IntelGenx Technologies Corp.

Edward Miller - Director, IR Horst Zerbe - President and CEO Andre Godin - EVP and CFO John Durham - VP of Operations

Swayampakula Ramakanth - H.C. Wainwright Greg Ison - Singular Research Patrick Tully - Endeavor Asset

Good morning, and thank you for joining us today for the IntelGenx third quarter Management call. With me on the call today are Dr.

Horst Zerbe, President and Chief Executive Officer; as well as Andre Godin, Executive Vice President and Chief Financial Officer; and John Durham, Vice President of Operations. During the course of this call, Management may make certain forward-looking statements regarding future events and Company's expected future performance.

These forward-looking statements reflect IntelGenx's current perspective on existing trends and information, and can be identified by such words as expect, plan, will, may, anticipate, believe, should, intends, and other words of similar meaning. Any such forward-looking statements are not guarantees of future performance and involve risk and uncertainties, including those noted in the Risk Factor attached as an exhibit to the Company's current 10-K report.

In addition any unaudited pro forma financial information is preliminary and does not purport to project the future financial position or operating results of the combined Company. Actual results may differ materially.

For the benefit of those of you who may be listening to the replay, this call was held and recorded on Wednesday, November 4, 2014, at approximately 9 am Eastern Time. Since then the Company may have made additional announcements related to the topics discussed herein.

Please reference the Company's most recent press releases and current filings with the SEC. The Company declines any obligation to update these forward-looking statements except as required by applicable law.

I would now like to turn the call over to Dr. Zerbe.

Good morning, and welcome to IntelGenx third quarter 2015, results conference call. I'm Very happy to be joined by Andre Godin, our Executive VP and CFO, as well as our VP of Operations, John Durham.

We'll be discussing a number of exciting topics on this call. First, I'm very pleased to report that we are for the first time in our new corporate offices.

It is most exciting for me as the founder of IntelGenx to see how we as a Company are evolving into a much stronger organization, and the record third quarter results reflect just that. We are demonstrating to the industry that IntelGenx is becoming one of the leading drug delivery companies globally.

I would like to thank all of the shareholders for your vote of confidence and for your loyalty to IntelGenx. We're excited in IntelGenx's future as our strategy is clearly proving that we are moving in a positive direction.

On today's call, we will review the growth of Forfivo sales from the last quarter, the we will talk about developments in our product pipeline. Andre Godin, will review our financials from third quarter, and John will give us an update on our new manufacturing facilities.

So first Forfivo sales, sales continue to grow in the third quarter and are now providing revenue for the Company which we are reinvesting back into our strong pipeline. Net sales of Forfivo for the quarter increased 16% compared to the second quarter 2015, with net sales reaching $2.5 million or $4.7 million gross sales.

This is in line with the previous growth. For the past nine months, net sales totaled to $6.3 million or $12 million gross sales, an increase of 117% compared to the nine month period in 2014.

We met last week with our partner Edgemont Pharmaceuticals in Texas, and we were very pleased with the progress they are making at growing sales. Forfivo is now performing to our expectations and we believe that Edgemont Pharmaceuticals is optimizing it's marketing tools with a greater degree of sophistication in reaching an even wider prescriber base going forward.

When examining where IntelGenx is today, what is most exciting is the true value of our strong pipeline. Much work in the quarter was accomplished in advancing these projects forward to future commercial launches.

So, let me briefly mention the PAR projects. We continue our project development work with PAR Pharmaceuticals, and the most advanced project our oral film product for the treatment of opioid dependence continues to advance well.

It has been under review at FDA since July of 2013. As we have reported before, IntelGenx and PAR are being sued for pattern infringement under Paragraph IV of the Hatch-Waxman Act.

The case is proceeding well and the court date has been set for November of 2015, and other one for December of 2015. We are confident that we will prevail, and together with our partner we are preparing for launch of the product by mid-2017.

The opioid dependence market is a very significant market for IntelGenx to enter. Second project is on track for an FDA submission by mid-2016.

The third project we have as we mentioned before, a total of three projects agreed upon with PAR, is still at an early development stage. We are currently manufacturing pilot batches with the intent to conduct the pilot bio study later this year.

As mentioned last quarter, PAR pharmaceuticals was recently acquired by Endo Pharmaceuticals. While our working relationship with PAR remains as strong and healthy as ever, PAR has informed us that the third project, the one that I was mentioning just before interferes with Endo's project pipeline, and PAR has therefore offered us to return the project and we will be under this, if this in fact happens, the sole owner of all results that have been achieved so far and we are free to offer the opportunity to other companies.

