Call Start: 16:30 January 1, 0000 5:00 PM ET
Precision Therapeutics Inc. (NASDAQ:AIPT)
Q1 2018 Earnings Conference Call
May 15, 2018, 04:30 PM ET
Todd Fromer - Managing Partner, KCSA Strategic Communications, IR
Carl Schwartz - Chief Executive Officer
Richard Gabriel - Head of External Business Development for TumorGenesis
Bob Myers - Chief Financial Officer
Gerry Vardzel - Chief Executive Officer, Helomics Corporation
Dana Allen - Goldman Sachs
Good day, everyone, and welcome to the Precision Therapeutics Q1 2018 Business Update Conference Call. Today’s call is being recorded. At this time I would like to turn the call over to Todd Fromer. Please go ahead.
Thank you all for participating in today's call to discuss Precision Therapeutics financial results for the first fiscal quarter of 2018. Joining me today are Dr. Carl Schwartz, Chief Executive Officer of Precision Therapeutics; Bob Myers, Chief Financial Officer of Precision; Gerry Vardzel, Chief Executive Officer of Helomics Corporation and Richard Gabriel, Head of Business Development of TumorGenesis.
Earlier today Precision Therapeutics issued a news release announcing its first quarter 2018 financial results. If you have not received this news release or if you would like to be added to the company's email distribution list, please visit the company’s website at www.precisiontherapeutics.com.
Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements regarding the operations and future results of Precision Therapeutics and Helomics Corporation. I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation, its Forms 10-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
With nothing further, I would like to turn the call over to Dr. Carl Schwartz. Carl, the floor is yours.
Thank you very much. And I appreciate it and welcome to everyone who has joined us today for today's first quarter 2018 earnings call. Although it's only been a few weeks since our last call we have made meaningful progress, across both our Skyline Medical and our Precision Oncology Division, and I'm pleased to have this opportunity to provide you with an update on these recent achievements.
I'll start by discussing our strategic plans in the Precision Oncology Market, before Richard Gabriel goes into more detail on the progress we are making in our TumorGenesis subsidiary. Then Gerry Vardzel, CEO of Helomics Corporation will provide an update on the recent developments at Helomics. I will then recap Skyline Medical's recent sales progress before turning the call over to Bob Myers, our CFO to discuss the financial results from the quarter in more detail before opening the call for Q&A.
First a quick update on our independent auditor. Subsequent to the quarter-end we welcomed Deloitte & Touche, a big four accounting firm, as our independent auditor. Given the major changes that are underway at the company it was important for us to have auditors that can handle the increase in workload as the scope of our business expands. We are very pleased to have passed Deloitte's very strict acceptance procedures and believe this appointment is reflective of our commitment to a strong corporate governance and best practices, as the company evolves.
Now moving on to our strategic plans to establish Precision Therapeutics as the leader in the field of precision oncology. The emergence of precision medicine is changing the face of cancer care by enabling physicians to predict responses to molecularly targeted drug, leading to better defined treatment options for patients. The global cancer growth market is expected to generate revenues of around $161 billion by the end of 2021 and according to Zion Market Research, this presents a major opportunity to position the company as an invaluable resource to life sciences companies operating within the precision oncology market as personalized targeted therapies are increasingly developed for the treatment of cancer.
The first quarter of 2018 was a transitional time for the company as we made rapid progress, accelerating our entry into this market with the formation of our TumorGenesis subsidiary and our 25% investment in Helomics Corporation. TumorGenesis was formed to pioneer a powerful new approach to growing cancer tumors in laboratory, with an initial focus on ovarian cancer.
We have already put together a strong team to drive this strategy, including appointing Dr. Mark Collins as the President of TumorGenesis. Mark joins us from Helomics where he's Vice President of Innovation and Strategy. He has held multiple executive roles in a variety of discovery, informatics and bioinformatics functions within the global pharma and founded three startup software companies in the machine learning and drug discovery space. He is a great addition to the team and his appointment will serve to enhance the collaborative relationship between TumorGenesis and Helomics.
In business development, we engaged Richard Gabriel as a consultant to lead the external business development strategy for TumorGenesis Incorporated. Richard has been instrumental in securing several technology licenses for TumorGenesis to advance the development of the next generation PDX tumor models and has a proven track record at both entrepreneurial and public company setting including, serving as a board member of Precision Therapeutics since 2016.
