Elite Pharmaceuticals, Inc. (ELTP) Q3 2018 Earnings Call Transcript
Published at 2018-02-12 15:57:05
Nasrat Hakim - President and Chief Executive Officer Carter Ward - Chief Financial Officer Kenneth Smith - Vice President, Legal
Good morning, ladies and gentlemen. And welcome to the Elite Pharmaceuticals’ Conference Call. At this time, all lines have been placed on listen-only mode. Before management begins speaking, the Company asked the following statement. This conference call contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this conference call. Listeners are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, Elite’s ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of SequestOx by the FDA, the steps Elite may take as a result of the CRL, and the action of the FDA require of Elite in order to obtain the approval of the NDA. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of SequestOx by the FDA and the actions the FDA require Elite in order to obtain the approval of NDA. These forward-looking statements are not guarantees of future action or performance. These risks and other factors, including, without limitation, Elite’s ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities and intellectual property, protections and defenses, are discussed in Elite’s filings with the Securities and Exchange Commission, including its reports on Forms 10-K, 10-Q and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. With that covered, it is now my pleasure to turn the floor over to your host, Mr. Nasrat Hakim, President and Chief Executive Officer of Elite Pharmaceuticals. Sir, the floor is yours.
Thank you, Kate. Good morning, ladies and gentlemen. My name is Nasrat Hakim. I am Elite’s President and CEO. This is Elite’s earnings call. So Carter Ward, our Chief Financial Officer will give us high summary of Elite’s financials. After which, I’ll come back with an update on SequestOX FDA and facilities, pending ANDA’s, R&D pipeline and sales and marketing and answer few questions that you have submitted to Dianne. Mr. Ward, you have the floor.
Thank you, Nasrat, and thanks everyone for calling in today. Friday, we filed our 10-Q for the quarter and for the nine months ended December 31, 2017. We’re on a March fiscal year. So the December quarter is the third quarter of our fiscal year ending March 31, 2018. Q is available on the Investors section of our Web site, which is elitepharma.com, or wherever else you may get your SEC filings. If you haven’t seen our Q yet, please get your copy from elitepharma.com or one of those other sites. I am going to briefly take you through some of the key parts of the financials and give some analysis and context on the numbers. Also, as always, we received questions and comments from our shareholders and others that follow Elite, and I will do my best to address those questions and comments from all of you that are financially related. So let’s start with the P&L, first the revenues for the December 2017 quarter were $2.5 million and that’s compared to $2.3 million for last year’s December 2016 quarter, so it’s a $200,000 increase or around 9%; the decent year-on-year increase, which is attributed to growth across almost all of our product lines; Phentermine, Naltrexone, Hydromorphone, Phendimetrazine, Isradipine, Lodrane, they were all up as compared to the prior year. The December 2017 Methadone revenues were slightly down as compared to the prior year, but they were significantly above revenues for the prior quarter, September 2017 quarter. So that leaves me to the next observation and that would be the increase in revenues from the last quarter to this quarter. Last time we spoke about the September 2017 quarter, we talked about revenues for that quarter of $1.6 million. Last Friday, we reported revenues of $2.5 million for the December quarter that’s a 56% increase on a quarter-to-quarter basis. I just mentioned that Methadone had a part to play in this increase, but all of our product lines were also up compared to the prior quarter. The takeaway here is that revenues are up both on a year-to-year and a quarter-to-quarter basis and that growth is due in very large part to growth throughout our product line; Phentermine, Phendimetrazine, Naltrexone, Hydromorphone, Isradipine, Lodrane, once again they were all up compared to last year and they were up compared to last quarter, and that’s something we like to see. One more thing on Methadone, most of you are probably aware that Methadone is the product that we manufacture on a contract basis and that contract technically expired on December 31st. And I did get a few comments on that. We're still working with our Methadone customer and discussing a renewal. There continues to be demand for this product. We've been getting orders from the customer and we have been honoring those purchase orders received from this customer and we continue to manufacture Methadone for them. Nasrat will be giving an update on all the product development that's going on in Elite, which will give you an insight into contract manufacturing’s decreasing role in Elite's long term strategic plans. But in the near term, contract manufacturing is important to us. We continue to make and ship Methadone and we expect to do so for some time. Moving down to P&L to R&D expenses, which were $2.5 million this quarter as compared to $1.5 million for the December 2016 quarter, the $1 million increase to approximately 67% increase. Now every quarter I point out that the numbers are important, but equally important is looking at what was done to incur these R&D expenses. Where and how the money was spent and what was achieved. And this remains the case. In this quarter, R&D costs were incurred in the reformulation and successful pilot study conducted on SequestOx. The completion of development of the first product being co-developed with SunGen, which led to ANDA filing last week, continued development of multiple products in Elite pipeline and the diligent response to FDA comments and request relating to the ANDAs that were previously filed. Just to remind you we now have five ANDAs pending with the FDA, an NDA filing for SequestOx, which has just demonstrated