Liminal BioSciences Inc.

Liminal BioSciences Inc.

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Liminal BioSciences Inc. (LMNL) Q3 2014 Earnings Call Transcript

Published at 2014-11-14 16:48:03
Executives
Pierre Laurin - President and Chief Executive Officer Bruce Pritchard - Chief Operating Officer and Chief Financial Officer John Maron - Chief Medical Officer
Analysts
Alan Ridgeway - Paradigm Capital Neil Maruoka - Canaccord Genuity Sanjay Jha - Panmure Gordon Jim Belin - Aldebaran Asset Management
Operator
Good day and welcome to the ProMetic Life Sciences Inc’s Third Quarter 2014 Results Conference Call and Webcast. I would like to introduce Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer; Mr. Bruce Pritchard, Chief Operating Officer and Chief Financial Officer; and Dr. John Maron, Chief Medical Officer. For your information, the presentation will be followed by a question-and-answer period. You can ask questions in the language of your choice. I will now turn the call over to Mr. Laurin.
Pierre Laurin
Thank you very much and good morning everyone. Apologies for our folks on the West Coast. This call is usually earlier than usual but we are very busy right now, John and I, attending the American Society of Nephrology Conference. And that’s the only way we could actually hold that webcast. So welcome everyone. I will remind everyone on Slide 2, that this presentation contains forward-looking statements about ProMetic's objectives, strategies and business that involve risks and uncertainties. And on that note I will move on to slide three which cover the agenda that we intend to discuss this morning at the webcast. We will start with the highlights in the quarter. Guidance again for the second half of this year, call it Q4. Bruce will then a step in and discuss the financials on the quarter and we will come back with some corporate update and a special focus on the Vanderbilt Study, and move on to discuss the milestone for year-end that we still have in the making and in outlook for 2015. So busy year, busy quarter. Fibrinogen commercial launch is on target for this quarter. We have had multiple development program with the affinity resin and we have announced on that front the $20 million follow-on investment from Thomvest, also provided additional working capital for the company to expand its activity and perform and advance products in the clinics. We are very happy for Bruce's promotion as a Chief Operating Officer which signals the inevitable moving from -- transiting from R&D, predominantly R&D company to a manufacturing and commercial activities related to the biopharmaceuticals in Laval facility and the expended capacity that is forthcoming. Very successful development in regulatory milestone through the quarter. Successful pre-IND meeting PBI-4050 and just like recently as well, Health Canada giving green light for 4050 for the trial in the renal patients. So exciting time. And again on Slide 5, we provided just weeks ago some guidance on the second half of '14. I am highlighting in green here two that were promised and we tick those box and intend to tick all the other boxes before year-end. We had a very strong Q4 in terms of revenue. And as Bruce will expand, there is always this issue of quarter-to-quarter variance. So this is no exception this year, very strong Q4 as a result of having some of those deals that we are finalizing, closing in this side of the quarter. Perhaps, Bruce, you would like to go on and discuss the financial results for Q3.
