Liminal BioSciences Inc.

Liminal BioSciences Inc.

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Liminal BioSciences Inc. (LMNL) Q4 2017 Earnings Call Transcript

Published at 2018-03-29 14:39:07
Executives
Pierre Laurin – Chief Executive Officer Bruce Pritchard – Chief Financial Officer
Analysts
Patrick Dolezal – New York Roger Bensen – Number One Corporation Rahul Sarugaser – Paradigm Capital
Operator
Good morning. My name is Chris, and I will be your conference operator today. At this time, I would like to welcome everyone to the ProMetic Life Sciences Inc. Fourth Quarter and Year End Financial Results Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. Pierre Laurin, Chief Executive Officer, you may begin your conference.
Pierre Laurin
Well, good morning, everyone, and welcome to this year-end 2017 financial results highlights and update on our activities. And before we start, I’d like to remind you as stated on Slide 2, that this presentation contains forward-looking statements about ProMetic’s objectives, strategies and business that involves risks and uncertainties. As you can see on Slide 3, there is a lot of information to go over this morning. We share our shareholders frustration over the delay associated with the DLA review of Ryplazim. But it’s not only bad news. I mean quite on the contrary, as you will see, there is a lot of that positive information that we want to share and we want to make sure that we take the time this morning to go over all those key value drivers and also provide more color on Ryplazim’s BLA review process and trend. So if we move to Slide 4, we are very proud to have discovered this new antifibrotic pathway with the first disclosure published in the American Journal of Pathology. We’re also very proud that in a matter of just a few days after its publication, this article quickly became the most read article in this journal ever. So it’s just goes to show the importance of our discovery. Because as you can see, and I am summarizing on Slide 5, what discovery mean. And for all interested parties that do not have a PhD in pharmacology, I refer those two receptors identified as critical in the fibrosis processes as good cop, bad cop. On Slide 5, you have on the left in the green box the good cop receptor, the GBR40. And you can see that genetically modified mice that do not have this receptor develop much more fibrosis from an injury compared to natural mice and PBI-4050 upregulates that good cop receptor. And on the right side, in the red box, we have the bad cop receptor, the GPR84. Genetically modified mice that do not have this receptor do not develop as much fibrosis compared to the natural. So our drug PBI-4050 hits both receptors, regulating these two master switches leading to a significant cascade of events favorable to the normal healing process. And this affects virtually all organs. We begin to see and observe in the Alström patients. I will not dwell on the following slide, Slide 6. However, it’s very important to actually see all the activities observed in over 30 animal models, and now in patients for our Phase 3 trial to date are the results of our drug resetting those two master switches, like activating breakers on the panel. Once duly reset, the healing process aim at regenerating normal tissue as opposed to fibrosis is promoted. So let’s take a few minutes on the clinical results disclosed yesterday on patients with Alström syndrome on Slide 7. We’ve disclosed mostly the MRI on the heart and the MRI of the liver and FibroScan. And there is more data that will be disclosed in the coming days as they are being further compiled and analyzed also some that will be released at the International Liver Conference on April 11 to 15. But in these patients we’re monitoring many organs and tissues because these patients suffer from a fibrosis process switched on all the time. Let’s start with Slide 8. I mean, to date, 12 patients that have received at least 24 weeks of treatment and 10 have received more than 36 weeks, of which actually three patients have received PBI-4050 for more than 72 weeks. Overall, this represents an average exposure of 52 weeks in those patients. So on Slide 8, the FibroScan results now in the 10 patients will receive at least 36 weeks of treatment showed a statistically significant improvement of the measure of liver thickness, down from 10.2 to 8.1, a decrease of 2.1 and significant with this confidence interval that tells you that really the trend in those patients is definitely significant. I mean, as you know, FibroScan is a noninvasive technique for the clinical assessment of fibrosis, and it actually has a very high degree of accuracy and reproducibility especially in patients that have established fibrosis. And I invite you to review this article – review article from Dr. Cassinotto but greater than F2, and check on Slide 9, I mean, we show results of our individual patients, and you can see reduction or stabilization of the liver fibrosis observed in nine out of 10 patients treated for 36 weeks or more. And again several of them are indeed in that severe significant or cirrhosis category, so very impressive results. Now on top of that, Slide 10, we’re updating the data by using a completely different method this time, the liver MRI and the liver MRI data also indicate the mean reduction from baseline, also clinically and statistically significant. And that, again, is another orthogonal measurement supporting the improvement of liver fibrosis. So, as I said before, more data being compiled, some of which will be disclosed at the International Conference in April 11th or so in