I would now like to turn the call over to Richard to recap the progress we have made, executing against our threat strategy so far and lay out what we can expect to see from TumorGenesis over the next several months.
Richard if you would please go ahead?
Yeah, thank you Carl. I'm pleased to be here today to talk about TumorGenesis. As Carl mentioned TumorGenesis is developing a new approach to growing cancer tumors in the laboratory.
This presents a major economic opportunity, as there is a shift away from the traditional patient-derived tumors mouse model or the PDX mouse model, to screen new drugs and toward more advanced technologies The National Cancer Institute has abandoned its standard cell lines and is evaluating patient-derived tissue samples as the new standard for drug screening technology, that it offers to institutions and researchers.
The NCI is keen on using patient-derived samples and has funded the only technology, the PDX mouse model to screen new drugs. It is searching for more robust and lower cost alternatives to the PDX mouse model, as many other pharmaceutical companies and developers. Our goal is to meet the needs of the NCI and the drug discovery industry with a solution that is cheaper, faster, more accurate than the PDX mouse model. Recent studies show the potential for helping physicians categorize and select best combinations of treatments for patient-derived tumor samples is expected to exceed several billion dollars per year.
BCC Research states that the non-human cell culture market is expected to top $300 million for the Clinical Research Organization services or CRO services and $250 million for assay kits by 2019. The compounded annual growth rate of this sector or the CAGR of three dimensional cell culture technologies is expected to top 30% by 2020. Our initial focus will be on ovarian cancer. Currently there are 24 mutations of ovarian cancer and TumorGenesis is focused on completing tumor generation for each of these mutations in the first half of 2019.
We also hold exclusive licenses for breast, pancreatic, colon, lung, brain -- and brain cancer which will drive our long-term expansion strategy. Each of these cancers can also produce many mutations which display different characteristics. Ovarian cancer cells fool a woman's immune systems into behaving as if nothing were wrong, thereby evading the immune system response. The TumorGenesis approach is designed to fool the cancer cells into thinking they are still in the patient -- patient's body which in turn will enable developers to test drugs in a model system that closely mimics the way tumors grow in the body. This will then provide more relevant patient tumor model for testing of drugs for personalized therapy and for the development of new drugs.
Testing of the TumorGenesis PDX tumors by pharmaceutical companies will take place in collaboration with Helomics, and will enable patients to determine how their particular cancer cells may respond to different chemotherapies. We are moving quickly to validate these new TumorGenesis technologies in a clinical setting with the help of pathologists, oncologists and of course patients. This involves taking the following actions. Step one, securing cancer samples by mutation. We aim to secure our first cancer samples over the next four to six weeks.
Stage two, discovering and announcing the first peptide sequence. This is estimated to be sometime in the third quarter of 2018. Stage three, selecting and optimizing the peptide structure for tumor growth, which we expect to be completed sometime in the fourth quarter of 2018. Once we have completed these first three stages, we can expect to enter stage four at the end of the fourth quarter growing our first commercial tumor. This tumor will closely mimic the characteristics of the patient’s tumor.
Once these tumors have been externally grown we can commence with our commercialization strategy. In parallel to these efforts, we are seeking pharma companies with ovarian cancer pipelines, to establish contracts with them for the TumorGenesis approach. These companies would be early adopters who will pay to explore our models. This is a very exciting time in our development, and we aim to keep our shareholders apprised as to when the milestones are reached.
Now I will turn it back to Carl. Carl?
Thank you, Richard. To complement and enhance our TumorGenesis offering in the precision oncology space we are deepening our relationship with Helomics. Subsequent to the quarter end we signed an LOI to purchase the remaining 75% of Helomics and bring our total equity stake to 100%. This transaction when completed forms a very important part of our growth strategy and will cement our competitive edge in the precision oncology market.
Acquiring Helomics will give us complete ownership of its one of a kind tumor database, which has been developed over 15 years of clinical testing. This data contains the drug response profiles of over 149,000 patient tumors. We believe this data has the potential to revolutionize the effectiveness of clinical trials and drug development and are excited about the opportunity to monetize these assets to grow revenues at Precision Therapeutic.