Bruce Pritchard
Thanks, Pierre, and good morning ladies and gentlemen. I’d like to ask you to move to Slide number 7 in the webcast. And as usual I will remind listeners that this part of today’s webcast is based on the financial statements for the quarters ended 30 of September 2014 and 2013, which have been reviewed by Ernst & Young, the corporation's auditor, as well as on the audited financial statements for the year ended 31, December 2013. All of these statements were been prepared under IFRS. The full annual financial statements for the Group can be found online at sedar.com. And, finally, all sums in the presentation today are in thousands of Canadian dollars except for per share amounts or if otherwise indicated. If we move on to Slide number 8, which is my regular analysis of the revenue for the year to date, which for 2014 is $12.5 million. The split of revenue is somewhat different to the previous year. Product sales have continued to grow with year-to-date product sales standing at $7.3 million, an increase of $0.5 million on the same nine months of 2013. At the same time, however, service and license revenues are only $5.1 million compared to the $8.8 million reported in the first three quarters of 2013. This reflects both the change in NantPro becoming a subsidiary earlier in the year and therefore eliminating any service revenues from that entity but also reflecting the fact that we are slowing the amount of external services provided to licensees, so as to retain more value for our own shareholders and our own pipeline. I move to Slide 9, and some of the key figures from the profit and loss account for the third quarter. I think it's fair to say that there is a fairly significant loss and everyone will have noticed that in the financial statements. But 50% of that loss is a non-cash accounting adjustment which rather [previously] [ph] is based on the success of the stock price in the quarter. I will come on and talk about that in a second, but if we go through this line-by-line. Revenues for the quarter were $2.3 million compared to $6 million for the third quarter of 2013. These year to date revenues of $12.5 million compared to $15.6 million in the first three quarters of 2013. As I mentioned on the previous slide, within this there had been a modest increase in product sales revenue. That increase related mainly to currency exchange and therefore there was little impact on cost of goods which remain consistent year-over-year at $4.7 million for the three quarters. Total research and development costs have increased over the same period of 2013. However, significant progress has been made towards delivering our stated milestones for both plasma derived and small molecule therapeutics. In addition, with NantPro now being part of the group, the R&D costs for that new subsidiary are also reflected as cost for ProMetic. With that context then, the research and development costs were $7.8 million in the quarter compared to $4.6 million in the same quarter of the previous year, bringing total research and development costs to around $23.4 million for the year to date compared to $12.4 million for the year to date 2013. Administration costs in the third quarter of 2014 were $3 million compared to $2 million in the same quarter of 2013, with that increase reflecting the increase in headcount and associated share-based compensation cost required to support our growing business. Finance costs are higher year on year reflecting the interest on the two Thomvest loans that we now have. And in this quarter, the fair value adjustment of the warrants that I mentioned earlier, significantly impacted the quarter to the tune of $10.4 million due to the substantial increase in the share price from 30 June, 2014 30 September, 2014. Again to remind everyone that this is an accounting transaction rather than a cash cost to the business. And finally, just on the year to date column, we have the two gains which we mentioned in the Q2 webcast, resulting from the change in the NantPro relationship from that of associate to becoming a subsidiary. As I mentioned in the second quarter, those figures were based on a preliminary allocation of the purchase price. We expect to finalize that valuation exercise this year and expect the result to remain similar or perhaps even to increase the game slightly in our favor. But no adjustments have been booked in the third quarter in relation to that transaction. So year-to-date EBITDA shows a loss of $19.7 million versus a loss of $5 million for year-to-date 2013. And that difference is clearly made up of the additional cost associated with advancing our R&D and product pipeline to the clinic and gearing up the business for commercial launch. So overall then, the group returned a net loss of $20.7 million or $0.04 per share in the quarter compared to a loss of $5.3 million or $0.01 per share in the third quarter of 2012, sorry 2013. And looking up at net loss then overall for the year to date, $5.9 million year-to-date 2014 versus $9.9 million year-to-date 2013. If I move then on to slide ten and analyzing the key figures from the balance sheet. Cash at the end of the quarter stood at $10.4 million compared to $17.4 million at the end of the year. Accounts receivable were $4.9 million compared to $14.2 million at year-end. Within that $4.9 million figure, trade receivables have reduced quite significant as a result of converting $6 million of the NantPro receivable into an equity investment but also as a result of the lower product sales in the quarter. Also, since the year-end the loan that we had with InvHealth has been repaid in full. Capital assets have risen by $3.2 million, representing mainly the investment that we continued to make in the production facility in Laval and also on the production plant on Isle of Man. Trade and other payables are down to $6.1 million compared to $7.9 million at year-end reflecting payments made in the year-to-date. Deferred revenues are at $1.5 million which reflects the recent upfront payment from Octapharma on the latest, the PO that was announced a while back. And deliveries on that order have not yet commenced and that’s their request. The warrant liability stood at $21.8 million at the end of the quarter and again, reminding everyone that this is a non-cash [adjusted] [ph] accounting entry so not really a payable our book. Long-term debt provided by Thomvest, shown here as $22.3 million, will also likely be repaid by the exercise of the warrants that were accruing this liability on. An increase in the figure since year-end is due to the accretion of interest as well as the addition of loan taken earlier in the quarter. Finally, as a result of the gains made on obtaining control of NantPro, the balance sheet has strengthened since year-end with total equity standing at $42.4 million from $18.6 million at year-end and total assets up from $49.9 million to $137.9 million. So wrapping up then on the financial results for the quarter, we are continuing to demonstrate our investment in product development and the value created by taking control of NantPro. Clearly we have had an impact this quarter of the share price movement affecting the warrant liability but I think all of the above are positive indicators of the potential returns to come. So I hand over now back to Pierre for the technical update.
