Liminal BioSciences Inc. (LMNL) Q2 2021 Earnings Call Transcript
Published at 2021-08-17 20:46:04
Good morning, ladies and gentlemen, and welcome to the Liminal BioSciences, Inc. Second Quarter 2021 Results Conference Call. At this time note that, all participants are in a listen-only mode. But following the presentation, we will conduct a question-and-answer session. [Operator Instructions] Also note that the call is being recorded on Tuesday August 17, 2021. And I would like to turn the conference over to Shrinal Inamdar, Investor Relations and Communications Manager. Please go ahead.
Thank you, operator, and good morning, ladies and gentlemen. This recorded webcast will be accessible from the Investor Resources page on the Liminal BioSciences website and will be available for replay later on today. For those of you dialing in, you can find a copy of our presentation slides on the Webcasts section of the website or via the conference call portal. Moving on to slide 2. I'd like to remind everyone that we will be making forward-looking statements during today's webcast, including remarks or current expectations concerning future developments of the pipeline, our ability to close any strategic transactions relating to our plasma-derived therapeutics business and/or non-core assets related thereto, regulatory plans, financing plans, our company, the impact of COVID-19 on our business and possible changes in the industry and competitive landscape. These forward-looking statements are based on our current expectations and beliefs on information currently available to us. These statements are subject to risks and uncertainties, including those contained in our updated reports that we filed with the US Securities and Exchange Commission, or SEC, and Canadian Securities Commissions from time-to-time, including our annual report on Form 20-F and our 6-K containing our press release on the results for the quarter ended June 30, 2021, each of which we have filed with the SEC and on SEDAR, that could cause actual results to differ materially from those contained in the forward-looking statements. Please note that these forward-looking statements made during this webcast speak only of our expectations as of today's date, and Liminal BioSciences undertakes no obligations to update these statements to reflect subsequent events or circumstances, except to the extent required by law. Moving on to slide 3. During this morning's webcast Liminal's Chief Executive Officer, Mr. Bruce Pritchard; and Liminal's President, Mr. Patrick Sartore will provide an update on the business highlights. Then Murielle Lortie, Liminal's Chief Financial Officer will present the financial and operational highlights for the second quarter or six months ended June 30, 2021. We will then follow with closing comments on the expected near-term milestones and a short question-and-answer period for financial analysts-only. I'd now like to welcome Liminal's Chief Executive Officer, Mr. Bruce Pritchard; and our President Mr. Patrick Sartore to the call and invite them to talk about Liminal's key recent developments. Bruce over to you.
Thank you Shrial and good morning everyone. So we have a number of updates to discuss today including the successful progress towards the execution of our strategy announced in January this year to divest our plasma business and become focused on small molecule development. Firstly, we were pleased to receive FDA approval of our BLA for Ryplazim as the first treatment option for patients with plasminogen deficiency type 1 hypoplasminogenia. Receiving our first drug approval was a milestone for Liminal and for the patient’s, caregivers, and physicians who have been with us every step of the way in this important research effort. With this approval ,the FDA issued a rare pediatric disease priority review voucher to our subsidiary Prometic Biotherapeutics Inc. who is the holder of the BLA. Prometic Biotherapeutics Inc. has subsequently entered into a definitive agreement to sell the PRV for gross proceeds of US$105 million. Under the terms of the previously announced share purchase agreement entered into with Kedrion, Liminal BioSciences is entitled to retain an amount equal to 70% of the net sales proceeds from the sale of the PRV, which should be approximately US$72.5 million. As we've previously communicated, the company has been focused on strategic alternatives to divest the plasma-related business and focus the company's activity on our small molecule therapeutics business. And today we're very pleased to be in a position where we've already closed on the divestment of two plasma collection centers and our plasma-derived therapeutics manufacturing subsidiary Prometic Bioproduction Inc. to Kedrion. More recently we've also entered into an agreement for the sale of the PRV as announced on August 9th, which will provide an important source of non-dilutive capital to advance the continued development of our small molecule pipeline. Patrick perhaps I can pass over to you to talk through the terms of the share purchase agreement with Kedrion and the sale of the PRV in some more detail.