outstanding results in a pilot study and several other products, which are being actively developed in our pipeline. That's where the costs have been incurred and those are the results so far. Also on our last call, I discussed the composition of the product development cost center in a little more detail. And I'd like to repeat some of that today, because it is an important part of Elite's capabilities and of our persona. It’s something that's importance for current or potential investors to know. So R&D costs are either external or internal. External costs consists of raw materials, clinical trials, regulatory fees and various other costs paid to third parties. Depending upon what we're doing, these costs will vary. Some quarters we may be running a clinical trial or have to purchase some expensive materials resulting in higher costs. This is an area where I particularly stress the importance of knowing what is being done and not just the actual amount of expense incurred. Internal costs are our employees, our lab and our factory. Having the proper mix of people and resources is key. It is the internal cost portion that gives an insight into Elite's capabilities. But I mentioned product development activity was and remains as high as I've seen since I joined Elite in 2009. We have more chemist formulators, technicians and regulatory affairs personnel than in the past. Our factory and labs have been significantly upgraded over the past few years, providing us with product development resources that are improved in both quantity and quality. And most importantly, due to our current size, we are nimble with most of those resources with our people, facilities and equipment. We're able to shift resources quickly between commercial manufacturing and product development as needed. And that's important to understand and realize with regards to Elite. So the takeaway with regards to R&D is that it's important to know what we are doing and achieving just as much as it is to know what's being spent. The spending is right there on our Ks and Qs filed. But there is so much more to that particular number, which is demonstrated by filings by successful trials, people, resources and facilities, that are sometimes not so impairment, but nevertheless critical if you want to understand the lead. Finally on the P&L statement, we reported an operating loss of $2.1 million for this quarter compared to $1.7 million in the December 2016 quarter, so $400,000 higher loss or approximately 23% as compared to last year. Once again, it’s important to look little more closely at the P&L and this one really jumps out. The $2.1 million loss this quarter was less than what we spent on R&D, while not completely 100% correlating the relationship between operating loss and level of R&D costs gives a good insight into Elite’s commercial operations. So our commercial operations, they are important to us to our overall operations, we need the revenues and the profits generated by commercial to fund our operations. The P&L demonstrate that commercial ops are doing just that and contributing in part to R&D, remember the loss is less than what we spent on R&D. So clearly, the overall losses, these types of losses they can’t go on indefinitely, even if commercial operations are positive, but our R&D is achieving filings that are moving through the FDA process. We are achieving positive trial results and we are moving forward with the development of a diverse pipeline. Our business model is just like everyone else in this industry, pipeline is our future and we’re working towards approval and commercialization of this pipeline to realize profits and increase shareholder value. The current level of commercial operations is helping us get there and the indicators are there to support my optimism that we’re moving toward commercialization of this pipeline of our pipeline and towards profits. And one last thing before Nasrat takes over, that’s a question that I received on the effects of the new tax law on Elite, the one that was signed in December through the Congress. There is a disclosure on this in Item 1A of our queue that’s the risk factor section of the queue. But to summarize, the new tax were mainly effects us in two areas and both in the future, they’re not currently affecting us. First, there is a change in how net operating losses are deducted. This will have the earliest effect on us of the two factors and it’s when we achieve taxable profits. Net operating losses are losses which we reported in the past, they’re accumulated and used to offset future profits and therefore decrease future income taxes. We have a large net operating loss, which is a valuable item to Elite. Prior to the new law, prior to the 2018, all net operating losses are fully deductible against future profits. Starting this year, the new tax law says that these NOLs, net operating losses, are deductable only up to 80% of income. Now whatever amount of the NOLs that you can’t use in a particular year, they’re not loss but in fact they’re just carried forward to the next year. So you’re still going to be able to deduct them eventually all of them, it’ll just takes a little longer. And one more thing on that it’s important that the NOLs accumulated prior to 2018, they still follow the old rules they’re grandfathered in. So it’s just the fresh NOLs from this year on that are effective. So the change in the net operating loss rules, it does have an effect on Elite and I’m hoping that we’ve become profitable sooner rather than later and then that would make this effect minimal. Second on the new tax law is that the decrease in the tax rate from 35% to 21% that’s obviously a big deal and it would have a significant effect. But once again, we need to be profitable first. One other thing, I also process the company’s payroll and I’ve noticed the decrease in tax withholdings on everyone’s paychecks. So our employees, they’re all getting a bigger paycheck, which that doesn’t affect, Elite has a corporation, but it’s appreciated by our employees and that includes me, I'm also an employee. Now, our Chairman and Chief Executive Officer, Mr. Nasrat Hakim would like to give an update and his comments.
