EX-99.2
Exhibit 99.2
Management’s Discussion and Analysis
Aurinia Pharmaceuticals Inc.
Q3 15
Third Quarter
Ended September 30, 2015
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS FOR THE THIRD
QUARTER ENDED SEPTEMBER 30, 2015
The
following Management’s Discussion and Analysis of Financial Condition or MD&A and Results of Operations provides information on the activities of Aurinia Pharmaceuticals Inc. (“Aurinia” or the “Company”) on a
consolidated basis and should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements and accompanying notes for the third quarter ended September 30, 2015 and the Company’s annual
amended MD&A and restated audited financial statements for the year ended December 31, 2014. All amounts are expressed in United States (U.S.) dollars unless otherwise stated. Dollar amounts in tabular columns are expressed in thousands of
U.S. dollars. This document is current in all material respects as of November 12, 2015.
The financial information contained in this MD&A
and in the Company’s interim condensed consolidated financial statements have been prepared in accordance with International Financial Reporting Standards or IFRS for interim financial statements as issued by the International Accounting
Standards Board or IASB. The interim condensed consolidated financial statements and MD&A have been reviewed and approved by the Company’s Audit Committee. This MD&A has been prepared with reference to National Instrument 51-102
“Continuous Disclosure Obligations” of the Canadian Securities Administrators. Under the U.S./Canada Multijurisdictional Disclosure System, Aurinia is permitted to prepare this MD&A in accordance with the disclosure requirements of
Canada, which are different from those in the United States.
Forward-looking Statements
A statement is forward-looking when it uses what the Company knows and expects today to make a statement about the future. Forward-looking statements may
include words such as “anticipate”, “believe”, “intend”, “expect”, “goal”, “may”, “outlook”, “plan”, “seek”, “should”, “strive”,
“target”, “could”, “continue”, “potential” and “estimated”, or the negative of such terms or comparable terminology. You should not place undue reliance on the forward-looking statements,
particularly those concerning anticipated events relating to the development, clinical trials, regulatory approval, and marketing of the Company’s product and the timing or magnitude of those events, as they are inherently risky and uncertain.
Securities laws encourage companies to disclose forward-looking information so that investors can get a better understanding of the Company’s future
prospects and make informed investment decisions. These statements, may include, without limitation:
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plans to fund the Company’s operations; |
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the Company’s intended use of the proceeds from the sale of the Securities; |
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statements concerning strategic alternatives and future operations; |
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summary statements relating to results of the past voclosporin trials or plans to advance the development of voclosporin; |
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statements concerning partnership activities and health regulatory discussions; |
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the timing of completion of patient enrolment in the Company’s AURA-LV and AURION studies; |
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the timing of commencement and completion of clinical trials; |
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the Company’s intention to seek regulatory approvals in the United States and Europe for voclosporin; |
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the Company’s intention to seek additional corporate alliances and collaborative agreements to support the commercialization and development of its product; |
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the Company’s intention to demonstrate that voclosporin possesses pharmacologic properties with the potential to demonstrate best-in-class differentiation with first-in-class status for the treatment of LN
(“lupus nephritis”) outside of Japan; |
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the Company’s intention to use the LN Phase 2b clinical trial program to gain a clearer understanding of voclosporin’s time to onset of action in patients suffering from LN; |
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the Company’s belief that recent granted formulation patents regarding the delivery of voclosporin to the ocular surface for conditions such as dry eye have the potential to be of therapeutic value;
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the Company’s belief that voclosporin has further potential to be of therapeutic value in other autoimmune indications and in the prevention of transplant rejection; |
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the Company’s intention to seek regulatory approval in other jurisdictions in the future and initiate clinical studies; |
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the Company’s anticipated future financial position, future revenues and projected costs; and |
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Plans and objectives of management. |
Such statements reflect the Company’s current views with respect to
future events and are subject to risks and uncertainties and are necessarily based on a number of estimates and assumptions that, while considered reasonable by the Company, as at the date of such
statements, are inherently subject to significant business, economic, competitive, political, scientific and social uncertainties and contingencies, many of which, with respect to future events,
are subject to change. The factors and assumptions used by the Company to develop such forward-looking statements include, but are not limited to: the assumption that the Company will be able to reach agreements with regulatory agencies on
executable development programs; the assumption that recruitment to clinical trials will occur as projected; the assumption that the Company will successfully complete its clinical programs on a timely basis, including the Phase 2b LN clinical trial
currently in progress, to enable the Company to proceed to conduct the required Phase 3 LN clinical trials and meet regulatory requirements for approval of marketing authorization applications and new drug approvals; the assumption the regulatory
requirements will be maintained; the assumption that the Company will be able to manufacture and secure a sufficient supply of voclosporin to successfully complete the development and commercialization of voclosporin; the assumption that the
Company’s patent portfolio is sufficient and valid; the assumption that there is a potential commercial value for other indications for voclosporin; the assumption that market data and reports reviewed by the Company are accurate; the
assumptions relating to the availability of capital on terms that are favourable to the Company; the assumption that the Company will be able to attract and retain skilled staff; the assumption that general business and economic conditions will be
maintained, and the assumptions relating to the feasibility of future clinical trials.
It is important to know that:
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Actual results could be materially different from what the Company expects if known or unknown risks affect its business, or if the Company’s estimates or assumptions turn out to be inaccurate. As a result, the
Company cannot guarantee that any forward-looking statement will materialize and, accordingly, you are cautioned not to place undue reliance on these forward-looking statements. |
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Forward-looking statements do not take into account the effect that transactions or non-recurring or other special items announced or occurring after the statements are made may have on the Company’s business. For
example, they do not include the effect of mergers, acquisitions, other business combinations or transactions, dispositions, sales of assets, asset write-downs or other charges announced or occurring after the forward-looking statements are made.
The financial impact of such transactions and non-recurring and other special items can be complex and necessarily depends on the facts particular to each of them. Accordingly, the expected impact cannot be meaningfully described in the abstract or
presented in the same manner as known risks affecting the Company’s business. |
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The Company disclaims any intention and assumes no obligation to update any forward-looking statements even if new information becomes available, as a result of future events, new information, or for any other reason
except as required by law. |
Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause
the Company’s actual results, performance, or achievements to differ materially from any further results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause such differences
include, among other things, the following:
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the need for additional capital in the longer term to fund the Company’s development programs and the effect of capital market conditions and other factors on capital availability; |
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difficulties, delays, or failures the Company may experience in the conduct of and reporting of results of its clinical trials for voclosporin, and in particular its current LN Phase 2b clinical trial;
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difficulties, delays or failures in obtaining regulatory approvals for the initiation of clinical trials; |
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difficulties, delays or failures in obtaining regulatory approvals to market voclosporin; |
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difficulties the Company may experience in completing the development and commercialization of voclosporin; |
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insufficient acceptance of and demand for voclosporin; |
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difficulties, delays, or failures in obtaining appropriate reimbursement of voclosporin |
Although the Company
believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, levels of activity, performance or achievements. These forward-looking statements are made as of the date hereof
and the Company disclaims any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For additional information on risks and uncertainties please see the “Risks and Uncertainties” section of this MD&A. Although the Company
believes that the expectations reflected in such forward-looking statements and information are reasonable, undue reliance should not be placed on forward-looking statements or information because the Company can give no assurance that such
expectations will prove to be correct.
Additional information related to Aurinia, including its most recent Annual Information Form, is available
by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR”) website at www.sedar.com or the U.S. Securities and Exchange Commission’s (“SEC”) Electronic
Document Gathering and Retrieval System (“EDGAR”) website at www.sec.gov/edgar.
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OVERVIEW
THE COMPANY
Corporate Structure
Name, Address and Incorporation
Aurinia
Pharmaceuticals Inc. or the “Company” is a biopharmaceutical company with its head office located at #1203-4464 Markham Street, Victoria, British Columbia V8Z 7X8 where clinical, regulatory and business development functions of the Company
are conducted. The Company has its registered office located at #201, 17904-105 Avenue, Edmonton, Alberta T5S 2H5 where the finance function is performed. The office of the Chief Executive Officer is located in Bellevue, Washington.
Aurinia Pharmaceuticals Inc. is organized under the Business Corporations Act (Alberta). The Company’s Common Shares are currently listed and
traded on the NASDAQ Global Market (“NASDAQ”) under the symbol “AUPH” and on the Toronto Stock Exchange (“TSX”) under the symbol “AUP”. The Company’s primary business is the development of a therapeutic
drug to treat autoimmune diseases, in particular lupus nephritis.