Now, with respect to any achievements on the tadalafil development, we've also made very significant progress with our reformulated VersaFilm tadalafil product, tadalafil as you know is indicated for the treatment of erectile dysfunction. In July of 2015, we received the results of a pilot bio study confirming that the film is fully bioequivalent with the brand product Cialis tablets.

The Company plans to submit 505(b)(2) NDA in 2016 to have the product ready for commercialization upon expiry of the substance patent in 2017. Now, a few words on our Company strategy.

We focus on three areas in building our product pipeline. We had initially developed a focus on generics that have a high barrier to market entry and our film for opioid dependence is a prime example of that element of our strategy.

We also look for lifecycle management opportunities and tadalafil again is a prime example for that source of new products as well as RIZAPORT, our migraine film. In addition, we are seeing tremendous opportunities in drug repurposing.

Now, what does that mean, drug repurposing means that we are looking at well established products that are previously approved by FDA for a certain indication and where clinical research indicates that these drugs maybe beneficial in a different indication. We have identified two of such opportunities and are in the process of developing those.

We are not yet at liberty to disclose the molecules themselves, but our team is currently examining these products and has identified the 505(b)(2) pathway as the appropriate regulatory pathway to bring these opportunities to the FDA review and to prepare them for launch. And we are looking forward to communicate our progress on those opportunities in early 2016, and with that I'd now like to turn the call over to our CFO, Andre Godin, who will review our Q3 financial results.

Andre?

Thank you, Dr. Zerbe.

As everybody saw in our recent publication, we are extremely pleased to have record third quarter here at IntelGenx. We continue to focus on managing our costs in an effort of keeping our strong financial discipline as well as maintaining positive EBITDA for the entire year.

Total revenues for the quarter were $2.38 million, representing an increase of 427% compared to third quarter 2014. Total revenues for the nine month period amounted to $3.59 million, representing an increase of 331% compared to the nine month period ended September 30, 2014.

The increases for the three months and nine month period, ended September 30, 2015, compared to the last year's responding periods are mainly attributable to the one time milestone payment of $3 million from IntelGenx licensing partner Edgemont Pharmaceuticals, triggered by Edgemont reaching in July 2015, $7 million of cumulative net trade sales of Forfivo XL over the preceding 12 months. From that $3 million milestone payment, $1 million was received in the current quarter and the $2 million balance will be received in Q1, 2016.

Nevertheless, 2.6 of the $2 million was recognized as revenue in the quarter ended September 30, 2015. Operating cost and expenses were $1.03million for the third quarter compared to $0.9 million in the comparable period of 2014.

Operating cost and expenses were $2.49 million for the first nine month of 2015, versus $2.35 million for the corresponding period of 2014. IntelGenx recorded operating income of $1.35 million for the quarter compared to an operating loss of $0.44 million for the quarter ended September 30, 2014.

That's an increase of $1.8 million. For the first nine months of 2015, the Company generated operating income of $1.1 million compared to an operating loss of $1.5 million for the comparable period of 2014, an increase of $2.6 million.

The Company generated net income of $1.35 million or $0.2 per share for the third quarter compared to a net loss of $0.43 million or negative $0.01 per share for the three months period ended September 30, 2014. Net income was $1.02 million or $0.01 per share for the first nine months of 2015, compared to a net loss of $1.49 million or negative $0.03 per share for the first nine months of 2014.

Cash on hand as at September 30, 2015 was $2.26 million, representing a decrease of $2.13 million compared with the balance of $4.39 million as of December 31, 2014. The decrease in cash relates primarily to investments made into our state-of-the-art manufacturing and laboratory facilities.

I will turn over to our VP of Operation, John Durham, to review the status of our new facilities.

Thank you, Andre. I'm pleased to report that excellent progress has been achieved in our construction projects.

We were able to move into our new administrative offices in September. We expect our new expanded laboratory to be completed in November, and we expect to begin the installation of new equipment's in our new state-of-the-art manufacturing facility in December.

The initial project is on budget and on schedule. However, a decision was made to expand the original project scope to ensure that we have the capability of developing products requiring the use of organic solvents.

