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Edited Transcript of PLI.TO earnings conference call or presentation 13-Nov-19 1:30pm GMT

Q3 2019 Liminal BioSciences Inc Earnings Call

MONT-ROYAL Nov 29, 2019 (Thomson StreetEvents) -- Edited Transcript of Liminal BioSciences Inc earnings conference call or presentation Wednesday, November 13, 2019 at 1:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Kenneth H. Galbraith

Liminal BioSciences Inc. - CEO & Director

* Murielle Lortie

Liminal BioSciences Inc. - CFO

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Conference Call Participants

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* Derren Nathan

Hybridan LLP, Research Division - Director & Head of Research

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Presentation

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Operator [1]

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Ladies and gentlemen, thank you for standing by, and welcome to the Liminal Biosciences, Inc. Third Quarter Results Conference Call.

(Operator Instructions) I would now like to hand the conference over to your speaker today, Murielle Lortie, Chief Financial Officer. Please go ahead, Madam.

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Murielle Lortie, Liminal BioSciences Inc. - CFO [2]

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Thank you, operator. Good morning, ladies and gentlemen. I would like to draw your attention to the safe harbor statement and the fact that this morning's presentation contains forward-looking statements about Liminal's objectives, strategies and businesses that involve risks and uncertainties. These statements are forward-looking because they're based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, Liminal's ability to develop, manufacture and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Liminal to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions.

You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in the annual information form for the year ended December 31, 2018, under the heading Risk Factors. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statements, even if new information becomes available as a result of future events or for any other reason, unless required by applicable securities laws and regulations.

All amounts are in Canadian dollars, unless indicated otherwise. Liminal reserves the right to make improvements, corrections and/or changes to this presentation at any time.

During this morning's webcast, I will present the financial highlights for the third quarter of 2019. Liminal's Chief Executive Officer, Mr. Ken Galbraith, will provide a business update, which we will then follow with a short question-and-answer period for financial analysts.

If I could ask you now to move to Slide 4 in the deck. As a quick reminder, this part of today's webcast is based on the condensed interim consolidated statements for the third quarter of 2019 as well as on the audited financial statements for the year ended December 31, 2018. All these figures were prepared under IFRS and the full annual information and important information can be found online at sedar.com.

Moving to Slide 5. Our graph shows the variability of total revenues quarter-to-quarter by segment. The purple color bar represents our bioseparation segment whose sales for the quarter was $4.5 million. This is $1.6 million lower than the same quarter in 2018. As the sales in this segment are custom design and as batch sizes and order frequencies are not regular, revenues and margins from this segment are quite variable from quarter-to-quarter.

On November 4, 2019, we announced the sale of Liminal's 100% ownership in Prometic Bioseparations Ltd. and its subsidiaries to a syndicate of private investors, KKR & Co Inc. Under which Liminal will be entitled to receive up to GBP 45 million, with up to GBP 32 million payable at closing of the transaction, subject to closing adjustments. This is expected in the fourth quarter of 2019. Liminal will also be entitled to receive up to GBP 13 million in deferred payments based on the achievement of full annual revenue thresholds of the divested business. The blue graph represents revenues from the plasma-derived therapeutics segment, which have ordinarily been generated from the sales of specialty plasma to third parties. However, as a result of the change in production forecast due to the delay of the BLA approval for Ryplazim announced in 2018, revenues have also been generated from the sale of excess normal source plasma to third parties over the past 5 quarters. Revenues from this segment were lower by $5.4 million during the quarter ended September 30, 2019 compared to the corresponding period of 2018, mainly due to a significant $5.6 million sale of excess normal source plasma in the third quarter of 2018.

On Slide 6, I would like to highlight the R&D expenses versus past quarters. As you can see, the overall R&D expenses were $4.5 million lower than the same quarter last year, mainly due to the plasma-derived therapeutics segment and, to a lesser extent, the small molecule segment, represented by the green bar. Reduction in salaries, preclinical and clinical studies occurred in both of these segments, and spending related to the validation of analytical assays and in-process controls in the manufacturing of Ryplazim decreased in the plasma-derived segment in 2019.

