IntelGenx Technologies Corp.

Rich Cockrell - IR, Cockrell Group Horst Zerbe - President and CEO Paul Simmons - CFO John Durham - VP of Manufacturing Operations

Swayampakula Ramakanth - H.C. Wainwright Greg Ison - Singular Research Patrick Tully - Endeavor Asset Management Jeffrey Benison - Little Gem Life Science

Thanks, Manny, and good morning everyone, and thank you for joining us today for the IntelGenx management update call. On the call today, we have IntelGenx's President and CEO, Dr.

Horst Zerbe; company CFO, Paul Simmons; and newly appointed Vice President of Manufacturing and Operations, John Durham. Today's call is being made available via the Investor Relations Section of the company's Web site at www.intelgenx.com.

Following remarks by management, we will open the call up to your questions. Now, during the course of this call, management may make certain forward-looking statements regarding future events and the company's 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, intend, 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 section of the company's annual report on Form 10-K filed on March 31, 2015.

Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on April 1, 2015 at approximately 10 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. IntelGenx declines any obligation to update these forward-looking statements except as may be required by applicable securities laws.

And with that, I'll turn the call over to Horst. Go ahead.

Thank you, Rich, and thank you to everyone who has called in. I appreciate your interest in the company.

Besides reviewing some 2014 financial highlights, I will provide specific updates on our anti-depressant Forfivo XL tablets. In addition, I will update you on our migraine film product RIZAPORT(TM), and inform you about some recent developments on our anti-hypertensive tablet product.

I will also discuss the status, strategic relevance, and funding of our new manufacturing facility. John Durham, our new VP of Manufacturing Operations is joining me on the call, and will be available to answer any questions regarding the status of the project.

Finally, Paul Simmons, our CFO, will give you a brief summary of our 2014 financial results. Let me start with Forfivo XL.

As you may know, Forfivo XL is our first FDA approved product. It is a high dose bupropion hydrochloride tablet, and is indicated for the treatment of major depressive disorder.

It is the only extended release bupropion hydrochloride product to provide a once daily 450 milligram dose in a single tablet. Essentially, Forfivo XL is the high dose generic version of Wellbutrin XL, utilizing our proprietary VersaTab technology.

The product is strategically very important for us. While the VersaTab technology is not our core technology, the revenues from this product allow us to achieve our strategic goal of establishing film manufacturing capability, and becoming a preferred developer and manufacturer of oral film products that are based on our VersaFilm technology.

As our 2014 sales results show, the product is quickly becoming the preferred prescription for patients who require this high dosage for the treatment of their severe depression. The product is being marketed in the United States under the terms of a licensing agreement with Edgemont Pharmaceuticals.

We are very pleased with the success we are having with Forfivo XL. In 2014, we more than doubled our revenue from the product.

We had total revenues of approximately $1.1 million in 2014, compared with half a million dollars in revenue in 2013. According to our market research firm, Symphony Health Solutions, gross sales of Forfivo XL totaled $8.9 million in 2014.

This is an increase of 230% when compared with sales of $2.7 million in the preceding year. In terms of script growth, the number of Forfivo XL prescriptions increased by 123% from over 16,000 in 2013 -- excuse me, to more than 30,000 in 2014.

The average month-on-month growth rate of Forfivo XL throughout 2014 exceeded 9%. We anticipate this trend to continue throughout 2015, and expect significantly higher revenues from the sales of Forfivo XL in 2015.

As you are probably aware, we settled our Paragraph IV litigation with Wockhardt back in November. Under the settlement agreement, Wockhardt has the right to market an authorized generic as of January 2018.

We believe that our settlement with Wockhardt will allow Edgemont to continue to sell Forfivo XL without generic competition until at least January 2018. Following our settlement with Wockhardt, Edgemont exercised its right to extend the license for the exclusive marketing of Forfivo XL for another year.

In exchange, we received a seven-digit milestone payment. The exclusivity will automatically extend if Edgemont reaches certain minimum net trade sales during the exclusivity period.