This capability was not included in the original scope of work that was considered to be strategically important and modifications in the original plan will require less than $230,000 and will not impact our current timelines. Once construction is complete and the equipment is in place, we will begin the process of development -- begin the process of equipment and facility qualification in preparation for regulatory inspections by Health Canada and the FDA.

We have already begun to recruit key positions within the operation to ensure sufficient resources for successful facility and operations approval. This new facility will enable greater profit margins for IntelGenx by firstly reducing our dependence on third party manufacturers, which also allows us to protect our manufacturing process knowhow and intellectual property, and secondly, enabling IntelGenx to offer complete support from concept to research and development, regulatory affairs, and commercial supply of VersaFilm product to our pharmaceutical partners.

This facility will position IntelGenx as the film development partner of choice. I'll now turn the call back to Dr.

Zerbe, to close us out for the day.

Thank you, John. We're most pleased by the great record results in Q3.

To summarize, firstly, net sales of Forfivo XL increased by 16% compared to the previous quarter. Secondly, we achieved an important performance milestone by reaching $7 million net trade sales in the preceding 12 months which entitles the Company to a milestone payment of $3 million.

Thirdly, our new manufacturing facility is soon to be completed, offering as many competitive advantages including full service to our customers or our projects are progressing well and are with the exception of the third project not negatively impacted by the acquisition of PAR by Endo. Ours product pipeline has never been stronger with considerable attention on drug repurposing which we believe will drive strong growth for the Company.

Before I turn the call over to questions, I’d like to thank everyone here at IntelGenx for their hard work this past year. We're very confident in IntelGenx's future and look forward to continuing on this positive momentum into 2016.

We thank you all for your attention and we will now turn the call over for questions.

Good morning, Horst and Andre. Congratulations on the quarter.

I have two questions.

Good morning.

It's certainly great to see the quarter go so well especially with the revenues that you received over the quarter. So, overall what have you and Edgemont learned in the past 12 months from the success of Forfivo commercialization that can help sustain that growth and also help IntelGenx learn in terms of commercializing future products?

Okay. This is Horst, thank you for the question.

It's actually a very good and very important question. We did discuss with the Executive Management at Edgemont at quite some detail their experience over the past two years with respect to the viability of their growth strategies, and we discussed their conclusions and what they're going to do going forward in order to maintain the current growth of the Forfivo sales.

And interestingly what they told us was that they have clear evidence indicating that future growth of the sales will be mainly due to broadening and widening the prescriber base, what has not worked in the past were any effort to increase the number of scripts per prescriber. That has been constant with very little impact by sales people or the like.

So, right now their strategy is focusing on systematically broadening the prescriber base. And from the data that we've seen, we have the utmost trust that that strategy will secure the growth of the product at least throughout 2016, we're confident that it will continue throughout 2017, but that's a little far, so I would at this point focus on 2016.

I hope this answers your question, RK.

That's good, but also how has that helped you and Andre, think about the future products? The one which I am thinking of is RIZAPORT, and I'm actually to going to get into that question at the same time.

What's the status of that product especially in Europe or could you - or when would you expect to learn from Germany and Luxembourg especially after your filing the new final paperwork they delivered to entities there?

Yeah, with respect to the status of the approval process, I can be quite specific with respect to your question as to anticipated launch date of the product, I have to be a little general there. But in response to your first question, we received as we previously announced an approval letter from the European Authority, and the product or the application I should say is now in the national phase in the two initial countries both being Germany and Luxembourg.

During the national phase there is typically no technical review of the application that has been completed during the multistate procedure, the national review focuses on the determination of the price, and that's right now ongoing, we expect that process to be completed anywhere between three and six months. Now, based on the progress that we have made there and based on the receipt of the approval letter, we have been seeing increased interest in the product in Europe, we're talking -- right now I'm not at liberty to disclose any names but we are in quite advance negotiations with a company in Spain that has an interest in launching the product initially in Spain and subsequently in other European countries.

We believe that the discussions as they are ongoing right now are in line with the anticipated approval timeline in Europe. The European regulatory process and the progress we've made there has also reignited interest here in the U.S., we see renewed interest there and above and beyond that we also see interest and have active negotiations ongoing for a commercialization of the product in Latin America.

All these discussions are ongoing and since no agreements have been signed yet, I'm not yet at liberty to disclose any names. That's what's happening with respect to RIZAPORT.

Okay?

Thank you. One last question before I get back into the line.

Regarding DAVA Pharmaceuticals, thanks for that update. So, now we understand project number three probably is coming back to you.

