Executives
Stephen Kilmer - Investor Relations Dr. Horst Zerbe - President and Chief Executive Officer Andre Godin - Executive Vice President and Chief Financial Officer Nadine Paiement - Vice President, R&D
Analysts
Swayampakula Ramakanth - H.C. Wainwright Greg Eisen - Singular Research Patrick Tully - Endeavor Asset Management
Operator
Greetings and welcome to IntelGenx Fourth Quarter 2016 Financial Results Management Call. At this time, all participants are in a listen-only mode.
A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.
I would now like to turn the conference over to Stephen Kilmer, Investor Relations in IntelGenx. Thank you.
Please go ahead.
Stephen Kilmer
Thank you. Good afternoon everyone and thank you for joining us on today’s call.
With me on the line are Dr. Horst Zerbe, IntelGenx’s President and CEO; and Andre Godin, our Executive Vice President and CFO.
Before we begin, I would like to remind you that all amounts mentioned today are in U.S. dollars and today’s call may contain forward-looking information that represent our expectations as of today and accordingly are subject to change.
We do not undertake any obligation to update any forward-looking statements except as may be required by U.S. and Canadian Securities laws.
A number of assumptions were made by us in preparing these forward-looking statements, which are subject to risks, and results may differ materially. Details on these risks and assumptions could be found in our filings with the U.S.
and Canadian Securities Commissions. I would now like to turn the call over to Dr.
Zerbe. Horst.
Dr. Horst Zerbe
Thank you, Steve. Good afternoon and welcome to the IntelGenx fourth quarter and year-end conference call.
On today’s call, I will provide corporate update and discuss the progress we made on our pipeline projects. Following that, Andre will then review our Q4 and year-end financial results.
Overall, we are very pleased with IntelGenx performance. I would just like to point out the most significant achievements.
We completed a record seven partnership transactions. We completed our state-of-the-art manufacturing facility, and as most of you may have read this morning, we announced that we obtained an exclusive license from Eli Lilly for their 166 dosing patent covering the tadalafil film erectile dysfunction product.
Besides that we strengthened our management team and we significantly advanced our product pipeline towards commercialization. First, a brief update on our facility.
The construction of the 17,000 square foot manufacturing laboratory facility is now completed. It will be fully operational by the end of this quarter.
We expect the Health Canada establishment license to be available in July of 2017. In order to achieve that we will call them in for an audit in May of this year.
We have already signed a lease for an additional 11,000 square feet of expansion space and the preparation for a facility expansion is already ongoing. This expansion became necessary because the implementation of manufacturing was requested by our partners and caused a significant increase of the anticipated manufacturing volumes.
However, the new facility will create a fivefold increase of our production capacity. In addition to that, it will offer a one-stop shopping opportunity for our partners and will significantly lower the acquisition cost for our partners.
It will also allow the protection of our IP. Finally, it presents a significant opportunity for additional revenue for the company.
Now some comments on our pipeline projects, first tadalafil film. Tadalafil film is indicated for the treatment of erectile dysfunction and pulmonary hypertension.
Our film is fully bioequivalent with the brand product Cialis tablets. Over the course of last year, we completed the manufacturing of the submission batches and stability studies are ongoing.
Also ongoing is the pivotal bio study that is required for inclusion in the submission trial, the result of that study is expected to be available in May and provided a positive outcome of this study, we plan to file the 505(b)(2) NDA in the June, July timeframe. Under current guidelines, we expect an 8 month to 12 months review time by FDA, so we expect approval of the product sometime in the second quarter of 2018, and accordingly a launch in the US around mid-2018.
Now an important element of the projects status is actually the IP and litigation status. The substance patent is about to expire in November 2017.
There are also three more Orange Book patents protecting the brand product, two formulation patterns, which were invalidated through an IPR process. However, those are now under appeal and a third patent, a so-called dosing patent, which we attempted to invalidate by submitting an IPR.
That led to a settlement with the Eli Lilly. And under the settlement we obtained an exclusive license for the 166 dosing patent and under that exclusive license Lily will not sue us for infringement of any of their patents covering the tadalafil film erectile dysfunction product.