The Company has the following wholly-owned subsidiaries: Aurinia Pharma Corp., Aurinia
Pharmaceuticals, Inc. (Delaware incorporated) and Aurinia Pharma Limited (UK incorporated).
Summary Description of Business
Aurinia is focused on the development of its novel therapeutic immunomodulating drug candidate, voclosporin, which is a next generation calcineurin inhibitor
(“CNI”). It has been studied in kidney rejection following transplantation, psoriasis and in various forms of uveitis (an ophthalmic disease).
The Company has, since September 20, 2013, rebranded, restructured and refocused itself around a strategy that focuses on the development of voclosporin
for the treatment of lupus nephritis (“LN”). The mechanism of action of voclosporin, a CNI, has been validated with certain first generation CNIs for the prevention of rejection in patients undergoing solid organ transplants and in several
autoimmune indications, including dermatitis, keratoconjunctivitis sicca (Dry Eye Syndrome), psoriasis, rheumatoid arthritis, and for LN in Japan. The Company believes that voclosporin possesses pharmacologic properties with the potential to
demonstrate best-in-class differentiation with first-in-class regulatory approval status for the treatment of LN outside of Japan.
The Company will also
continue to evaluate opportunities for other indications of voclosporin to create shareholder value.
LN Clinical development program
In June, 2014 AURINIA announced the initiation of its global 258 patient LN Phase 2b clinical trial to evaluate the safety and efficacy of voclosporin as a
treatment for LN. LN is an inflammation of the kidney that if untreated or inadequately treated can lead to end-stage renal disease and the requirement for life-long dialysis, or even death.
The LN Phase 2b clinical trial, called “AURA–LV” (Aurinia Urine protein Reduction in Active Lupus with Voclosporin) or AURA, is being
conducted in 20 countries and is a randomized, controlled, double-blind study comparing the efficacy of voclosporin against placebo in achieving remission in patients with active LN. The AURA-LV study is designed to demonstrate that voclosporin can
induce a rapid and sustained reduction of proteinuria in the presence of extremely low steroid exposure and fulfill specific regulatory requests. It will compare two dosage groups of voclosporin (23.7mg and 39.5mg) administered with mycophenolate
mofetil (MMF) vs. MMF alone. All patients will also receive oral corticosteroids as background therapy. There will be a primary analysis to determine complete remission at week 24 and various secondary analyses at week 48 which include biomarkers
and markers of non-renal SLE.
The Company’s AURA-LV study continues to progress with activities in the third quarter of 2015 focused on recruitment,
enrollment and treatment of patients with lupus nephritis (LN). Over 90 sites have been set up in 20 countries worldwide. The completion of patient enrollment is forecast to occur around the end of 2015. Un-blinding and disclosure of the primary
trial data is scheduled within one month of the last enrolled patient completing 24 weeks of active treatment.
In support of this large, randomized, LN
Phase 2b clinical trial, the Company announced on February 9, 2015 the initiation of an open label, exploratory study to assess short term predictors of response using voclosporin in combination with MMF, in patients with active LN. The
“AURION” (Aurinia early Urinary protein Reduction Predicts Response) study being conducted at multiple sites in Malaysia will examine biomarkers of disease activity at 8 weeks and their ability to predict response at 24 and 48
weeks. The Company continues to recruit patients into its AURION study with enrollment of this small pilot study now expected to be completed by the end of the fourth quarter of 2015 from the previously reported date of September 30, 2015 as
patient enrollment has been slower than originally forecast.
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The results from the AURION study will contribute to the growing base of clinical data being generated by the
company utilizing voclosporin for the treatment of LN. The AURION study should provide a more clear understanding of voclosporin’s time to onset of action in patients suffering from LN.
STRATEGY
The Company’s business
strategy is to optimize the clinical and commercial value of voclosporin, its late stage clinical candidate. In particular, the Company is focused on the development of voclosporin as an add-on therapy to the current standard of care, CellCept®, which was developed by the Aurinia Pharma Corp. management team during its tenure at Aspreva Pharmaceuticals Inc.
The key elements of the Company’s corporate strategy include:
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Focusing the Company’s resources on advancing voclosporin through a robust LN Phase 2b clinical trial. |
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Mitigate development risk by leveraging the ALMS database and management team’s experience – The Company has certain rights to utilize the ALMS database including its use in planning, designing and informing
the LN Phase 2b clinical trial. |
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Upon successful completion of the Phase 2b trial, plan to initiate the required Phase 3 clinical program for LN. |
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Evaluate other voclosporin indications – While the Company intends to deploy its operational and financial resources to develop voclosporin for LN, the Company believes that recent granted formulation patents
regarding the delivery of voclosporin to the ocular surface for conditions such as dry eye have the potential to be of therapeutic value. The Company will explore its strategic options to exploit shareholder value from this intellectual property.
The Company also believes that voclosporin has further potential to be of therapeutic value in other autoimmune indications and in the prevention of transplant rejection. Management will consider strategic opportunities for these other potential
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Consider other business development opportunities including potentially in-licensing other suitable clinical compounds that would be a strategic fit for the Company under the right circumstances and timing.
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Status of the Company’s Development Program in LN
The Company’s clinical strategy involves layering voclosporin on top of the current standard of care
(CellCept®/MMF and steroids) as a multi-targeted therapeutic (“MTT”) approach to induce and maintain remission in patients suffering from active LN. In 2012, the Company gained
alignment with both the Cardio-Renal and Pulmonary, Allergy, and Rheumatology Products divisions of the FDA on its proposed Phase 2b protocol. The Company has an active Investigational New Drug (“IND”) application with the FDA and is
currently recruiting patients into its robust Phase 2b LN clinical trial.
With the existing evidence that supports the utility of CNIs in combination
with MMF in treating LN, the robust safety data base of voclosporin generated in other disease states and the fact that CellCept®/MMF in combination with the other CNIs is the standard of care
in solid organ transplant patients, it is reasonable to consider that voclosporin is a risk-mitigated clinical asset for the treatment of LN.
About
Lupus Nephritis
The Lupus Foundation of America (“LFA”) estimates that approximately 1.5 million people in the United States of America
and up to 5.0 million people worldwide suffer from systemic lupus erythematosus (“SLE”). Approximately 90% of patients suffering from SLE are women of child-bearing age. The disease causes severe impairments on quality of life and
wellbeing. Of the patients suffering from SLE, 40-60% experience renal manifestations of the disease resulting in inflammation of the kidney. These patients are considered to have LN and have a high probability of advancing to end stage renal
disease and dialysis if left untreated.
Based on the work performed by the former Aspreva team, the ALMS data has been reported in several respected
journals, including, the New England Journal of Medicine (Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Solomons, N et al; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med.
2011 Nov 17;365(20):1886-95) and the Journal of the American Society of Nephrology (Appel GB, Contreras G, Dooley MA, Ginzler EM, Isenberg D, Jayne D, Solomons N et al; Aspreva Lupus Management Study Group. Mycophenolate mofetil versus
cyclophosphamide for induction treatment of lupus nephritis. J Am Soc Nephrol. 2009 May;20(5):1103-12. Epub 2009 Apr 15.) These publications and subsequent alterations in treatment strategies by physicians caring for patients suffering from LN
have established CellCept®/MMF as the standard of care for the treatment of LN. This shift in the treatment paradigm for LN and the establishment of CellCept® use as a relatively uniform treatment approach for these patients has, in the view of the Company, caused the LN market to evolve into an attractive and mature market opportunity.
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Despite CellCept® being the current standard of care for
the treatment of LN, it remains far from adequate with fewer than 20% of patients on therapy actually achieving disease remission after six months of therapy. Data suggests that a LN patient who does not achieve rapid disease remission upon
treatment is more likely to experience renal failure or require dialysis at 10 years (Chen YE, Korbet SM, Katz RS, Schwartz MM, Lewis EJ; the Collaborative Study Group. Value of a complete or partial remission in severe lupus nephritis. Clin J Am
Soc Nephrol. 2008;3:46-53.). Therefore, it is critically important to achieve disease remission as quickly and as effectively as possible. The data suggests that the majority of patients in the United States suffering from lupus will not achieve
complete remission and are not adequately treated (BioTrends® Research Group In., ChartTrends® SLE, December 2010).
