Liminal BioSciences Inc.

Liminal BioSciences Inc.

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Biotechnology

Liminal BioSciences Inc. (LMNL) Q4 2018 Earnings Call Transcript

Published at 2019-04-02 18:25:11
Operator
Good morning, and welcome to ProMetic Life Sciences' Conference Call, to discuss the Company's Q4 and Fiscal Year End 2018 Earnings issued yesterday following the market close. We will begin today's call with Management's discussion followed by a question-and-answer period open to financial analysts. For your convenience, the press release related to today's call is available on the Investor's and Media section of the Company's website at prometic.com, and is also available on SEDAR. Please note that the remarks on this conference may contain forward-looking statements about Prometic's current and future plans, expectations, intentions results levels of activity, performance goals or achievements or any other future events or developments. Forward-looking statements are based on information currently available to management. And on the investment and assumptions based on factors that management believes are appropriate and reasonable in the circumstances. However, there can be no assurance such estimates and assumptions will prove to be correct. Many factors could cause actual results, levels of activity, performance achievements, future events or developments to differ materially from those expressed or implied by the forward-looking statements. As a result, Prometic cannot guarantee that any forward-looking statement will materialize and you are cautioned not to place undue reliance on these forward-looking statements. Except as may be required by law, Prometic has no obligation to update or revise any forward-looking statements, whether as a results of new information, future events or otherwise. For additional information on these assumptions and risks please consult the cautionary statement regarding the forward-looking information contained in the company's MD&A, dated April 1, 2019 available on sedar.com. I would now like to turn the conference over to Professor, Simon Best, Chairman of the Board and Interim CEO. Please go ahead.
Simon Best
Thank you, operator. Good morning, everyone and thank you for joining us on our Q4 and fiscal year 2018 earnings call this morning. On the line with me today is Bruce Pritchard, our Chief Operating Officer and Chief Financial Officer. In addition to presenting our financial results for 2018 our priority today is to highlight the financing challenges we face, share our assessment of what needs to be done to fix these and to restructure the balance sheet. To underpin our appreciation of the seriousness of the financial situation and our commitment to fixing it ASAP, we've invested a significant amount of time and effort to ensure that all of the required disclosures released ahead of this call have been prepared with as much breadth and depth and transparency as possible. The past year was a milestone year for Prometic, bringing some fundamental, corporate and financial challenges. These challenges,[Author ID1: at Mon Apr 8 15:56:00 2019 ] however,[Author ID1: at Mon Apr 8 15:56:00 2019 ] allowed us the opportunity to step back to review our business and develop a stronger and more focused strategic plan which has proven attractive to new investors, motivating them to work with management to potentially refunds finance Prometic, so that it's sustainably funded to deliver core objectives. Beyond the core challenges of fixing our balance sheet, Prometic remains blessed with an exciting product pipeline for which our strategic priorities are to get our two late stage assets to the market expeditiously for rare disease indications. We intend to accomplish this via a commercial partnership RyplazimTM in congenital deficiency in 2019 and then by developing PBI-4050 for Alström Syndrome for a possible market launch by Prometic itself in 2021. We will also commit continued investment to progress in the strong small molecule pipeline that shows considerable promise in major antifibrotic indications and we anticipate being able to deliver the confirmation of the clinical efficacy and value of PBI-4050 in liver fibrosis and IPS in 2021. I'd now like to turn the call over to Bruce to present our 2018 results and to set the scene for our ongoing financial challenges and what we propose to do about it.