Together Helomics data sets [ph] and TumorGenesis tumor model will offer the most advanced technology in the market to advance the clinical testing of new personalized cancer therapies. Testing cancer cells in the lab before they're treated in the patient's body provides an actionable roadmap for patients and their oncologists to guide therapy and positively impacting patient outcome. This is truly a unique offering, combining artificial intelligence with personalized oncology.
With that I'll now turn the call over to Gerry Vardzel, CEO of Helomics. Gerry is going to talk to you about what Helomics has been doing over the past quarter and our expectations for the business growth in full [ph].
Thank you Carl. It's a pleasure to be here today to provide an update on the progress we are making in each of our different areas of the Helomics business. There is significant demand from pharma companies for rich molecular data on patients with various diseases, especially cancer, to drive patient selection for increasing targeted trials for immuno-oncology drugs, companion diagnostic, biomarker discovery and validation and drug repurposing.
Both pharma companies and investors have shown an appetite paying substantial sums to access such data. Helomics has a highly valuable asset in the form of actionable big data on patients with cancer that details how their tumors respond to chemotherapy.
Helomics is in a strong position to rapidly realize this asset and generate high revenues to the company. To recap our business model for those of you who are not familiar, we think of the business in terms of three complementary pillars, all which are currently revenue generating and have growth strategies in place. The first, the integrated clinical CRO business. This leverages our state-of-the-art CLIA lab to provide specialty services to pharma, biotech and diagnostic companies to drive the development of new therapy and diagnostics during clinical trials.
We have formed contracts with diagnostic, biotech and pharmaceutical companies, to grow revenues. While this area of the business is currently in the early stages of its ramp, we have signed multiple projects and have several more in the work. CRO services is an increasing trend and multibillion dollar market and this division has high potential for growth as the industry matures and more and more Precision Therapeutics and our clinical trials.
The second dChip bioinformatics; this is a proprietary artificial intelligence powered bioinformatics engine that provides actionable insight from the rich patient data Helomics collects as part of its diagnostic business. Pharma and diagnostic companies use the dChip to aid disease diagnosis or drive patient selection for clinical trial. Revenues from dChip range from $50,000 for a simple pilot study, a $100,000 to $250,000 for a more comprehensive study or annual subscription to the platform and up to $500,000 for a partnership that involves the CRO elements.
Helomics currently has an in depth data generated from over 149,000 tumors over 15 years of clinical testing. dChip is a key part of this integrated clinical CRO services, allowing researchers to mine this knowledge base to produce actionable insight that will drive biomarker discovery development, patient recruitment and selection for clinical trials and drug repurposing initiatives. This has the potential to generate very significant revenue.
The volume of tumor specimens that we profile is continuously rising, which in turn generates additional data for our tumor bank. We are currently securing three tumor specimens a week and are working to increase this number to 50 per week by the end of the year. As we ramp towards this target our revenues will grow in kind and we expect to be breakeven for the third quarter.
Helomics and Precision Therapeutics are able to rapidly bring the dChip to market with a relatively modest investment and see significant return on investment since over $180 million was already invested in data collection. To accelerate this process, we are negotiating several key strategic collaborations to enrich the knowledge base that dChip has on ovarian cancer.
The third, our precision oncology insights, this involves comprehensive tumor profile using the power of our artificial intelligence and the dChip to provide a personalized oncology roadmap for patients and their oncologists. Our outreach efforts to oncologists have ramped significantly over the past several months and we are pleased to have received positive feedback and validation for our precision oncology insights approach. We are also working to form strategic deals for precision oncology insights with academic medical centers around the world to generate additional revenues.
These intangible assets will create increasing value to the company as we execute on this strategy. While we're not the only company in the space, we believe we can be the leaders in the market for the six cancers we are targeting; ovarian, breast, pancreatic, colon, lung and brain cancer. What differentiates us in the world of precision oncology is our focus. We're specifically attendant to the oncology insights for six specific cancers and we intend to be the world leader in the artificial intelligence for those six cancers, providing actionable data that can facilitate the development of precision therapy.