Thank you, Bruce. So, just to, add to your comments on, the FDA's approval of Ryplazim. This is a well-deserved milestone for everyone who worked so hard, on this at Liminal. Over the last two years, the manufacturing operations, quality assurance, quality control and the process development teams strive to address the gaps identified by the FDA in our first application. The clinical and regulatory teams also ensured that, we presented the efficacy data to build on the initial evidence from the PK results. And all of this was delivered despite the difficulties and challenges resulting from COVID-19. As you mentioned, we've already made significant progress, in the divestment of our plasma-derived therapeutics business. With the first transaction for the plasma collection centers located in Winnipeg, Manitoba and Amherst New York to our subsidiaries of Prometic Plasma Resources Inc. and Prometic Plasma Resources (USA) Inc. having closed in May for a total of US$17 million, representing approximately CAD20.6 million. This included an option agreement, with Kedrion for the right to acquire the remainder of our Plasma-derived therapeutics business, prior to June 15 2021. On June 15, Kedrion extended the option agreement, for additional proceeds to Liminal of US$600,000. Under terms of the share purchase agreement, Kedrion will acquire the remainder of our business in two transactions. The first transaction for the acquisition of our Plasma-Derived manufacturing business or PBP closed in early July for US$9.1 million, subject to adjustments. This was referred to as the first closing. While the second transaction for the divestment of Prometic Biotherapeutics Inc. or PBT, is subject to the fulfillment of certain conditions precedent, including the sale of the PRV by PBT. The sale of PBT is anticipated to close for a purchase price of US$5.2 million subject to working capital adjustments. PBT will use an equivalent of 30% of the net proceeds it receives from the sale of the PRV to pay PBP for services rendered which will result in PBT retaining an amount equal to 70% or approximately US$72.5 million of the PRV net proceeds. The net proceeds will be payable to Liminal prior to closing the divestment of PBT, also referred to as the second closing. The second closing is subject to customary conditions closing conditions including expiration of applicable U.S. antitrust clearance requirements. As a result of all these transactions, Liminal has received proceeds to-date of US$32 million. And upon closing the asset sale agreement and the share purchase agreement Liminal is expected to have received an estimated total anticipated proceeds of US$104.5 million. Not only do these transactions allow us to achieve our objective of streamlining our operations to become focused on small molecule development going forward. We are particularly pleased that we have been able to do this in a way that puts Ryplazim in the hands of an established player in the plasma-derived product space, with the capability to ensure this important product gets rapidly to patients. We're also happy that we were able to reach our preferred outcome in divesting both the plasma collection centers as well as the Ryplazim related business to the same buyer. We look forward to updating you on all our progress, on closing the sale of PBT with Kedrion and monetizing the PRV. I'll now hand over to Murielle, to update on the financials for the quarter.
Thank you, Patrick. If I could ask you now to move to slide 7 in the deck, as a quick reminder, this part of today's webcast is based on the un-audited consolidated interim financial statements for the quarter ended June 30th 2021. All figures are prepared under International Financial Reporting Standards and the full annual information and other important information can be found online, at sec.gov and sedar.com. Our financial information is presented in Canadian dollars and all references during the webcast to dollars, means Canadian dollars and all references to U.S. dollars means U.S. dollars. For simplicity, some numbers being discussed have been rounded. On slide 8, I'd like to review selected information from our results for -- from continuing operations. As the sale of the Plasma-derived therapeutics segment was determined to be likely, results of the operations of the Ryplazim business and the plasma collection activities are presented as discontinued operations and the assets and liabilities were reclassified under the held-for-sale line, presented in the current portion of the consolidated statement of financial position at June 30, 2021. Research and development expenses from continuing operations were CAD 4 million for the second quarter of 2021, which were similar levels to the second quarter of 2020. The costs associated with the ongoing fezagepras Phase I multi-ascending dose or MAD study that started in December 2020, offset – was offset by a decrease in government grants, share-based payment expenses and payroll-related expenses as well as other operating expenses. Administration expenses from the continuing operations were CAD 8.6 million for the second quarter of 2021, similar to the level spent in the second quarter of 2020. Finance costs were CAD 1.7 million for the second quarter of 2021, an increase of CAD 1.4 million, compared to the second quarter of 2020. As a result of the long-term debt issuances in the third quarter of 2020, following the issuance of a secured and convertible debt in July 2020 and a term loan in September 2020, as we drew down our full line of credit with SALP. Net loss from continuing operations net of taxes was CAD 12.6 million for the second quarter of 2021, compared to CAD 13.2 million for the second quarter of 2020. Gain on sale of subsidiaries was CAD 10.7 million for the second quarter of 2021, as a result of the sale of the plasma collection centers in May 2021 and with proceeds received to date or to June 30 related to the sale of the Ryplazim business. The loss from discontinued operations for the quarter ended June 30, 2021 was CAD 30.2 million, an increase of CAD 15.6 million, compared to the corresponding period in 2020. The increase is mainly due to the recording of a provision for onerous contract of CAD 20.9 million, regarding a