We expect Edgemont to reach the sales target in the second quarter of 2015. This event will trigger a significant milestone payment, which we expect to earn in fiscal 2015, and which, as we believe, will turn the company profitable in 2015.

Finally, I would like to respond to a question that I've been asked frequently by investors. The 450 milligram daily dosage of bupropion hydrochloride is only approved in the United States.

In all other countries, the highest approved dosage is 300 milligrams. This means that Forfivo XL tablets currently can only be sold in the U.S., in order to commercialize the product in Europe or elsewhere we would have to conduct expensive safety and efficacy studies.

A few South American countries issue marketing authorizations based on FDA approvals, and we are looking for partners in that area. However, many South American countries have restrictions on pricing, which could have a negative effect on sales in these countries.

Now, let me turn to our plans to establish a manufacturing facility for our growing platform of VersaFilm products. As a technology-focused drug delivery company, it is vital that we protect our proprietary manufacturing technologies.

Establishing in-house manufacturing capability enables us to move efficiently protect our trade secrets and patents by eliminating our dependence on external manufacturing partners. Yesterday, we announced our plans to relocate into a state-of-the-art fully GMP compliant facility in Montreal.

On completion of our new facility we will offer our pharmaceutical partners complete support from concept, research and development, and regulatory affairs to actual commercial supply of our VersaFilm products. It also will enable us to better manage the cost of goods, which will in turn improve our profitability.

Construction work on the 17,000 square foot facility will commence this month, and renovations are expected to be completed within six months. All these agreement includes a right of first offer for additional expansion space of approximately 11,000 square feet.

Our target occupancy date is September of 2015. We plan to fund the construction portion of the project from cash on hand.

As I mentioned earlier, John Durham, our VP of Manufacturing Operations is on the call today, and will be available to answer any questions you may have regarding the status of the new facility, and our manufacturing plants. We also have ordered the manufacturing equipment required for the commercial manufacturing of our oral film products, including two packaging lines, and compounding equipment.

The equipment installation validation will be completed within the next 12 months. To fund the purchase and installation of equipment for our new film [ph] manufacturing facility, we received CAD500,000 in cash as part of a 3.5 million credit facility from BMO, Bank of Montreal.

The credit facility is supported by a 50% guarantee from Export Development Canada, Canada's export credit agency. I would like to point out that for a moderate investment of $6 million into leasehold improvements and state-of-the-art manufacturing equipment, we will become a fully GMP compliant manufacturing partner for our clients.

Starting as early as 2017, this investment will generate significant incremental revenues for the company. Turning now to our migraine film product; we continue to work on the commercialization of our migraine treatment RIZAPORT(TM).

In close cooperation with our development partner RedHill Biopharma, we are currently working through supplier and FDA issues, and expect to have FDA approval for the product later in 2016. As announced last December, the German Federal Institute for Drugs and Medical Devices, the so-called BfArM, has validated the European application submitted for RIZAPORT.

The formal review of the application commenced on November 25, 2014. This means that we may expect BfArM's feedback regarding the MAA during the second half of 2015.

It is important to note that the European Regulatory Authority is satisfied with the compliant status of the API and that therefore the import alert issued by the FDA has no effect upon the European application. Other key milestones during 2014 included the completion of a pilot biostudy with our tadalafil film which is indicative for the treatment of erectile dysfunction.

The study indicated bioequivalency with the brand product Cialis tablet. We plan to submit a 505(b)(2) NDA in 2016 in order to have the product ready for commercialization immediately upon expiry of the substance patent in 2017.

In November of last year, we also successfully completed the pilot clinical study for a new VersaFilm product which is intended for the treatment of schizophrenia-related disorders. Therapeutically relevant plasma concentrations were reached significantly faster with our VersaFilm product, compared to conventional tablets.

This confirmed the suitability of the film product for the intended indication. We believe our product will be a significant improvement over existing medications.

However, in order to maintain our competitive advantage, we're unable to disclose further details related to this product at this time. As you are aware, in January of last year we signed another development and commercialization agreement with PAR Pharmaceuticals for two new projects.

