancer is rare, it is been well proven that women ultimately diagnosed with ovarian cancer have a better survival outcome if their initial surgery is performed by a trained oncology specialist. However, we had never focused on the benefit of truly understanding the care pathway of a patient who is not at elevated risk for ovarian cancer or the risk patient. And that’s what this paper reviewed. The NPV of OVA1 when used in conjunction with clinical assessment and ultrasound finding is 99%, meaning there is only 1% likelihood that the mass is cancer if OVA1 score is low risk. There are several clinical and health economic benefits of knowing this information.
First, the OB/GYN is reassured that any surgical management can safety performed without the need for referral to a higher level of care. Second, the patient is not forced to leave the practice where she received a routine care. Last, our surgical management with OB/GYN is less costly than the same benign procedures done with the gynecology oncologist. This is something we will be outlining in detail in our paper plan for publication in Q4. We believe that giving the physician useful information for both the elevated risk and low risk OVA1 patient will have a wider impact on the overall care of women with adnexal masses.
Now moving on to our recently accepted and scheduled to be published in Q4, 2017 paper titled, Economic Impact of Increased Utilization of Multivariate Index Assay Testing to guide treatment of ovarian cancer, a payer perspective. IN this paper, we used both commercial and Medicare claims data from 62 million members, of which 37 million were Medicare and 25 million were commercial covered live. We then constructed a budget impact to model to estimate the economic consequence of substituting OVA1 versus the single biomarker assay and assessing the likelihood of pelvic mass malignancy in pre-menopausal and post-menopausal women. The result showed significant savings on both the Medicare and commercial side with the highest per member per months savings seen in the commercial side of up to $0.17 per member per month, translating to a monthly savings of $3.4 million for plan with 20 million covered live. This model could be modified in the future to be applied to Overa as well.
Lastly, I want to conclude with an update on how we are increasing physician clinical awareness and knowledge surrounding OVA1. Our focus has been to educate providers and patients on the clinical usefulness OVA1 for classifying women as either elevated risk of malignancy or low risk of malignancy before going to the operating room. As discussed in the last earnings call. Vermillion had a strong presence in national ACOG this past May. Currently, we are focusing our efforts to be the first test to provider chooses in the work of adnexal masses by being present at regional programs for large number women healthcare providers attend to learn the latest update and technology that impact their practice of medicine. The OMNIA program. Since OMNIA have begun l1 years ago, they have educated over 37,000 women healthcare providers in both live and online CME courses. Each live program educates approximately 475 providers in one day. Vermillion will be attending nine live programs hosted by OMNIA for the remaining half of 2017. Given our sales team the opportunity to connect with approximately 3300 providers. Our local sales repetitive will be attending the programs in their geographical area thus allowing them easy access to many providers all at once, maximizing their face to face time with both and current prospective new customers.
Moving forward, we will continue to focus our efforts in both education and our studies on the clinical usefulness of using OVA1 prior to any surgical management for adnexal masses. Additionally, we will continue to educate women on the signs and symptoms that maybe associated with pelvic mass disease. By creating a patient portal for women to take a symptom index quiz, thus allowing them to have educated discussion with their healthcare provider.
I’ll now hand this back to Valerie.
Thank you, Marra. I’ll now give you an update on our three revenue channels: domestic, international, and ASPiRA IVD. On the domestic front, we believe that we can capture significant market share over time. We’ve had significant year-over-year retention of customers due to our new and current customer retention program. This increase is in base customers is directly driven by our focus increasing on same store growth, enhancing overall retention and also with active personalized patent efficacy program which I’ll go into in a few minutes. By embracing this shift, the team is driving increasing adoption of OVA1 within our existing customer base. The new sales efforts and refocus are driving our change and paying dividend. Through the changes in our sales force we grew our base of customers while increasing our specimen per M.D. by 33%. We are also seeing nice dividends already in our expanded our sales force. These recent additions in key market further reduced our non covered territories which have experienced 10% reduction in volume.