Pierre Laurin
Well, thank you. And anyone having questions related to the financials, as you know during the Q&A Bruce is there. And let's move on to Slide 12 if you want, and expand a little bit more on the Vanderbilt Study. This study was performed by Dr. Ray Harris, who is Chief of Nephrology at Vanderbilt at President Elect of the American Society of Nephrology, and his colleague Ming‐Zhi Zhang. The study was performed under a total arms length material transfer agreement, where under material transfer agreement ProMetic provides the University with a certain amount of PBI-4050 for them to perform a study without us controlling at all the study. And in fact it's a model that they have perfected at Vanderbilt called the db/db eNOS‐/‐ mice. Which is, if you go on Slide 13, not good prognostic for those type of mouse that have a genetic makeup that creates a combination of severe hypertension and diabetes. And you can see here Dr. Harris has listed for us a list of things that go wrong in those animals and impacting dramatically the kidney, most organs in fact. Kidney, but the focus of the poster presentation during the ASN, which is only 10%-15% of the entire results, there is more to come from that study and stay tuned. But so far, what's been disclosed is the impact on the kidney and the pancreas. And I will let also John comment later in this presentation. On Slide 14, just to highlight certain aspect of this terrible condition. That is the red bar here that shows the dramatic loss of protein by the kidney. So we have published before data in the db/db animal model. This is just diabetic mouse and to these mice we remove one kidney, so it's uninephrectomized mice model to accelerate the condition. But this one is actually even more dramatic and you have this massive of loss protein in urine which is one of the tool by which biomarker, let's call it that way, that physician nephrologists will use to determine the prognostic of the patient. On Slide 15, there is this nice compilation of data that simply shows that the animal on the dark, the black line, that animal that are not treated simply progress dramatically. They keep on having more and more protein shed in urine, showing that the kidney further deteriorated and PBI-4050 protects that from happening. So there is a preservation of the glomerular filtration rate and kind of a protection of the kidney in those animal that are treated, which is quite spectacular. And what you can do in animal that you [cannot] do in human is reflected on Slide 16 and some follow on slides where you have beautiful pictures of what's going on in the kidney. So on Slide 16 on the left, you have some different staining technique to show that in the first two pictures on the upper left, you have dark red and some blue that is indicative of nephrons totally being destroyed, compromised and replaced by fibrotic material. And Dr. Harris and his team have been able to elegantly illustrate the pathway and the mechanism of action of PBI-4050 and to clearly confirm our data but in a very dramatic model. So on Slide 17 again, you have images of kidneys recovered from animals that are treated with PBI-4050 and you look at those kidney, despite the fact that these animals are still hypertensive, because PBI-4050 has no effect on hypertension. Despite the fact that they are diabetic and hypertensive, the kidney is protected unlike those that are not on the drug and you see all the blue on the left on the Slide 17, that is indicative of the presence of collagen. A few more slides here before I pass the line to John. Other type of approach that Vanderbilt have at their disposition here on Slide 18. Clearly, using a staining technique that selectively color the collagen, and you can see here the massive amount of collagen that you have in the non-treated animal. Little filtration unit called the [indiscernible] and again preventing that little unit of filtration to function. It's replaced by fibrous material unlike the animal treated with PBI-4050. Same thing on Slide 19. You have that now, a staining technique that colors the collagen IV. So clear indication that PBI-4050 reduces the fibrosis. Another very important marker on Slide 20 is the myofibroblast that actually are activated and they are the culprit that actually secrete and lay out the collagen. Again those red arrows show clear areas where the myofibroblasts are really activated, in the non-treated animal compared to PBI-4050. And one thing that will come back later as well to explain the superb effect on glucose, and I will let John explain this to you, but you have here again an evidence on Slide 21, where there is less infiltration of macrophage in the animal kidney treated with PBI-4050. And again, that infiltration leads to inflammation, leads to the collagen deposition. And, again, from