CNIs and Lupus Nephritis
Aurinia’s lead drug,
voclosporin, belongs to a class of drugs called CNIs. There are only two other oral marketed CNIs available, cyclosporine and tacrolimus. Cyclosporine was introduced to the marketplace in the early 1980s while tacrolimus was first marketed in the
mid-1990s. Both cyclosporine and tacrolimus have lost key patent protection and have not been approved for the treatment of LN outside of Japan. For the past 20 years these products, in combination with CellCept®/MMF and steroids have been the cornerstone for the prevention of renal transplant rejection with greater than 90% of all renal transplant patients leaving hospital on lifelong CNI plus MMF
therapy (UNOS database).
In late 2008, the Japanese Health Authority became the first major jurisdiction in 50 years to approve a pharmaceutical agent
for the treatment of LN. This product was the calcineurin inhibitor tacrolimus. In addition to this approval, a substantial amount of recent data has been generated, primarily from investigator initiated trials that supports the use of either
cyclosporine or tacrolimus for the treatment of various forms of lupus including LN. The addition of tacrolimus, layered on top of MMF and steroids akin to the widely accepted and utilized transplantation regimen, appears to dramatically improve
complete response/remission rates in LN (Bao H, Liu ZH, Xie HL, Hu WX, Zhang HT, Li LS. Successful treatment of class V+IV lupus nephritis with multitarget therapy. J Am Soc Nephrol. 2008 Oct;19(10):2001-10. Epub 2008 Jul 2 and .Liu , Zhi-Hong et
al., 2012 ASN Abstract SA-OR097). This approach to treatment can be considered a MTT approach to treating LN as is routinely used in transplantation. Complete remission rates of up to 50% have been reported utilizing this approach. Long term
follow-up studies in LN suggest that the early reduction in proteinuria as seen in complete remission leads to improved renal outcome at ten years. (Houssiau FA, Vasconcelos C, D’Cruz D, Sebastiani GD, de Ramon Garrido E, Danieli MG, et al.
Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis. Lessons from long-term followup of patients in the Euro-lupus nephritis trial. Arthritis Rheum. 2004 Dec;50(12):3934-40).
The Company plans to utilize this MTT approach to treating LN patients with voclosporin.
About voclosporin
Voclosporin is an oral drug,
administered twice daily. It is structurally similar to cyclosporine A (“CsA”), but is chemically modified on the amino acid-1 residue. This modification leads to a number of advantages the Company believes offer relevant clinical benefits
as compared to the older off-patent CNIs.
Voclosporin mechanism of action
Voclosporin reversibly inhibits immunocompetent lymphocytes, particularly T-Lymphocytes in the G0 and G1 phase of the cell-cycle, and also reversibly inhibits
the production and release of lymphokines. Through a number of processes voclosporin inhibits and prevents the activation of various transcription factors necessary for the induction of cytokine genes during T-cell activation. It is believed that
the inhibition of activation of T-cells will have a positive modulatory effect in the treatment of LN. In addition to these immunologic impacts recent data suggests that CNIs have another subtle but important impact on the structural integrity of
the podocytes (Faul C, et al. The actin cytoskeleton of kidney podocytes is a direct target of the antiproteinuric effect of cyclosporine A. Nat Med. 2008 Sep;14(9):931-8. doi: 10.1038/nm.1857). This data suggests that inhibition of
calcineurin in patients with autoimmune kidney diseases helps stabilize the cellular actin-cytoskeleton of the podocytes thus having a structural impact on the podocyte and the subsequent leakage of protein into the urine, which is a key marker of
patients suffering from LN.
Potential voclosporin clinical benefits
The Company believes that voclosporin has shown a number of key clinical benefits over the existing commercially available CNIs (tacrolimus &
cyclosporine). Firstly, CNI assay results have indicated that voclosporin is approximately four times more potent than its parent molecule cyclosporine, which would indicate an ability to give less drug and produce fewer potentially harmful
metabolites. Secondly, cyclosporine inhibits the enterohepatic recirculation of mycophenolic acid (“MPA”), the active
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metabolite of MMF. The net effect of co-administration of CsA with MMF is reduced MPA systemic exposure by as much as 50% (D. Cattaneo et al. American Journal of Transplantation,
2005:12(5);2937-2944.). This drug interaction has not been observed with voclosporin and it is not expected that MPA blood exposure levels will be reduced with voclosporin co-administration. This is an extremely important fact to consider as
most patients being treated with voclosporin for LN will already be taking MMF. Furthermore, pharmacokinetic and pharmacodynamics (“PK-PD”) analysis indicate lower PK-PD variability for voclosporin versus tacrolimus or cyclosporine, to the
extent that the Company believes flat-dosing can be achieved for voclosporin. The currently available CNIs require extensive therapeutic drug monitoring which can often be costly, confusing and time consuming for treating physicians.
In a head-to-head study comparing voclosporin against cyclosporine in the treatment of psoriasis, cyclosporine was shown to cause significant increases in
lipid levels as compared to voclosporin. The difference was statistically significant. This is important considering the fact that most lupus patients die of cardiovascular disease. In another study comparing voclosporin against tacrolimus in
patients undergoing renal transplantation, the voclosporin group experienced a statistically significantly lower incidence of glucose intolerance and diabetes than tacrolimus treated patients. Additionally, in the Japanese tacrolimus study that led
to the approval of this drug in Japan, almost 15% of tacrolimus patients experienced glucose intolerance (Miyasaka N, Kawai S, Hashimoto H. Efficacy and safety of tacrolimus for lupus nephritis: a placebo-controlled double-blind multicenter
study. Mod Rheumatol. 2009;19(6):606-15. Epub 2009 Aug 18). This is a major limitation for physicians wanting to use this agent in lupus and is a well described side effect of tacrolimus.
The Company believes that voclosporin can be differentiated from the older CNIs and thus possess a unique position with the market.
Scientific Rationale for Treatment of LN with voclosporin
SLE including LN is a heterogeneous autoimmune disease with often multiple organ and immune system involvement. T-cell mediated immune response is an important
feature of the pathogenesis of LN while the podocyte injury that occurs in conjunction with the ongoing immune insult in the kidney is an important factor in the clinical presentation of the disease.
The use of voclosporin in combination with the current standard of care for the treatment of LN provides a multi-targeted approach to treating this
heterogenous disease (similar to the standard approach in preventing kidney transplant rejection). Voclosporin has shown to have potent effects on T-cell activation leading to its immunomodulatory effects. Additionally, recent evidence suggests that
inhibition of calcineurin has direct physical impacts on the podocytes within the kidney. Inhibition of calcineurin within the podocytes can prevent the dephosphorylation of synaptopodin which in turn inhibits the degradation of the actin
cytoskeletion within the podocyte. This process is expected to have a direct impact on the levels of protein in the urine which is a key marker of LN disease activity.
REVISION OF PRIOR PERIOD COMPARATIVES FOR
CORRECTION OF ACCOUNTING FOR WARRANTS
As described in note 6 to the
unaudited interim consolidated condensed financial statements for the third quarter ended September 30, 2015, the Offering completed by the Company on February 14, 2014, resulted in the issuance of 4.73 million warrants, exercisable
for a period of five years from the date of issuance at an exercise price of $3.22 per warrant. The holders of the warrants may elect, in lieu of exercising the warrants for cash, a cashless exercise option to receive common shares equal to the fair
value of the warrants based on the number of warrants to be exercised multiplied by a five day weighted average market price less the exercise price, with the difference divided by the weighted average market price. If a warrant holder exercises
this option, there will be variability in the number of shares issued per warrant.
A review of the application of IFRS to these previously issued
warrants has resulted in a revision of prior period comparatives for restatement of the Company’s previous accounting for the warrants.
In
accordance with IFRS, a contract to issue a variable number of shares fails to meet the definition of equity and must instead be classified as a derivative liability and measured at fair value with changes in fair value recognized in the statement
of operations and comprehensive loss at each period end. The derivative liability will ultimately be converted to the Company’s equity (common shares) when the warrants are exercised, or will be extinguished upon the expiry of the outstanding
warrants, and will not result in the outlay of any cash by the Company.
In the original accounting determination, the estimated fair value of the
warrants was recorded in equity at $10.42 million, offset by an allocation of issuance costs of $739,000. At initial recognition the Company should have recorded the estimated fair value of the warrants as a liability at $9.11 million, with
allocated issuance costs of $646,000 recognized as other expense. In addition, at March 31, 2014, based on the trading price of the Company’s shares at that time, the Company should have adjusted the estimated fair value of the derivative
warrant liability to $8.04 million, resulting in a gain on revaluation of derivative warrant liability in the statement of comprehensive loss for the three months ended March 31, 2014 of $1.06 million. At June 30, 2014, based on the
trading price of the Company’s shares at that time, the Company should have adjusted the estimated fair value of the
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derivative warrant liability to $15.06 million, resulting in a loss on revaluation of derivative warrant liability of $7.02 million in the statement of comprehensive loss for the three months
ended June 30, 2014. At September 30, 2014, based on the trading price of the Company’s shares at that time, the Company should have adjusted the estimated fair value of the derivative warrant liability to $9.79 million, resulting in
a gain on revaluation of derivative warrant liability of $5.27 million in the statement of comprehensive loss for the three months ended September 30, 2014.