While I cannot disclose the specifics of the products due to confidentiality clauses in the agreement, I can tell you that we made excellent progress throughout 2014 on both projects. The submission of an ANDA for the first of these two projects is planned for 2015.

In September of 2014, our development partner for our antihypertensive tablet project, DAVA Pharmaceuticals discontinued its support of the project, because the acquisition of DAVA by Endo Pharma had created a redundancy. Subsequently, we terminated the development agreement with DAVA, and as of March 2015, we have regained full ownership of the product.

We're currently in the process of revising the development timeline with the objective to submit an ANDA in 2016. And with that, I'd like to turn over to our CFO, Paul Simmons, who will comment on the financial results we achieved in 2014.

Thank you, Horst, and good morning everyone. I would like to start by reminding everybody that unless otherwise stated, all amounts quoted are in U.S.

Dollars. We ended fiscal 2014 with cash on hand of $4.4 million compared with cash of $5 million as of December 31, 2013.

The decrease of $0.6 million in cash relates to the net effect of cash used in operating activities of $1.4 million, cash used in investing activities of $0.4 million, and an unrealized foreign exchange loss of $0.4 million, partly offset by cash provided at financing activities of $1.6 million, which came from the exercise of warrants. Accounts receivable circled $0.7 million as of December 31, 2014 compared with $0.1 million at December 31, 2013.

The accounts receivable balance at December 31, 2014 included an amount of $0.6 million that was invoiced to Edgemont Pharmaceuticals in the fourth quarter of 2014. Payment against the invoice was received in February 2015.

Revenue for the year ended December 31, 2014, increased to $1.7 million, representing an improvement of 75% from $0.9 million in the previous year. Revenue recorded in fiscal 2014 includes $1.1 million related to Forfivo XL, which was more than double, $0.5 million recorded in the previous year.

Fiscal 2014 revenue also included $0.6 million earned for successfully achieving development milestones for certain R&D projects currently under development, compared with $0.5 million earned in fiscal 2013. Total cost on expenses increased from $2.6 million in fiscal 2013 to $3.4 million in 2014, primarily as a result of an increase in R&D expenses incurred in the development of our second PAR project, together with R&D expenses incurred for the completion of a pilot biostudy with our VersaFilm tadalafil product for erectile dysfunction, and for the completion of a pilot clinical study for our INT0036 VersaFilm product intended for the treatment of schizophrenia-related disorders.

In addition, selling, general, and administration costs increased due to legal expenses related to our Paragraph IV litigation with Wockhardt that was settled in November, 2014. The net loss increased from $1.6 million in fiscal 2013 to a loss of $1.7 million in 2014.

And the loss per share was $0.03, same as in fiscal 2013. I would now like to turn it back to Horst for some closing remarks.

Thank you, Paul. As you can see, 2014 was a pivotal year for us, paving the way towards profitability in 2015.

Here are, again, the highlights. We closed 2014 with a healthy bank balance of more than CAD5 million in cash, that adequately covers the CAD2.9 million required for the build out of our new premises.

We have negotiated government-backed bank financing of up to CAD3.5 [ph] million to fund the purchase of new manufacturing equipment. Work on our state-of-the-art manufacturing facility has commenced, and we plan to occupy our new premises in September, 2015.

Over a total investment of $6 million, IntelGenx will become a full service provider to our partners, generating income from commercial film manufacturing, starting in 2017. Revenues from Forfivo XL sales more than doubled, and are expected to keep growing at that rate throughout 2015 and beyond, helping to turn the company profitable in 2015.

Together with our development partner, RedHill Biopharma, we're working through [ph] issues related to our migraine film product, and are on track for a launch of the product in 2016. We increased our cooperation with PAR to three projects, and added two more film projects to our pipeline; one for the treatment of schizophrenia-related disorders, and the other for the treatment of Parkinson's disease.

And with that, we will now be happy to answer any questions.