Paris. So now the cardiac MRI data on Slide 11 and 12. I mean, simply Dr. Moran and myself. The analysis of the interim cardiac MRI data indicates the reduction of cardiac fibrosis in each patient after initiation of treatment. This has a P value of p.001 [ph], extremely significant. If you look at the table on Slide 11, you will notice that all patients from whom we have cardiac MRI historical data have progression of their fibrosis. They have progression of their fibrosis to the tune of 3% to 5% every year. And you will look at the fourth column, all of them has responded to the treatment with the reduction of that trend. And you will notice as well that the longer the treatment exposure, the more profound the effect. Slide 12 is another way to present the data. The length of the red dash-line the response to the duration of fibrosis data that we have for those patients and the length of the green dash-line is the duration of the treatments for each of those patients, so very impressive data. So what’s next with the Alström Syndrome program, on Slide 13? Well, we’re continuing the trial in the UK. There is more data to compile and analyze and will be presented. And as I mentioned, the presentation in the – during the Liver Conference in just few days from now. We’re scheduled to meet with the FDA during the summer and the EMA to define the clinical and regulatory pathway for those patients. Assuming agreement, this would expand the sites to Europe and in the USA. And there’s going to be further data readout throughout the 2018 and 2019. I mean clearly the sales this is – this program bodes well for those patients who are in dire need of anti-fibrotic treatment. But it also provides further evidence to support our clinical development program, not just for PBI-4050 but for also the analogs, PBI-4547 and PBI-4425. So if we switch to IPS, Slide 14 and 15. I mean, let’s go to Slide 15. People have commented that we only have 12 weeks from our IPF Phase 2 trial. I mean that’s true. You can’t deny that. That’s 12 weeks compared to 52 weeks, which is required for licensure. However, you have to note that both nintedanib and pirfenidone, the trend observed at 12 weeks already determine the course of the results for the following months. It’s too early to draw definitive conclusions, but we can’t help, but looking at the favorable trend observed at 12 weeks in IPF patients in our Phase 2 trial. And now we see the clinical activity with a much longer treatment exposure in the hard-to-treat patients like Alström patients, it really bodes well for our forthcoming pivotal Phase 3 trial in IPF patients. If you look at Slide 16, and you will understand why we chose IPF as the primary indication to develop PBI-4050. It is still an unmet medical need, growth with both OFEV and Esbriet reaching now annual sales or exceeding actually annual sales of up to $1 billion. And on Slide 17, we have done – provided you with more granularity on the U.S. market. There is about 140,000 patients diagnosed with IPF in the States and a majority of whom are actually mild to moderate, which is the target patient population in the Phase 3 pivotal trial and which also the patient population treated by OFEV and Esbriet. And you can see that the vast majority of patients are still not treated by any IPF drugs because they are mild to moderate. They do not either tolerate or wish to start the treatment with a product that has severe side effects. So, therefore, there is a large patient population totally unserved. And if we can demonstrate on the longer duration trials that the combination with nintedanib do provide additional clinical benefit, you can see that the target patient population for PBI-4050 is actually quite significant. Slide 18 is further data information really further explaining why we’re focused on IPF. And it’s clear that the currently identified patient base is growing. I mean there’s actually more patients being diagnosed than those dying each year and that means that the patient base is increasing. In fact, at that rate, probably by 2022, 2023 this will no longer be a orphan indication. By definition, it’s probably going to be greater than 200,000 patients, especially if more patients now getting treated and having an extended medium survival time from diagnosis. This mean that, that indication could actually reach or exceed 400,000 patients by 2030. And IPF is just one of many interstitial lung disease for which a dire need for antifibrotic treatment is required, so very promising indication to pursue one where we have a clear regulatory pathway. And that leads me to Slide 19 where we have agreement with the FDA on design of our pivotal trial. This is going to be an all timer study as you know and we’re expecting to dose patients mid year and this is going to be a trial with sites in the U.S., Canada, Europe and Australia. We also are working hard to and make sure that we can include sites in Japan for that trial and possibly as well a site in China. Both sites in Japan and in China have also participated in trials before. So they are extremely well equipped to participate in international trials. So Slide 20 summarizes based on our past disclosure on a refined focus therapeutic pipeline, PBI-4050 now being totally focused on IPF and Alström Syndrome and 4547 joining the club of the clinical asset now, which leads to Slide 21 to fairly busy schedule over the coming quarters with a consistent news flow of clinical milestones, generated by all the programs and we look forward to update you on this exciting Small Molecule Therapeutics program. Bruce, perhaps you could cover Slide 22.