There was no impact on cash from operating, financing or investing activities.
Detailed analysis of the impact resulting from the correction of accounting for these warrants for the three and nine month comparative periods ending
September 30, 2014 is provided in note 2 to the unaudited interim consolidated condensed financial statements for the third quarter ended September 30, 2015.
RECENT DEVELOPMENT
The Company received
a final receipt from the British Columbia Securities Commission on October 19, 2015 for the Short Form Base Shelf Prospectus (the “Shelf Prospectus”) of Aurinia dated October 16, 2015. The Company had previously filed on
September 17, 2015 the preliminary short form base shelf prospectus with the securities commissions in each of the provinces of Ontario, Alberta and British Columbia in Canada, and a corresponding shelf registration statement on Form F-10 with
the U.S. Securities and Exchange Commission (the “SEC”) under the U.S./Canada Multijurisdictional Disclosure System.
The Shelf Prospectus and
corresponding shelf registration statement allows Aurinia to offer up to US$250 million of common shares, warrants and subscription receipts or any combination thereof during the 25-month period that the Shelf Prospectus is effective. The Shelf
Prospectus is intended to give Aurinia the capability to access new capital from time to time. The amount and timing of any future offerings will be based on the Company’s financial requirements and market conditions at the time. The Company
has no immediate intention to undertake an offering.
The specific terms of any future offering under the Shelf Prospectus will be established at the time
of such offering. At the time any of the securities covered by the Shelf Prospectus are offered for sale, a prospectus supplement containing specific information about the terms of such offering will be filed with applicable Canadian securities
regulatory authorities and the SEC.
RESULTS OF OPERATIONS
For the third quarter ended September 30, 2015, the Company reported a consolidated net loss of $5.21 million or $0.16 loss per common share, as compared
to a restated consolidated net income of $2.75 million or $0.08 income (fully diluted basis) per common share for the same period in 2014.
The change was
primarily attributable to an increase of $2.24 million in Phase 2b LN clinical trial costs and a decrease of $4.11 million in the non-cash gain on the quarterly fair value revaluation of the derivative warrant liability for the three months ended
September 30, 2015 compared to the same period in 2014. In addition the 2014 net income reflected a gain on extinguishment of a liability of $1.75 million associated with other contingent warrants. There was no similar item in 2015.
For the nine months ended September 30, 2015, the consolidated net loss was $14.54 million or $0.45 loss per common share compared to a consolidated net
loss of $13.06 million or $0.46 loss per common share for the comparable period in 2014.
After adjusting for the non-cash impact of the revaluation of
the warrant liability, the net losses from operations for the three and nine month periods ended September 30, 2015 were $6.37 million and $18.18 million respectively compared to $2.52 million and $11.73 million for the same periods in 2014.
The Company recorded higher research and development costs for the three and nine month periods ended September 30, 2015 compared to the same
periods in 2014 for the Phase 2b LN clinical trial program as discussed in the “Research and Development expenses” section below.
Revenue
and deferred revenue
The Company recorded revenues of $57,000 and $178,000 respectively for the three and nine month periods ended September 30,
2015 compared to $72,000 and $210,000 for the comparable periods in 2014.
The remaining deferred revenue related to the 3SBio Inc. and Paladin Labs Inc.
fee payments is being amortized on a straight line basis which approximates how the Company expects to incur patent annuity costs for certain specified countries related to meeting its obligations under the terms of the applicable agreements.
7
Research and Development expenses
Net research and development expenditures increased to $4.67 million and $12.33 million respectively for the three and nine month periods ended
September 30, 2015 compared to $2.43 million and $6.02 million respectively for the three and nine month periods ended September 30, 2014. The increase in expenditures reflect higher costs related to drug distribution, patient recruitment,
enrollment and treatment activities for the LN Phase 2b clinical trial as the number of patients in the trial increases.
CRO and other third party
clinical trial costs were $3.67 million and $8.74 million respectively for the three and nine month periods ended September 30, 2015 compared to $1.75 million and $4.25 million respectively for the three and nine month periods ended
September 30, 2014. The Company incurred drug supply costs, primarily for drug packaging, stability and distribution, of $393,000 and $1.37 million respectively for the three and nine month periods ended September 30, 2015 compared to
$343,000 and $673,000 respectively for the three and nine month periods ended September 30, 2014.
Salaries, annual incentive pay and employee
benefits were $297,000 and $907,000 respectively for the three and nine month periods ended September 30, 2015 compared to $209,000 and $677,000 respectively for the three and nine month periods ended September 30, 2014. The Company
incurred higher salaries and benefits in 2015 due to the hiring of five additional employees over the last year and executive and staff salary increases. The effect of the salary increases were partially offset by lower costs for its Canadian
employees in 2015 due to the foreign exchange effect of a lower Canadian dollar relative to the U.S. dollar.
The Company recorded non-cash stock
compensation expense of $140,000 and $773,000 respectively for the three and nine month periods ended September 30, 2015, (2014 - $Nil and $Nil) related to stock options granted to R&D personnel on January 6, 2015, April 7,
2015 and August 17, 2015.
Travel expenses related to research and development were $71,000 and $196,000 respectively for the three and nine month
periods ended September 30, 2015 compared to $22,000 and $144,000 respectively for the three and nine month periods ended September 30, 2014.
Patent annuity and other fees expensed were $79,000 and $231,000 respectively for the three and nine month periods ended September 30, 2015 compared to
$89,000 and $253,000 respectively for the three and nine month periods ended September 30, 2014.
Corporate, administration and business
development expenses
Corporate, administration and business development expenses were $1.38 million and $4.70 million respectively for the three and
nine month periods ended September 30, 2015 compared to $1.40 million and $5.49 million respectively for the three and nine months period ended September 30, 2014. Corporate, administration and business development expenses included
non-cash stock-based compensation expense of $539,000 and $1.96 million respectively for the three and nine month periods ended September 30, 2015 compared to $286,000 and $1.77 million respectively for the three and nine month periods ended
September 30, 2014. The stock-based compensation expense in 2015 resulted primarily from the grant of options to Board directors and corporate, administration and business development personnel on January 6, 2015, April 7,
2015, June 2, 2015 and August 17, 2015 whereas the 2014 comparable expense related to stock options granted to the Chief Executive Officer and the Board of Directors on February 18, 2014.
Other significant expenses were as follows:
Salaries,
incentive pay accruals and employee benefits were $376,000 and $1.10 million respectively for the three and nine month periods ended September 30, 2015 compared to $460,000 and $1.44 million respectively for the three and nine month periods
ended September 30, 2014. The decrease for the nine months ended September 30, 2015 from the comparable period in 2014 was the result of lower incentive pay to corporate and administration personnel in 2015.
Trustee fees, filing fees and other public company costs were $131,000 and $371,000 respectively for the three and nine month periods ended September 30,
2015 compared to $199,000 and $642,000 respectively for the three and nine month periods September 30, 2014. Costs for the three months ended September 30, 2015 included the costs of filing the Base Shelf Prospectus whereas the comparable
period in 2014 included the costs for filing and obtaining the NASDAQ Listing. The comparable period for the nine months ended September 30, 2014 also included costs of $184,000 to obtain a TSX listing.
Professional and consulting fees were $84,000 and $482,000 respectively for the three month and nine month periods ended September 30, 2015 compared to
$221,000 and $742,000 respectively for the three and nine month periods ended September 30, 2014. This decrease reflected lower legal fees, audit fees and other advisory fees in 2015 compared to 2014.
Director fees were $74,000 and $239,000 respectively for the three and nine month periods ended September 30, 2015 compared to $86,000 and $341,000
respectively for the three and nine months periods ended September 30, 2014. The decreased in director fees in 2015 reflected reduced compensation levels and a reduction in the number of Board members.
8
Travel and promotion expenses related to corporate, administration and business development were $47,000 and
$187,000 respectively for the three and nine month periods ended September 30, 2015 compared to $43,000 and $192,000 respectively for the three and nine month periods ended September 30, 2014.