Bruce Pritchard
Moving to the next slide. Good morning, ladies and gentlemen. So if we could move to Slide 6 in the deck of the company's webcast and just a quick reminder that this part of today's webcast is based on the financial information for the fourth quarter of 2018 as well as on the audited statements for the year ended 31 December, 2017 and 2018. All the figures were prepared under IFRS and the full annual information and important information can be found online at sedar.com. Everything that I'm referring to this morning is in thousands of Canadian dollars except where indicated. So if we can move to Slide 7. Dominating the Q4 financials are two large non-cash accounting entries. The first, gain of CAD 34.9 million was caused by the modification of the Thomvest debt in the fourth quarter of 2018. The extension of the maturity dates and associated attributes constituted a significant modification to the original terms of the debt. Under these conditions we're obliged to reverse the previous accounting treatment and re-book the transaction based on its new parameters resulting in this paper gain. The second accounting entry is a charge of CAD 150 million relating to the impairment of IVIG related assets. As a consequence of the realignment of business strategy following the change in leadership, all development resources have been dedicated to represent for the foreseeable future. This extends the timeline within which the final CMC development for IVIG can be completed. In addition, our lack of cash is has delayed the development of commercial scale manufacturing capacity for that product. The combined impact of these items delays the launch beyond the limit of accounting rules for the recognition of future economic benefit and as a consequence an impairment charge of CAD 137 million relating to the NantPro intangible combined with the write-off of other assets related to IVIG amounted to have non-cash charge of CAD 150 million. It's important to note that this does not signify any issue with the underlying IVIG program other than a slippage in timelines. If I can transition now to Slide 8. For 2018, revenue reached $47.4 million, an increase of $8.3 million over 2017. The bioseparation segment performed particularly well compared to 2017, with an increase of $5.9 million or 35%. 2018 total revenues included $22.8 million of normal source plasma sales. This plasma was originally destined for the commercial manufacture of Ryplazim. However, the delayed launch of that product has allowed us to remonetize that asset and reduce overall working capital requirements. 2017 revenues included $19.7 million of nonrecurring income related to milestone and licensing payments. On the right side of the slide, we've built up the revenues for the quarter -- for each quarter. The purple bars show a quarter-over-quarter growth in the bioseparation segment. The plasma-derived therapeutics is essentially made up of ad hoc sales of normal source plasma in the last 3 quarters of the year. On Slide 9, I'd like to highlight the R&D expenses versus the previous year. As you will see, the overall R&D expenses decreased by $8.7 million. Expenditure on manufacturing activities increased slightly as we continued to make progress towards the submission of a BLA amendment for Ryplazim. During this phase, we are not capitalizing any of the production costs to inventory as we did in 2017, resulting at a higher charge to the P&L account for manufacturing in 2018. Internal nonmanufacturing costs as well as external contract R&D expenses have decreased significantly, both through cost control and through the completion of clinical programs ongoing in the prior year. On Slide 10, I'd like to review selected information from our Q4 financial statements. I've already provided the breakdown of revenues on an earlier slide, but recapping, total revenues for the full year were $47.4 million compared to $39.1 million during 2017, representing an increase of $8.3 million. In the quarter, total revenues were $10.6 million compared to $6.6 million in the comparative period of 2017, representing an increase of $4 million. As we continue to experience revenues from each source vary significantly from period to period, with this year being particularly impacted by our plasma sale; whereas last year, it was impacted by milestone and licensing revenues. Cost of sales and other production expenses were $38 million in 2018 compared to $10.1 million in 2017, representing an increase of $27.9 million. Cost of sales and other production expenses were $7.6 million in the quarter ended December 31st compared to $2.4 million in the corresponding period in 2017, representing an increase of $5.2 million. The majority of these noted increases for 2018 and Q4, respectively, are the result of the sales of normal source plasma in 2018. As mentioned before, R&D expenses were $91.7 million during 2018 compared to $100.4 million for the corresponding period in 2017, representing a decrease of $8.7 million. In the quarter, R&D expenses were $21.1 million compared to $28.2 million for the corresponding period of 2017, representing a decrease of $7.1 million. And as I mentioned on the previous slide, this is a compound effect of an increase in the manufacturing charge and a decrease in other research and development expenditure. For the year, administration, selling and marketing expenses were consistent. Moving to the total adjusted EBITDA for the corporation, this was negative $101.6 million in 2018 compared to negative $110.1 million for 2017, representing a decrease in adjusted EBITDA loss of $8.4 million. And $23.6 million negative for the quarter compared to $49.8 million negative for the comparative period of 2017, representing a decrease in EBITDA loss of $25.7 million in the quarter. And again, the main reason for the decrease in the year is related to R&D. Finance costs were $22.1 million in 2018 compared to $8 million in 2017, representing an increase of $14.1 million. And this reflects the higher level of debt during 2018 compared to 2017. In the quarter, the cost was $6.6 million compared to $2.7 million in the corresponding period of the same -- sorry, corresponding period in the prior year