all angles, this study confirmed the antifibrotic activity of the PBI-4050. Finally, you have few more nice slides. And I have some that are so impressive I have enlarged and made posters for my office, quite inspiring. But again the dark spot on the left here on Side 22 indicating some significant oxidative stress. Again, not a good sign when you have that lighten up, that means that you organ is in distress, it's inflamed, and it's not performing well. PBI-4050 significantly reduced that feature. And finally, one of the major culprit in the pathway of fibrosis is CTGF, which is a marker that we will use as well in human studies. And you can see again, heavily expressed in the non-treated animal versus the one of PBI-4050 on the right. Let me pass on now for John Maron for Slide 24 of the study with Vanderbilt.
John Maron
Good morning, everyone. I think this is one of the most important slides in this presentation. You note, in this case it's animals treated with PBI-4050 where things light up, and that’s a good thing. Autophagy is the process by which the kidney repairs itself from damage. And what we are showing here is that PBI-4050 by preventing ongoing damage is allowing the kidney to regenerate itself. So it's a very important finding. It confirms what we have seen in our own work. And if we go to Slide 25, this gets perhaps even more exciting. If you look at graph A on the top left-hand corner, this is showing the serum insulin levels in these mice if they are untreated and just left to carry on. You can see, between 8 weeks of age to 24 weeks of age is [prerogative] [ph] for, in the serum insulin levels. In other words, this is diabetes. If you look at graph B, underneath that. You see in red, if we start treating the animals at 8 weeks of age, that we preserve the serum insulin levels, you don’t get that fall. And graph C shows you very clearly that even if you start later from that 16 weeks, which is pretty advanced age for a mouse, you can see that we take the insulin levels back to the 8 week level before they started to get severe diabetes. And what is shown very nicely in the picture on the right hand side, PBI-4050, you can see dark areas, that’s insulin preserved in the islets. Very very important finding. So we have not only this anti-fibrotic, anti-inflammatory effect in the kidney, but we are also preserving function of the pancreas in these animals. And then Slide 26 shows you the outcome of these effects. You can see the animals in red treated with PBI-4050 live on whereas all the animals untreated are dead by 26 weeks of age when we start treatment late in the course of 16 weeks. Very very important finding. Obviously, it's a hard, very definite endpoint. And this is really very strong confirmation of the effect of PBI-4050 in this very difficult model. I think there is a number of things to talk about regarding this work. First of all, it's independent validation of lots of work done at ProMetic. Secondly, as I have said, it's a very very difficult model. As Pierre emphasized, we don’t just have the natural effect of diabetes, we have had a severe hypertension to it as well. And that is getting very close to what happens in humans with diabetes. Secondly, if the treatment is started late in the course, it still has a substantial improvement in outcome. And then this finding, finally, that we have also protected the pancreas as well as the kidney, is very very important. I will hand it back to Mr. Laurin.
Pierre Laurin
Thank you, John. Let's move on maybe to Slide 28. As some may have picked up already that we were also presenting at the American Society of Nephrology meeting in Philadelphia a new data for PBI-4047. So, yes, PBI-4050 is definitely our lead compound in clinical trials but this is not a product as a standalone. We clearly with this paper, which I will not expand on this call, but you can see that we have a very good handle on the receptors involved in creating this rather spectacular effect. And that we have other drug candidates that we are advancing. This one in particular has a very very profound effect on glucose and diabetes therefore, as well as reduction of the complication in the kidney. But this is being achieved at one-tenth of the dose that PBI-4050 is requiring in the same model. So very promising. You will see therefore the creation of a pipeline of products that will enable ProMetic to actually position it's drug candidates in various fibrotic conditions and that’s our objective, is over time to have different compounds targeting different organs, different indication, so that it provides for superior return for our shareholders. On Slide 29, perhaps, John, you want to comment on the fact that we just got the healthcare approval, Health Canada approval to commence the study. I believe you started dosing the patients?