Good morning, Horst, and Paul. How are you folks?

Very good.

Well, thank you.

Regarding Forfivo, it's great to see that the product is really doing well, both on scripts and sales. What are the plans of Edgemont to keep this trend going?

I remember, last time, you were talking about how they are improving on their sale force numbers. What are they doing this year, or plans for this year to keep that trend moving in the right direction?

This is Horst talking, and thanks for the question. As I believe, we mentioned in previous communications, Edgemont has tripled its sales force from 10 to currently 30 sales people, which is one indication as to the direction into which they're headed with respect to their promotional activities.

We also heard from Doug Saltel, their CEO that they continue to increase and improve their efforts with respect to their electronic marketing strategies.

Okay, thank you on that. And then regarding the milestone payments, I understand that they're expecting something -- some major payment this year, but beyond that, is there any other milestone payments from Edgemont, or that is it as far as this particular agreement goes?

There are further milestone payments, RK, that we have reason to believe we will incur over the next couple of years. You mentioned the one that we're expecting in 2015.

Already, that one will be triggered by Edgemont reaching certain minimum net trails. We actually expect them to be reaching that target in the second quarter of 2015.

Beyond that, we're expecting milestone payments, very significant ones, for reaching certain exclusivity targets as per the agreement that we have with Edgemont. One payment will be due upon Edgemont marketing the product without a competing product for 42 months; that payment will be due in 2016.

And then there's another one which will be due after they have reached or enjoyed an exclusivity of 60 months. In between, there may be milestone payments for Edgemont to be reaching certain minimum sales targets.

I cannot specify those, because we have to observe confidentiality commitments under the agreement with Edgemont, but qualitatively speaking, those are the payments that we're expecting.

Thank you, Horst [ph], for that additional color, Horst. Regarding the new plant that IntelGenx is putting up; one of the statements that you made this morning is that the facility would help to generate significant revenue from 2017.

Can you please expand on that statement, what exactly should we be expecting by that?

Principally speaking, our strategy is that we will manufacture all of our VersaFilm products in this facility. The one and only exception may be our migraine film product, where we have a contractual agreement with a CMO, Lohmann Therapy Systems.

With our partner PAR, we have an arrangement under which a portion of the products that we are developing for them will be manufactured at our facility, and another portion at a contract manufacturing facility. And then going forward, everything else, our erectile dysfunction product, the schizophrenia product, and whatever else we have in the pipeline will be manufactured in our own plant, and hence, generating incremental revenues.

Okay. And then on the schizophrenia product that you just touched upon, and in the 10-K you said that the Phase 1 is complete, so when would we see some of the data, and what are the next steps for this schizophrenia drug?

The study that we completed in November is a pilot biostudy, which confirm that we're reaching effective plasma levels much earlier than the conventional tablet product. We're now in discussions with a clinical researcher in Germany to plan, and subsequently conduct for us an efficacy study to confirm that our film product in fact delivers the efficacy results that we expect from the product.

That study is in the planning phase, and at this point I'm unable to provide you with any exact date as to when the study will be conducted. The only qualitative statement I can make is that we expect the study to be conducted in the first half of 2015.

Okay. Thank you, and I will step back later on the line.

Thanks RK for the questions.

Good morning. Hi.

I'd like to ask about -- follow-up on the RIZAPORT product. I understand the situation as you've described it; in Europe the authorities are essentially accepting your vendor, your API vendor there that you qualify the drug initially, or you tried to initially in the United States, but the FDA has pushed back against that vendor.

Is it possible that you would expect that you will use two vendors for this key ingredient, the original vendor in Europe, and then subsequent alternate vendor in the United States?

That is very true, Greg. First of all, thank you very much for your question.

That is very true. We're assuming at this point that we will be going forward with two different vendors.

Just a slight correction, the original vendor, the one that is listed in the FDA application is an Indian vendor, not an European vendor. It's an Indian vendor.