for the same reason. Putting this in context, total long-term debt on the consolidated statement of financial position was $122.6 million at September 30, 2018, compared to $83.7 million at 2017. I've already referred to the gain on the extinguishment of liabilities and the impairment charge, so I'm not going do it again. So overall, the company incurred a net loss of $237.9 million during 2018 compared to a net loss of $134.8 million for 2017. That represents an increase in the net loss of $119.5 million, predominantly due, as we've said, to the impairment charge in the year. If I transition now to Slide 11 and turning to the balance sheet. Cash decreased by $15.8 million at the end of 2018 compared to the end of 2017. Cash balances are directly influenced by the timing and size of financing events and operating revenues and expenditures. Cash flow issues and plans for fixing the balance sheet will be discussed later in this morning's conference call. Accounts receivable increased by $5.2 million at December 31 compared to the previous year, mainly due to the timing of trade receivables related to the sales of normal source plasma. The income tax receivable increased by $4 million at December 31, 2018, over the prior year, mainly due to recording of refundable R&D tax credits recognized in operations in the U.K. during 2018. Inventories decreased by $24 million year-over-year, principally due to the sale of normal source plasma inventory. Capital assets decreased by $4.2 million year-over-year due to the write-down of equipment impacted by the delays and timing around our IVIG program. Intangible assets decreased by $136.8 million year-over-year, which I've already explained. Long-term debt increased by $38.9 million year-over-year. The increase results primarily from the drawdown on the nonrevolving credit facility during the year. Please also note that due to accounting rules, the carrying value of the debt on our balance sheet is $125.8 million. The actual sum due at maturity will be $238.8 million based on exchange rates prevailing at the 31st of March, 2019. On Slide 12, and then wrapping up the finance section, I want to comment on a figure that was highlighted at the AGM, which was cash used in operations. In 2017, we had used $122.6 million of cash in operations, and in 2018, we had used $82.5 million. It's worth noting that this benefits from the $22.8 million sale of normal source plasma. But when normalizing for that asset -- for that item, our spend was around $105.3 million in operations, a reduction of $17.3 million or 14% over 2017. I had forecasted at the AGM that I hoped overall to achieve cash savings of around 10% to 15% in 2018, and we realized 33%. However, we remain focused on delivering our cost controls in a balanced way to allow us to keep key activities associated with the delivery of a business development deal and securing Ryplazim approval underway. But going forward, this is obviously subject to the securing of additional financing. This concludes my remarks, and I'll now turn the call back to Simon to resume the business update.
Simon Best
Thanks, Bruce. So let's now focus on how we're going to fix the balance sheet and address our increasingly urgent need for cash. We go to Slide 14. Firstly, I must thank Thomvest for their continuing support. However, both we and they recognize that continuing to provide this in the form of debt is simply exacerbating an obstacle to raise a new equity investment and increasing the downstream challenges of future repayment. Although we were able to use an at-the-market facility quite effectively during December and January, tactical use of such facility is insufficient to sustain the business longer term. Bruce Pritchard and I therefore went on the road in February and March. In fact, we've been almost continuously on the road for about 6 to 8 weeks to follow up with institutional investors who had indicated interest in investing in our meetings last year and then again at the JPMorgan conference in January after the leadership transition, to update them on our plans, but to also get their honest feedback about any and all factors holding them back from actually putting cash down. And very clearly, the primary obstacle identified was the extent of the growing overhang caused by the scale of the company's debt obligations and the associated security packet. So we're working hard with Thomvest to address this expeditiously and we'll provide an update at the appropriate time. Discussions have been promising, and while all parties are working constructively, I should note that no agreement has been reached at this time and any resolution would require the agreement of the company, Thomvest and new investors on key terms and conditions, including valuation. So although I can't be more specific on timing yet, given our liquidity position, a restructuring necessarily will be executed ahead of the second element of the balance sheet fix, which is to close at least 2 substantial transactions, being executed by Lazard, recognizing that ensuring a robust cash position underpins Prometic's negotiating position in those transactions and provides confidence to partners for those transactions over the company's long-term viability. So let me now provide a few more details on the transactions on Slide 15. As I mentioned earlier, we have potential transactions with Lazard, these are progressing well and are expected to close in the second half of the year. I can confirm, as I did in the annual report, that one of these transactions is to secure a partner to commercialize Ryplazim. We're seeking a partner that has sales, marketing and clinical infrastructure already in place, addressing the right physicians to optimize our rapid market penetration and then to optimize reimbursement. And with -- starting with the U.S. launch, of course, following FDA approval. And we're confident that allowing the drug to grow faster in the hands of a larger player will also allow us to capitalize on its market impact more efficiently. We will likely remain the sole global manufacturer in this deal, noting that, as Bruce has already explained, both the market sizes and volumes required to address these for Ryplazim