Converting top non covered territories to covered territories is a priority while we train and demonstrate success with our initial expansion. We are confident that our new customers will continue to adopt OVA1 at a strong pace where we have sales force presence. We’ve completed 2,418 test during the second quarter. If you compare the growth in territories with field representatives versus territories with no field coverage, covered territories grew 19% per day year-over-year, while non covered low touch area decreased 10% year-over-year per day. For example, in our Michigan territory we experienced 29% year-over-year growth per quarter, while our Maryland grew 47% year-over-year per quarter. In addition to sales force expansion, we’ve also rolled out our new patient efficacy program. This program which we piloted in Q2 and just expanding in late Q2 by increasing the investment into the program by 300% is critical to the overall customer and patient experience. We now offer prior to the test being performed and estimate to patients with most commercial insurance plan that show their anticipated out of pocket cost. Providing this transparent cost information helps patients make informed financial decision. So far we’ve had 90% test order rate with this program.
This helps us to productively manage patient concerns of their payer coverage. In addition to our getting sales force we are focusing on expanding contract coverage coupled with domestic regional partnership. Our technology is documented strength of our alternative technology such as CA125 and ROMA, and agreement with right strategic distribution partners in time are expected to help increase market share.
In addition to the launch of OVA1 and OVA1 plus, we’ve also launched our second generation test Overa with our targeted launch program. Coupling publication volume and reimbursement strategy together is critical to the rollout. As you know, recently we’ve received our CPT code T0A0003U for Overa and we just recently attended the July 31 CMS meeting to support our reimbursement strategy for Overa. More information to come on this in future earnings call.
Let’s now to insurance coverage. The number of lives under positive medical policy increased to almost 96 million in the second quarter, which is about 30% of the lives in the U.S. Our market access team has performed well and is now focused on turning these positive coverage decisions into contracts allowing patients to access OVA1 as an in network benefit. We are waiting for credentialing for several plans with which we’ve entered into agreement. We expect to make continued steady progress on the expanding coverage of OVA1 in the remainder of 2017.
I am now going to move on to our other revenue channels, international and ASPiRA IVD. We continue to have discussions regarding two international business models: centralized and decentralized, designed to meet the unique needs for each country outside of the U.S. We expect to implement our web services platform in key countries in the near term, while we expect the impact of our initial international contract to be minimal as we work through market regulatory payer issues in the local jurisdiction but we expect sales outside of the US to have a positive impact on volume and revenue in 2018 and beyond.
In addition, we are developing protocol on studies in two strategic countries. More to come as we roll out.
We believe that Overa’s proving diagnostic technology coupled with the ability to utilize the Roche Cobas platform will be a solid foundation for global commercialization so women worldwide can more easily benefit from our technology. Keep in mind that about 90% of the ovarian cancers worldwide are outside of the U.S and we have just started to enter that market.
I am now moving on to ASPiRA IVD. ASPiRA IVD recently celebrated its one year anniversary. It is now fully functioning clinical trial testing site with the following accomplishments. We just landed our first companion diagnostic study partnership with the Top 10 pharmaceutical companies directly. The therapy under its development is a monoclonal antibody whose target is PTK7 and is being administered to patients with ovarian cancer, triple negative breast cancer and non small cell lung cancer.
We are also continuing to testing for the global DLL-3 companion diagnostic rolling trial sponsored by a major pharmaceutical company as well as in vitro diagnostic company for patients with small cell lung cancer. As reported in the last earnings call, we continue to see studies focused oncology therapies such as DLL3 to have slower patient enrollment than previously budgeted. This represents the potential risk to Q3 revenue realization for ASPiRA IVD.
Our last objective is building one of a kind pelvic mass repository which is intended to be the core of our big data engine and public mass portfolio. The goal of this repository to support the development of new products and productive analytics in ovarian cancer as well as differential diagnosis of benign pelvic condition. We have a specimen repository in database that has close to 5,000 specimens with known pathology. In addition to that we have added an IRB approved protocol for specimen and data collection of 7,000 plus clinical laboratory specimen. This assessment is in process and we plan to have a total of 12,000 plus specimen in the repository when it’s completed.