The bioseparation segment R&D expenses are generally consistent quarter-to-quarter.

On Slide 7, I'd like to review selected information from our profit and loss accounts. I've already provided the breakdown of revenues on an earlier slide, but recapping, the $7 million decrease in Q3 is principally due to the reduction in sales of excess normal source plasma by $5.6 million in addition to a reduction in bioseparation product sales. The $14.5 million decrease for the 9 months ended September 30, 2019, compared to the corresponding periods in 2018 are a result of nonrecurring normal source plasma sales of $19.7 million in 2018, offset by an increase of specialty plasma and bioseparation sales of $2.3 million and $2.9 million, respectively.

The cost of sales and production during the quarter and 9 months ended September 30, 2019, decreased by $6.2 million and $19.1 million, respectively, compared to the corresponding period in 2018. But both decreases are mainly due to lower volumes of normal source plasma sold in 2019, which also impacted margins significantly as sales of normal source plasma were at lower margins.

R&D expenses were $19.6 million during the quarter ended September 30, 2019, compared to $24.1 million for the corresponding period in 2018, representing a decrease of $4.5 million. As mentioned previously, this is mainly due to lower expenses in the development of Ryplazim and our small molecule segment. R&D expenses were $63 million during the 9 months ended September 30, 2019, compared to $70.5 million for the corresponding period in 2018, representing a decrease of $7.6 million. This difference is explained by the reduction in spending with third parties on clinical and preclinical studies and the completion of analytical assay validation and in-process controls in the manufacturing of Ryplazim amounting to $9.2 million.

Salaries decreased by $3.3 million due to the reduction of headcount accompanied by a reduction of general operating expenses. These decreases were partially offset by the increase in share-based compensation. In 2018 and '19, there was no commercial production of plasma-derived therapeutics as the focus was on addressing comments received by the FDA following their audit at the end of 2017. And therefore, the cost of manufacturing was classified as R&D expenses.

The increase of $4.1 million in administration, selling and marketing expenses during the quarter ended September 30, 2019, compared to the corresponding period in 2018, is mainly attributable to the increase in share-based payments expense of $1.6 million and to the increase in legal and audit fees of $1.6 million. The increase of $15.7 million in administration, selling and marketing expenses during the 9 months ended September 30 is mainly attributable to the increase in employee compensation expense of $13.4 million, which includes a noncash increase in share-based payment expense of $11.3 million as well as increased legal and audit fees of $2.1 million. This was partially offset by a decrease in consultant fees relating to the marketing of products.

Legal and audit fees have increased as a result of the number of complex transactions incurred in 2019 and in preparation of our NASDAQ filing. The increase of $2.2 million on the total adjusted EBITDA for the quarter ended September 30, 2019, compared to the corresponding period in 2018, is mainly due to the decrease in R&D expenses that exceed the increase in administrative, selling and marketing costs. The removal of the depreciation of right-of-use assets of $1.3 million and the interest expense on lease liabilities of $2 million also contributed to the improvement. The increase of $16 million on the total adjusted EBITDA for the 9 months ended September 30, 2019 compared to the corresponding period in 2018 is mainly as a result of the increase in margin from sale of goods of $5 million, and the reduction in R&D excluding share-based payments expense of $12.5 million. This was partially offset by the increase in administration, selling and marketing, excluding share-based payments expense of $4.4 million.

The removal of the depreciation of right-of-use assets of $3.7 million and the interest expense on lease liabilities of $5.5 million are other factors explaining the difference. Noting, however, that the comparison is limited as the accounting for leases is very different in each period.

Finance costs decreased during the quarter and 9 months ended September 30, 2019, by $4 million and $2.7 million, respectively, compared to the corresponding periods in 2018. These decreases reflect a lower level of debt during 2019, following the April 23, 2019 debt restructuring. The adoption of new lease standard IFRS 16 leases at the beginning of 2019 under which lease liabilities are recognized for the discounted value of the future lease payments at initial adoption and with interest expense recognized over the term of each lease contributed to the increase of finance costs in 2019. The new standard was adopted using the modified retrospective approach. And as such, the 2018 figures are not restated.