are substantially greater than previously anticipated. This is, per se, good news for shareholders, however, it has caused a material delay to IVIG development and the associated impairments in our financials that Bruce has explained. Regarding the second possible transaction with Lazard, we are not yet ready to disclose specifics, but I can confirm that it involves the disposal of assets that are no longer deemed core to our future success and are a greater strategic and monetary value to third parties. We'll keep you to up to date on this front in a clear and timely manner over the coming months. So let's now look a bit more at Ryplazim. Well, it's looking -- it has proven to be in a -- more and more valuable as a late-stage asset as we've interacted with potential partners as we further developed our own forecast. So the potential revenues in this drug have been the main driver and interest from outside parties, both in congenital deficiency, and in due course, in acute and acquired indications. Our proprietary PPPS technology will enable the commercial production of the plasminogen at scale and positions us well to remain the sole global supplier of the drug. To date, Ryplazim has received three important designations from the FDA: Rare pediatric disease, orphan drug and fast-track. And I want to confirm that these are unaffected by the BLA resubmission time scale. These are promising indicators of the drug's market impact upon commercialization. With regard to the BLA timeline, we expect to refile the Ryplazim BLA for congenital plasminogen deficiency during the latter half of this fiscal year, enabling launch by a chosen partner in the first half of 2020. We recognize and are disclosing that the timescales have stretched. However, we would stress that it's both more important to both Prometic and its potential commercialization partners to get the BLA right this time with no further delays following resubmission. So what's the current situation? We have substantially completed the development of all of the key process controls, which are the nub of what the FDA requested in the CRL. However, the last of these required a more complicated validation process than we expected, and it's taken a bit longer than we expected. In addition, our external consultants who have been working with us closely throughout all of this have recommended that we should add some few weeks at the end of the process to work with them to conduct a final beginning-to-end review and add it to the final documentation to fully derisk it before submission. So on the slide, this lays out the key steps, and many of these will be familiar to you. We are at the tail end of finalizing assay validation. But I would point your attention to the red arrow and the fact that the BD transaction is entering full due diligence, and we will be scrutinized in the next few weeks by potential buyers, which we believe we are ready for. They will obviously, I am sure, interrogate this hard. But in terms of the risk factors here, a deal on the basis of thorough due diligence by experts in the field is a major derisking factor, and we are confident in a deal that will bring with it revenues in the relatively short term. And I would suggest that this really should be the focus of investors on this product rather than trying to sort of second-guess the minutiae of the exact dates on which it's approved. The process we have here now is derisking in quite a significant aspect. You can move to the next slide. I know there's been curiosity for some time about what's happened with the small-scale initial exploratory study in plasminogen in a sub-cut formulation for tympanic membrane. So let's just briefly report on that. The first cohort of this study was completed in 2018. This was done at a low dose at the request of the Swedish authorities for initial dosing. It was 50% of what we always predicted would be the optimal dose. And the efficacy results were relatively modest, which confirms what we had always have expected, that a higher dose will be acquired for conclusive data. So we're going to continue the next phase of the study with a more concentrated plasminogen formulation that's currently under development. And once that's available and once finances allow, we will resume enrollment and use the new formulation to treat subjects at the higher dose level that we believe will confirm efficacy in due course. For the time being, however, the study's been put on hold while the formulation development continues. Let's now shift to small molecules wherein this pipeline holds great promise. And indeed, the response to the data that has come out of our Alström's program over the last year and is being presented by invitation at an increasingly large number of conferences, not just in rare diseases, but in many chronic diseases, where fibrosis is core, is a real -- it supports the fact that the small molecule pipeline, the anti-fibrosis story, is a really important area of focus in our revised strategic business plan. The data from the Phase II trial in Alström's has provided us with a solid basis for a Phase III pivotal trial. We're currently designing and fine-tuning the endpoints with the FDA. Our trials in Alström syndrome have generated credible evidence that PBI-4050 truly addresses the fundamental mechanisms of fibrosis and has the potential to address major unmet needs in multiple major indications, of which our data relevant to liver fibrosis in later-stage NASH patients looks particularly compelling. These conclusions feed nicely into our goal of getting our later-stage assets to market in a timely manner as we anticipate that the approval of PBI-4050 in Alström syndrome will indeed prove to be a springboard for our pipeline into major antifibrotic indications. Going in the next slide. We've also received positive feedback from our academic peers on the upside antifibrotic potential of PBI-4050, with the publication of peer-reviewed studies published in high-impact journals, including the 3 on this page: The mode of action study and American Journal of Pathology; and then a study on the impact on fibrosis in kidney in the JCI; and then more recently, in liver in the Journal of Pharmacology. And