Thank you, Carter. I did not notice that increase you’re talking about on my paycheck, since you haven’t given me one in 4.5 years. Dianne received several questions via email and phone calls. So I tried to organize my presentation around; first, what I would like to update you on and second the questions that we have received. So we'll be covering SequestOx facility and GMP updates, FDA, status of the pending ANDAs, pending R&D projects and sales and marketing. So I'll start with a review of Elite’s ongoing activities and the progress on our pipeline and strategies. So for our pipeline, we'll start with NDAs and that is our SeaquestOx. We recently reported very good news on SeaquestOx. So let me start with a review of this product. You might remember from our last investor call that I discussed the importance of SeaquestOx and how we had identified certain modifications to SeaquestOx that showed promise in the lab studies in vitro. That we thought these modifications might address updates from some about the delay in Tmax. And if you recall, we have passed all attributes versus the brand, the only issue we had was with Tmax -- the only issue the FDA had was with Tmax. Lab study showed that the modified formulations improved the solution substantially over our original formulations in Medias simulating fat conditions, and we were hoping that the improved solution will translate into a shorter Tmax of the new formulation. So to that end, we found out if the modifications would work on humans in order to find out if the modifications would work on humans, we ran a pilot study. This was only a pilot study with 12 subjects. We decided on a pilot study rather than a large pivotal bioequivalence study in order to keep the cost down, and also it will allow us to go with more than one formulation and still contain the cost. Our goal was to identify the best option to take forward into a bioequivalence study with a larger number of subjects. The pilot study was a randomized single dose study. We dosed 12 subjects with the modified formulation and 12 subjects with the reference drug, Roxycodone. The pilot results were outstanding. The Tmax with the modified SeaquestOx improved drastically and was essentially equivalent to the reference drug. The mean Tmax was 2.5 hours for the modified SeaquestOx formulation and 2.3 hours for the reference drug. The range of Tmax was 1.3 hours to 5 hours for both products. The range was identical. This was a dramatic improvement over the original formulation. In this pilot, we also measured the partial AUC, AUC is area under the curve for different time points. This is a measure of the amount of the drug that gets into the bloodstream. The partial AUC between 0.5 hours and 4 hours for the modified formulations were 80% to 110% of the reference drug, compare that to the original formulation where it was 10% to 50%. Based on the drug onset performance results, we believe that we have a path forward for SeaquestOx. The next step for SeaquestOx therefore will be a presentation of the pilot results to the FDA. We will need the FDA to confirm that their previous guidance on SeaquestOx formulation modifications will apply to this modified SeaquestOx formulation. So we can confirm what studies are needed for resubmission of the NDA. Some final points on SeaquestOx. The FDA has granted Elite a 12 month extension as we showed with you before for resubmission of the NDA that goes until the end of 2018 and the PDUFA filing fee waiver continues unless until that time. I would also mention that people commented to me about the abuse-deterrent formulation tested in the pilot study and listed in the SequestOx press release. This one product used an abuse-deterrent formulation that was not the sequest or naltrexone technology. Indeed, Elite continues toward at a range of product and technologies, we are extremely excited about this. But because it is in early space development, we will not be commenting about it further at this time. FDA facility and inspection. I am very happy to report the positive FDA inspection that we recently completed at our facility in New Jersey. First, we have the preapproval inspection in December that we shared with you before for an ANDA filed by Elite. At the conclusion of that inspection in December, the FDA issued us no observations. The inspection was classified as No Action Indicated, NAI. At about the same time in December, we receive a close out letter for an FDA warning letter regarding pharmacovigilance that we got the previous year. This removed any potential restrictions that might have applied from the warning letter. In addition, just last week, the FDA completed another inspection of our facility. This one was a full GMP inspection whereby they covered four quality systems. Like in December, we again received no observations and this inspection was also classified as No Action Indicated. I am very pleased and proud of the positive outcome of these inspections. Two inspections with zero observations is outstanding for any company nevertheless for a