I want to point out that the license is a US license, it does not apply to or it does not include other territories. In the meantime, we have progressed negotiations with potential licensing partners and while we cannot promise anything we can qualitatively state that the discussions with those potential partners are progressing very well.
The next project I would like to discuss is the Part project and that is entirely driven by paragraph for litigation with Monosol and Indivior. As we announced earlier Part and IntelGenx prevailed on patents and lost on a third patent, the so-called 514 patent and when I say win and lose, I am referring to the claim construction rulings.
Now, shortly after we received the ruling for this third process patent, the so-called 514 patent, TEVA also litigated this patent and received a film construction ruling, which was entirely different from ours. In other words to be precise TEVA under that main construction ruling did not infringe.
We viewed the ruling and then decided together with our partner Part to file a motion to reopen our case because quite frankly a non-infringement ruling for TEVA and an infringement ruling for Part and IntelGenx on the very same patent doesn't make any sense. The judge currently considering our motion to reopen and while we expect to obtain the same ruling as TEVA received it in case that might not be the case we are prepared to appeal the ruling.
In addition to that litigation, Mylan has also filed an IPR against this very same 514 patent, that IPR is based on new evidence and there is some indication that Mylan might be successful with that IPR, which again means for IntelGenx and Part that the patent will disappear and we will then most likely be free and clear. We expect a ruling for the fourth trial on the process patent that was held in November to be issued in June of this year.
Now a few comments on the progress we made with our migraine film, our rizatriptan film in cooperation with our co-development partner RedHill, we signed an exclusive licensing and commercialization agreement with Korean company, Pharmatronic for commercialization of the product in South Korea. Anticipated launch in that country is the first quarter of 2019 and I just want to mention that we secured manufacturing rights under that agreement.
At the same time, we are working with Grupo Juste in Spain on the commercial launch in Spain. Anticipated launch date is mid-2018.
In order to make sure that the launch preparations move forward swiftly, we established across a functional launch team with participation from both companies. As far as the US status is concerned, we are planning to re-submit the 505(b)(2) NDA in the third quarter of 2017.
The approval is expected in - for the first quarter of 2018. I just want to point out that the approval would trigger a $500,000 match down payment by our co-development partner RedHill.
Marketing discussions are ongoing with additional potential partners of Europe, South America and the USA. We just very briefly like to respond to frequent comments I received on the delay of the resubmission.
That delay was caused firstly by the change of the API supplier, which we were forced to undertake under the complete response letter that we received for the initial submission. Secondly, we decided to perform a manufacturing side change from the initial European contract manufacturer to our own manufacturing facility and that manufacturing side change was necessary in order to simply speaking keep the product life because the contract manufacturer in Europe made the product unaffordable.
The manufacturing side change necessitated the manufacturing of multiple batches and so that caused this additional delay. We are now on track for submission as I have just mentioned by mid-year and expect approval in Q1 of next year.
Some comments on the projects we have with Chemo Group as I mentioned before, we signed a total of four deals with the Chemo Group and by virtue of that number of projects the relationship with Chemo has become an important strategic partnership for us. The combined addressable market of these products exceeds $4 billion.
Payments that we received from Chemo in 2016 already exceeded $1 million and I would just like to mention that discussions for a fifth product with Chemo are currently ongoing. A few words on our new product with Endo, we announced late last year, to be precise in December, that we assigned a new development and commercialization agreement with Endo Ventures for a new CNS product.
Under the terms of the agreement we are not at liberty to disclose neither the molecules nor any financial details of the deal, nor can we disclose what the delivery platforms are. We mentioned though that this is the second product that we now have in place with Endo Group, the first is the Par project Cardinal [ph] belongs to the Endo Group and we received a significant upfront payment upon signature of the agreement that we are entitled to milestone payments upon achieve certain development milestones at the backend.
We agreed on a profit split again, I am not at liberty to discuss any key details of these arrangements. We very recently announced a binding term sheet with a Canadian company by the name Tetra Bio-Pharma for the development and commercialization of a product containing dronabinol.
The product was indicated for the treatment of cancer pain. The addressable market of that product is in excess of $5 billion.