Previously, the embedded interest component in each lease payment was recognized as part of the lease expense included in the various functions presented in the statement of operations, such as cost of sales and other production expenses, R&D and administration, selling and marketing. The interest expense on the lease liabilities was $1.8 million and $5.5 million for the quarter and 9 months ended September 30, 2019, respectively, and are partially offsetting the decline in interest expense from the long-term debt.

Loss on extinguishments of liabilities was $92.4 million for the 9 months ended September 30, 2019 principally as a result of the company concluding a debt restructuring agreement on April 23, 2019, with its major creditor, Structured Alpha LP. The debt was reduced to $10 million plus interest due in exchange for the issuance of 15,050,312 common shares. The difference between the adjustment to the carrying value of the loan of $141.5 million and the amount recorded for the shares issued of $228.9 million was recorded as a loss on extinguishment of a loan of $87.4 million. This amount essentially representing the immediate recognition of the accreted interest that would have otherwise been recognized as finance costs over the years until the maturity of the long-term debt. The portion of the loan that was not settled was modified into an interest-bearing loan at 10% stated interest payable quarterly. The modification of the terms was treated as an extinguishment of the previous loan and the reissuance of a new loan for accounting purposes.

The difference between the carrying amount of the extinguished loan of $4.7 million and the fair value of the new loan of $8.5 million was recorded as a loss on debt extinguishment of $3.9 million. The new loan has a higher fair value, mainly because it's an interest-bearing loan with regular interest payments, while the previous loan contained implicit interest in the face value with payment due upon maturity. And as such was being accreted over the life of the loan. The expense represents an immediate recognition of a portion of the unrecognized interest expense on the old loan.

The net loss increased slightly by $0.8 million during the quarter ended September 30, 2018 compared to the corresponding period of 2018, mostly explained by the reduction in finance costs and R&D expenses, offset by increases in administration, selling and marketing, and the reduction in current income tax recoveries related to the U.K. R&D tax credits. The net loss increased by $95.7 million during the 9 months ended September 30, 2019, compared to the corresponding period of 2018. This is mainly driven by the increase of the loss on extinguishments of liabilities of $19.1 million caused by the debt restructuring that occurred during the second quarter of 2019 as well as the increase in the share-based payments expense of $16.1 million, but was partially offset by the decrease in other R&D expenses.

Turning now to the balance sheet on Slide 8. Cash increased by $52.9 million compared to December 31, 2018 with a closing balance at September 30, 2019 of $60.4 million. Cash balances are directly influenced by the timing and size of financing events and operating revenues and expenditures. The increased balance at September 30, 2019 is mainly due to the net proceeds of approximately $70 million received in the equity raise of April 23, 2019, and $39.2 million received from the rights offering completed in June 2019.

Accounts receivable decreased by $6 million at September 30, 2019 compared to December 31, 2018 mainly due to the collection of trade receivables. Current income tax receivables decreased by $0.5 million because of foreign exchange rate variations versus 2018 year-end rates. Inventories at September 30, 2019 decreased by $2.6 million compared to December 31, 2018 as a result of reduced inventory purchases in the plasma-derived segment until preparation of Ryplazim commercial batches commences.

Capital assets decreased by $3.7 million at September 30, 2019 compared to the December 31, 2018, mainly due to the adoption of IFRS 16 and the transfer of finance leases to the right-of-use assets on January 1, 2019, and the depreciation expense taken thereon during the period. Regarding the right-of-use assets and lease liabilities as of September 30, 2019 $37.2 million in right-of-use assets and $42.9 million of lease liabilities were recognized, while the long-term portion of operating and finance lease inducements and obligations of $2.8 million were derecognized as a result of the adoption of IFRS 16 at the beginning of the year.