John Maron
Yes, we are moving right along. We are in the most important animal to study, the human. We have already commenced a study of multiple doses of 4050 in patients with advanced diabetic nephropathy that will be a multi-dose study as it said and therefore very important. We believe that we will not see any significant changes in the pharmacokinetics in these patients based on our animal work. And then we are betting busier and busier. In 2015 we will be continuing to look at patients with advanced diabetic nephropathy, both in Canada and in the United States. We have approval from Health Canada to move ahead with that study. And we have, as Pierre said, discussed this with the Food and Drug Administration and will be submitting an IND to extend that study to the United States in Q1 2015. Idiopathic Pulmonary Fibrosis, another very difficult disease. We are going to start an open label study in that. We have extremely good results in our animal models for that condition. And it's crying out for more effective therapy. And then we will also be starting another study in a condition, an orphan condition which is rare but involves intense fibrosis and severe type 2 diabetes. And based on animal work, we would again expect to see good results in that disease. Back to Pierre.
Pierre Laurin
Well, thank you, John. And just to wrap it up. Again on Slide 30, milestones to year-end. So I will remove the first two that were in the green in the previous slide to leave you the following. That we still intend to announce the additional orphan indication for PBI-4050 and you already have received a bit of a cue from John just a few minutes ago. We are in good shape to file the IND for IGIV or IVIG with the FDA. We intend to disclose two additional plasma derived orphan drugs. Very well positioned to close before year-end some deals that will provide financial contribution, access to market and provide additional manufacturing capacity. And of course now you can take Q3 out of the H2 guidance but we are still holding on to our guidance which then translates into a significant Q4 in terms of revenue. And like if we slip to Slide 31, a bit of an outlook for 2015, what to expect. Well, I will start from the bottom this time just to bridge on my previous comment. You should expect as well a very strong first half of next year as there is also deals that we are making great progress and may not fall this quarter but fall in Q1. And therefore between what we know will fall in Q4 and what we can expect to also close for this first half of 2015. We are in extremely, extremely good shape. Back to the top of the slide though. 2015 will be strong with some development in regulatory milestone. Again, we will be, about the same time next year, we will have four plasma derived biopharmaceuticals in phase 3. In fact we will be filing the BLA for plasminogen around that time. And we will be in a good shape to have generated PBI-4050 proof of concept data in humans. We are pursuing different studies and therefore some of them are likely to provide us with some indication of translation data between animals and humans, which is one of the key objective for 2015. We should be also announcing the advancement of two new small molecules, PBI-4547 has already been flagged as a likely candidate to be ready to enter clinical program in Q1 2016. And we also expect to receive several different orphan drug designations throughout the year based on some filings that we have already done and some that we will be doing in the coming weeks. In should be also a year rich on the partnering side. Again, partnering to bring complementary expertise and financial contribution to the program. And mostly the fact that now the company is in good position with several assets moving into the clinical stage here and partnering to provide us with some access to markets. So on that note, I would like, operator, to open the floor for questions.
Operator
(Operator Instructions) And your first question comes from Alan Ridgeway with Paradigm Capital. Please go ahead. Alan Ridgeway - Paradigm Capital: Pierre maybe just, or John ,maybe for you since you are part of the Vanderbilt study section. Just one question on that. On the last slide on the survival. What is it that is killing the animals in this model? Is it kidney failure or is it some other organ failure?