At what point would we get a little bit more insight into what this project number three is or how much advancement has been achieved with this product so that we can understand what's the potential for that product?

Quite honestly RK, since this is a generic opportunity, it might take another while until we're able to disclose -- and we might not be able to disclose the molecule until after an ANDA has been filed, and that is very typical for the generic industry and how generic companies are trying to protect their product opportunities. You will never find generic companies disclosing molecules that they are actively working on prior to submission of the application to FDA.

So, I would like to point out that this is very likely what is going to happen to the third opportunity as well. What I can say is that we are advancing the product or the project meanwhile quite rapidly, we are preparing a clinical batch for a pilot biostudy, that's going to happen soon, most likely no longer with participation from PAR.

But that will not have any impact on the progress that we will be making with the opportunity. As soon as we have received final word from PAR, we will go out and actively contact other companies for a commercialization deal for this opportunity.

Thank you, Horst. Thanks very much for all your answers.

You're very welcome, RK.

Thanks. Good morning, Horst, and Andre, Edward, and John.

Want to follow-up on the RIZAPORT. Since we were just talking about RIZAPORT, could you just confirm again I guess the status that last we all talked about -- you're still working on creating new submission batches in the United States, last we talked the new submission batches to qualify the API -- the new API supplier with FDA, is that still the case?

Are you just still moving forward with that?

Yeah, first of all, good morning Greg, and thanks for the question. That is correct, we have reached agreement with our co-development RedHill Biopharma, to move forward on the qualification and most importantly manufacturing of the three new submission batches, that is in progress and we remain on schedule for a target resubmission date of early second half of 2016, which would point towards an approval date of early 2017, for this product.

But you're right, this is still very much alive and in progress, the preparation for the manufacturing of these three resubmission batches.

I see, I see. Okay, you've talked before about a central nervous system drug for schizophrenia along with the second drug that was too early to talk about.

Could you update us on that product, is there anything new to discuss there?

First on the schizophrenia product, I'm still not at liberty to disclose the molecule. This is one of the opportunities where we are using our oral film technology to provide patients with a tangible therapeutic benefit.

In this particular case we are replacing an inhalation product which is hampered by a very severe lens program that FDA has imposed on the brand product to make the patient's life much easier by only having to take our film without the presence of a physician and without rescue medication being present. We have been able to improve the film product significantly with respect to onset of action, this is a rescue medication, so onset of action is the most critical feature.

We are still -- or I should say, we continue, to improve this feature our target is to have relevant plasma levels created within the first five minutes post administration and our most recent in vitro results indicate that we are very well underway towards accomplishing this objective, and on that basis we are now preparing a clinical study that is supposed to confirm this finding. Once we have the Phase 1 data available, that is supposed to be the case either by the end of this year or very early in the first quarter of 2016, we will then move towards the performance of a Phase 2a study to confirm in a clinical setting that the product meets the requirements for a true rescue medication.

Okay. And you've indicated for this is pretty large market that you're marketing.

Yeah, yeah that is supposed to be a very significant market.

Understood, there was also another job that you disclosed I guess in the last 10K for hypertension, you labeled it INT-0001 is that drug still under development?

We here at IntelGenx progressed the development as far as we could, meaning, we have completed the formulation development, we have conducted pilot bio studies confirming that we are bio-equivalent with the reference product, and we are now talking to several commercialization or potential commercialization partners that have indicated interest in the opportunity. So that is the current status with respect to 001.

Okay. Good, let me just kind of go backwards and talk about the quarter itself, let me confirm something you said I didn't heard -- wasn't sure if I heard it correctly, did you say gross sales for the quarter were $4.7 million?

Yes.

$4.7 million or $4.5 million?

$4.7 million gross.

$4.7 million gross and $2.5 million net. Okay, good.

Compared to other quarters this is like a higher ratio of net sales to gross sales than say in the last couple of quarters, is there any kind of reason for the improvement in your net retention of gross sales versus the past?

It's mostly due to price increase. That change ratio gross to net, mostly a function of price increase.

Okay. So, should I assume that that price increase sticks and will be carried forward into the next quarter and so on?

We're not in control of that but I think that's a fair assumption. Edgemont is controlling that, we did -- sorry Andre for stepping in -- we did discuss with Edgemont their pricing strategy.