contract we have with a contract development and manufacturing organization or CDMO, which is no longer required, as a result of the Plasma-derived therapeutics segment divestiture. This was partially offset by lowering – lower operating expenses, mainly due to a reduction in production, as we awaited the outcome of the FDA review of our BLA and our efforts to sell these businesses along with the reduction in costs incurred compared to 2020, when we were preparing for the refiling of the BLA and since our R&D facility in Rockville, Maryland has been closed since the end of 2020. The resulting net loss was CAD 32 million for the second quarter of 2021, compared to CAD 27.8 million for the second quarter of 2020. Moving to Slide 9. I'd now like to walk through major elements that impacted our cash and cash equivalents throughout the quarter – throughout the year-to-date. These cash flows include both the operating – continuing operations as well as the discontinued operations. We started 2021 with CAD 45.1 million of cash and cash equivalents. CAD 29.6 million was used in operating activities, a decrease of CAD 2.3 million compared to the same period in 2020. The decrease is due to the reduction in R&D spending and the increase in government grants collected. CAD 6.1 million of cash was used in financing activities related to lease payments and interest on outstanding debt. This is a CAD 1.5 million increase compared to the same period in 2020, mainly due to the timing of lease payments and an increase on interest payments on the long-term debt as our debt balance has increased. CAD 21.1 million of cash was generated from investing activities, mainly due to the proceeds of CAD 21.4 million we received in connection with the divestiture of the Plasma-derived therapeutics segment. These uses and receipts of cash resulted in a cash and cash equivalent balance at June 30, 2021 of CAD 29.6 million. Moving to Slide 10. At June 30, 2021, our net working capital was CAD 38.3 million, which included CAD 29.6 million of cash and cash equivalents. On June 9, we received proceeds of US$9.1 million for the sale of PBP. On August 6, we signed an asset purchase agreement to sell our PRV for US$105 million, which Liminal will retain an amount of 70% of net proceeds upon closing of such transaction. We also expect to receive US$5.2 million for the sale of PBT, subject to working capital adjustments, once that transaction closes. Given Liminal's main activities continue to be in the R&D stage, management has concluded that as of June 30, it did not have sufficient funds on hand to continue its operations for at least the next 12 months. In our cash management efforts, we've been operating at low spending level, pacing our investments on new research programs and reducing infrastructure costs where possible, while continuing to take steps to further transition our company to focus on the development of our small molecule product candidates. Our liquidity resources are allocated in priority towards the fezagepras Phase I MAD study and our earlier stage one discovery programs for our selective GPR84 antagonist and OXER1 antagonist. Until the company closes the sale of the PRV completes the significant financing or can generate sufficient revenues to finance its future cash requirements. It may likely need to secure additional external financing which may include public or private equity offerings, debt financing, strategic collaborations, asset divestitures or other sources. Bruce perhaps you'd like to talk a little bit about the key expected milestones
Great. Thanks very much, Murielle. So, I guess, if we could move on lastly to slide 11. On the small molecule pipeline, as many of you know we recently announced an update to previously disclosed clinical activities for fezagepras. Over the last year we've been consistent in our disclosures on maintaining that our decisions to move forward with any of our clinical activities will be purely data-driven. And based on interim PK results from the ongoing fezagepras Phase I multiple ascending dose clinical trial, we decided to stop our plans to move fezagepras into a Phase II clinical study in IPF and a Phase Ia/IIb study in hypertriglyceridemia as we evaluate the impact of the PK data profile observed in that ongoing Phase I clinical trial. It is important to note again that no safety issues have been observed to-date. Every clinical trial provides us with more insights. And currently the next steps for fezagepras are to complete that MAD study, evaluate the data and that could potentially include other preclinical experiments before determining the choice of any other potential indications for future development of that compound. On our early-stage drug discovery portfolio both our GPR84 antagonist program and our OXER1 antagonist program are currently at the preclinical stage. And pending the outcome of our preclinical research and successful identification of preclinical drug candidate for both compounds, we plan to initiate preclinical IND-enabling program to support first-in-human Phase I single ascending dose clinical trials for both candidates in healthy volunteers for safety and tolerability. We expect to be able to provide more color on a potential new indication for fezagepras as well as more granularity on the development plans for GPR84 and OXER1 before the end of this year. As always given the ongoing unpredictability of COVID-19 for our future operational objectives we may need to amend guidance on the expected progress and nature of our business going forward with an improved understanding of how COVID-19 may impact our future operations including ongoing and future clinical studies. We continue towards closing the opportunities for the disposition of the non-core assets to provide additional funding for our ongoing operations and programs beyond 2021 and are focused on delivering our highest priorities for 2021 and 2022. So we'd now like to address any questions that any of our financial analysts may have. So thank you very much operator and to everyone on the phone and actually could open up now to the financial analyst Q&A section.
Thank you, sir. [Operator Instructions] And your first question will be from Yasmeen Rahimi at Piper Sandler. Please go ahead.