Furthermore, unlike most other companies applying artificial intelligence in this space Helomics already has the data obtained from over 15 years of running its chemo effect treatment selection biomarker assay and other molecular tests. We believe our specialized approach in this one of the kind data library of 149,000 tumor profiles will make us the go to provider in our segment of the industry.
With that, I will now turn the call back over to Carl, so that he can provide an update on the sales of the STREAMWAY System.
Thank you Gerry. Our Skyline Medical Division continues to gain sales momentum as evidenced by the strong revenue growth of 135% reaching $411,593 in the first fiscal quarter. This was driven by the sale of 16 STREAMWAY Systems compared with the three in the first quarter of 2017. Our improved revenues were the result of our expanded U.S. sales based force which has lead to higher sales to new customers and four unit sales that were incremental to sales to a prominent Minnesota-based hospital system. To-date we have sold 123 STREAMWAY Systems and our customers include some of the top hospitals from the U.S. such as the University of Virginia and Intermountain Health Flagship Hospital in Utah.
To accelerate our sales strategy and secure new customers we are ramping our marketing efforts, and increasing our presence at key industry conferences. While Q1 is typically a slow time for industry events we have already participated in several conferences in the current quarter and are constantly exploring new opportunities to raise the profile of the STREAMWAY System among key decision makers within the medical field.
The majority of our sales today have been in the interventional radiology and this is where we believe, there is the most immediate opportunity to grow revenue. Within this market our main focus for 2018 is on large volume liver transplant center and the referring facility [ph] due to the large volume of paracentesis procedures performed at these facilities.
In addition we aim to leverage our success securing sales to IR rooms, to expand into other departments using a deep and wide approach. These targets include endoscopy surgery, urology and cystoscopy which we believe present a promising opportunity for us to grow sales.
Another key element of our sales strategy is to penetrate key international markets and during the first quarter, we opened our new European headquarters, headed up by our Vice President of International Sales, John Paul Rasschaert. We also hired a Director of Sales in Germany with over 40 years' experience and have negotiations underway with independent distributors in France, the UK, Germany, Spain, Portugal and the Benelux region.
While in its early days, we're extremely pleased with the progress that our European sales team has made, educating the market about the unique benefits of the STREAMWAY System. And we expect to secure our first sales in this market during the second half of 2018. Based on the ongoing discussions that are underway with hospital chains and medical clinics based in Europe and the interest we have generated over the past several months, we expect to make meaningful STREAMWAY sales in Europe in the second half of 2018. Europe is a major untapped market and we will continue to invest in this exciting opportunity to grow our international footprint.
Now I’ll turn the call over to Bob Meyers, to discuss our financial results for the quarter in more detail. Bob, please go ahead.
Thank you, Carl. I will turn now to our financial results for the fiscal quarter ended March 31, 2018, which we filed with the SEC earlier this afternoon. Revenue for the quarter ended March 31, 2018 was $411,593 compared with $175,166 for the quarter ended March 31, 2017. We sold 16 STREAMWAY systems during the first fiscal quarter compared with three STREAMWAY system sales in the first quarter of 2017.
As Carl mentioned, we are pleased with the ramp up in STREAMWAY system sales that we have witnessed in the first three months of 2018. And we believe our sales and marketing campaign for the STREAMWAY system will continue to gain traction throughout the remainder of the year. Our awareness campaigns to improve the use of disposable filters and cleaning products, continues to drive higher usage among existing customers, generating recurring revenues. Furthermore, we expect to secure our first revenues from Europe in the latter half of this year.
Gross profit for the quarter ended March 31, 2018 increased to $294,250, compared with gross profit of $134,174 in 2017. Gross profit margin was 71.5% of revenue, a decrease of 7 basis points compared with 78.9% of revenue for the same period in 2017. Total operating expenses for the quarter March -- ended March 31, 2018 were $2.1 million compared with $1.5 million reported in the prior year. This increase was primarily due to sales and marketing expenses which increased $403,084 due to the addition of sales reps and increased participation at medical conferences.
The net loss available to common shareholders for the quarter ended March 31, 2018 was $1.8 million or $0.15 per share on 11.4 million weighted average shares outstanding. This compares with a net loss available to common shareholders for the quarter ended March 31, 2017 of $1.3 million or 21% per share on 6.5 million weighted average shares outstanding.