Now, just a quick comment as to why we have this situation that Europe accepts and FDA does not; Health Canada has issued a compliance statement for our Indian vendor. Now, Canada is member of the so-called Mutual Recognition Agreement under which a large number of countries, European countries mostly, and non-European countries, amongst them Canada mutually accept regulatory assessments.

Since Health Canada has cleared the Indian vendor of our API, Europe accepts the compliance status of that vendor, and therefore has no problems accepting them for the European application. The United States FDA is not a member of the Mutual Recognition Agreement, and therefore, insists on their import alert for API supplied by the originally listed vendor, and we therefore qualified an alternative vendor for the API.

Okay, I understand that. Thank you.

Continuing on about the RIZAPORT, in the United States you filed a 505(b)(2) NDA on it. This gives you that so-called three-year marketing exclusivity.

But has any competitor initiated a paragraph for litigation against you, or do you expect that one will in order to come out with the generic in the way that Wockhardt has done with Forfivo, or do they have to wait for it to be approved for them to actually file that?

Yes. First of all, Greg, a slight correction; we are not eligible for three year's exclusivity because our application -- and you correctly stated that it is a 505(b)(2) NDA.

This 505(b)(2) NDA is not supported by an efficacy study, and only [ph] in a case where the application supported by efficacy data does the applicant qualify for market exclusivity. Then, to answer your question, we do not expect a Paragraph IV challenge because they have already nine generic tablets being approved by FDA, and so, I can simply not or see that the brand company Merck will sue the tenth product entering the market under Paragraph IV.

I mean, you never know, but it's to me quite inconceivable that we will be faced with Paragraph IV litigation. But like I said, you never know the brand of course has every right to sue us under Paragraph IV.

And the legal basis is there, because our application is supported by a bioequivalency study.

Okay, okay, I understand that. If I could go back to Forfivo, and the milestone payments that you're expecting in the next two years, you have two types of milestone payments; the sales threshold milestones, and the exclusivity milestones.

Reading the documents that you filed with the SEC, the exclusivity milestone payments had 42 months and 60 months, included provision that they're payable assuming that the sales of the drug have achieved specific sales levels on a trailing 12-month basis. Are those sales levels which required for the exclusivity milestones the same sales levels required for the separate sales milestones?

Is it the same dollar amount?

Paul -- I'll turn it over to Paul to respond to that question, Greg.

Sure.

Hi, Greg. The sales milestones differ in the early years from the -- that is a sales milestone that need to be triggered in order for the exclusivity payment also to be triggered.

Like Horst said earlier, we expect that to happen in 2016. Does that answer the question?

I think so. So if I understand correctly, then the 42 months sales milestone that accompanies the exclusivity period milestone is your second sales milestone, not your first sales milestone; is that correct?

That's correct. It's not the milestone that we will trigger this year.

There is a subsequent sales milestone that we will trigger -- believe we will trigger in 2015, and then another one thereafter. And based upon that third trigger, that's when the exclusivity milestones will also kick in.

Got it, got it. Okay.

Another question; in the 10-K you said something, I guess it was new or I hadn't seen it before, at least I hadn't, and that on Forfivo, you expect to be paying a type of royalty on net income of your Forfivo sales to your former co-development partner, after -- and now that you've recovered your own cost that you had [ph] specified. In terms of computing net income for Forfivo on which this 10% royalty would be paid, what types of costs would you offset against your revenue coming in on Forfivo to get to net income because it's -- you have royalty income and milestone income generally, and I don't see what cost you would have to offset against that?

There are no costs to offset against that, Greg. It's quite simply whatever income we now receive we will have to pay a percentage royalty to our former co-development partner.

And that's in perpetuity? Am I correct in assuming that?

Yes, yes.

Okay. Okay.

That was part of the deal that we did back in 2010, I believe, when we acquired the remaining ownership rights in the project that we became 100% owners, but there was a provision for a continued -- royalty.

Got it, got it. Going back to the milestones, and specifically 2014, you disclosed the revenue on Forfivo in 2014, but when I look at the remaining revenue to get to the top-line number for the year there's some other milestone payments.