Stock-based compensation expense
For stock option plan
information and outstanding stock option details refer to note 7 of the interim condensed consolidated financial statements for the three and nine months ended September 30, 2015.
In the third quarter ended September 30, 2015, the Company, on August 17, 2015 granted 323,000 stock options to certain officers and a new employee
of the Company at a price of $3.40 (CDN$4.45). The options are exercisable for a term of five years and vest in equal amounts per month commencing September 17, 2015 and continuing up to and including August 17, 2016.
The Company had previously granted stock option as follows:
On
January 6, 2015, the Company granted 960,000 stock options to officers, directors, and employees of the Company at a price of $3.59 (CDN$4.25) per common share. On April 7, 2015, the Company granted 48,000 stock options to employees of the
Company at a price of $4.15 (CDN$5.19). On June 2, 2015, the Company granted 60,000 stock options to directors of the Company at a price of $3.47 (CDN$4.31). All of these options are exercisable for a term of five years and vest in equal
amounts per month over twelve months.
On February 18, 2014, the Company granted 1,192,200 stock options to certain directors and officers of the
Company at a price of $3.19 (CDN$3.50) per common share. The options are exercisable for a term of ten years and vest over specific time periods with the exception of 50,000 options which vested in 2014 upon the Company achieving a specific
milestone.
Application of the fair value method resulted in charges to stock-based compensation expense of $679,000 and $2.74 million respectively for
the three and nine month periods ended September 30, 2015 (2014 – $286,000 and $2.02 million) with corresponding credits to contributed surplus. For the three and nine month periods ended September 30, 2015, stock-based compensation
expense has been allocated to research and development expense in the amounts of $140,000 and $773,000 respectively (2014 – $Nil and $Nil) corporate and administration expense in the amount of $539,000 and $1.96 million respectively (2014
– $286,000 and $1.77 million); and restructuring costs in the amount of $Nil and $Nil respectively (2014 – $Nil and $253,000).
Amortization
of intangible assets
Amortization of intangible assets was $429,000 and $1.18 million respectively for the three and nine month periods ended
September 30, 2015 compared to $359,000 and $1.08 million recorded in same periods in 2014.
Restructuring costs
Restructuring costs were $Nil and $Nil for the three and nine month periods ended September 30, 2015 compared to $60,000 and $1.03 million respectively
for the three and nine month periods ended September 30, 2014.
The 2014 comparable restructuring costs incurred was primarily for an adjustment to
the estimated provision for loss on the Edmonton sublease agreement during the quarter.
On February 14, 2014 the Company signed a NICAMs Purchase
and Sale Agreement with Ciclofilin Pharmaceuticals Corp. (“Ciclofilin”), a company controlled by the former Chief Executive Officer and Chief Scientific Officer, whereby it divested its early stage research and development
Non-Immunosuppressive Cyclosporine Analogue Molecules (“NICAMs”) assets, consisting of intellectual property, including patent applications and know-how to Ciclofilin. There was no upfront consideration received by the Company and future
consideration will consist of milestones relating to the clinical and marketing success of NICAMs and a royalty. Due to NICAMs early stage of development, the Company estimated the fair value of the consideration to be $nil at the time of the
disposition and as at September 30, 2015. In the first quarter of 2014, the Company recorded $216,000 of restructuring costs related to the NICAMs. These restructuring costs consisted of severances of $115,000 paid to the three employees
working on the NICAMs and $101,000 of other NICAMs related expenses, including wage and patent costs incurred from January 1, 2014 to the divestiture date and stock compensation expense of $253,000 for stock options granted in February, 2014 to
the former Chief Executive Officer pursuant to his termination agreement.
9
Other expense (income)
The Company recorded other income of $55,000 and other expense of $126,000 respectively for the three and nine month periods ended September 30, 2015
compared to other income of $1.69 million and $1.75 million respectively for the three and nine month periods ended September 30, 2014.
Other
expense (income) included the following items:
A foreign exchange gain of $69,000 and $132,000 respectively for the three and nine months period ended
September 30, 2015. The Company had recorded a foreign exchange gain of $27,000 and a loss of $164,000 respectively for the three and nine months period ended September 30, 2014.
Revaluation expense adjustments on long term contingent consideration to ILJIN of $25,000 and $298,000 respectively for the three and nine month periods ended
September 30, 2015 compared to $105,000 and $743,000 respectively for the three and nine month periods ended September 30, 2014.
Other expense
(income) for the three month period ended September 30, 2014 reflected a gain on extinguishment of warrant liability of $1.75 million. There was no similar item in 2015.
The nine month 2014 comparable figure also included a gain on re-measurement of warrant liability of $646,000 and $203,000 of share issue costs allocated on a
pro-rata basis to the warrant liability arising from the February 14, 2014 private placement. There were no similar items in 2015.
Gain (loss) on
derivative warrant liability
The Company recorded non-cash gains on the derivative warrant liability of $1.16 million and $3.64 million respectively
for the three and nine month periods ended September 30, 2015 compared to non-cash gain on the derivative warrant lability of $5.27 million and loss of $1.33 million respectively for the three and nine month periods ended September 30,
2014. These revaluations fluctuate based primarily on the market price of the Company’s common shares. The derivative warrant liability is more fully discussed in the sections “Revision of prior period comparatives for correction of
accounting for warrants” and “Critical estimates in applying the Company’s accounting policies”.
LIQUIDITY AND CAPITAL RESOURCES
The
Company is in the development stage and is devoting substantially all of its financial and operational resources and efforts towards the development activities for its drug, voclosporin. The recoverability of amounts expended on research and
development to date, including capitalized intellectual property, is dependent on the ability of the Company to complete the required development activities.
Sources and Uses of Cash for the three and nine month periods ended September 30, 2015 and September 30, 2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Sources and Uses of Cash
(in thousands of dollars) |
|
Three months ended September 30 |
|
|
Nine months ended September 30 |
|
| |
2015 |
|
|
2014 |
|
|
Increase
(Decrease) |
|
|
2015 |
|
|
2014 |
|
|
Increase
(Decrease) |
|
| |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
| Cash used in operating activities |
|
|
(5,198 |
) |
|
|
(4,024 |
) |
|
|
(1,174 |
) |
|
|
(12,928 |
) |
|
|
(13,560 |
) |
|
|
632 |
|
| Cash provided by (used in) investing activities |
|
|
8 |
|
|
|
(10,013 |
) |
|
|
10,021 |
|
|
|
(23 |
) |
|
|
(10,060 |
) |
|
|
10,037 |
|
| Cash provided by financing activities |
|
|
56 |
|
|
|
477 |
|
|
|
(421 |
) |
|
|
839 |
|
|
|
47,348 |
|
|
|
(46,509 |
) |
| Effect of foreign exchange rate on cash and cash equivalents |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(16 |
) |
|
|
16 |
|
| Net increase (decrease) in cash and cash equivalents |
|
|
(5,134 |
) |
|
|
(13,560 |
) |
|
|
8,426 |
|
|
|
(12,112 |
) |
|
|
23,712 |
|
|
|
(35,824 |
) |
At September 30, 2015, the Company had a total of $20.58 million in cash, term deposits and a bank discount note,
recorded as a short term investment, compared to $25.74 million at June 30, 2015 and $32.70 million at December 31, 2014.
10
Net cash used in operating activities for the three and nine month periods ended September 30, 2015, was
$5.20 million and $12.92 million respectively compared to cash used in operating activities of $4.02 million and $13.56 million respectively for the three and nine month periods ended September 30, 2014. Cash used in operating activities in
2015 and 2014 was composed of net loss, add-backs or adjustments not involving cash and net change in non-cash working items, which in the first nine months of 2014 included repayment of the drug supply loan in the amount of $1.20 million.
Cash provided by investing activities for the three month period ended September 30, 2015, was $8,000 compared to cash used in investing activities of
$10.01 million for the three month period ended September 30, 2014. The Company purchased a bank discount note for $9.99 million in 2014 that was required to be reflected as a short term investment and as an investing activity.
Cash provided by financing activities for the three and nine month periods ended September 30, 2015, was $56,000 and $839,000 respectively compared to
cash generated by financing activities of $477,000 and $47.35 million for the three and nine month periods ended September 30, 2014. The Company received $Nil and $685,000 for the exercise of warrants for the three and nine month periods ended
September 30, 2015 respectively. The Company also received $56,000 and $154,000 from the exercise of stock options for the three and nine month periods ended September 30, 2015 respectively. On February 14, 2014, the Company received
net proceeds of $48.31 million from the private placement equity financing and in turn paid out the financing milestone to ILJIN (contingent consideration) of $1.6 million in the same period. The Company also received $477,000 and $641,000 for the
exercise of warrants for the three and nine month periods ended September 30, 2014 respectively.