IntelGenx is responsible for the development and manufacturing of the product, while the Tetra is responsible for funding the entire program and also responsible for commercialization of the firm. Financial terms include a re-sizable upfront payment, which we are not yet at liberty to disclose.
In addition we are entitled to milestone payments upon achieving certain performance milestones, plus entitled to a royalty unmet sales. Tetra to its subsidiary vital pain is about to meet with FDA to discuss specifics of the clinical development program.
And last, but not least, an update on our Montelukast program. Montelukast, is our most important and most advanced drug repurposing opportunity.
It is indicated for the treatment of the degenerative diseases of the brain like Alzheimer's, like cognitive impairment and other similar diseases. The addressable market of that product is in excess of $5 billion, and expected to grow very significantly over the next years.
We completed and that have been announced a Phase 1 clinical study for the first time Montelukast was administered in the form of a film product to humans. The plenty objectives where firstly to demonstrate that IntelGenx's oral film product will abide a therapeutic effective blood level to Montelukast; and secondly at Montelukast when delivered using IntelGenx oral film successfully crosses the blood frame barrier.
Both of these objectives were achieved. We increased bioavailability by 52%, compared to the reference product, which is the tablet product and we also demonstrated that the molecule process, the blood brain barrier in relevant concentrations.
Based on that study outcome, we have now a Phase 2a, a so-called proof of concept study in preparation. The study will be supervised by C5R [ph] which is a Canadian governing body or studies in the Alzheimer and dementia area.
The study will be conducted in patients suffering from mild to moderate Alzheimer's disease, patient enrolment is likely to commence in April May timeframe. We are still discussing questions that were posed by the C5R governing body.
Those will soon be resolved and we expect results of that study to be available by the fourth quarter of this year. The commercialization strategy for this product will be decided mostly depending upon the outcome of that proof of concept study, we might either decide to partner the study with a relevant industry partner or we might decide to move the development through at our own expense, like I said that will depend on the outcome of that study.
Overall, I’m very pleased with the progress we're making with our pipeline products and also with our efforts to transform IntelGenx into a global leader in pharmaceutical oral films. And I would now like to turn the call over to our CFO, Andre Godin who will review our Q4 financial results.
Andre?
Andre Godin
Thank you, Horst. Good afternoon everyone.
As Horst mentioned, I will take a few minutes to discuss the company's financial performance for Q4 and for the fiscal year ended December 31, 2016. Total revenues for the three-month period ended December 31, 2016 amounted to $1.9 million, representing an increase in revenue of $400,000 or 27% compared to $1.5 million for the three-month period ended December 31, 2015.
Total revenues for the 12-month period ended December 31, 2016 amounted to $5.2 million, representing an increase of 100,000 or 2% compared to $5.1 million for the 12-month period ended December 31, 2015. The increase for both the 3-month and the 12-month period compare to the previous years - from the corresponding periods was mainly attributable to upfront payments received throughout 2016.
The mix of revenue components in 2016 continued to shift from royalty and milestone. The deferred revenues from the monetization of Forfivo and upfront payments from multiple agreements signed in the period.
Operating costs and expenses were $6.2 million for the full year of 2016, versus $3.71 million for the corresponding 12-month period in 2015. The increase is mainly attributable to increase in salaries attributable to multiple new hire at management and employees’ level, as well as increases in both BD and patent expenses.
Now with the exclusive license from the patent expenses should go down in 2017. Also the company recorded an operating loss of 981,000, compared to an operating income of $1.4 million for the comparable period of 2015.
After a slow start in deferred tax of 2016, we recorded more than $1 million in EBITDA in the second half of the year, which brought our EBITDA back to almost breakeven for the entire year. Net comprehensive loss was $1.5 million or $0.02 on a basic and diluted per-share basis for the 12-month period of 2016, compared to net comprehensive income of $800,000 or $0.01 on a basic and diluted per-share basis for the comparable period of 2015.
As at December 31, 2016, the company's cash, cash equivalents and short-term investments totaled $4.5 million. Fortunately we have the necessary financial resources to continue existing executing on our commercialization plant and other important elements of our growth strategy.