small company. Elite worked hard and continues to improve our quality and compliance systems. This provides a strong foundation on which to build the company and launch new products from our pipeline. Our pipeline, Elite continues its focus on development of new products and our pipeline represent the strength of our company. We may have two commercial products but the heart and soul in this company is our pipeline. To review SequestOx, NDA is perhaps what we’re best known for, but Elite currently has many ANDAs in development and in clinical studies, all five already with FDA that has substantial value. The most recent ANDA filing was last week and it was an ANDA for an immediate release Central Nervous System, CNS product that we co-developed with our partner SunGen. For which there are brand and generic sales of $400 million. And Next ANDA filing was expected to be submitted next, is expected to be submitted next quarter. This is a generic that we also co-developed with SunGen. It is an extended release product for which there are brand and generic sales of approximately 1.6 billion. We have successfully completed all the bioequivalence studies require Fasted, Fed and Sprinkled and we have completed most of the stability required. We expect to file this product, which is going to be our new avatar next quarter. Elite has filed five ANDAs, including one we just filed last week and we continue to respond to information requested by the FDA for each of these filings. As we gain experience, we improve the quality of our filings and our responses, and we continue to build a stronger regulatory filing group for our future filings. We look forward to approvals for those products soon. Growth in our pipeline, Elite's pipeline is the source of growth for this company and for the stock. We have invested heavily into our pipeline. And as we begin to receive approvals on launches, these products we expect to see substantial growth in the company and our stock. To summarize, we have five NDAs pending. This is a large number for a company our size. We have provided market revenues for the products in our pipeline and you will see that these products are in markets of substantial size. We expect to see the first approvals for these products as I said soon. The news on SequestOx was very positive. In the pilot study, we were able to address the Tmax concerns expressed by FDA with minor modification to the outside layer. I was asked about the naltrexone and if it was ran as part of a pilot study. Naltrexone was used in both cases in formulation A and B. There was no modification to the Naltrexone B. We only modified the excipient, one excipient and the oxy layer. We believe this creates a path forward for us to file this product with FDA. However, we will first wait till we hear back from FDA so we'll have no surprises. We continue to spend on future product development activities. Elite expects to be submitting other products this year. As I mentioned, the extended lead generic co-developed with SunGen will be filed next quarter. There will be other products that we are conducting clinical trials for and potentially could be filing towards the end of this year. Finally, our financials have been consistent. Our revenues based on about $2 million per quarter provide a base, which we can grow substantially as our pipeline products are launched. We continue to believe that Elite's price is undervalued. We believe the current price does not reflect the value of the Elite pipeline and we expect the price to react positively to the developments underway and grow as we get products approved on launch. One of the questions was about sales and marketing, so I'll say couple of quotes about sales and marketing. As I've updated you before, we have multiple options. We can start the sales and marketing group by ourselves that has its advantages and disadvantages; advantages and that you get to keep all the profits; disadvantages that you got to carry all the costs and there is the issue with the working capital. Anytime you create or remanufacture lots, you need to sell it, you don't get paid for several months. So you have to carry that dead-weight of millions of dollars for a while and for small company like us that that is stopped. We are speaking and have spoken to several partners about sales and marketing. We can also launch with one of our current partners. We have three, Dr. Reddy, Epic and TAGI. And that would solve the working capital issue. However, you'll have to share the profits with these entities. And finally, we have spoken with SunGen about the joint venture, because we have so many products incoming with SunGen. It would make sense for us to set up a sales and marketing team to sale both for our products and we can tag along Elite's products on SunGen products that are not in common between the two entities. All ideas are possible. We have not made any decisions yet. But whatever we decide, we'll be definitely in Elite’s best interest. Several questions were submitted as I stated earlier, so I'll try and go