we continue to have a pipeline of high-impact publications coming through. And I believe we have 5 currently in the pipeline that will come out in high-quality journals over the coming months. Looking more at Alström's in detail. Alström syndrome is an ultra-rare disease. It's an autosomal recessive genetic disorder that we believe affects between 500 and 1,000 people worldwide. The 500 being those that we are most aware of in North America, in Europe and in some high-incidence countries that form the core of our understanding of the disease. Alström's syndrome start -- patients start to develop fibrosis in childhood, which progresses increasingly severely into multiple organ systems as they grow older, in the later stages of the disease. If you look at the next slide. PBI-4050 shows great promise in helping reduce fibrosis in Alström's patients and addressing the unmet needs in other organ systems in other diseases. There are currently no effective or approved treatments for this terrible disease, and PBI-4050 represents a potential first-in-class therapy to reduce fibrosis in these patients. We already have orphan drug and rare pediatric designations from the FDA, also orphan drug designations from the EMA. And in the U.K., a promising innovative medicine designation from the U.K. regulatory authority, the MHRA. And as I mentioned earlier, our Phase II clinical study, which included 12 patients, showed a dramatic and meaningful impact on fibrosis. I you could, the next slide. So we expect to begin our Phase III clinical study on this drug in the second half of the year, which bridges into the potential to expand our clinical program into other rare liver diseases in which patients suffer liver fibrosis of comparable severity to Alström's patients. So what's expected in Phase III? By means of delivering a contextual update, we held 2 type C meetings with the FDA in 2018, and our final type C meeting related to the Phase III study has been scheduled very shortly. We will finalize our study's protocol after getting the FDA and EMA's final comments. In addition, the European regulatory input is ongoing and investigators have been recruited in North America and Europe in anticipation of commencing the trial in the second half of the year, following an agreement with FDA of the trial design and the endpoints. We anticipate that the Phase III clinical study will consist of a randomized, double-masked, placebo-controlled, single-crossover study, but we believe we will need to include no more than 50 Alström's patients, of which, at least 1/3 will be pediatric, although they will be all the order than 12 in order to be sure that they've already developed sufficient fibrosis to show an appropriate expected response to the drug. We're already working with the international Alström's patient advocacy organization, ASI, Alström Syndrome International, who are keen and eager and well-placed to assist in conducting the study. Looking more broadly on the small molecule pipeline. We're continuing to plan how best to progress PBI-4050 for IPF. But here, we've had to take notice of recent feedback from several potential, and in principle, interested big pharma partners, that in their view, our data from the initial small-scale open label Phase IIa IPF trial was indicatively promising, but not sufficiently robust to secure a partnering deal, given the significant costs, risks and timescales of Phase III trials. As such, we will need to conduct a placebo-controlled randomized Phase II study of a sufficient duration and size to conclusively confirm efficacy, competitive advantage and market value before securing a partnership in this challenging disease. Looking more broadly, we expect, once fundraising and in-progress transactions are completed, to initiate multiple additional clinical studies in 2019 to explore potential disease indications beyond Alström's for PBI-4050, including trials in IPF and in liver fibrosis, both of which, subject to fundraising, we expect to begin in the second half of the year. We're also planning to take the next small molecule, PBI-4547, into Phase I testing in healthy volunteers towards the end of the year as well. And finally, we're in the process of reviewing emerging renal rare disease opportunities which we believe could be the next wave of high-value stepping-stones to other bigger indications. Okay. So finally, whilst we've faced mounting challenges in 2018 that need an urgent solution in the coming days, we remain confident that Prometic is set for success as we deliver on our strategic business plan. I'll close by reiterating our strategic priorities for the coming year. Top of the list, of course, is fixing the balance sheet by securing the cash needed to deliver on the plan. Secondly, how are we going to do it? We're going to raise equity through debt restructuring and conversion to both maintain strong support from Thomvest and gain strong support from new institutional investors, whilst at the same time, completing transactions supported by Lazard. We're going to capitalize on the increased potential of Ryplazim for congenital deficiency and the increased opportunity through commercial partnerships with potential -- to market potential to realize value from a launch in 2020. And finally, we propose to continue investment to progress our very strong small molecule pipeline with considerable promise and value creation catalyst attainable in 2021. Finally, regarding the future permanent Chief Executive leadership for Prometic, we have met with a number of talented, experienced and passionate candidates. Indeed, several of whom have volunteered their interest to us, that are excited by the prospect of leading the next important stage of a refreshed company. As of today, we don't have any formal news to announce on this front. However, we will share details of any leadership decisions as soon as they become available. In the meantime, I remain fully engaged and committed in leading the organization through the transition period and in helping to move the company towards our promising and commercialized reality in the future. That concludes my remarks. We now open the call and welcome the opportunity to answer any questions.