That said, as Horst mentioned earlier, we are expanding our manufacturing footprint and capabilities, which will naturally result in higher expenses. While current cash on hand should be able to take us forward for at least the next four or five quarters we are exploring ways to strengthen our balance sheet.
I can't give any color on that today, but I can assure everyone that as always IntelGenx remains committed to building shareholders value and minimizing shareholders solution. I will now turn the call back to Dr.
Zerbe to conclude our remarks.
Dr. Horst Zerbe
Thank you, Andre. Again, we're most pleased by the progress we made in Q4 and in the entire year 2016.
And here again the highlights were, we signed a record seven partnerships deals with Grupo Juste, Pharmatronics, Endo ventures and the Chemo Group. We completed Phase 1 of our state-of-the-art commercial manufacturing plant and have started working on Phase 2, with the intent to increase manufacturing capacity bi-fold.
We strengthened our executives team to reach a settlement with Eli Lilly and change exclusive license for the 166 dosing patent, which will give us a free and clear path towards product launch, we successfully completed a Phase 1 study with our Montelukast product and are now in the final stages of preparing a Phase 2 proof-of-concept study and be very significantly advanced the other pipeline projects for commercialization and now, and I really want to point that out. The focus is now less on acquisition of new products.
Our priority is clearly on delivering on the existing contracts. None of these accomplishments would have been possible without the support of our board, our stakeholders, and most importantly the hard work and dedication of our staff and a heartfelt thank you to all of them.
Before we turn the call over for questions, I would like to inform you that I invited Nadine Paiement, our VP of R&D to answer any questions pertaining to regulatory IP or R&D. Thank you.
Operator
[Operator Instructions] Our first question comes from Swayampakula Ramakanth from H.C. Wainwright.
Your line is open.
Swayampakula Ramakanth
Hi Horst, this is RK from an HCW. One of the questions that I have from your initial remarks is regarding the expansion of the manufacturing facility.
So, I'm just trying to understand is it possible for you to tell us a little bit more about the partners who are asked - who are asking you to increase this footprint and how does it actually impact further partnership conversations. And also during this expansion, is it possible for you to get some of the partners to help pay for the cause in that expansion process?
Horst Zerbe
First of all thank you RY for the question. Let me comment this way, as I mentioned before, we signed total of seven new partnership deals in 2016.
For each of these deals, we retained full manufacturing rates. What that means is that a debt was sort of unexpected before we went into the facility projects.
That means that approximately around 2021 we will have reached of our manufacturing capacity limit in the existing facilities and in order to be prepared for additional manufacturing quantities, we simply had to make the decision to expand the facility. As far as your second comment or question, as to whether any of our partners are willing to contribute to the funding of that expansion we have planned to handle that completely independently.
We have the funds to complete the Phase 1 of the expansion and we will be sufficiently funded to complete Phase 2 as well. We have not approached any of our partners for contribution because we want to maintain our independence as a development and manufacturing partner.
So that has never been an issue for us.
Swayampakula Ramakanth
Okay, thank you. And then regarding the tadalafil product, congratulations on getting exclusive rights from Lilly on the patent, but in terms of commercialization, what kind of partners are you looking for and does Lilly by allowing you, by giving you the rights to the patent, do they have any say in terms of commercializing the product?
Horst Zerbe
Okay, to answer the second part of the question first, none whatsoever. We have an unconditional license if you will.
They have no input whatsoever into the selection of any partners, so whatever else may be, the license is for our product or the US territory. No further condition and it will be in effect upon approval of our product.
That’s all. As far as the first part, I cannot be specific, but what I can tell you is that since we announced that we are in settlement negotiations with Lilly and initially achieved an exclusive license, the interest in partnering with us has risen pretty dramatically and even more so now that we received an inclusive license.
I cannot be specific obviously, I cannot disclose any names, what I can say qualitatively is that we are discussing the opportunity with several potential partners, very large to mid-size and small and the entire range, at the end I think I need to leave it at that.
Swayampakula Ramakanth
Okay, thank you. And then the last question from me is on Rizaport and your relationship with RedHill.