It's not clear what projects the remaining milestone dollars are allocable to. Can you disclose that or is that something you just don't want to disclose?

It's something that we're not at liberty to disclose. The only thing that we can say is that they relate to the PAR projects.

As you know, we have three projects currently ongoing with PAR Pharmaceuticals, and those milestones relate to PAR, but we can't break it down any further.

Understood. Regarding the manufacturing space that you're moving into, will you move your existing office space into this new space at 6425 Abrams, and leave the old space -- your existing administration?

This is John Durham speaking. Yes, we will be moving the entire IntelGenx operation from the existing space to the new space, so are offices, laboratories and the future manufacturing.

Okay, and did I hear you correctly, you said you have an option for another 11,000 square feet in that building?

Yes, we do.

Got it, got it. And my final question, and I'll let someone else go, is do you intend to manufacture product for anyone else in that facility which is not your product, which would essentially mean a contract manufacturing relationship, or will you devote your capacity only to the manufacturing your products that you have under development?

Greg, if the opportunity presents itself we will certainly do that. We have had requests for contract manufacturing, so again, if the opportunity presents itself and if it makes sense to us we will certainly and definitely engage in contract manufacturing services.

Okay, great. Thank you.

You're very welcome.

Hi, Horst. Hi, Paul.

So just a couple of quick questions; if you could just clarify a couple of things; firstly, can you talk at all about the sales trends from first quarter in Forfivo on their [ph] publicly available? And also, I'm not clear on this royalty that you have to pay the original development partner.

Is that -- I heard someone mention 20%. Do you have 20% of the sales, or do they have anything to do with the sales under exclusivity in milestones or only there sales royalties that you're receiving?

And that's 20% of your percentage, right, and not 20% of the gross, if I understand it correctly? And also, if you can comment at all on any partnership discussions that are ongoing, obviously, can you give that a lot in detail, but just maybe when we can expect to hear some news on that.

Good morning, Pat, and thanks for the question. I will respond to the first question.

As far as royalty payments, I will turn over to Paul for that. What we do see -- we do not have the full picture for the first quarter of 2015 yet.

We have seen the sales and the scripts up until mid-March, and what I can say qualitatively is that the trend that we've seen throughout 2014 is clearly continuing throughout the first quarter of 2015, and we do believe beyond that. I hope that answers that part.

And for the second part, regarding royalties, I'll turn over to Paul.

Good morning, Patrick.

Good morning.

Just to be clear, now that we have recovered our expenses on the Forfivo project any income that we receive related to Forfivo XL will trigger a royalty payment to our former partner. Though it doesn't matter whether we receive royalty income from sales of the product, sales milestone income, or exclusivity milestones, they will now share in that income.

Does that answer your question?

Yes, it does, thank you. So just a couple of other questions; I know that not all of this milestones information that you can discuss, but if I understood you correctly, based on current trends of high single-digit month-over-month sales growth on Forfivo, do you expect to trigger milestones which will yield multiple seven-figure payments in each of the following 3 years, 2015, 2016 and 2017?

Is that accurate?

That is a very good summary, yes, Patrick.

Okay. And, Horst, you discussed earlier some additional marketing strategies that Edgemont is [indiscernible].

Can you give us any detail about that?

Unfortunately, Patrick, at this point not; what I disclosed before, maybe that they tripled there their sales force, and that they are further stepping up their electronic marketing efforts is really all I can say at this point. What I can tell you is that when they share their first quarter results with us they will, at least that's what they've done in the past, provide us an overview of their marketing activities, and their strategy going forward.

So we expect that to be available by mid-May. And I will be more than happy to discuss that aspect once we've received that information from Edgemont, provided, however, that we are at liberty to disclose under the confidentiality obligations that we have with them.

Okay. And just, lastly, if you can comment at all, I don't know if you can, on any, not specifics obviously, but when you would hope to hear some news about the partnership discussions, either on the CNS drug, or RIZAPORT, or anything else for that matter in terms of partnership announcements?