Use of Proceeds
On February 14, 2014, the Company completed a private placement with net proceeds of $48.31 million, the net proceeds of which were to be used to advance
the clinical and non-clinical development of its lead drug voclosporin, as a therapy for LN, and for general corporate purposes. A summary of the anticipated and actual use of proceeds up to and including September 30, 2015 from that financing
are set out below (other than working capital):
|
|
|
|
|
|
|
|
|
| |
|
Expected use of proceeds for
period to September 30, 2015 |
|
|
Incurred for period to
September 30, 2015 |
|
| |
|
(in thousands)
$ |
|
|
(in thousands)
$ |
|
| Research and development of voclosporin |
|
|
22,046 |
|
|
|
20,669 |
|
|
|
|
|
|
|
|
|
|
| Other corporate purposes |
|
|
|
|
|
|
|
|
| Corporate, administration and business development |
|
|
8,706 |
|
|
|
7,654 |
|
| Repayment of drug supply loan |
|
|
1,290 |
|
|
|
1,290 |
|
| Payment of financing milestone to ILJIN |
|
|
1,472 |
|
|
|
1,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
11,468 |
|
|
|
10,544 |
|
|
|
|
|
|
|
|
|
|
For the period from the date of the private placement to September 30, 2015, the actual use of proceeds were slightly
less than the original estimates. This is primarily the result of actual voclosporin Phase 2b clinical trial expenditures to date being less than originally estimated due to a difference in timing of these expenditures. No significant impact on the
Company’s ability to achieve its business objectives and milestones as a result of this variation is expected.
Funding requirements
The Company is devoting its financial resources to its research and development activities, which consist primarily of conducting its ongoing voclosporin Phase
2b LN clinical trial and its corporate, administration and business development activities.
The Company believes that its cash position will be
sufficient to finance its operational and working capital needs, including completion of the LN Phase 2b clinical trial until at least the end of 2016.
The Company’s future funding requirements will depend on the future development plans for voclosporin beyond the current Phase 2b LN clinical trial and
potential strategic business development opportunities.
The Company will need to issue additional equity or seek additional financing through other
arrangements to further the development of voclosporin beyond the current Phase 2b LN clinical trial. Any sale of additional equity may result in dilution to the Company’s shareholders. There can be no assurance that the Company will be able to
successfully obtain future financing in the amounts or terms acceptable to the Company, if at all, in order to continue the planned operational activities of the Company. If the Company is unable to obtain financing to fund the development program
and its future operational activities, it may be required to delay, reduce the scope of, or eliminate the planned development activities, which could harm the Company’s future financial condition and operating results.
11
CONTRACTUAL OBLIGATIONS
The Company has entered into contractual obligations for services and materials required for the LN Phase 2b clinical trial and other operational activities.
Future minimum lease payments for its premises and the minimum amount to exit the company’s contractual commitments are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| (in thousands of dollars) |
|
Total |
|
|
Less than
one year |
|
|
Two to three
years |
|
|
Greater than
three years |
|
| |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
| Operating lease obligations (consists of premise leases) |
|
|
448 |
|
|
|
369 |
|
|
|
79 |
|
|
|
— |
|
| Purchase obligations |
|
|
118 |
|
|
|
118 |
|
|
|
— |
|
|
|
— |
|
RELATED PARTY TRANSACTIONS
Stephen P. Robertson, a partner at Borden Ladner Gervais (“BLG”), acts as the Company’s corporate secretary. The Company recorded legal fees,
incurred in the normal course of business to BLG of $33,000 and $84,000 respectively for the three and nine month periods ended September 30, 2015 compared to $11,000 and $15,000 respectively for the three and nine month periods ended
September 30, 2014. Mr. Robertson became the Company’s corporate secretary on June 16, 2014. The amount charged by BLG is based on standard hourly billing rates for the individuals working on the Company’s account. The
Company has no ongoing contractual or other commitments as a result of engaging Mr. Robertson to act as the Company’s corporate secretary. Mr. Robertson receives no additional compensation for acting as the corporate secretary beyond
his standard hourly billing rate.
OFF-BALANCE SHEET ARRANGEMENTS
To date the Company has not had any relationships with unconsolidated entities or financial partnerships, such as entities referred to as structured finance
or special purpose entities, which are established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. The Company does have off-balance sheet financing arrangements consisting of various
lease agreements which are entered into in the normal course of operations. All leases have been treated as operating leases whereby the lease payments are included in Corporate, administration and business development expenses. All of the lease
agreement amounts have been reflected in the Contractual Obligations table above.
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS
The preparation of interim condensed consolidated financial statements in accordance with IFRS often requires management to make estimates about, and apply
assumptions or subjective judgment to, future events and other matters that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures. Assumptions, estimates and judgments are based on
historical experience, expectations, current trends and other factors that management believes to be relevant at the time at which the Company’s interim condensed consolidated financial statements are prepared. Management reviews, on a regular
basis, the Company’s accounting policies, assumptions, estimates and judgments in order to ensure that the interim condensed consolidated financial statements are presented fairly and in accordance with IFRS.
Critical accounting estimates and judgments are those that have a significant risk of causing material adjustment and are often applied to matters or outcomes
that are inherently uncertain and subject to change. As such, management cautions that future events often vary from forecasts and expectations and that estimates routinely require adjustment.
Management considers the following areas to be those where critical accounting policies affect the significant judgments and estimates used in the preparation
of the Company’s interim condensed consolidated financial statements.
12
Critical estimates in applying the Company’s accounting policies
Contingent consideration
Contingent consideration
is a financial liability recorded at fair value. The amount of contingent consideration to be paid is based on the occurrence of future events, such as the achievement of certain development, regulatory and sales milestones. Accordingly, the
estimate of fair value contains uncertainties as it involves judgment about the likelihood and timing of achieving these milestones as well as future foreign exchange rates and the discount rate used. Changes in fair value of the contingent
consideration obligation result from changes to the assumptions used to estimate the probability of success for each milestone, the anticipated timing of achieving the milestones, and the discount period and rate to be applied. A change in any of
these assumptions could produce a different fair value, which could have a material impact to the results from operations.
The key assumptions used by
management include the probability of success for each milestone (35% - 70%) and a discount rate of 10%. If the probability for success were to increase by a factor of 10% for each milestone this would increase the obligation by approximately
$726,000 at September 30, 2015. If the probability for success were to decrease by a factor of 10% for each milestone this would decrease the obligation by approximately $726,000 at September 30, 2015. If the discount rate were to increase
to 12%, this would decrease the obligation by approximately $171,000. If the discount rate were to decrease to 8%, this would increase the obligation by approximately $187,000.
Derivative warrant liability
At
September 30, 2015 the estimated fair value of the derivative warrant liability was $6.96 million (September 30, 2014 - $9.79 million) which resulted in a gain of $1.16 million and $3.64 million respectively for the three and nine month periods
ended September 30, 2015 related to the derivative liability warrants compared to a gain of $5.27 million and a loss of $1.33 million respectively for the three and nine month periods ended September 30, 2014.
The Company considers expected volatility of its common shares in estimating its future stock price volatility. The risk-free interest rate for the expected
life of the warrants was based on the yield available on government benchmark bonds with an approximate equivalent remaining term at the time of the grant. The expected life is based upon the contractual term.
The Company uses the Black-Scholes option pricing model to estimate fair value. The following weighted average assumptions were used to estimate the fair
value of the derivative warrant liability on September 30, 2015 and September 30, 2014:
|
|
|
|
|
|
|
|
|
| |
|
September 30,
2015 |
|
|
September 30,
2014 |
|
| Annualized volatility |
|
|
84 |
% |
|
|
85 |
% |
| Risk-free interest rate |
|
|
0.95 |
% |
|
|
1.48 |
% |
| Expected life of warrants in years |
|
|
3.38 |
|
|
|
4.38 |
|
| Dividend rate |
|
|
0.0 |
% |
|
|
0.0 |
% |
| Market price |
|
|
2.84 |
|
|
|
3.24 |
|
| Fair value per Warrant |
|
|
1.53 |
|
|
|
2.07 |
|
This is a level 3 recurring fair value measurement. The key level 3 inputs used by management to determine the fair value are
the market price and the expected volatility. If the market price were to increase by a factor of 10% this would increase the obligation by approximately $982,000 at September 30, 2015. If the market price were to decrease by a factor of 10%
this would decrease the obligation by approximately $956,000. If the volatility were to increase by 10%, this would increase the obligation by approximately $599,000. If the volatility were to decrease by 10%, this would decrease the obligation by
approximately $636,000 at September 30, 2015.