with over as many as I can. The first was regarding a statement that Purdue made. I think it was this weekend by [indiscernible] Television that Purdue can you comment on the impact positive/negative the news that Purdue Pharma is no longer promoting oxycontin and other opioids to doctors. In a series of state and municipal lawsuits that blame the company for contributing to the opioid epidemic. I heard the news this weekend and I read few articles about the subject. I have an opinion that it is the law or it has insight to what Purdue is doing. In my own opinion, I’ve always thought of Purdue as an IP law firm with a pharma arm. So they do anything that is not in their best interest. Now that they cut the sales and marketing force only by 50%, they’re not catering to doctors. The fact is who in the medical community have not heard of oxycontin. So I am not sure that they gave up anything except that was a symbolic gesture, because they’re getting sued by just about every single state. I do not see us benefiting or anybody benefiting from this action of not going to doctors because that doesn’t allow our product to get to the market and compete with them. As long as the lawsuits and they continue to stop others from entering the market, add-on thing they’re doing anything other than symbolic and because they’re actually in trouble with multiple states. Status of partners, partnership with SunGen and the filing that was supposed to go in December, the filing went in last week. We got delayed. We turned over the applications to SunGen. The application is supposed to be in their name and they took six weeks to review it. And as soon as they finished, we file the application. Status of the amendment for the Oxy APAP, it was filed. The FDA responded that they’ll communicate their decision to us between July and October. We have not heard anything beyond that. I am in constant communication with the project manager to ensure that that is sooner than later. Status of the amendment for Hydro APAP, we have not responded yet. We prioritized the product we filed with SunGen in addition to two other filings, and this will go out shortly. We’re running behind on that. A - Nasrat Hakim: After amendments are filed, how long before we can expect the response, approval from the FDA? Do you know where the drugs are in the queue? Honestly, I don’t want -- once you prepare your ANDA and file it with the FDA, they go through the entire thing and give you a complete response later, indicating something simple, go ahead and change the labeling and launch or something more complicated. And each ANDA is different. So I’m not going to go through all the details, but I’ll give you one example. We filed Oxy APAP and Hydro APAP. Both of them have tablets are scored, when a tablet is scored, it means you’re saying that you can break it in half and take half. There are regulations on what you test when a tablet is scored. So for Oxy APAP, which we file first for the scored tablets, we cut them in half, made an half put them on stability chamber call them back and 30 days plus the brand tested them and compare then everything was fine. The FDA reviewed that and have no issue with it. We filed Hydro APAP, we did the exact same thing we did for Oxy. This review and chemist decided to ask us for one more thing, they wanted to know what kind of impurities could result when you break it. So back to the drawing board, we have to put samples again make them put them stability, test them and report back to the FDA. So the question that the FDA comes up with dictates how long does it take and where that sit in the queue. Their obligation is to answer to you with an extra minus time, but the answer doesn’t have to be yes, its more questions. And this is why we’re beefing up the registration department to keep up with the questions that the FDA keep asking. And some of things are very consistent and some are not. So it’s creates an issue for us. Has the response been filed for the FDA complete response letter for Hydro, I just answered that. Is there anything holding back approvals on Elite’s and such as the facility or more work needed to be done? The facility, as I said, we have passed two inspections back-to-back with zero for [indiscernible], it doesn’t get better than that. So it’s not holding up anything. What’s holding it up is the questions that the FDA will ask all the time it takes FDA to review the responses. Does not Nasrat feel confident this will be approved? Yes, it's just a matter of time. I can’t tell you when, I'm hoping it’s within the next few months. But I'm very confident our applications, these two will definitely be approved and hopefully soon. Okay. The status of the undisclosed generic? I am hoping to see an approval in Q2 or Q3 of this year for the underscored generic and then we’ll disclose it. When does Elite expect to hear from the FDA about generic oxycontin ANDA? We’ve all the FDA response, they sent an inquiry and we're in process of responding to them. Once we do, then they'll respond back but right now the