Bruce Pritchard
Sure. Thanks, Pierre. Good morning, ladies and gentlemen. So as Pierre said, with a mixture of both disappointment and some positivity that we’re announcing this morning the combination of our agreements with SRAM. Having not remitted the funds associated with the license fee and initial milestone payment within the specified payment terms, SRAM is in breach of their license agreement with us. As a result, ProMetic was in a position to exercise its contractual rights and opted to terminate the license agreement on the 27th of March, 2018, thereby resulting in the return of all the rights previously conferred under the licensing agreement back to ProMetic and making them available to be part of any subsequent licensing transaction. Although the deal only recently terminated we have taken the necessary financial provisions in our year-end statements released yesterday. In October of 2017, the Chinese government disclosed a series of regulatory measures favorable to foreign companies seeking to commercialize therapeutics in China. These reflect the government’s aim to change China from a generic to a proprietary philosophy of drug development and in those terms China into the strategic and vital market for pharmaceutical companies. These measures include changes in the regulatory system, allowing the use of clinical data generated outside of China, a faster regulatory review as well as lower taxes on selected drugs. Without expectations around the status of any deal making, it’s fair to say that the mounting strategic interest in the Chinese market expressed by several pharma companies with whom we’re having discussions, and the fact that we have no asset that we would be in a position to potentially advance IPF in China independently, we decided to exercise our rights to terminate the current partnership agreement with SRAM. By holding 100% of the rights for PBI-4050 and related compounds, all indications in China keeps all ProMetic options open to maximize the value of our assets in this important market. If you can now move to Slide 24 and 25. I’d also like to take a few minutes to discuss the announcement regarding the delay in the plasminogen approval. So we truly understand the disappointment this delay would bring to our shareholders. And today, we want to provide as much reassurance and guidance as possible based on our recent facts. Regulatory reviews and it’s related process between the company and the regulator, dialogue has been ongoing throughout the BLA review. However, based on our most recent discussions with the FDA, our own delayed cycle review meeting, we now have sufficient certainty that we’ll be unable to answer the final questions from the agency in time to meet the April PDUFA action date. This is due to the time involved in the completing the final requested tasks. And we, therefore have taken the unusual step of preempting the final communication from the FDA, which is expected on or the PDUFA date on making this announcement today. On the positive note, the FDA has confirmed that our clinical data are satisfactory and our manufacturing plant and equipment have no material deficiencies. The areas requiring remediation relates not to the chemistry per se nor to the specification of the product, but rather to the controls and tests are used intervals during the manufacturing process. The FDA has requested the additional controls be inserted into the process and we’re confident that these can be fully achieved. Indeed by the expected PDUFA date of April, over 90% of these changes will already be in place. However, it will be necessary for us to manufacture additional to support the implementation and validation of these process changes. We expect to complete the manufacturing of the additional validation lots in the summer of 2018 and anticipate being able to provide the FDA with the new CMC data for its review in the fourth quarter of 2018. We recognize that plasminogen has many additional clinical uses and are committed to ensuring that the production process controls are suitably robust and fully to the satisfaction of the FDA, which will ensure that licensing for future indications can be achieved smoothly. The FDA requested the new CMC data be submitted as an amendment to the current BLA, has invited ProMetic to submit at the same time the long-term 48-week clinical data instead of through the originally agreed upon supplemental BLA process. This will allow the FDA to consider granting full-licensure under the current BLA. And if granted, this is expected to allow a faster sales ramp-up from launch than could have been achieved had provisional licensure been obtained by the current PDUFA date. The Company continues to interact with the FDA and will provide a further update when it is in a position to disclose a new PDUFA date. Pierre, I will hand back to you at the moment to go back over the final slides on Ryplazim.