First of all, the good news is they have a clear strategy, they are very conscious about not exaggerating the price increase because that could result in a frustration of a prescriber and could actually cause a decrease in scripts for reporting period, that is not the case. So, so far Edgemont's pricing has been received positively or at the very least not negatively impacted in anyway on scripts.

Scripts continue to grow at roughly the quarter-over-quarter rate as before.

Okay.

Does that answer your question?

Yes, it does. And that actually leads into the question I had written down next, which was, can you disclose the script -- the prescription count for the third quarter?

We haven't -- we try to look it up during this call. I don't have it at my finger tips, Greg.

But qualitatively speaking, we looked at that and the script quote is in line with the previous quarter-over-quarter script.

Okay. Given the growth you're seeing in Forfivo right now, do you believe you're on track to continue to learn the other -- are you on track to continue to earn the other mile stones that are set up for you with Edgemont on that drug?

Yeah, I mean obviously we had, like Horst previously mentioned we had a great conversation with Edgemont. I would be very cautious here in terms of whether we will and when meet the next milestone.

We are hopeful that we will meet the milestone in 2016, but as Horst mentioned, I mean it's not under our control. At the end of the day Edgemont seems to be doing a great work right now.

We're happy about their strategy because obviously we discussed that very extensively with them, but at the end of the day their performance will determine whether we will catch on the next few milestones. There are many milestones to come in this agreement with Edgemont, and we're hopeful that we will meet them in due time, but I wouldn't give any guidance as to when and what would be the amount that we would earn, but to make a long story short we're hopeful that we will achieve some milestones within the next 2016 and 2017.

Okay. And if I could follow up now on -- speaking of milestones the other drugs themselves, you've talked about the status I guess RIZAPORT in Europe, you've received the approval letter and now you're going for national approvals, if you receive national approvals in three to six months and you're talking to partners about partnering with them to start marketing the drug in Europe, would you expect that once you actually sign marketing agreements with any partner in Europe for RIZAPORT that you would receive an upfront payment from them, is that standard procedure something everyone would expect?

Yes. I mean we haven't started to deal yet.

So, I can't commit to anything obviously Greg, but what we have presented to interested companies is a deal structure under which we would receive a sizeable upfront payment, that upfront payment would at the very least cover all remaining expenses required for the requalification of the alternative API supplier and for the manufacturing of the resubmission batches, and such an upfront would be in the low seven digit range. And that's quite customary in this sector to expect a deal structure like that.

Okay. That's good, I'm typewriting that down.

That's RIZAPORT in Europe the potential partner in there. In 2016, are there any other drugs for which you think you would reasonably expect you may receive an upfront payment as they progress into marketability, for instance the PAR drugs that they're keeping, first two drugs, do you have an expectation of receiving an upfront payment on those in 2016?

Not on the PAR projects, I mean we received upfront payments there, but our expectation clearly is that we will receive upfront monies for a couple of programs that we have in our pipe line and where currently very active negotiations or ongoing. Again, I cannot guarantee anything and as before we're not providing any guidance, but we are we are very confident that we will receive monies as you just described, an upfront monies in the coming year in 2016.

When you say on a couple of programs in your pipeline, are these drugs in the pipeline that we haven't discussed in this call already? I'm trying to think about what we've already covered here.

Sounds like you have other drugs that we haven't discussed in the past, for instance the repurposing drugs, stuff like that, it hasn't really been discussed in great detail.

Greg, let me try to be a little more specific without violating any confidently, obligations. One program where we do expect upfront money and very sizeable development fees is a generic product and ANDA opportunity in the area of drug repurposing.

I am not so sure that those programs might require a bit of investment of our part before we get to the point that we can expect upfront payments from a partner and it is -- I'm thinking of one of these repurposing opportunities where the opportunity is clearly there but I wouldn't want to commit. On the other hand if we look at those opportunities that we discussed during this call, I'm thinking for example erectile dysfunction, there we see a very high probability that we will receive or that we will sign a deal which would entitle us to an upfront payment.

Okay. And do you think you might sign such a deal in 2016 which goes to 2017?

Yes.

Yes, okay, good. Something else I had here, I think that's it at the moment, I'll let someone else go, thanks.

Okay. Thank you, Greg.

Good morning, gentlemen. Congratulations on a great quarter.

Good morning, Pat, and thanks.

Good morning, Patrick.

Good morning, Andre. So, just a couple of quick questions., previously at conferences you talked -- I know it's tough for you to put color on some of these things but there were two deals where term sheets had been received and accepted, and I'm just wondering are those away from the ones that you're discussing, are those part of the ones you're discussing, what are the timing of those?