Intangible assets decreased by $0.8 million due to an impairment on a patent that is no longer expected to generate profit before expiry. Accounts payable and accrued liabilities decreased by $11.9 million at September 30, 2019 compared to December 31, 2018, mainly due to the reduction of $11.6 million of accounts payable as the company caught up on the payment of supplier invoices that were due after it successfully raised financing during the second quarter of 2019.

Long-term debt decreased by $114 million at September 30, 2019 compared to December 31, 2018, primarily as a result of the debt restructuring on April 23, 2018, which reduced the carrying amount of the long-term debt to $10.6 million, including interest due. Total assets at September 30, 2019 were $182.4 million as a result of the increased cash position. Total equity has grown from a deficiency of $63.1 million to $106.7 million of equity.

That concludes the financial portion of the presentation. I'd now like to welcome Liminal's Chief Executive Officer, Mr. Ken Galbraith to the call and invite him to provide a business update. Ken?

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Kenneth H. Galbraith, Liminal BioSciences Inc. - CEO & Director [3]

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Thank you, Murielle, and good morning, everyone. With my first 6 months as CEO now behind me, I can say I'm pleased with the progress we're making towards our plan to make significant changes in our business, with a primary focus on the development and commercialization of our Small Molecule Therapeutics business.

Our main goal is to focus our energies on the best opportunities that we have to be successful in developing new medicines to meet serious unmet needs of our patients. In doing so, we'll focus our activities in areas where we have the greatest capabilities and experience in order to be successful. And making these changes in focus, we will seek to reduce our headcounts and cost structure by simplifying our business to those selected focused therapeutic areas. We are also getting a greater degree of financial stability in our operations than previously in order to adequately fund our long-term strategic vision. Many of our activities over the past 6 months have been focused on simplifying our business and achieving greater financial stability for our business.

In addition, I've been focused on ensuring that we have the skills and experience necessary within our human talent pool to reflect these major changes in our business and our culture, to position us better for both short-term and long-term success. Over the past 6 months, these are a few of our key activities. We improved our financial position significantly through the conversion of almost all of our outstanding debt to common shares in Q2 2019. Concurrently, we completed new equity offerings providing gross proceeds of USD 85 million to finance our ongoing operations as we embarked on our strategic plan for the company's transition. We also continue to actively pursue a listing of our common shares on NASDAQ, which should provide enhanced liquidity and trading for both our current and prospective shareholders. We made significant changes to the composition of our Board of Directors to provide the skills and experience necessary for oversight of our strategic plan, and we expect to make further additions to our Board in conjunction with our potential NASDAQ listing.

We made significant changes to our leadership team, including the announcement today of the recent recruitment of Moira Daniels, an experienced regulatory affairs professional, who will provide the skill and experience necessary to help the team accomplish the short-term and long-term objectives in our strategic plan including the filing of our BLA for Ryplazim in both the United States and Europe and our regulatory interactions for PBI-4050.

We completed the first transaction on our strategic process led by our advisers at Lazard with the sale of the bioseparations business located on the Isle of Man to KKR which we expect to close soon.

On closing, we expect this transaction to add approximately CAD 2 per common share in immediate cash with the potential for future performance-based payments. We took a key step in our R&D strategy by commencing clinical developments of our second small molecule compound, PBI-4547 with an intended focus in treating fibrosis and NASH, and other liver diseases. We've completed the first 3 dose cohorts in the single ascending dose studying healthy volunteers with no significant safety or tolerability issues noted.

We've chosen to take a pause before commencing the fourth dose level cohorts to gain a better understanding of the human pharmacokinetic results seen to date and study comparisons to the PK seen with PBI-4547 in our preclinical animal studies. We'll report our next steps in the Phase I study as soon as our additional research on this matter is completed.

And finally, we took a key step in refreshing our vision and corporate culture with the renaming of the company to Liminal Biosciences to better reflect our future strategic direction. I'm very pleased with our accomplishments in these first 6 months while realizing we have much work to do in the coming weeks and months to align the company's operations with our strategic plan and to execute that plan with a high-quality effort necessary to build value for our shareholders. In the coming recent months, I expect you will see further actions being taken that are necessary to allow the company to be successful and I'd like to discuss a few of those with you now.