Operator
[Operator Instructions] Your first question today comes from the line of Rahul Sarugaser of Paradigm Capital. Your line is open.
Rahul Sarugaser
Primarily, I really have one question around the BLA. So we recognize that -- though the unfortunate stop in last March and then now we had in October the positive note from the FDA regarding the BLA. And so there was, I assume, some anticipation of the refiling with BLA in the short term. However, now you are recognizing it more in the latter half of this year. So could you please provide a little more color around sort of the 18-month timeline that it's taking?
Simon Best
Okay. I'm going to ask Bruce. With his COO hat on, he's in charge of that process. So Bruce, could you give a little more color to what I included in the presentation?
Bruce Pritchard
Yes, absolutely. Thanks, Simon and Rahul. The reality is, when we had the meeting with the FDA in October, we were discussing the plan with them for the various assays and validation steps that we intended to put in place. And we had to wait until that meeting was concluded to then commence work on that. Clearly, what we didn't want to do was get down a path where we were getting ahead of ourselves, working on assays that were ultimately not going to be satisfactory to the FDA. So the process started after October, and we've been working on that since. As Simon said, we've done rather well with that, however, the very last assay has caused us some technical challenges, and the team have been working pretty flat out on getting those resolved. We're now coming to the end of that process, and we should be able to get those -- that final assay validated in relatively short order. But unfortunately, with this, we are dealing with a biologic. It's not a completely linear process, and we have to take some of these challenges as they come along the way. But I think we're making good progress now with that final validation. And we should be in a position to begin the rest of the process pretty soon
Operator
Your next question comes from the line of Dave Martin of Bloom Burton. Your line is open.
Dave Martin
A couple of questions. So with all the new control feed in the manufacture of Ryplazim and the complexity of putting the CMC section together for IVIG, I had a couple of questions about the PPPS process. First, I'm wondering is the plasma run through dap filters before you run it through the chromatography absorbent. Is the process run at room temperature or refrigerated temperatures? And what's the largest batch that you've run so far?
Simon Best
Thanks, Dave. Again, I'll ask Bruce to give the initial response to that.
Bruce Pritchard
Okay. So I mean, in terms of the details of the initial 2, we don't really talk in detail about that process. There's some proprietary information around that. But -- in terms of the filtration steps that are used. In terms of the largest batch size we've run, at our Laval facility runs at 250-liter batch size. However, we have been running 750-liter batch size in our Winnipeg facility.
Dave Martin
Okay. Next question, so at your Analyst Day in November 2016, it was mentioned that there was an IMF survey that identified 2,100 billings for surgeries for ligneous conjunctivitis. And that was substantially more than the 500 patients predicted by the frequency of the disease mutation. On the Q3 call last year, you indicated that about 300 patients have been identified. I'm just wondering, the reason for the gap between those numbers, and also whether those patients, if you know, are they transiently affected? Are they chronically affected? Could they just body lesions? Or are they systemic?
Simon Best
David, with respect, I think you're mixing up the patient numbers for Ryplazim, ligneous conjunctivitis, which is what we disclosed at the November '16 Analyst Meeting; and then the patient numbers for Alström syndrome, which are much smaller, which are the ones that we referred to at the second meeting. So they're different populations. So ligneous conjunctivitis, if manifest, will return for patients with congenital deficiency for life, which is why they need supplementation with Ryplazim on a regular basis continuously. And if they take it, we've seen now in over 5,000 infusions, most of which were for patients where the main manifestation were ligneous conjunctivitis. Once they have established the right dosing regime for them, there were no further recurrences of lesions at all. Alström's syndrome is a much smaller disease. The Alström Syndrome international has a registry of about 500 patients, which is what I referred to on the call today. That may have grown a bit since even in the last year. Because as the -- there is interest in the disease has grown, and it -- although it's not the primary indication, Rhythm Pharmaceuticals are actually testing a drug for genetic obesity. And as genetic obesity is a feature of Alström's syndrome, they are including a few Alström's patients in genetic obesity trial, which is largely focused on another celiopathy, which is Bardet-Biedl syndrome. So there's more -- as potential treatments comes forward, as the disease gets a higher profile, the registry is growing. So Alström Syndrome International actually knows about 500 patients. But based on the epidemiology and the genetics, the literature suggests that there are probably 1,000, maybe slightly more worldwide. And gradually, as we get the drug to the market, I suspect that we will find out for sure and patients will emerge in other territories. But I think the basis of the -- of your worry is actually mixing up the two populations.