The company had cash, cash equivalents and marketable securities of approximately $2.2 million as of March 31, 2018 compared with $0.8 million as of December 31, 2017. The increase in cash was due to $3 million of net proceeds from the public offering and the over allotment option exercised by the underwriter.
With that, I now turn the call back to the operator to open the line for questions.
Thank you. [Operator Instructions] We’ll take our first question from Dana Allen.
Yes, hello. That's one of the most interesting Q calls I've ever heard. So I think my first question -- I do have several, I think it may have already been answered. I did some research on my official numbers, [ph] but I thought I saw that Helomics have $50 million invested in it. Did I hear you say that $180 million was invested in the database?
Yeah, over the years, this is Gerry Vardzel, good question, over $180 million has been invested in the company.
Okay. And I thought I saw some place outs that in the last 12 months or previous year whatever that had about $8 million in annual sales is that true?
I'd like to answer that. This is Bob Myers the CFO. That is not true. That was really was alluded to in an article written by a third party individual. $8 million is the amount that is included in a deal that we have with Helomics regarding our first 20% of the ownership where we have stock that is in escrow and will be released to them on the first $8 million earned.
Okay good. And is there currently revenue at Helomics?
Yes there is.
Approximately how much a year is it?
We're not prepared to answer the amount at this point in time, I'm sorry.
Okay. And I heard in the presentation that -- I think by Richard you said something about the breakeven will be achieved possibly by third quarter, is that for the whole Helomics or was that just for the particular thing that you talked about?
Gerry, do you want to answer that or let me.
You can answer it.
We were talking about Helomics specifically with the third quarter that they will approach breakeven.
That's impressive. And what is the headcount at Helomics?
18 okay. And the tumor growing thing sounds like amazing opportunity. Is there anyone out there that's ahead of or you being able to do this?
This is Richard Gabriel. I don’t think that there are -- that there is anyone that's doing this combined approach. We actually found, as a team three separate technologies that we licensed in and merged -- we'll merge them in with the existing tumor -- with the existing Helomics technologies. And I'm not aware of anyone that has done that. I mean there could be, but I'm not aware of anyone.
So it sounds like you're out there looking to buy the stuff, so pretty good chance that nobody is out there. So is this cloning or how does the tumor that's inside someone who's obviously sick, how do you get that to grow it outside the body?
Well there is a series of -- in the body, peptides and glycoproteins and a variety of other markers, signal to cells back and forth what's good, what's bad. It's a very complicated environment. We have over the years, the NCI included have narrowed down the cancer cells to where only the cancer cells survive. What we've learned as a group of oncology developers over the years is that that's not such a good idea, that we have to preserve the tumor environment.
So the technologies that we licensed in use a combination of peptides, support systems which would be in essence the structure as well as combination. But we're working on it really hard.
Okay and on the dChip thing, is that literally in IC or is that software. What is the dChip?
It's a machine learning system that we've built out using from our 150,000 plus tumors data, mostly on molecular data and drug response which is our differentiator of drug response data.
So it's not actually an IC chip, the term dChip is used but really it's a system that probably runs software on hardware, is that correct?
It’s software, it’s in essence.
Yeah. Yeah. Okay. Got you. I've just been in the software industry, so interested in that, good. And then on STREAMWAY trying to divide out the revenue by the numbers sold, it sounds like they sell for about $25,0000 each, is that approximately correct?
That's correct. Our list price is $24,900.
Okay. So that's pretty good guess. And on that, how many do you -- what annual rate of sales, you are expecting a 100 this year, it sounds like you will even get more in Europe, what annual unit count you think is necessary for that division to be cash flow positive?
I am not prepared to give you that answer at this point in time. We did changes unfortunately to the amount of revenue that we receive for our disposables. Ideally, we would be reaching a two-thirds of revenue on our disposable income at an exponential rate. And that means that, it lowers the amount of units that we have to add out there on a breakeven end. So that’s kind of dynamic, it’s just a little difficult to go into on this call.
All right. And the other thing, your market cap, I think was like $11 million before your buying Helomics, so it's maybe $15 million or $16 million, something in that neighborhood. For the level of excitement we have, in terms of potential, it sounds like this tumor growing thing just for your company alone, could potentially be $500 million of your revenue. Tell me if I'm crazy or something like that but it sounds like a very big opportunity, do you see it the same way?