With 6 months of being CEO now behind me and with our transition underway with the pending divestiture of PBL, I believe I'm now in a better position to initiate our plans to transform and simplify our business operations as we focus primarily on our Small Molecule Therapeutics business. We will seek efficiencies and synergies in rationalizing and simplifying our cost structure to conform with the new strategic plan. Over the course of the next year, I expect a substantial reduction in our workforce through either divestiture of operations as with the 100 employees currently at PBL who will shortly belong to an independent company owned wholly by KKR, or due to our expected marketing partnership for Ryplazim, which will see us focus on our primary role as a supplier of Ryplazim to our marketing partner, or with a new focus in R&D strategy within the small molecule therapeutics business and for cost efficiencies to be gained in our corporate operations as the company's overall workforce shrinks to fit the needs reflected in the strategic plan.

Beyond reductions in our personnel cost, we will evaluate all other operating costs and infrastructure in order to find cost savings that will simplify our operations, extend our runway and importantly, provide the ability to fund our most important research and development investments. Despite the overall expected headcount reduction over the next year, we will continue looking to add key individuals in our talent hubs to address gaps in skills and experience that we will need over the longer-term to execute our strategic plan.

As we make these changes over the course of the year ahead, the financial impact should be reflected in our future operating results in future quarters and leave us with an enhanced financial position. Also, we're making excellent progress with the ongoing work to support the filing of our BLA for Ryplazim and are confident in our ability to file the BLA during the first half of 2020 as previously disclosed. Much of the work to achieve that milestone is behind us, and we look forward to discussing our proposed filing with the FDA in a formal pre-BLA meeting to be held in 2020.

We will also continue our discussions with European regulators to provide a pathway for seeking approval of Ryplazim in major markets in Europe. Our progress with the BLA for Ryplazim has allowed us to continue active and constructive discussions on a marketing partnership, which we hope can be completed to allow sufficient time for pre-commercial activities by our marketing partner, to prepare for the potential launch of Ryplazim in the United States after FDA approval and to seek marketing approval in other countries.

Gaining approval for our first product in 2020 would be a major milestone for the company and we continue to dedicate substantial time and resources to this goal. Also, we spent the last several months completing a strategic review of our R&D strategy and product portfolio in the Small Molecule Therapeutics business to ensure we can focus and fund the highest quality R&D programs with the greatest chance of successfully treating serious unmet medical needs in our chosen therapeutic categories. We recently attended 2 major scientific and medical meetings over the past week. Kidney Week in Washington, D.C. being the annual meeting of the American Society of Nephrology, and the Liver Meeting in Boston being the annual meeting of the AASLD. Both meetings allowed us to present our recent research efforts in these disease areas, in both oral and poster presentations, in a peer-reviewed setting, and also to gain a better understanding of the competitive environment for us in developing new medicines in these disease areas. I'm very pleased with the reception to our research programs by both industry and medical professionals, reflecting the high-quality nature of our research team and programs.

We've also been evaluating opportunities to enhance our current product portfolio and research focus through in-licensing, collaboration and product acquisition. Over the course of the next year, I would expect our R&D strategy to continue to evolve and develop with the goal of ensuring we are investing in world-class science and drug development of the highest quality, whether it stems from our current biologic targets and compounds or new novel targets and compounds. We will announce enhancements to our R&D strategy at the appropriate time as decisions are made or transactions completed.

We expect to have additional interactions with the FDA, EMA in the first quarter of 2020 to further discuss our plans to conduct a Phase III clinical study to support regulatory filings for the marketing approval of PBI-4050 in the treatment of patients with Alström syndrome. These discussions have been ongoing for a lengthy time period, but are necessary for us to ensure that we have an appropriate regulatory pathway to bring this new medicine to patients suffering from Alström syndrome. We also expect to commence further randomized controlled Phase II clinical studies with PBI-4050 in 2020 beyond Alström syndrome and look forward to discussing these studies further as soon as they are underway.