Pierre Laurin
Thank you, Bruce. Well, yes, simply on Slide 26, again, and emphasis on what you mentioned for the Ryplazim or IV plasminogen is indeed going to target initially congenital deficient patients. And we’re going to pursue the advancement of potential use for other indications, which include the one illustrated on Slide 26 or related to acquired deficiency or deficiency surrounding exacerbation of lung injury or even patients with acute exacerbation with IPF. And we’re totally committed to generate the data over the coming months to support these additional indications. The net result of this actually summarized on Page 27 is that, I hope shareholders will realize that ProMetic is now extremely well positioned with two late-stage clinical assets to potentially address all the spectrums of IPF patients. I mean from mild to moderate with potentially a chronic treatment administered with a pill taken once a day in PBI-4050 would have to potentially prevent the reduction of their loss of function and reduce the number of acute exacerbation. But also now Ryplazim position to potentially address acute exacerbation in severe patients where they have accumulation of fibrin in their lung and further depriving them of lung capacity. So it’s rather exceptional that a company would have that kind of extensive potential coverage of a unmet medical need as significant as IPF. And that allowed the company to be focused. Focused, not just from an R&D point of view, but also from a commercial point of view as well as our MSLs in the ground, talking to the specialist and really building a core expertise around the understanding and serving this patient community. So in summary, on Slide 28, we have a robust but focused pipeline. We said in previous disclosure that we will focus our development on PBI-4050 for IPF and Alström and we also explained that we’re pulling back on advancing too many products at the same time and instead investing on adding indications on plasminogen. We have IVIG here that is riding behind with near completion of all clinical trials for adult cohorts for the filing of the BLA in the U.S. So I mean all those programs look extremely promising in terms of value creation. And we’re extremely proud of that pipeline. So perhaps, Bruce, time to turn to the financials for the fiscal year-end 2017.
Bruce Pritchard
Okay. Thanks Pierre. If we can move now to Slide 29. So before getting into the details of my presentation, I just want to recognize the significance of today’s announcement of the financial statements themselves and associated concerns on cash run. So during the following slides, I will address these concerns head-on and provide as through analysis as I can. As usual the information I’m discussing today is based on the financial information for the fourth quarter of 2017 and 2016 as well as on the audited financial statements for the year ended the 31, December, 2017. All of these statements are prepared under IFRS and the information for the group can be found online at sedar.com. Finally, all sums in today’s presentation are in thousands of Canadian Dollars, except for per share amounts or where otherwise indicated. So if we move to Slide 30 and revenue by quarter. Revenue for 2017 has seen a steady build up on a quarter-to-quarter basis. Specifically the product sales shown in blue on the slide have produced the second largest year in history of the bioseparation group in GBP terms. In the fourth quarter, total revenues were $6.6 million, comprising of product sales of $5.5 million, service revenues of $0.9 million and rental revenues of $0.2 million. On Slide 31 and looking at the annualized revenues, I mentioned on the last slide, strong year for bioseparation’s group. For the full year, revenue from rising sales were $16.5 million compared to $12.9 million in 2016, an increase of 34%. Service revenues for 2017 were $1.9 million, down 44% versus $3.4 million in 2016. Rental revenue stood at $1 million for the year compared to $0.1 million in the previous year, simply reflecting the full year impact of the revenue stream arising from the Belleville facility acquired in late 2016. Clearly the biggest driving new item in 2017 was milestone and licensing, which came from the Small Molecule Therapeutics segment. These revenues amounted to $19.7 million and pertained to a license agreement signed with our Chinese partner during the third quarter of 2017. There were no milestones and licensing revenues in the year ended December 31, 2016. During the fourth quarter of 2017, we’ve written off the related accounts receivable since the licensee had not remitted funds associated with the license fee and initial milestone payment within the specified payment terms. And, as I mentioned earlier, the license agreement was recently terminated by ProMetic. Notwithstanding, the provision for the receivable, total revenues for the year stood at $39.1 million compared to $16.4 million in 2016. On Slide 32, looking at the key expenses by quarter and the fourth quarter, there are two out of the ordinary transactions affecting the numbers. Notwithstanding those, however, the expenses by quarter in the graphic show broad consistency quarter-to-quarter across all expenses categories. And this accords with the message that we gave to our shareholders at our AGM last May. The