Pierre Laurin
It's a good question. And in fact, all systems failed. It's kidney -- kidney conditions worsened. The animals have no insulin left, it's depleted. They have failure in their liver. It's the end game. But I would say kidney and liver are the main culprits. Alan Ridgeway - Paradigm Capital: Okay. Great. Thanks. Then just moving on to the 4050 clinical program. Can you guys give us some guidance as to what the size of the three studies will be as far number of patients you enroll or plan to enroll. And maybe on what the timing could be for how long those studies will take before you will be able to share some data with us.
Pierre Laurin
So we will start from, I am looking at slide 29, Alan, and starting with the orphan condition you can expect this is going to be like a 15-18 type patients with very well defined base line and open label. And some centers in Canada and in the U.K. for this one. Possibly in the U.S. but we have already identified the principal investigators and even the patients with regard to the conditions in both Canada and the U.K. So we are looking at 18-20 patients for that Phase 1b/II and the orphan condition to be announced. In the case of Idiopathic Pulmonary Fibrosis, again, the open label study we are looking at 40 to 50 patients. Again, well identified centers in Canada and U.K. Eager patients to participate. This is no fun, when you are diagnosed with this. And as John mentioned earlier, the current therapy although helping some patients, they have not shown much effect on the moderate to severe cases. And they are the one that are the most desperate and motivated to be trials. And the Phase I/bII DKD patient study is slightly larger. It's double blind, crossover -- not crossover, double blind, three groups, two dose, one placebo and two different dose. You are looking here more in range of 140 patients. Again, centers across Canada. Vanderbilt [Sanford] [ph] will be involved in the States and we will start there and expand. But it's a total of about 120 patients for that. Alan Ridgeway - Paradigm Capital: Okay. And cost of the three trials, ballpark?
Pierre Laurin
Ballpark, I think what will impact 2015 is in the range of $7 million to $8 million. But it's going to be like slow start and ramping up towards the year-end. So manageable cost, Alan, along with our other program. The IVIG program as you know is -- we have incurred most of the cost to make the clinical GMP material already. Right. So this is an interesting point that I want to make here is that, in Q4, and in Q3 and throughout the year, we have done a lot of work to prepare the clinical trial. And part of that for biopharmaceutical is the expensive cost of making the GMP material. So when you are on the study, then you have already incurred all those costs. So it's only the CRO that is left to manage. So the IVIG clinical trial for example, is going to be about $3.5 million spread over 2 years. The [indiscernible] will start much later in the year to impact, but it's again maybe 1 million- 2 million a year. So even though they are late stage clinical assets they don't tax heavily the P&L. And overall, we can manage this program with our current program. Alan Ridgeway - Paradigm Capital: So just I want to clarify. 7 million-8 million is the 4050 cost for next year?
Pierre Laurin
Yes. Alan Ridgeway - Paradigm Capital: Okay. And then just very last thing from me and I will jump off. When do you think you will get data from each of the three?
Pierre Laurin
Well, the open label study is one where you have access to data at all times. So there is some biomarkers that we expect to see light up the right way sooner. The double-blind placebo-controlled study is not going to open up unless you have results that forces you to stop the trial and put all patients on the drug. But at the end of the day, I expect this study to go it's full distance because you need that data. So that's why we may also had some open label and DKD patients. Just that that we have early evidence of proof of concept confirming the dose and we can commence the pivotal study. Right.
Operator
Your next question comes from Neil Maruoka with Canaccord Genuity. Please go ahead. Neil Maruoka - Canaccord Genuity: Just first on fibrinogen. You are on track for launching in Q4. Are there any -- is there any additional validation of the manufacturing process that’s required before commercialization. And I know it's for non-medicinal use but are there any regulatory approvals that are required before you get the drug on market.
Pierre Laurin
No, not for the use intended as a GMP product and purchased by pharma company to combined with their own medical device or their own product. So we should we move forward to advance fibrinogen for use in humans to treat, for example, hypofibrinogenemia or other conditions. So an IV, then you would have to run that like typical clinical trial to get approval as such. So it's a GMP self-declared compliance with certificate of analysis that complies with the relevance pharmacopeia that allows you to sell those products. Neil Maruoka - Canaccord Genuity: And on the manufacturing, are you all set there?