Today, we are still seeing approximately 20% return rate on patient consent which is much higher than we anticipated. Keep in mind, patient consent allow us to receive additional clinical and diagnostic data as well as pathology report which are the gold standard in diagnostic. This will allow us to see how doctors truly manage low risk as well as high risk patients with our technology. Once we have enough data, we intend to publish on this as well. As we all know, ovarian cancer remains one of the most challenging diagnosis to make early in the disease process. We believe that harnessing this data will truly be key to understanding the origin, contributing factor, prevention and successful treatment of this disease through the development of future bio informatics solution.
The end goal of our program is the incorporation of our data and specimen as well as the collaboration of top academic institutions to share clinical, epidemiological, genetic, proteomic data on various types of benign and malignant pelvic mass condition.
In closing, we believe that the second quarter of 2017 was another milestone quarter in terms of revenue, growth in specific regions and payer success to set a stage for the rest of 2017. Through 2018 we plan to define our company success using these four metrics. Number one is revenue growth. Revenue growth will be how we measure the effectiveness of our new and integrated sales processes, as well as leveraging partner laboratories and our decentralized platform. Number two is reimbursement expansion including percent paid, averaging price and expansion of payer coverage. Number three is the continued development of scientific and clinical evidence which may service the foundation for test adoption including the management of low risk and high risk patients, additional guideline inclusion and payer coverage policies. And number four is our profitability. As we grow revenue and improve operating efficiency with the eventual goal of profitability and continued investment back into the business.
We look forward to keeping you apprised of our progress during 2017. Our end in mind is to maximize stockholder value by saving lives and saving money for the overall healthcare system.
We are now happy to answer your questions.
And we will take our first question from George Kafkarkou.
Hi, guys. Good afternoon, guys. I got a couple of questions but I was very intrigued by the second half of the call. But firstly let me just ask if I could the direct client bill customer we lost, just when and why and who they are going with? When do we lose them? When did we know? And why did they move away and who are they using now?
Sure. So, George, I’ll answer that. We recently found out about it and actually a few weeks ago and basically they are a legacy client bill account from Quest. So typically we go direct to the physicians so they were the middleman between us and our physicians. And typically client bill accounts are low margin arrangement. They don’t allow the diagnostic service company to have their relationship direct with the customers. So now the customers have the ability to send to us directly. In addition, we will own the complete customer experience with the doctor’s order to result delivery in the billing component. So it did come as surprise but we believe again we are going direct to the customers and they are allowing us to go to direct to the customer as well.
Okay, that’s good. I mean it’s good that we go direct the fact that the legacy I understand that perspective and it’s low margin. So longer term that’s probably good thing right. Although we probably take a small hit in the number of tests for Q3 right.
Yes. So as we reported Q3 is a normally soft quarter because it is summer, unfortunately women they have vacation, kids are out of school, so it’s a soft quarter but there will be additional softness due to the loss of this legacy client bill account.
Okay. You mentioned we’ve entered into agreement. I think that was with relevance to potentially national payer. Did I hear that correct?
So we are – so the payer process, in the kind of go through it the payer process first you are out of network, then you have positive medical policy and then basically you basically go to an agreement on contract. So we are in the process of credentialing going through that contract stages with several plans right now. We’ll have more on our next earnings call or maybe sooner once we finish the process.
Yes, I know predicting timing is always very difficult with these things. And if I can call you from the last earnings call, it’s not a question of if, and it’s a question of when .So it’s – it appears we are making progress. You are confident Valerie that we are making progress. That will get one or more national payer committed to us this year, correct?
So what I am saying George is we have several — we are going to the credential process with several payers. I can’t say one or more national because we have several payers we are in the credential process with. And we will have — unfortunately we don’t have the news for this call but there is more to come on that.
Okay. Any updates on partnerships on partners either both domestic or international in terms of increasing if you like in effect our sales force?
So we are as we are looking at specific partnership in regions where we have what I considered the payer possible worked out, the partnership there is nothing I can announce on it. We are in discussions in several regional markets but there is nothing that I want to announce at this time. And then in international, I don’t know whether you picked up on the review but we have two strategic countries that we are moving forward with and things don’t — how can I say get done as quickly as we would like them to get done but we’ve two very key I want to say study protocols as well as potential partnership that we will be giving more details on, on the next call.