This is on the US resubmission and launch. You said there is a milestone payment that you could recognize from RedHill, is this is divided between submission and launch or is this purely on launch?
Horst Zerbe
This is on approval.
Swayampakula Ramakanth
On approval, okay. Thank you.
Horst Zerbe
You're welcome.
Operator
Your next question comes from Greg Eisen of Singular Research. Your line is open.
Greg Eisen
Sure thing. Thank you, good afternoon Horst and Andre.
Horst Zerbe
Good afternoon.
Andre Godin
Good afternoon.
Greg Eisen
Just looking at the income statement for the quarter, revenue is $1.9 million, I was estimating $900,000 to $930,000 of the continuing amortization of the Forfivo fee, so that would mean the rest of them, basically remaining 1 million is from up fronts, can you disclose how many different partners you received upfront payments from this quarter, is that something you can do?
Horst Zerbe
Yes, we received upfront payments from three partners. Through three deals obviously.
Greg Eisen
Understood, three deals. Were any of these upfront payments from drugs or deals regarding drugs that you have not previously discussed?
Andre Godin
No, they are not, there all have been agreements that were announced in Q4.
Greg Eisen
Okay.
Andre Godin
But they are all public information.
Greg Eisen
Understood.
Andre Godin
What [indiscernible] has mentioned, we unfortunately, because most of these deals if not all are genetic we cannot mention the specific terms on each of them, but obviously overall this is about the amount we received in Q4.
Greg Eisen
Got it, understood.
Andre Godin
Received or receivables sorry.
Greg Eisen
Understood, I understood how that works. Moving back on to tadalafil, trying to understand you’ve got the 166 patent license, the other two patents that were under the IPR attack were essentially invalidated, but I think you said that Lilly was appealing that in validation, am I correct in understanding that?
Andre Godin
That is correct, but I would like to turn over to Nadine or the VP of R&D, she is also responsible for IP. She can comment on that question, Nadine.
Nadine Paiement
So there is currency and appeal on those two assets and fill the decision from the judge or from the - on the validity of those capacities probably there will be no launch because the risk here of changing the decision from the court is still valid in.
Greg Eisen
Okay. So you wouldn't launch before that appeal is said, so that you know you are not subject to those two other patterns.
I am trying to build minor cases, go ahead.
Andre Godin
Greg, it does not affect us, those two patents.
Horst Zerbe
That was more a general comment by Nadine and keep in mind, in addition to those two what we refer to as particle size patterns there will still be 166 dosing patent that I elaborated on a little more and that thing is still in advanced litigation. And at this point good until 2020.
Greg Eisen
For now it is an effective patent? Until 2020?
Horst Zerbe
Yes.
Greg Eisen
But you have a license for it right now?
Horst Zerbe
Correct.
Greg Eisen
Got it, understood. I am trying to understand and trying to kind of build out the case in my mind of what hurdles there might be forgetting to market, and obviously the big one is as you are getting to the 505(b)(2) past the FDA, and –
Horst Zerbe
I can comment on that Greg, I want to make it crystal clear. From an IP standpoint there are no further hurdles for us.
Our one and only hurdle if you is as you just pointed out getting passed FDA, with getting the NDA approved. That’s the only hurdle left for IntelGenx.
Greg Eisen
Right and you were, I think in your prepared comments, going back to my note, so I have a lot of notes here, the pivotal bio study is ongoing and that would be available in May, so you think you could file the NDA June or July, within 8 to 12 months review time, figure approval could be in the second quarter of next year of 2018?
Horst Zerbe
Correct.
Greg Eisen
That is what you said. Okay.
Horst Zerbe
Yes.
Greg Eisen
I think you said the substance patent expired in 2017 anyway?
Horst Zerbe
Yes, it is November 21.
Greg Eisen
Oh that’s right. That sounds right.
That is the one that expires later this year. Right, understood.
Okay, let me move on. So that is the key, just getting past the old Uncle Sam there, but could you give us any more background and color on the Dronabinol, let me see if I say right, Dronabinol term sheet that was announced on February 9, what are the steps involved in you getting that to market, and how do you plan to approach that again?
Horst Zerbe
It is a 505(b)(2) application and it is a 505(b)(2) that is going to have to be supported by full clinical development. So this will be a long term development program.