ball is in our corner. Update on SequestOx? We want to approve that, the pilot study on January -- perhaps Nasrat can provide more color as to the next steps. There is really not much except the following. We are extremely happy with the results, not only for SequestOx and Oxy anti-abuse, but because this is a platform, once it works on one IR we can use it on all other opioids. So we're very happy with that. We want to make sure that the FDA doesn't hit us with another curve ball like the Tmax and ask for more studies that we cannot afford. So we are writing up our analysis and we'll be submitting it soon to FDA and hopefully their response, definitely their response will determine our next move. Question regarding SequestOx, okay. The following questions are sent by Dr. W -- submitted for questions. The SequestOx pilot results, PR was somewhat confusing. Did Elite successfully test two versions of the formulations of SequestOx with or without Naltrexone? Both of them were with Naltrexone. The third one had the technology difference. So we tested three, two were exactly the same Naltrexone B that we have used in all of our trials for SequestOx since its inception. Okay. Again, there was no change to that. The change was an excipient in outer layer. If without, why not it was with? Does Elite anticipate being allowed to bridge this clinical data to the original SequestOx submission to avoid having to repeat HAL and P3 trail? That is exactly the issue. The FDA indicated the last time we don't have to do this. Now that we are successful, I would like it in writing, because I don't want to go through all the costs of running the DE trials and then for refiling the ANDA and then they come back with, yes, how about if you do one more thing? We need it upfront. We are not Pfizer. We are a company that cannot afford to waste a lot of money. So we would like them to respond first exactly to your question and that will determine our next step. When will you present data from SequestOx, the Tmax pilot to FDA? We started compiling the data immediately, I anticipate within the next month or so. Is there still time to get SequestOx filed again by the end of 2018? The step number one is to hear from FDA, depending on what they tell us, I'll tell you exactly when we're going to file. Can you share any details on the unique abuse deterrent formulations without SequestOx’s of Naltrexone that was included in the pilot study? No, except to say, I am extremely excited about this formulation because it also is a platform that apply to all the IRs and it happened to be about maybe 10% of the cost. So we're extremely excited about this, but it's still too early in the next few months. Once Dr. Smith files a pattern and we do a little more trials, we’ll update a little more about it. How soon can we realistically expect ANDA launches on Percocet, Norco, ADT, oxycontin, once FDA approval is given? Again, I hate to say this, but I can't answer this question at this time. Once we get the approval, we’ll find out the best partnership, which was working non-concurrently and then we let you guys know. Question about the trademark. Some stockholders noticed that the trademark of SequestOx was not renewed. Is there a particular reason for this, Dr. Smith?
So we're still using the SequestOx mark to mark, but trademark is subject to both common law and federal law. So we follow the federal registration, but we filed it with intend to use mark, because if it hasn’t been used in commerce. So product can’t be used in commerce unless the FDA approves it and once the FDA approves it, then it’s actually used in commerce. So these intend to use marks are approved, and ours was approved on December 22, 2015. But you only have three years to actually file a statement of use. And in that statement of use is a statement it says, we started using this in commerce on this particular date. So unlikely that by December 22, 2018 we’ll actually be using it in commerce at that time. Simply because what Nasrat said about the trails and things will still need to do. So I’ll have to refile this intend to use mark at some later date. So we haven’t given up on a trademark, it’s just like I said, it has to be used in commerce and we’re using it in all our press releases and stuff. And so it’s still subject to common law. So we’ll keep up with it and refile it, it’s still pending right now. But we’ll probably have to refile it before we’re able to file a statement of use.
Thank you, Dr. Smith. And thanks…
Just one thing, people haven’t heard Dr. Smith before. That’s Dr. Ken Smith. He is our in-house IP attorney as you could tell, that’s his subject matter expert and we get technical questions like it’s best to get the answer from the guy who knows the best.
And Dr. Smith has a PHD in bio-chemistry in addition to JB and MBA only.
Well, that was our last question. Thank you ladies and gentlemen. And thank you operator. Have a wonderful day.
Yes. Thank you, ladies and gentlemen. This does conclude today’s conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.