And then I have a couple more follow on questions.

They are further along. But I have to be very general with my response, but the qualitative response would be that we are actually quite a bit further along.

Okay. So, that's something we could see in the near term?

Yeah.

Also, I just want to be clear on something, else, if I understood you correctly, on the manufacturing of the three resubmission batches that are of RIZAPORT, you and your new facility will be manufacturing those batches and also commercial batches going forward?

I'm sorry Pat, could you please repeat that, you didn't come through clearly.

Yes, on RIZAPORT, I'm just wondering about that manufacturing of the three resubmission batches that have to be done and also the commercial manufacturing, is that something that you plan to do in your new facility?

That is an option that we are evaluating, yes.

Okay. Also it was mentioned that there were some additional capability that you're building into your new facility about organic solvents.

Is that as a result of discussions with the potential partner or what brought that about and what are the advantages of that?

A number of factors went into that decision. One is, simply speaking a consequence of the fact that one of our -- actually a couple of our important pipeline projects involve solvents, and since we are pursuing the strategy of eventually manufacturing all of our development programs in-house once they reach the commercialization stage, we naturally have to be prepared to be able to handle solvent base coating masses as well.

So, it's a reflection mostly of that aspect. The other aspect is that we want to be able to in the future also handle transdermal products.

We have received quite a few requests or transdermal products and since all transdermal products involve solvents that also prompted us to make the decision to have our -- to establish compatibility with solvent base coatings.

Okay. And finally just on the third PAR project, do you perceive this as a positive in a way that Endo obviously views, Endo/PAR obviously views this opportunity as a large opportunity because they're gone after the same opportunity in-house on their own it sounds like.

So, do you view this as easily marketable and a potential positives that you can take it back with -- and how much investments have been made dollar wise roughly on this project that you just get to retain?

Yeah, really Pat, thank you for the question. It provides me with an opportunity to clarify the situation a little further.

First of all, let me clearly restate that the quality and the character of our relationship with PAR remains as strong and as positive as ever. PAR is facing the problem that the third project that we have with them prevents a deal breaker or let's say is in violation with their agreement with Endo, so they have no choice but to discontinue the project and so they came to us and informed us that they would be willing to return the project to us.

We would then become the sole and full owner of all results that so far have been generated. Now with respect to the cost aspect that you just mentioned, PAR has been paying for the development of the program, today till we have not sunk a penny into the development of the program rather they had -- PAR has paid all the bills, and we're getting the results of these efforts if you will for free.

So, in my view this is not a bad situation for us at all, while clearly and considering the healthy relationship that we have with PAR, I would probably like to continue the program with PAR, the fact that we're getting it back and have the opportunity to offer this now more advance opportunity to other potential partners is not a bad thing either. So, all-in-all I view this development as at the very least neutral but probably has even a slightly positive development because we have now the opportunity as I mentioned before to offer a more advanced program with more tangible elements to other interested parties.

Okay. And you view it as a highly marketable product?

Absolutely, yeah.

Okay. Thank you very much.

Let me comment on that last aspect. As I said, we view it as a nice opportunity and marketable product but let me also put this in perspective with the other programs that we have with PAR compared with our opioid dependence program, it's certainly a much smaller opportunity.

But being much smaller than an opioid dependence film doesn't make it a small part, it's still a very attractive opportunity. So, I would like to put this a little bit in perspective.

Okay. [Indiscernible] opioid products, do you still expect if sometime in the third quarter as to the approvability of the product?

A - Horst Zerbe Short answer is yes, we have received communication from FDA that leads us to believe that we will receive tentative approval as we previously anticipated, meaning in the time that you just described. But as I said before Pat, the timeline for the launch of the product is no longer driven by the FDA review.

It is rather driven by the Paragraph IV litigation, and as I indicated in my introduction the litigation is progressing very well. We are very confident that we will prevail and that would lead to a ruling by mid 2016.

And so also with respect to the litigation timeline we believe that we are on track with our anticipated timeline for the conclusion of the ligation process.

All right, I think that's it. I appreciate your time and congratulations again on the great quarter.

Thank you very much, Pat.

Thank you, Patrick.

Well, if there are no further questions, I would again like to thank all of the participants on this call and our shareholders in general for their confidence and loyalty in our Company. And with that, we would like to conclude this call.

Thank you very much again.