Fair value of stock options
Determining the fair value of stock options on grant date, requires judgment related to the choice of a pricing model, the estimation of stock price volatility
and the expected term of the underlying instruments. Any changes in the estimates or inputs utilized to determine fair value could result in a significant impact on the Company’s reported operating results, liabilities or other components of
shareholders’ equity. The key assumption used by management is the stock price volatility. If the stock price volatility was higher by a factor of 10% on the options granted during the nine months ended September 30, 2015 this would have
increased the stock compensation expense on options granted during this period by approximately $146,000. If the stock price volatility was lower by a factor of 10% on grant date this would have decreased the total stock compensation expense for the
quarter by approximately $157,000.
13
Critical judgments in applying the Company’s accounting policies
Revenue recognition
Management’s assessments
related to the recognition of revenues for arrangements containing multiple elements are based on estimates and assumptions. Judgment is necessary to identify separate units of accounting and to allocate related consideration to each separate unit
of accounting. Where deferral of upfront payments or license fees is deemed appropriate, subsequent revenue recognition is often determined based upon certain assumptions and estimates, the Company’s continuing involvement in the arrangement,
the benefits expected to be derived by the customer and expected patent lives. To the extent that any of the key assumptions or estimates changes, future operating results could be affected.
Impairment of intangible assets
The Company
follows the guidance of IAS 36 to determine when impairment indicators exist for its intangible assets. When impairment indicators exist, the Company is required to make a formal estimate of the recoverable amount of its intangible assets. This
determination requires significant judgment. In making this judgment, management evaluates external and internal factors, such as significant adverse changes in the technological, market, economic or legal environment in which the Company operates
as well as the results of its ongoing development programs. Management also considers the carrying amount of the Company’s net assets in relation to its market capitalization, as a key indicator. In making a judgment as to whether impairment
indicators exist at September 30, 2015, management concluded that there were none.
RISKS AND UNCERTAINTIES
The Company has invested a significant portion of its time and financial resources in the development of voclosporin. The Company anticipates that its ability
to generate revenues and meet expectations will depend primarily on the successful development and commercialization of voclosporin. The successful development and commercialization of voclosporin will depend on several factors, including the
following:
| |
• |
|
successful completion of its clinical program in LN, including the LN Phase 2b clinical trial currently underway; |
| |
• |
|
Timely completion of the LN Phase 2b clinical trial; |
| |
• |
|
receipt of marketing approvals from the FDA and other regulatory authorities with a commercially viable label; |
| |
• |
|
securing and maintaining partners with sufficient expertise and resources to help in the continuing development and eventual commercialization of voclosporin; |
| |
• |
|
maintaining suitable manufacturing and supply agreements to ensure commercial quantities of the product through validated processes; |
| |
• |
|
acceptance and adoption of the product by the medical community and third-party payors; and |
| |
• |
|
the ability of the Company to raise future financial resources if and when required. Future additional sources of capital could include payments from potential new licensing partners, equity financings, debt financings
and/or the monetization of the Company’s intangible assets. There is no assurance of obtaining additional future financing through these arrangements or any arrangements on acceptable terms. |
A detailed list of the risks and uncertainties affecting the Company can be found in the Company’s Annual Information Form which is filed on SEDAR and
EDGAR. Additional risks and uncertainties of which the Company is unaware, or that it currently deems to be immaterial, may also become important factors that affect the Company.
Capital management
The Company’s objective in
managing capital is to ensure a sufficient liquidity position to safeguard the Company’s ability to continue as a going concern in order to provide returns for shareholders and benefits for other stakeholders.
The Company defines capital as net equity, comprised of issued common shares, warrants, contributed surplus and deficit.
The Company’s objective with respect to its capital management is to ensure that it has sufficient cash resources to maintain its ongoing operations and
finance its research and development activities, corporate, administration and business development expenses, working capital and overall capital expenditures.
Since inception, the Company has primarily financed its liquidity needs through public offerings of common shares and private placements. The Company has also
met its liquidity needs through non-dilutive sources, such as debt financings, licensing fees from its partners and research and development fees.
14
There have been no changes to the Company’s objectives and what it manages as capital since the prior fiscal
period. The Company is not subject to externally imposed capital requirements.
Financial risk factors
The Company’s activities expose it to a variety of financial risks: market risk (including currency risk, interest rate risk and other price risk), credit
risk and liquidity risk. Risk management is carried out by management under policies approved by the board of directors. Management identifies and evaluates the financial risks. The Company’s overall risk management program seeks to minimize
adverse effects on the Company’s financial performance.
Liquidity risk
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall due. The Company manages its liquidity risk through
the management of its capital structure and financial leverage. The Company successfully completed a $52 million private placement on February 14, 2014 which is expected to provide the Company with sufficient financial resources to conduct the
LN Phase 2b clinical trial and other corporate, administration and business development activities until at least December 31, 2016. It also manages liquidity risk by continuously monitoring actual and projected cash flows. The Board of
Directors and/or the Audit Committee reviews and approves the Company’s operating budgets, as well as any material transactions out of the ordinary course of business. The Company invests its cash in term deposits and bank discount notes with
30 to 180 day maturities to ensure the Company’s liquidity needs are met.
Interest rate, credit and foreign exchange risk
The Company invests in cash reserves in fixed rate, highly liquid and highly rated financial instruments such as treasury bills, term deposits and bank
discount notes which are all denominated in US dollars. The Company does not believe that the results of operations or cash flows would be affected to any significant degree by a sudden change in market interest rates relative to its investment
portfolio, due to the relative short-term nature of the investments and current ability to hold the investments to maturity.
The Company is exposed to
financial risk related to the fluctuation of foreign currency exchange rates which could have a material effect on its future operating results or cash flows. Foreign currency risk is the risk that variations in exchange rates between the United
State dollar and foreign currencies, primarily with the Canadian dollar, will affect the Company’s operating and financial results. The Company holds its cash reserves in US dollars and the majority of its expenses, including clinical trial
costs are also denominated in US dollars, which mitigates the risk of foreign exchange fluctuations.
As the Company’s functional currency is the
U.S. dollar, the Company has foreign exchange exposure to the CDN dollar.
The following table presents the Company’s exposure to the CDN dollar:
|
|
|
|
|
|
|
|
|
| |
|
September 30,
2015 $ |
|
|
September 30,
2014 $ |
|
| Cash and cash equivalents |
|
|
102 |
|
|
|
194 |
|
| Accounts receivable |
|
|
41 |
|
|
|
27 |
|
| Accounts payable and accrued liabilities |
|
|
(515 |
) |
|
|
(552 |
) |
|
|
|
|
|
|
|
|
|
| Net exposure |
|
|
(372 |
) |
|
|
(331 |
) |
|
|
|
|
|
|
|
|
|
|
|
| |
|
Reporting date rate |
|
| |
|
September 30,
2015 $ |
|
|
September 30,
2014 $ |
|
| $CA - $US |
|
|
0.749 |
|
|
|
0.893 |
|
|
|
|
|
|
|
|
|
|
Based on the Company’s foreign currency exposures noted above, varying the foreign exchange rates to reflect a ten
percent strengthening of the U.S. dollar would have decreased the net loss by $37,000 as at September 30, 2015 assuming that all other variables remained constant. An assumed 10 percent weakening of the U.S. dollar would have had an equal but
opposite effect to the amounts shown above, on the basis that all other variables remain constant.