first of the 2 Q4 event and most obviously, is the bad debt provision. As I mentioned on the previous slide, having a ample opportunity for our partner to remit the funds associated with the agreement and those funds not having been received, the partner has been deemed to be in breach of the license agreement and as a result of the corporation was in a position to exercise its contractual rights and opted to terminate the license agreement on the 27th of March, thereby resulting in the return of all the rights previously conferred under the licensing agreement back to ProMetic and making them available to us the part of any subsequent licensing transaction. At the same time, we also confirm the termination of agreements with SRAM. During the fourth quarter, then we choose to write off accounts receivable of $18.5 million to bad debt expense and then reversed holding taxes of 19 – sorry, $1.9 million, expected to be paid on this transaction. The sums are slightly different to those originally recorded as revenues due to exchange rate variances. Secondly, in relation to the delay of the approval of Ryplazim, have taken provision for $2.7 million of product, which would have been held an inventory and used for commercial sales, but will now be used in patients in the clinical trial continuing to receive this effective treatment. Allowing for those key adjustments and usual year-end true ups for compensation and so on, the figures for Q4 are very consistent with the other quarters showing our control on costs. On Slide 33. If I analyze the Q4 research and development figure compared to the Q3 figure, it shows, again, the consistency of the numbers across all segments. The biggest difference in R&D cost quarter-over-quarter was in the plasma derived therapeutics segment revealing a difference of $4.9 million, of which $2.7 million relates to the inventory adjustment as I mentioned in the previous slide. The remaining difference of $2.2 million is attributable to additional staff costs and consulting costs associated with supporting the plasminogen BLA. On Slide 34, if I look at year-over-year costs, the year-over-year expansion would show a difference of $35 million driven by two key areas. Firstly, the 2017 bad debt writeoff driving $20 million of that difference, and secondly an increase of $15 million in nonmanufacturing R&D. The increase in nonmanufacturing R&D reflects the broadening of the clinical and preclinical activity over 2016 as a whole. And we have seen on Slide 32, during 2017, the R&D costs would have been relatively static quarter-to-quarter in 2017. In 2016, the cost actually ramped up quite significantly towards the end of the year. The charts for the manufacturing platform and for admin have remained broadly static year-over-year. If you move now to Slide 35. I think the slide which I’ve used for the past few quarters helpful to break down the total R&D spend into the constituent areas. In 2017, 73% of our R&D was related to our PPPS platform. And of that figure, approximately half related to manufacturing activity. As I mentioned before, this remains classified as R&D cost until we commence commercial product sales, at which time it will meet cost of goods spending on the Small Molecule program was $19.2 million during 2017, covering both clinical and preclinical expenditure. On Slide 36, looking at the loss figures. On the previous slides are discussed the key components of the P&L, again. And these obviously then result in the following loss and EBITDA figures. So for the fourth quarter of 2017, we’re reporting a loss of $41.6 million compared to a loss of $40.1 million in the same quarter of 2016. This equates to a loss of $0.05 per share in Q4 of 2017 compared to $0.06 per share in the same quarter 2016. EBITDA in the quarter was negative $49.4 million compared to negative $34.3 million in 2016, an increase in the loss of $15.1 million. And that’s attributable to the bad debt writeoff, offset somewhat by improved revenues. For the full year, the loss was $120 million in 2017 compared to $110.7 million in 2016, or $0.16 per share in 2017 compared to $0.17 per share in 2016. EBITDA for the full year was negative $110.1 million compared to negative $98.5 million. And the bad debt writeoff has actually no net impact on the full year EBITDA. The difference this time is attributable to the increase year-over-year nonmanufacturing R&D spend that I explained on Slide 34. If we move on now to Slide 37 and at the balance sheet. Looking at the balance sheet cash and cash equivalents stood at $23.2 million at the end of 2017 compared to $27.8 million at the end of 2016. 