Pierre Laurin
Yes, we are all set. Neil Maruoka - Canaccord Genuity: Okay. And just a follow up question on Alan's question regarding the survival data for 4050. Did you follow -- were those rats sacrificed, or the mice sacrificed at the end of the 30-weeks or is there any data beyond that?
Pierre Laurin
No. I mean these animals at one point pass 30-weeks, they have to be sacrificed because then you also harvest the tissue and this is where you can start making analysis of what improved from an histology point of view, from a physiology point of view. So all those tissues, kidney and so on, are recovered for histological, for various cytokine analysis. And again, what's shown here is one but they have repeated this study umpteenth time. This type of survival difference we have seen also in the very chronic model, nephrectomized rat model. We have seen in the long fibrosis model. Typically you get north of 85%-90% of the animal treated that are surviving and you need to euthanize them at the end of the study versus those that are not treated that falls of the map throughout the study. And in fact researchers will have to calibrate those study because you want to analyze the animal at the same time point. And in the case of Vanderbilt, it's quite -- I am personally very pleased with this because the FDA is clear. They accept the design that we are going to go forward with our DKD study as measurement of biomarkers and so no. That in itself will be enough for licensure as we all know. But that type of spread between a treated cohort versus non-treated for licensure will include the same type of outcome. That’s morbidity, delay for dialysis. And it bodes well because in every animal study we do, this is what you see. Neil Maruoka - Canaccord Genuity: Final question, just on the partnering. You talk about partnering out your, [partner drive] [ph] therapeutics. Would those partnerships look similar to the plasminogen partnership that you have or would you be looking to give up, retain more upside for ProMetic?
Pierre Laurin
Much more upside. The plasminogen agreement that we have done is rather unique from many perspective. First of all, when we entered into our agreement with Imatec, it was a paper project. I mean we were advancing the process but we signed this thing two and half years ago. We didn't even have Laval security yet and so on. And the agreement that we have with Imatec, let's not forget, committed $10 million to the plasminogen development for a share of the global rights but also [indiscernible] $100 million of capital investment for the facility in Taipei. So it was still a rich deal, the bulk of which being of balance sheet. Going forward, what we have been able to do now is to retain much more value for each of the product we are advancing. And the licensing, partnering agreement will be to bring in not only financial contribution but ability to penetrate market far more efficiently. Let's think of just Europe for example. If you look at most companies launching orphan drugs, they are more, pro rata more successful in achieving good revenue in the U.S. then they are in Europe. Because in Europe albeit the market is big, it's segmented in 20-25 different countries, each having their own reimbursement policies and so on. So we are very much interested in partnership that will involve bringing expertise such as market for Japan and Europe.
Operator
[Operator Instructions] Your next question comes from Sanjay Jha with Panmure Gordon. Please go ahead. Sanjay Jha - Panmure Gordon: Just wanted to ask a question on plasminogen. Have you got some idea now what is sort of the pricing, sort of market, that you are expecting when you launch in 2016? Or is it too early to talk about?
Pierre Laurin
Well, it's a bit early to talk, Sanjay. I mean it's not to say that we are not working on that. Obviously, what will be entering into such equation is the average type of treatment that such patients have right now and that you could alleviate by prophylactically treating them with plasminogen. So that all falls into the same equation. Those that we have interviewed so far to, in preparation of the clinical program and talking to KOLs involved in this condition, report eight to 12 surgeries per year. Recurring events requiring a lot of healthcare professional assistance. And all those ramp up the cost that is otherwise required to keep the patient away from problems. So all of those is factored in when you propose a price and granted such price by the payer. Sanjay Jha - Panmure Gordon: Okay. [Staying] [ph] at plasma protein, you said you would announce two more this year. You said you are going to announce two more drugs this year in plasma protein. Is that correct?
Pierre Laurin
Yes. Sanjay Jha - Panmure Gordon: Yes. So is there a -- what drives the numbers? Is that because you are getting better at it or is it sort of given by resources. Should we expect a lot more in next year? I mean what's the...?