15
CONTINGENCIES
| i) |
The Company may, from time to time, be subject to claims and legal proceedings brought against it in the normal course of business. Such matters are subject to many uncertainties. Management believes that the ultimate
resolution of such contingencies will not have a material adverse effect on the consolidated financial position of the Company. |
| ii) |
The Company has entered into indemnification agreements with its officers and directors. The maximum potential amount of future payments required under these indemnification agreements is unlimited. However, the Company
does maintain liability insurance to limit the exposure of the Company. |
| iii) |
The Company has entered into license and research and development agreements with third parties that include indemnification and obligation provisions that are customary in the industry. These guarantees generally
require the Company to compensate the other party for certain damages and costs incurred as a result of third party claims or damages arising from these transactions. These provisions may survive termination of the underlying agreement. The nature
of the obligations prevents the Company from making a reasonable estimate of the maximum potential amount it could be required to pay. Historically, the Company has not made any payments under such agreements and no amount has been accrued in the
accompanying interim condensed consolidated financial statements. |
INTERNAL CONTROLS OVER FINANCIAL REPORTING AND
DISCLOSURE CONTROLS
In conjunction with the filing of the unaudited interim consolidated financial statements on May 15, 2015 for the first
quarter ended March 31, 2015, management determined that a restatement of its previously issued audited consolidated financial statements for the year ended December 31, 2014 was necessary. The Company, in the second quarter of 2015
implemented a remedial measure whereby it will contract an external independent accounting expert to provide advice and guidance when the Company encounters significant or complex financial instrument issues and/or transactions. The CFO and the
Audit Committee Chair will be responsible for making the determination of when to utilize the external accounting expert.
Except as noted above, the
Company did not make any changes to its internal control over financial reporting during the three and nine months ended September 30, 2015 that materially affected or are reasonably likely to materially affect, the Company’s internal
control over financial reporting. The design of any system of controls and procedures is based in part upon certain assumptions about the likelihood of certain events occurring. There can be no assurance that any design will succeed in achieving its
stated goals under all potential future conditions, regardless of how remote.
UPDATED SHARE INFORMATION
As at November 12, 2015, the following class of shares and equity securities potentially convertible into common shares were outstanding:
|
|
|
|
|
| Common shares |
|
|
32,287,000 |
|
| Convertible equity securities |
|
|
|
|
| Derivative liability warrants |
|
|
4,548,000 |
|
| Other warrants |
|
|
1,368,000 |
|
| Stock options |
|
|
2,670,000 |
|
16
Quarterly Information
(expressed in thousands except per share data)
Set forth
below is selected unaudited consolidated financial data for each of the last eight quarters:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Three months ended |
|
| |
|
2015 |
|
|
2014 |
|
|
2013 |
|
| |
|
Sept 30 |
|
|
Jun 30 |
|
|
Mar 31 |
|
|
Dec 31(a) |
|
|
Sep 30(a) |
|
|
Jun 30(a) |
|
|
Mar 31(a) |
|
|
Dec 31*^ |
|
| Revenue |
|
|
57 |
|
|
|
59 |
|
|
|
62 |
|
|
|
68 |
|
|
|
72 |
|
|
|
71 |
|
|
|
67 |
|
|
|
712 |
|
| Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Research and development costs |
|
|
4,670 |
|
|
|
4,330 |
|
|
|
3,330 |
|
|
|
3,092 |
|
|
|
2,433 |
|
|
|
2,547 |
|
|
|
1,040 |
|
|
|
691 |
|
| Corporate, administration and business development costs |
|
|
1,380 |
|
|
|
1,414 |
|
|
|
1,905 |
|
|
|
1,399 |
|
|
|
1,405 |
|
|
|
1,713 |
|
|
|
2,373 |
|
|
|
899 |
|
| Restructuring and acquisition |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
36 |
|
|
|
60 |
|
|
|
403 |
|
|
|
569 |
|
|
|
29 |
|
| Amortization and impairment of tangible and intangible assets |
|
|
434 |
|
|
|
363 |
|
|
|
398 |
|
|
|
410 |
|
|
|
373 |
|
|
|
369 |
|
|
|
369 |
|
|
|
591 |
|
| Contract services |
|
|
1 |
|
|
|
4 |
|
|
|
5 |
|
|
|
8 |
|
|
|
11 |
|
|
|
10 |
|
|
|
8 |
|
|
|
— |
|
| Other expense (income) |
|
|
(55 |
) |
|
|
83 |
|
|
|
98 |
|
|
|
42 |
|
|
|
(1,690 |
) |
|
|
(954 |
) |
|
|
899 |
|
|
|
200 |
|
| Gain (loss) on derivative warrant liability |
|
|
1,163 |
|
|
|
5,402 |
|
|
|
(2,927 |
) |
|
|
(1,441 |
) |
|
|
5,268 |
|
|
|
(7,017 |
) |
|
|
416 |
|
|
|
— |
|
| Net income (loss) for the period |
|
|
(5,210 |
) |
|
|
(733 |
) |
|
|
(8,601 |
) |
|
|
(6,360 |
) |
|
|
2,748 |
|
|
|
(11,034 |
) |
|
|
(4,775 |
) |
|
|
(1,698 |
) |
| Per common share ($)
Net income (loss) – basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic |
|
|
(0.16 |
) |
|
|
(0.02 |
) |
|
|
(0.27 |
) |
|
|
(0.20 |
) |
|
|
0.09 |
|
|
|
(0.35 |
) |
|
|
(0.22 |
) |
|
|
(0.14 |
) |
| Diluted |
|
|
(0.16 |
) |
|
|
(0.02 |
) |
|
|
(0.27 |
) |
|
|
(0.20 |
) |
|
|
0.08 |
|
|
|
(0.35 |
) |
|
|
(0.22 |
) |
|
|
(0.14 |
) |
| Common Shares outstanding |
|
|
32,287 |
|
|
|
32,267 |
|
|
|
32,062 |
|
|
|
31,818 |
|
|
|
31,577 |
|
|
|
31,369 |
|
|
|
31,354 |
|
|
|
12,375 |
|
| Weighted average number of common shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic |
|
|
32,278 |
|
|
|
32,237 |
|
|
|
31,859 |
|
|
|
31,774 |
|
|
|
31,516 |
|
|
|
31,359 |
|
|
|
21,848 |
|
|
|
12,374 |
|
| Diluted |
|
|
32,278 |
|
|
|
32,237 |
|
|
|
31,859 |
|
|
|
31,774 |
|
|
|
33,249 |
|
|
|
31,359 |
|
|
|
21,848 |
|
|
|
12,374 |
|
| (a) |
These figures have been restated from those originally presented as more fully described in note 2 to the unaudited interim consolidated condensed financial statements for the third quarter ended September 30,
2015. |
| * |
These figures have been restated from those originally presented as more fully described in note 3a to the audited consolidated financial statements for the year ended December 31, 2014. |
| ^ |
On September 30, 2013 the Company completed a plan of arrangement with ILJIN and Aurinia Pharma Corp. and acquired Aurinia Pharma Corp. The Company determined a preliminary fair value of the reacquired rights,
intellectual know-how and goodwill related to the plan of arrangement and acquisition of Aurinia Pharma Corp. However, at September 30, 2013 management was still in the process of determining the fair value of the assets and liabilities
acquired and therefore the allocation between these asset categories was subject to change. Management completed the evaluation and made the final purchase price adjustments in the fourth quarter of 2013. As these adjustments related to the third
quarter ended September 30, 2013 the Company restated the figures for the third and fourth quarters of 2013. |
Summary of Quarterly
Results
The primary factors affecting the magnitude of the Company’s losses in the various quarters are noted below and include the timing of
research and development costs associated with the clinical development programs, timing and amount of stock compensation expense, fluctuations in the non-cash gain (loss) on derivative warrant liability resulting from required quarterly fair value
adjustments and other specific one-time items as noted below.
The general increase in research and development costs for the quarters from March 31,
2014, reflect costs incurred for the ongoing LN Phase 2b clinical trial.
Gain on derivative warrant liability for the three months ended
September 30, 2015 was $1.16 million.
Gain on derivative warrant liability for the three months ended June 30, 2015 was $5.40 million.
17
Corporate, administration and business development costs included non-cash stock-based compensation expense of
$897,000 for the three months ended March 31, 2015. Loss on derivative warrant liability for the three months ended March 31, 2015 was $2.93 million.
Loss on derivative warrant liability for the three months ended December 31, 2014 was $1.44 million.
Gain on derivative warrant liability for the three months ended September 30, 2014 was $5.27 million. Other expense (income) reflected a gain on
extinguishment of warrant liability of $438,000 a gain on re-measurement of warrant liability of $646,000. Loss on derivative warrant liability for the three months ended June 30, 2014 was $7.02 million.
Corporate, administration and business development costs reflected non-cash stock-based compensation expense of $1.04 million for the three months ended
March 31, 2014. Gain on derivative warrant liability for the three months ended March 31, 2014 was $416,000 composed of $1.06 million gain from revaluation adjustment at March 31, 2014 less share issue costs allocated to derivative
warrant liability of $646,000.
#1203 – 4464 Markham Street
Victoria, BC V8Z 7X8
18