Beyond the addition of Ms. Daniels, we're continuing our search for 2 additional key positions within our drug discovery development function, and we hope to complete these searches in the near future with high-quality experienced candidates to join my leadership team. We were very pleased recently to complete an agreement for a line of credit with our major shareholder, which could provide a future source of funding for us if ever needed. Even though we have no current plan to draw down any portion of the line of credit, increasing our financial stability with the line of credit while continuing to pursue a NASDAQ listing and continuing business discussions with respect to Ryplazim marketing partnership was important to our ability to execute our strategic plan for the benefit of all stockholders. We are very appreciative for having a major shareholder willing to provide such potential financial support for the company and its employees when it is needed.

And finally, we continue to pursue a NASDAQ listing for our common shares in order to increase our efforts to raise the profile with U.S. investors of the new Liminal and our new strategic plan to build a patient-focused R&D organization of the highest quality of science and operational excellence in order to provide novel therapeutic options for unmet patient needs within our chosen areas of therapeutic expertise and strengths. We will provide updates on this process at the appropriate time.

Now the past 6 months have not been without challenges and difficulties, but I am very confident that we are gaining positive momentum in our operational focus and execution, stability in our financial situation, a stronger and more experienced talent pool and an even stronger commitment to the benefits we hope to deliver to our shareholders and executing our new strategic plan. I look forward to reporting continued progress on our new strategic plan in the weeks and months ahead, and thank our employees and shareholders for their continued support through this transitional period for the company. Major changes in our business were necessary and major changes are being made, and we'll continue as we make this transition to the new Liminal.

As I said before, we're continuing on a different and better path to Liminal Biosciences and one that we believe will be a better path that leads us to our goal of building a successful global life science company focused on developing new medicines for patients around the world that will make a difference in the lives of those patients.

We would now like to take time to address any questions you may have. I'll turn it back over to you operator for the Q&A session.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Your first question comes from the line of Derren Nathan from Hybridan.

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Derren Nathan, Hybridan LLP, Research Division - Director & Head of Research [2]

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Just a couple of questions with me. Firstly, with regard to the sale of the bioseparations division. I was just wondering, in terms of IP connected to other plasma therapeutics that Liminal or Prometic has said in the past, do you still retain those? And is there any prospects of value being derived there? And then secondly, as you mentioned, I know the increase in preclinical data presented on various fibrotic conditions in the small molecule franchise, not all of which currently have an outlined clinical program. I'm just wondering, could we expect this clinical program to accelerate? Or is it all going to be partner dependent?

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Kenneth H. Galbraith, Liminal BioSciences Inc. - CEO & Director [3]

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Yes, thank you for the 2 questions. On the first question with respect to the sale of PBL, again, the underlying PPPS technology will still rely -- will still be with Liminal. We're providing access to IP rights that PBL would need to run their business on an autonomous basis. But underlying IP technology would still rest with Liminal and allow us to develop other plasma therapeutics, as you mentioned, beyond Ryplazim. So that's one thing I'd like to note.

Secondly, I think we have a pretty strong preclinical research program in many disease areas, which we probably have not talked about in the company previously. And obviously, the basis of those preclinical programs is to -- once we can identify the appropriate clinical indication and the correct molecule from our library of compounds, then we would look to pursue clinical programs in those therapeutic areas. So our goal of the strategic plan, over the next couple of years, is to have multiple compounds from our current portfolio being advanced in clinical development in multiple therapeutic areas in respiratory, in liver disease and in kidney disease. So we would look to build a portfolio of multiple compounds in multiple therapeutic areas, all based primarily on the antifibrotic focus of those compounds.

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Operator [4]

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There are no further questions at this time. I'll turn the call back over to the presenters.

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Kenneth H. Galbraith, Liminal BioSciences Inc. - CEO & Director [5]

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Well, thank you very much operator. And thank you, everyone, and folks on the phone, for your time and attention. And we look forward to updating on our progress over the course of next quarter and with our year-end financial results as well. So thank you very much for your time and attention.

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Operator [6]

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This concludes today's conference call. You may now disconnect.