Hi, team. Thank you so much for the update and congrats on the PRV. I think, it would be helpful to just maybe frame perhaps how soon the PRV transaction would close and you would therefore be eligible for the proceeds of US$72.5 million that could be really helpful. And then maybe a little bit color in regards to the pipeline? How soon could we be expecting an update as you guys are thinking about continued development? And I know you're being very thoughtful. But any color you can give beyond the comments made in terms of timeline and indications could be helpful? Thank you again for taking my questions.
Perfect. Thanks, Yasmeen. I'll kick off on this, and then I'll ask Patrick, if he wants to chip in on any additional color. In terms of the closing of the PRV, as we've mentioned this is subject to certain closing conditions. They're predominantly driven by the US antitrust clearance review. Yasmeen, as you probably know, there is a standard time line for that. We don't have control over that time line. But there's a standard process to go through that's fairly well documented. So we would anticipate that all being well with that, that we would receive the funds certainly this year, and hopefully before the time that we have the next analyst call for our Q3 results. In terms of the pipeline and where we're going, again, we're working very hard on this right now. As you know, the ongoing MAD study is progressing. We're almost at the end of that. By the time, we analyze the remainder of that data look at the additional preclinical work that we're looking at, at the moment with fezagepras. We would hope that we are in a position to provide further granularity on both where we're going with the fezagepras program, and indeed the timing and outlook for both the GPR84 and OXER1 programs in a similar sort of time frame. So, certainly before the end of this calendar year.
Thank you so much. And we’re very much looking forward to it.
Thank you. Next question will be from Edwin Zhang at H.C. Wainwright. Please go ahead.
Hi. Thanks for taking my questions. Congrats on the successful divestment and we look forward to the new development of Liminal. First question, I want to follow-up on the new indication. We know the next indication for fezagepras depends on the PK data analysis. Can you please comment more on how the PK data drive your decision? And what are the candidate indications and your current consideration? What is your thought process here? Lastly, do we exactly learn your final choice this year? And then I have a follow-up.
Okay. Let me tackle those then – and then we'll get to your follow-up question. In terms of feza, there's a limit to what I can say right now just given the nature of where we're going. But it was clear that when we studied the PK data for the drug, it was not going to be an appropriate drug for patients in the two indications that we were looking at. We are continuing to work with the compound. At this stage, it's not appropriate for me to disclose what the indication is that we're looking at, but it is something that we are working on both commercial analysis and preclinical work to ensure that we fully understand the validity of that indication, before we make an announcement. As I answered to Yasmeen, we would hope to be in a position before the end of this year to elucidate what that indication will be and what the go-forward development plan for the compound will look like. But obviously, as I said, that's all kind of pending the sort of positive outcome of the review of that data that we're working on right now.
Great. To Murielle, first, I want to thank you for your very kind help over the years. Best wishes in all you do next. Maybe a quick question for you on the PRV, are you going to recognize the payment in full or with the deferred portion? Thank you.
Thanks, Edwin. In terms of recognition of the payment, when we received the PRV. We haven't finalized our accounting position, but the intention is to – I mean, we will have received the full proceeds of the PRV, when we receive them is to recognize those – the cash proceeds.
Thank you. Next question will be from Doug Loe at Leede Jones Gable. Please go ahead.
Yeah Thanks very much operator, and good morning all. Just a quick question and just again on your GPR84 antagonist program. Bruce just -- it wasn't clear to me listening your commentary on your expected milestone slide whether or not the GPR84 drug candidates that you have identified? Is it actual or conceptual as why -- which you mean are you still at the lead optimization phase, or have you actually identified a candidate that you expect to move forward in preclinical IND-enabling studies? And then just on a related theme, I just wasn't sure whether or not the candidate notional or otherwise that you expect to advance into preclinical testing is based on a fezagepras backbone i.e. are you taking advantage of all of the pharmacologies you would have learned from some of your legacy testing in metabolic disease, or are there some novel chemistries that you're working on in the background? And I'll leave it there. Thanks.
Thanks, Doug. I'll answer as much of that as I can at this stage. So the answer to your first question, I think I maybe covered in the narrative and apologies if it's not very clear from the slide. But we're still at lead optimization for that particular drug candidate. Again we would hope to be able to update more about that in the next quarter's call. On the basis of that, it's probably too early to fully answer your question, your second question. Once we've got the candidate, we'll be able to elucidate further on that.
Thank you. And at this time Mr. Pritchard we have no further questions. Please proceed, sir. End of Q&:
That's great. Thank you very much, operator. Well again ladies and gentlemen thank you for taking the time to join the call. Again just echoing Edwin's comments we'd like to thank Murielle, for her time as CFO of the corporation and we wish her well as she moves on to her new opportunity. Thank you all for joining the call today and we look forward to updating you on the company progress on our next call. Thank you.
Thank you, sir. Ladies and gentlemen this does indeed conclude your conference call for today. Once again thank you for attending. And at this time we do ask that you please disconnect your…