Have we announced the countries at least or no?
No, we have not. But you [Multiple Speakers]
Okay. I say one of them have strange access like I do. In any event, did I hear you mentioned and I was writing note in a flurry towards the end, did I hear PTK7 partnership — PTK7 is ordinarily associated, it’s a receptor that’s associated ordinarily with colon carcinoma right? And it’s a gene as I understand and I know Pfizer is targeting PTK7 for cancer by generating an antibody drug conjugate against the receptor. I am kind of surprised that you mentioned PTK7. How is that relate to us as OVA1? I am confused by that. Have I explained the question okay? Do you understand my confusion?
Yes, so let me — so PTK7 is a basically it’s a therapy under development, monoclonal antibody, so they are targeting the PTK7 in terms of monoclonal antibody and developing a companion diagnostic. So can’t mention the pharma company just yet but you are pretty good in terms of your detective work. And what they are looking at is PTK7 being used for ovarian cancer, triple negative breast cancer and non small cell lung cancer. Our involvement is supporting the discovery work on this companion diagnostic through our IVD trial services. So it’s our ability to access ovarian cancers specimen helps us with that relationship, George.
So how did that happen? Did the big pharma company, though I think I know who it is reached out to you or you reached out to them? How did that play out? I will be interested find out, I think that’s relevant.
Yes. So as you can imagine we were into IVD so IVD was spawn of leveraging our specimen bank and our database as well as there is a lot of disruption in the IVD trial business because of Covance being bought by LabCorp and Quintile, so we are taking advantage of some of the disruptions and building relationship directly with pharma?
You must be excited by that right.
We are very excited, yes, yes, it’s milestone for us.
We haven’t announced any news on that right before this call?
No, we have not.
And we’ll take our next question from [Indiscernible]
Hi, guys. Thank you for taking my questions. I had a question with regard to what you are doing with respect to patient efficacy programs and whether you could give us some more detail on that.
Sure. Thank you, [indiscernible], good afternoon. So our patient efficacy program and it’s something that it really is tailored to improve the patient experience on twofold. One is as you know these patients who have mass are anxious and when the doctor tells you have mass, the patient is halfway listening so the patient efficacy program allows us to also not only to discuss with them their deductible with their insurance so they can understand they are out of patient, they are out of pocket cost but also it allows us to have an education, a session with them and why the doctor order OVA1. So it does two fold is helps with education because they may not be listening to the doctor but also better understand what significance of the test that the doctor has ordered and in addition to that what will be their out of pocket cost depending on their insurance company. So it’s a program that is done had huge success and I think it’s going to pay us huge dividend in terms of bridging the time between our current payer coverage until we get into 100% of covered live in the US, as well as a great forum to educate the patients on OVA1 and pelvic masses in general .
And there are no further questions at this time. I’d like to turn the call back over to management for any closing or additional remarks.
Thank you, Stephney. To conclude, we are executing on our plan to change the course of pelvic mass patient management in the US as well as worldwide. We are focused on our growth phase which includes sales and payer adoption while diversifying our revenue channels with international and ASPiRA IVD. In parallel, we’ve laid the foundation for our one of kind pelvic mass repository which is intended to be core of our big data engine and pelvic mass portfolio. You’ve already seen some of the fruits of this with our risk of malignancy report which combines the OVA1 results with ultrasound and we plan to incorporate as a symptom index online product into our offering soon. As we build upon our database, we plan to build upon our existing platform to not only change the way ovarian cancer is managed but also push ovarian detection upstream and build the proprietary portfolio to manage the pelvic mass condition which impact one out of every five women in the US. Our end goal is to serve a global market with strong proprietary science, coupled with the platform which will drive profitability and overall shareholder value. Thank you for joining us today and thank you for interest in Vermillion. We look forward to seeing you at upcoming medical meetings and investor conferences.
And ladies and gentlemen, this does conclude today’s conference. We thank you for your participation. You may now disconnect.
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