2016 also showed $11.1 million of marketable securities, which were liquidated during 2017. The accounts receivable were $6.8 million at the end of 2017 compared to $8.3 million at the end of 2016. Income tax receivable has increased by just over $3.7 million in year due to the combination of increased levels of R&D tax credits, mainly in the UK., which will be received in cash during 2018, offset by the write-down of certain taxes. Inventories are a key feature of this year’s balance sheet standing at $36 million at the end of 2017 compared to $13.6 million at the end of 2016. And actually given the news around Ryplazim approval, there maybe some concerns regarding the inventory figures. The year-end inventory figure of $36 million includes $20.1 million of Ryplazim. This is unaffected by any of our process changes. The only Pg inventory carried at the end of year is valued at $6.8 million. The final product specifications have not changed. So that inventory on hand will be unaffected. During the fourth quarter we did take provision for some products, which I mentioned earlier, that will be used in ongoing compassionate use cases. In addition, the raw plasma that we have has a long shelf life and is also readily marketable so it could be sold off if required. There was continued investment in capital assets in our production facilities for both plasma and resins during the year explaining the year-over-year increase. And finally, the increase in long-term debt reflects the additional loans entered into with Thomvest during the year and disclosed throughout the year. So if I move on now to Slide 38 and talk a little bit about cash runway. Clearly, the biggest concern for our shareholders will be our cash runway through to product approval. I cannot pertained that this is these challenges. However, plans are already in place to bridge 2018 in a sense to the manner as possible. Firstly I’ll comment on year end our pro forma cash at 31st December, 2017, which from the combination of cash on hand expected inflows from bioseparation sales and various tax credits together with the undrawn line of credit balance amounted to $127 million, which at a macro level is sufficient to fund the year. However, you will notice I have italicized the line of credit because a full drawdown on that is not our planning. During 2018, I’ll be overseeing several cash management activities falling into the broad categories of cost management and revenue generation. On the cost management side we’ve already disclosed our focused approach to R&D program and this will ensure that we can deliver on key objectives for controlling the overall envelope of spend. We’ve already focused that platform on PBI-4050 for Alström syndrome and IPF. And in turn we’ve discontinued our cystic fibrosis program and will not spend any further on CKD or DKD. We will also be further controlling our discretionary expenditures as much as possible, while focusing on key activities in manufacturing and regulatory. Of course, we have to maintain the infrastructure require to deliver on our plans, including securing the Pg approval. On the revenue generation side, we’re confident that we can execute on licensing transactions. But if we – but we will do so if and only if the terms and valuation offered to us makes sense to our shareholders. We’re constantly in discussions with potential partners. However, many things the pace at which these discussions progress and how far they advance. For instance, primary indication motivating partner discussions also evolve over time. Since the positive data observed in IPF patients in our Phase 2, compounded by the long-term efficacy observed in Alström patients and the green light from FDA to proceed for pivotal Phase 3 program constitute tipping points changing the course of partnering discussions. We realize there is no better not to comment on this status of discussions until there is a deal to be announced. However, partnering and business development remains the highest priority for us. In the event that it takes longer than expected to reach an attractive partnership deal, we will return to the capital market on a selected basis to strengthen the balance sheet, which per se should improve our leverage to close optimal deals. As I said, the path forward may not be straightforward, but we have a plan which will bring us to 2019 and to the approval of Ryplazim and the priority review voucher. Although the delay in approval is disappointing, the FDA has given us a clear path to approval and in one which we will execute on. So, Pierre, I will now hand back to you to wrap up the presentation.
Pierre Laurin
Well, thank you very much, Bruce. This was quite clear and very happy with your comments on Slide 39. Perhaps it’s time, Chris, to open the floor to questions from our participants.
Operator
[Operator Instructions] Your first question comes from Patrick Dolezal with New York. Your line is open.
Patrick Dolezal
Hi. Thanks for taking my questions. So just Ryplazim I have a couple here. With the FDA looking at some of the 48 week data, I was just kind of curious what specifically they’re going to be looking for in that data set if that’s safety or if that’s efficacy data as well?
Pierre Laurin
Hi, good morning, Patrick. Yes, the data more or less monitored patients on all front. Our interest here is obviously during that period we have now exceeded 3,200 infusions. And during that period patients have not had any recurrence of lesions. As you recall during the acute phase, the 12 weeks, patients showed up with lesions and we were showing the resorption of those lesions. Now the data on 48 weeks is confirming that those patients throughout that nearly year treatment are not seeing their lesions coming back. So it’s a combination of efficacy, which is 100% response rate so far. 100% patients do not have recurrence of lesions. And we have not had any single severe adverse events related to the drug, nor patients dropping from treatment. So it’s a very, very strong clinical package.