Pierre Laurin
It's a very good question. First of all, we already know more than two, right. But we have committed to two because other parameters that need to fall in place will be ready by year-end to disclose those two. We also have some orphan drugs that we are in discussion with already with companies that we could consider alternative ways to commercialize them. There are -- and it's such a question I could spend an hour on this one, Sanjay. Because you have to bear in mind that when we have anchored the backbone of PPS to manufacture a protein such IGG and Alpha 1-antitrypsin and plasminogen and fibrinogen, to name just those. It's not just about being able to make those proteins. But we took careful attention to make sure that we could recover a myriad of other proteins that we know how to recover, we know what purity level, the yield and we also have started formulating them. But it's going to be a question of how do we sequentially introduce those into the development program and it's involved, again, a myriad of considerations. But we have made a commitment to announce two more this year and there will be more next year for sure. Sanjay Jha - Panmure Gordon: So can I just ask one more question on [bio separations] [ph]. I know it's not always talked about. But what's driving that next year or what are the factors, what the visibility?
Pierre Laurin
Well, next year what's driving is going to be again some and more of the clients that have approval demanding more resin. There is also development programs that converge into manufacturing and supply. So we have announced over the past two years, development programs with global companies. These were all successful and these companies have done are filing notifiable change to their process which will then trigger more resin sales. And of course, Laval ramping up and other capacity for PPS plants ramping up, this will command more resin sales. So the resin sales will be driven by existing clients. We have about 15 of them that have regulatory approval. And as much as it's been a slow start to that business, we can just see that the work order is lining up nicely. But the PPS plans themselves order a massive amount of resin that will be a key driver as well for that resin sale.
Operator
Your next question comes from Jim Belin with Aldebaran Asset Management. Please go ahead. Jim Belin - Aldebaran Asset Management: I believe that there was an [affinity] [ph] resin contract that ended this last October. That was a five-year contract. I am wondering whether that contract with that client has been renewed?
Pierre Laurin
Bruce, you want to handle this?
Bruce Pritchard
Sure, yes, happy to handle that. So the answer to that is that we are in the process of renegotiating that contract right now and we are just at the point of getting the contract in a position where both parties can be happy. So we are working on that one.
Operator
Your next question comes from [Ari Lesser] Please go ahead.
Unidentified Participant
I just want to ask a quick question about PBI-1402. I haven't heard any updates in quite a while on that partnering relationship and how that’s gone and if there is any progress. Thanks.
Pierre Laurin
Thank you for the question. Yes, PBI-1402 had its time and it's interesting because it kind of gave birth to PBI-4050. In December 2009, we met with the FDA and we had during that meeting our data with the phase IB/II in chemo induced anemia patients. We had our massive amount of data confirming that PBI-1402 in various animal models was not exacerbating cancer unlike [epo] [ph]. [Epo] [ph] was exacerbating cancer in different models and the ability to [indiscernible]. And we also had unique data with the similar compound like PBI-4050 in renal model. And we all showed up at the FDA, explaining to the FDA that we had this type of different receptors. This was not [epo] [ph] related. And we showed the data that confirmed this. And the FDA concurred with us but also explained that the landscape for anemia was extremely muddy. They were not able to provide us any guidance in terms of clinical trial progression but strongly suggested that we focus on fibrosis because in their opinion the data we had was extremely encouraging. And that this was by far a larger market, larger problem and definitely unmet medical need. From that point on we focused on PBI-4050 and fibrosis. And I think it was the right decision. 1402 is by far not dead. It's actually being revamped and reformulated and it's going to be repositioned and you will probably see it pop again in the pipeline of ProMetic and look forward for that day. But the focus right now is really to progress our fibrosis program with 4050.
Operator
There are no further questions at this time. I will now turn the call back over to the presenter.
Pierre Laurin
Well, again, thank you very much for participating in this call. Exciting year and exciting first half of next year, and we are in extremely good shape to deliver on the promised value and look forward to more webcast to update you on exciting programs. Thank you again everyone.
Operator
Ladies and gentlemen, this concludes today's conference call. You may now disconnect.