Operator
Your next question comes from the line of Derren Nathan of Hybridan. Your line is open.
Derren Nathan
I note that most of the business development activity you're talking to about your core assets refers to Ryplazim at the moment. I was just wondering, why have you not mentioned PBI-4050 at all in the same vein? Because it does have many, many applications and you've taken on the bite-sized one. But perhaps some of the larger ones might be rightful for partnering as well.
Simon Best
They are. I mean -- so the Alström is purely, both clinically and financially, efficient way of demonstrating high impact in a small number of patients. By itself, it's a small disease. But I think in the presentation, I made it clear that, no, we want to take -- but -- well I guess 2 things: first of all, we've a lesson learned from doing what was probably an underpowered and not big enough from the outset study in IPF. We're not going to embark on larger diseases in which we can't afford to do appropriately sized and scaled trials. But absolutely, in our forward plans, and in which we've been presenting to potential incoming equity investors, which has generated enthusiasm, they think we should take 4050 into at least two large indications: IPF on an appropriate scale; but also liver stage -- liver fibrosis in later-stage NASH, where although there's a lot of other drugs addressing the earlier stages of NASH around fat accumulation and then the attempts to remove the fat or remove the impact of the fat towards causing liver damage, the actual space of patients who've been through that phase and have liver damage and then need help to reverse it or reduce it, that space is pretty empty. And we're being encouraged to go into it. And KOLs in the field have been encouraging us and are now supporting us to design those trials. So no, we want to go into larger indications and start those trials later in the year. And indeed, what's happening in kidney is very interesting because, fairly quickly, although over the last couple of years, sort of standard of care for mainstream diabetes treatment has changed and advanced with the launch of new STLG2 SGLT2 inhibitors. Actually, the genetics of understanding and segmenting kidney disease, both directly certainly with diabetes and other forms of kidney disease, is throwing up the fact that, actually, what were previously thought to be sort of monolithic larger diseases are actually potentially a bit like NASH, you know, ones that may have multiple segments, including significant sizes of rarer renal indications that could also be things that we could take 4050 into. So Ryplazim, essentially, the business development conclusion is it's got the potential to be a big drug, and one where a partner that has the right infrastructure can actually grow it much faster than we can. So business development actually in a way is just focused on doing the right deal there, but then of supporting the partner to grow that product. In terms of actually building the value for the future of the business, that's where we really want to take investor dollars and R&D dollars to build the evidence that, much as we saw how the market responded to the Galapagos Phase II IPF and the FibroGen Phase II IPF, clinical results that were actually statistically no more well-founded than ours, the market reaction placed very significant value on those, which we didn't get credit for because of the weakness of our balance sheet and our vulnerability. So we know what we need to do, and that's what we will do with -- as new investors come in between now and the end of the year.
Derren Nathan
And very interesting that you've got the investor interest. Are you getting much industry interest in some of these larger indications as well? I mean, IPF, I guess, there's a few obvious ones, whom at one point, I thought might have been quite worried by the progress Prometic was making.