Patrick Dolezal
Great. Thank you. And I just want a little bit more granularity on how receiving the full licensure during the first half of 2019 could allow a faster sales ramp-up from launch as opposed to the provisional licensure in April?
Pierre Laurin
Well, this pertains pretty much with the ability of the company to impress upon payers of the clinical benefit of the treatment. We expect to have publications and data published that we can use with providing evidence to those payers. But obviously, there is no better reference than the FDA sanctioned prescribing information, having the long-term clinical data in the prescribing information package, confirming the patients being on treatment for a long period of time do not need a surgery or other means to remove the lesions. If providing strong health economic evidence of the benefit for the patients. So obviously accelerated regulatory approval is based on the PK data with some initial evidence of efficacy. The 48 weeks provide more reassurance to the payers that it is of clear benefit to reimburse on the drug as opposed to the heavy cost of medical procedures otherwise required to remove the lesions.
Patrick Dolezal
Okay great, thank you.
Pierre Laurin
Thank you, Patrick.
Operator
Your next question comes from Roger Bensen of Number One Corporation. Your line is open.
Roger Bensen
Thank you. On the IVIG situation, which wasn’t covered so much in the call so far, Baxter is spending $1 billion to build a plant to make the stuff and which is in short supply, and it’s my understanding that we can produce a better product at a lower price than they can. It’s a multibillion product now and increasing. Have you got any guesstimates as to the size of business that we might be doing an IVIG in the next few years?
Pierre Laurin
Yeah, thank you Roger and good morning. IVIG is indeed a product that is extracted, manufactured following the process of plasminogen. It’s been our view to actually benefit and have this product contribute to our P&L. It will be greatly driven by the volume of plasma we process to address the plasminogen expected revenue growth. And we’ve provided guidance relative to our current capacity that will be in excess of $100 million per year in terms of revenue. As you know, our plans despite the fact that we have great yield in our process. Our plan is not to go after high tonnage protein such as IVIG, but will certainly enjoy the contribution to the P&L of our products such as IVIG as we process the plasma. The value inferred by leader of plasma process by from products such as Inter-Alpha 1 protein and/or plasminogen are far superior. So we’re looking at a business model really that is smaller footprint, much smaller number of leaders of plasma to process to generate a like a biotech or pharma type margin with our proprietary products.
Roger Bensen
Thank you.
Pierre Laurin
Thank you, Roger.
Operator
Your next question from Rahul Sarugaser. [Paradigm Capital] Your line is open.
Rahul Sarugaser
God morning, gentlemen, thank you very much for taking my questions. I have one very quick question. Thank you for the clarity around the delay on plasminogen. So looking at 4050 and your IPF trial, you acknowledged that the data is relatively early that’s been presented. When do you expect to see further time point interim data being released? And that’s my question. Thank you.
Pierre Laurin
So, thank you and good morning Rahul. I think that the expected milestone for the clinical trial was a summarized on Slide 21. So we will have an interim readout on that Phase 3 for futility in the second half of 2019. And given that we’re looking at trend shifts, analysis, long-term historical data in shift of fibrosis progression in Alstrom patient, this becomes an open label trial and we expect to be in a position to update constantly our shareholders with the data on Alstrom. Now Alstrom is an indication of its own, as we explained. But it’s also a very, very interesting point of reference with efficacy in multiple organs in very-hard-to-treat patients. And therefore, it serves as a kind of prebarometer of what one can expect out of IPF patients. But the IPF trial obviously is placebo-controlled and the only visibility for that study will come through the interim analysis currently expected in the second half of 2019.
Rahul Sarugaser
Thank you very much.
Operator
There are no further questions at this time I will now return the call to our presenters.
Pierre Laurin
Well, again, thank you much for participating to this webcast. We look forward to continue to update. As we say, we share frustration with regard to that delay on Ryplazim BLA process, but also as Bruce explained a very clear path forward, very strong clinical data. So nothing to be worried about on this one. And we have the matters in hand in terms of addressing the NDA’s request. So we look forward for more update in the coming days on Alstrom and look forward to for a successful future with our pipeline. Thank you, again, for your participation. Thank you.
Operator
And this concludes today’s conference call. You may now disconnect.