Pat, in all honesty, that's of course a very difficult question. I don't want to promise anything that eventually turns out not to become reality.

What I can tell you is that we are talking to, actually, a number of companies that are interested in RIZAPORT, not only in the U.S., also, for example, here in Canada where in fact we have -- we're conducting very advanced discussions. In the U.S., there is continued strong interest in the opportunity.

Quite frankly, if you will hurdle that perspective partners are wrestling with, I might say, are the relatively high-class associated with the qualification of the alternate API supplier, we're talking pretty significant money just for little under $2 million, which of course we want to get reimbursed by a perspective partner. That makes the negotiations at times difficult, but we continue to be confident that we will conclude these negotiations successfully.

I also have to say that we are not fully in control of our own destiny, so to speak. We license the opportunity to our development partner, RedHill Biopharma.

RedHill Biopharma is responsible under our contractual agreement for finding a marketing partner. What we're doing there is helping them and using -- utilizing our connections here under U.S.

market to find a partner, but whatever we do there has to be done in close corporation and in agreement with RedHill Biopharma. I hope that shed some light on the situation and clarifies some of that.

Yes, it does, and just dealing other non-generics in the market currently, haven't you seen evidence in other drugs like Suboxone where a syndrome can have a big impact on the market versus those with the tablets that are previously sold?

I mean, Suboxone, clearly is by far the most significant player in the film segment. There were some recent launches of other film products.

It is too early to make a final assessment as to the success of these products. The indication, however, is that these products will also be very successful.

I'm specifically referring to BDSI's efforts in that respect. We know of other products that are not yet on the market, but in development that we believe will also be very successful.

Thank you very much for your time.

I'm sorry.

Thank you very much for your time. I appreciate it.

You're very welcome, Pat.

Hey, Manny. This is Rich.

We have time for one more question.

Horst, you made the fact that you get, you received the rights back to the [indiscernible] products, and it sounded almost like a negative, the way you said it. But I just would like you to go into that opportunity a little more, because this is something that was hung up by your -- you had a partnership that you couldn't really get out of, and it's a very difficult drug to make, and there aren't many generics on the market, and they're probably all going in at least in the $100 million range, and I think you should bring out that opportunity and talk about it a little bit more; not be embarrassed that you got it back.

Jeff, thank you very much for that question and comment; I have to say if I came across that way, as you've apparently perceived it; that was completely unintentional. As a matter of fact, we do view our antihypertensive rizatriptan has a very significant opportunity.

You're absolutely right there. The frustration if you may have sensed that it all was more due to the fact that for a long, long time, we were stuck with our previous partner DAVA Pharmaceuticals.

And there was a very long time when nothing happened, and all and only at the very end we learned that this was due to the fact that they were acquired by Endo, and that acquisition had created a redundancy. But no, that impression was entirely wrong, and I really would like this opportunity to state that we are very pleased that we regained full control over that product.

And we are very anxious to move forward with it. We view this as a major opportunity and have in fact already received or seen interest by significant partners in a partnering arrangement for this thing.

What do you think it would cost to get for you to do all the studies to get that filed?

It's a biostudy, which in this case will be -- or bioequivalency study to use the proper term, which in this case will be a little more expensive because we are talking [indiscernible] and it is an extend [ph] with these products, or therefore we may have to conduct a fasting and a fed study arm. So the study might run up to $1 million.

That's my gut estimate, if you will. Let's say a $1.5 million possibly, 2 million to complete the development.

But that's really -- I shook this out of my sleeve, so to speak.

Well, I think the opportunity on that is so large that I would hope that rather than partnering it off, I think if you -- you'll get that development money together and do it yourself the -- once it's filed, then you have all the data. It will be a lot worth more valuable than do something now, but…

Jeff, it depends how the situation evolves. If we get attractive offer, partnering offers we will partner it, if not, we would certainly be able financially and technically to complete that development ourselves.

We will see what happens.

Okay, thanks a lot, Horst. Bye-bye.

You're very welcome, Jeff.