Okay, how do you explain how tiny your market cap is today?
I think that our market share is in transition. We have had over the years a number of medical device investors that are stuck with this on our STREAMWAY system. And we have now realized that precision medicine is the way to move and that we have made this right turn into Precision Medicine market, and that we are gearing everything towards that as well as increasing of course our STREAMWAY Systems.
So we haven’t yet attracted the biomed and pharma type of investor. I think they're waiting to see what happens with the Helomics acquisition, which is very, very near. And I think that we should hopefully see a positive result in the market once that occurs.
Yeah. It sounds so -- it seems extremely rare. And by the way I would suggest you taking this conference call or whatever and going to have a article of it [ph] or whatever producing a slideshow or something to go along that because this is maybe the most interesting conference call that I've ever listened to, in terms of potential. So congratulation guys on putting together a great presentation.
That’s it from me.
[Operator Instructions] We will go next to Rob Dove [ph] of Skyline Medical.
Hey guys. I am not with Skyline. I own the software, that's what it is. On this STREAMWAY system we did 16 [ph] in the third quarter, have we sold any in the second quarter yet?
Yes, we have. I am looking at the end of the second quarter to be approaching the number we had in the first quarter.
Okay. Good. Are we still on target for the total for the whole year just in the United States, it’s about 100 or 200, I don’t remember if off the top of my head.
100, and yes, we are on target.
Okay. And with the Europe, [indiscernible].
Oh, yes sir.
Okay. And the last thing I saw [Author ID1: at Thu May 17 11:41:00 2018
]in the news about the NASDAQ, [indiscernible] your $1,000 bid. When is the Helomics acquisition supposed to be completed?
Right now we are under $1 but we are not in danger of NASDAQ issuing us any letter that takes 30 days of continuous bid price being under $1. So we are on the early stages of that as we have gone over a $1 a couple of times. Certainly we hope that the Helomics defined merger agreement would change that and then the close of that merger as well. We expect to close that merger very, very shortly. You may hear that within the week certainly.
That sounds really good. I think that [indiscernible] have been answered for me. That does it. Appreciate it.
[Operator Instructions]. With no further questions in the queue, I'd like to turn the call back over to Carl Schwartz with any additional or closing remarks.
Thank you operator. Before closing today's call. I'd like to reiterate how excited we are about the opportunity before us. There is a major healthcare revolution underway and our entry into the Precision Oncology phase will enable us to leverage this opportunity to drive growth and build shareholder value. We're incredibly excited about Precision Therapeutics' future and believe we have a major opportunity to accelerate our growth by positioning the company as an integral partner to the life sciences' industry as we develop personalized targeted, cancer treatment.
By bringing together the most advanced technology under one roof and focusing on innovation, we believe we can make a real impact on patient's outcome to play a transformational role as we enter this new era of medicine. For investors, it's very important for you to understand the model we have created here. Our complementary business areas generate individual revenue stream that build on one another and generate sales momentum across of all company. Furthermore we're now at a point where we can rapidly start to monetize our offering and take advantage of synergies between TumorGenesis and Helomics.
Helomics' three interconnected business areas are already revenue producing. The Oncology Insights division not only generates revenues from the Oncology client base, it also drives tumor assessment donations, which in turn grow our intangible asset base that virtual biobank. Likewise while TumorGenesis aims to bring in revenues direct, upon the direct sale of it's lab grown commercial tumors, it also generates revenue growth at Helomics by driving business to the Precision Oncology Insights Division which is responsible for the testing of tumor.
Of course this will ultimately add even more tumor specimens to the biobank, raising the valuation of the Precision Therapeutics on the whole. We believe this business model in which the various revenue streams stack up against each other -- stack upon each other I should say, will drive shareholder value in the near term and fuel our ascent to become a leading Precision Medicine company in our six core focus areas; ovarian, breast, lung, colon, pancreatic and brain cancer.
With that I will now close the call. Thank you once again for everyone who joined us. And I look forward to updating you again on our Q2 call. Thank you.
This does conclude today's conference. We thank you for your participation. You may now disconnect.
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