At the very least, are we going to have to conduct a full Phase 2 evaluation, whether or not we then will have to go to, or will have to conduct a Phase 3 will quickly tend on the outcome of the Phase 2. We might be able to achieve an additional approval under which the Phase 3 would have to be conducted, post approval, but that is speculative right now.
The legal environment would allow that whether FDA rules along those lines remains to be seen and like I said that is essentially depending upon the outcome of the Phase 2 study.
Greg Eisen
Okay.
Horst Zerbe
And I would ask Nadine to please comment if we assume for the moment, we are lucky or Tetra is lucky and gets a waver on the Phase 3, what would be a likely Phase 3 for - to that post approval, what would be a potential approval date. Least we are looking at 2021 right?
Nadine Paiement
Depends how quickly we can start the Phase 2 run. If we assume that the Phase 2 would last at least a year that it would burn at the end of this year that we then need the approval.
The entire process will take at least two year and a half to three years from now.
Horst Zerbe
So then comes the review, so what we are into past 2020? So, 2021, I mean it is all speculative at this point Greg.
I am sure you understand, but it is time that could make sense.
Greg Eisen
Understand, well it is important for me and all investors will be able to understand that that is going to be a longer fuse for success and then the market that really didn’t expect it.
Andre Godin
But Greg, just to clarify something, there will be some milestone payment in R&D revenue in the process. But at the back end the manufacture - not the manufacturing, but the royalty will probably be in the 2021 timeframe, but in the process the agreement also comes with milestones and R&D revenue.
Greg Eisen
Right. I think the phrase funding was used to really to describe touch with responsibility, will they be funding the entire R&D cost or a portion of it?
Horst Zerbe
The entire R&D cost.
Andre Godin
Yes, 100%.
Greg Eisen
And as far as, Andre how you could account for that is that, basically offset against your R&D expenses on the income statement and not showing as revenue?
Andre Godin
It is shown as revenue because IntelGenx basically makes a small premium on R&D revenue. We obviously don’t charge our partner at our cost.
There is a premium which is our margin that we make on all our R&D revenue and that’s why it is showed as R&D revenue, because there is profit within the revenue.
Greg Eisen
Okay, now turning to the plant expansion, can you talk about the timing of when that will begin spending and about how much that will cost you?
Horst Zerbe
I would turn over to Andre for that.
Andre Godin
We will probably start in the summer, and it should probably take six to nine months, so the spending would start later this year. Obviously, we are looking at different options, I mean debt option is from far the number one option and I am already obviously working on that one.
There is a leasing option, there is convertible debt option, I mean there is many different options for financing this expansion, but we are advanced in - we wouldn’t go ahead blindly to a project like this one, so we were pretty much clear on how we are going to do it and then you will get some color on that in the coming weeks and months.
Greg Eisen
Okay and the expansion includes, the cost includes building of the lease space that you described across any equipment.
Andre Godin
Yes exactly, it increases everything.
Greg Eisen
Okay. And you don't have a number right now, for a range of numbers to get it correct?
Andre Godin
It would be probably a bit lower than the Phase 1. I wouldn't want to start drawing numbers because we still have to do our homework, but they would be less expensive than the Phase 1 that we did, that we just did.
Greg Eisen
Sure. That sounds reasonable.
That’s good enough for right now. I guess it is at a range at least of understanding.
Turning to kind of the expectations of the 2017, is there anything you can give us regarding your expectations for SG&A and R&D spending plans for the coming year versus say what you expect in 2016?
Andre Godin
I wouldn't want to go to into specifics, but I can tell you that SG&A did not really go up that much, it should be pretty much stable because we have built the team in 2016. So, basically for 2017 there will be, the team is in place now and obviously everything, there is always an increase in running a business as you know but we should have maybe a little bit less patent cost because of the settlement we are letting.
So, if we consider all that we should stay in the same range. R&D will definitely increase in 2017, but because with most of the partnership that we signed in 2016 the seven partners that Horst referred to earlier there is development that comes with it, but the good thing is that we will have R&D revenue that will compensate, but the R&D expense itself will definitely go up from 2016.