Simon Best
Well, worried is the wrong word. I think everyone knows that the existing drugs both have some significant side effects. They also have short patent lives. So, once that does affect the sort of financial modeling of the value potentially of IPF down the road, it's still nasty drugs with significant unmet needs. And we do believe that 4050 really has the potential to secure approval as a firstline therapy. But I think the answer to the broader question is interesting, it's changed. Prometic has had the curse for a long time of the too good to be true syndrome and on the small molecules it really has changed in the last year. So, as we've not only to the Phase 2 data in Alström's it was based initially on 36 weeks and then 52 weeks data. But we've actually continued to treat most of those patients now for over two years and the beneficial trends that we saw in reduction of fibrosis have continued and as we have shared our Head of Research, Lyne Gagnon has presented that data at conferences and have been invited to present that data not just at rare disease conferences but at liver conferences, at cardiac conferences, at pulmonary conferences. The word is getting out to big pharma, that this isn't just sort of you know one-off drugs for a one off disease. This is a class that can affect fibrosis and multiple diseases. So we are now actually sent for JPMorgan meeting we had several big pharma actually didn't come in and say, well, tell us about 4050 for IPS even for NASH. But tell us about your antifibrotic portfolio and round the table representatives of multiple chronic disease therapeutic areas and a lot of interest. Now that has led to a new wave of early but substantive discussions going into some of those big chronic disease areas that you know could be massive opportunities down the road. Now I'd make two comments on that. First of all, it's very early, so I'm not we're at the beginning of a of a serious dialogue about the potential of our portfolio in a number of big chronic diseases, however,[Author ID1: at Mon Apr 8 16:08:00 2019 ] in terms of building or rebuilding shareholder value and chromatic, so relatively modest amounts we can actually take an IPF [Author ID1: at Mon Apr 8 16:09:00 2019 ]and liver fibrosis, we can build the data to support the huge potential value of 4050 and the rest of our pipeline in much bigger indications and we're not going to rush into partnerships until we can really leverage that data. So the plan is to take 4050 further down the road ourselves, which we can do with relatively modest amounts of capital and then you know leverage that as again we saw [Author ID1: at Mon Apr 8 16:12:00 2019 ]the previous market responds to other antifibrotics and these the recent NASH, some of the more successful NASH trials you know and that's where we want to be and where we can be in 18 to 24 months
Operator
Your next question comes from the line of Doug Miehm of RBC Capital Markets. Your line is open.
Doug Miehm
Couple of questions just in terms of follow up and then some on the financials and number one, are you going to be able to tell us when you've completed the batches for Ryplazim as part of the BLA filing?
Simon Best
Doug, we just don't believe it's helpful quite frankly because that you know the process from here to approval right that's a key milestone. That’s why it is on that chart but by itself it's not going to tell you how much long are we're going to take and we would really rather shift and I know, this is mea culpa on the company's communications in the past. The only way we can shift from under promising and over delivering is getting ourselves the leeway to reflect the realities of complex regulatory and development processes and highlighting single steps in multiple stage processes with lots of moving parts, we really don't think helps anybody which is why we would rather set bigger brackets to deliver and then you know, release the important, the really important news which is we have refiled and that's what matters.
Doug Miehm
In that case, can you tell me what the burn rate is going to be over the next six months and as part of that how much cash are you going to require? What’s your intention in terms of financing and how much debt needs to be converted to have a reasonable amount on the balance sheet?
Simon Best
Okay. So Bruce, can you have a go at that and I'll supplement if necessary.
Bruce Pritchard
Yeah. So I mean in terms of the burn rate and what we've spoken about before Doug [Author ID1: at Mon Apr 8 16:21:00 2019 ]is that.[Author ID1: at Mon Apr 8 16:21:00 2019 ] The burn rate will be broadly consistent with the reduced level of burn that we've experienced this year. We obviously will have some savings from certain programs but we're forecasting being able to undertake certain new clinical programs as outlined by Simon. These obviously won't start until we've secured financing. I think you know we've been consistent historically with the message about having to raise an appropriate amount of financing and the plan that we're putting forward currently is to refinance the business to allow us to not be in the same position again that we currently find ourselves. So with the business development transactions that we go lining up plus the new equity we would like to be able to be in a position to fund the company for two and half to three year window. In order to be able to do that, we are looking for probably in the region of CAD 50 million to CAD 70 million of financing.
Doug Miehm
And how much of the – right now its CAD 122 million but end of the year was but how much of that debt would you expect to be converted into equity as well?
Bruce Pritchard
Well, again at this stage until we finalize the financing syndicate, we don't have a precise answer to that question, but I would imagine that we will be expecting to see substantially a substantial component of that debt converted to the equity. So the vast majority of that converted to the equity in order to get new equity investors comfortable.
Doug Miehm
Okay. And would it be fair to assume conversion of that debt that company's current share price of CAD 0.25?
Bruce Pritchard
Again, I do think we can speculate on that at this stage. I mean it will be something that is driven by the market. The most important thing here clearly is ensuring that we get the capital for the business and that will be driven by the price that we are offered in the market.
Operator
There are no further questions in queue at this time. I turn the call back over to the presenters.
Simon Best
Thank you very much operator. Well, thank you, everyone on the call for joining us this morning. Thank you to analysts for good questions and we look forward to the next steps in getting Prometic in the right place to leverage the pipeline and the assets, which you all supported for a long time and which in a merit continued support and in the meanwhile we're going to nail that with new investors and restructuring the balance sheet so that they can take this forward and build value for all of us. Thank you. Bye.
Operator
And this concludes today's conference call. You may now disconnect.