Greg Eisen
So, you have the revenue of the compensation for the increased cost.
Andre Godin
Yes.
Greg Eisen
On a net of funded R&D, you are truly out of pocket R&D, can you expect that to be up materially or close to the same?
Andre Godin
That will be slightly higher because we had to add to our team, I mean Nadine seem as grown over 2016, so that will be reflected for the full 2017, but it should not be, it should not have that much of an impact, it’s mainly, the spending that we will do on the development cost on the 2016 partnership that we accomplished.
Greg Eisen
[Indiscernible]
Andre Godin
Yes.
Greg Eisen
Okay. Turning to, you mentioned, you talked about Montelukast, I see from your website that you are making a presentation in, I guess entered the week in Vienna, is that being webcast?
Andre Godin
No, it’s not been webcast. But we will provide some more info information, some more color on the Vienna show at some point probably in, probably next week or something like that, but it is not being webcast.
You're not going to be able to see it live.
Greg Eisen
Okay.
Horst Zerbe
It is a pollster presentations.
Andre Godin
Yes it is the pollster representation. Greg, we have a hard stop at 5:30 and we - I can see that we have other callers.
Greg Eisen
Okay, I will let someone ask online. Thanks again.
Horst Zerbe
And if you have any more question, feel free to call me directly, and I can answer your question. I just want to make sure that everybody gets the chance to ask questions.
Greg Eisen
Okay. Thanks Andre, thanks Horst.
Horst Zerbe
Thank you, Greg.
Operator
Your next question comes from Don Hutchison of Safe Harbor [ph], your line is open.
Unidentified Analyst
Hi there. Most of my questions were already asked, just my final enquiry might be that during the remainder of the year what type of let’s say catalysts for propel or stock a bit would be reasonable to look at in terms of potential announcements?
Horst Zerbe
Basically the most significant ones which certainly be, first of all the successful completion of the pivotal bio study for tadalafil, then the sufficient bodes of the 505(b)(2) for the tadalafil film and then the resubmission of the rizatriptan, 505(b)(2) NDA decides that, probably the most significant event would be towards the end of the year that will be the outcome of the proof of concept study or Montelukast and in between we have another number of events, but shortly mid-term it is certainly, the pivotal bio study I repeat that at the two filings rizatriptan and tadalafil.
Unidentified Analyst
Okay. Thank you.
Horst Zerbe
You’re welcome.
Operator
Your next question comes from Patrick Tully of Endeavor Asset Management. Your line is open.
Patrick Tully
Hi, good afternoon. Horst how many patients are in the study to Montelukast study?
Horst Zerbe
I turn over to Nadine for that, she is the expert. We have just received the comments on our protocol from the expert that we are discussing this study with and then the final number of subject or patient has not been finalized yet.
So, it will be decided in the next few weeks, but for the moment they prefer not to mention any number.
Patrick Tully
In excess, can you tell me is it in excess of 50 patients?
Nadine Paiement
It is in excess of 50 patients.
Patrick Tully
It is. Okay.
The reason you bought up the Q launch for patents on tadalafil, I assume that was because competition will have a tough time getting through the course, but you are not impacted by those two orange book patents, is that correct?
Horst Zerbe
That is correct. I mean, I cannot comment on the roles and problems of our competitors, but I can tell you that we are not facing that kind of problem anymore.
We have to be –
Patrick Tully
Okay. Andre just real quickly, was there any - go ahead.
Horst Zerbe
I’m done.
Patrick Tully
Okay, Andre was there any cash received from the signed deals that were signed in the fourth quarter, did any of that cash debt received or pushed into the first quarter?
Andre Godin
Yes. Basically, we had about $1 million of accounts receivable as of Q4, at the end of Q4, at the end of the year.
So that cash was received in Q1.
Patrick Tully
Okay, so the balance sheet has expanded greater than what we saw at December 31.
Andre Godin
Yes.
Patrick Tully
Okay, all right. That's it.
Thank you.
Andre Godin
Thank you, Pat.
Horst Zerbe
You're welcome.
Operator
There are no further questions at this time. You may now disconnect.