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July 2016 Corporate Presentation
Forward-Looking Statements
1
Certain of the statements made in this presentation may constitute forward-looking information within the meaning of applicable Canadiansecurities law and forward-looking statements within the meaning of applicable U.S. securities law. These forward-looking statements orinformation include, but are not limited to statements or information with respect to the projected worth of the lupus nephritis (LN) market,that voclosporin is potentially a best-in-class calcineurin-inhibitor (CNI) with robust intellectual property exclusivity and the likelihood of dataexclusivity in major markets, the expectation that voclosporin will be the only CNI with a label for LN, the expected progress of the AURIONstudy; the anticipated commercial potential of voclosporin for the treatment of LN; and anticipated interactions with the US Food and DrugAdministration. When used in these marketing materials, the words “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”,“plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements or information. [
We have made numerous assumptions about the forward-looking statements and information contained herein, including among otherthings, assumptions about: the market value for the LN program; that another company will not create a substantial competitive product forAurinia’s LN business without violating Aurinia’s intellectual property rights; and the size of the LN market. Even though the management ofAurinia believe that the assumptions made and the expectations represented by such statements or information are reasonable, there canbe no assurance that the forward-looking information will prove to be accurate.
Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and otherfactors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results,performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks anduncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described inforward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: the market forthe LN business may not be as estimated; and competitors may arise with similar products.
Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described inforward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events tonot be as anticipated, estimated or intended. Also many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipatein such statements. Accordingly you should not place undue reliance on forward-looking statements or information.
Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in thispresentation are qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks anduncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing theCanadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S.Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.
Experienced Management Team
2
Over 100 years of combined corporate life sciences industry experience
Charles A. Rowland , MBA, CPA Chief Executive Officer
Michael R. Martin, BSc Chief Operating Officer
Neil Solomons, MD Chief Medical Officer
Dennis Bourgeault, CPA, CA Chief Financial Officer
Lawrence D. Mandt, BS VP Regulatory Affairs & Quality
Robert Huizinga, RN, MSc, CNeph VP Clinical Affairs
Bradley Dickerson, BA, Management GM Americas & Global Commercial Assessment
Clinical stage pharmaceutical company focused on the global nephrology and autoimmunity markets
Developing a novel Phase 2b lupus nephritis (LN) therapy, voclosporin, a calcineurin-inhibitor (CNI) and NCE with certain advantages over existing therapies
Lupus market is projected to be worth ~$3B* by 2019 in the US/EU
– Lead asset granted FAST TRACK designation by the FDA
Strong safety package with robust clinical rationale:
– Efficacy of multi-targeted LN therapy has been established
– Well characterized safety profile - >2,000 patient exposures – some for multiple years
– Voclosporin is potentially a best-in-class calcineurin inhibitor (CNI) with robust IP*^ exclusivity
– Supportive 8 week proof of concept data - AURION
AURA-LV global clinical Phase 2b trial in LN has completed enrolling at 265 patients with data read-out sometime in Q3/16 → AURION study is ongoing
Aurinia Investment Highlights
3
*^Includes 5 year PTE*Data Monitor
SLE an autoimmune disorder impacting ~ .5-1.5M* people in U.S.
– Highly heterogeneous; can affect the heart, lungs, skin, joints, vasculature system and kidneys
~40-50% of SLE patients develop lupus nephritis
– LN is inflammation of the kidney caused by SLE
– If left untreated or inadequately treated, LN can lead to end stage renal disease, dialysis, renal transplant and death
No FDA or EMA approved LN therapies
Systemic Lupus Erythematosus (SLE) & Lupus Nephritis
(LN)
4
*Lupus Foundation of America (LFA) estimate
While at Aspreva, Aurinia Management Executed the ALMS Study (Establishing CellCept® as Current SoC)
5
Despite CellCept®, Significant Unmet Medical Need Remains:
>90% of Patients Fail To Achieve Complete Remission**
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Remission Responder Non-Responder
92%
43%
13%
8%
57%
87%
LN patient outcome based on treatment response*
Not on Dialysis @ 10 years On Dialysis at 10 years
20%
40%
60%
80%
100%
6 months
~54%respond
<10% achieve complete remission**
*Chen et al. Clin J. Am Soc Neph. 2008: Response = 50% reduction in proteinuria Remission = Proteinuria <.33g/24hrs**Aspreva Lupus Management Study – ALMS (NEJM/JASN). Complete remission requires proteinuria of <.5g/24hrs and presence of inactive urinary sediment
Rapid control & reduction of proteinuria in lupus patients reduces the need for dialysis*
% o
f P
atie
nts
Higher remission rate reduces the
risk of ESRD*
6 NASDAQ - AUPH
CNIs are inhibitors of calcineurin phosphatase and the combination of MMF & CNIs are standard of care (SoC) for prevention of rejection in solid organ transplants
The immunology of lupus supports treating LN patients with a similar approach to that used in transplant patients (multi-targeted therapy)
Strong rationale for voclosporin use in LN
– Potent effects on T-cell activation and immunomodulatory effects
– T-cell mediated immune response important feature of pathogenesis of many autoimmune diseases, including LN
Need for MTT with Best-in-Class Calcineurin
Inhibitor (CNI) in Lupus Nephritis - voclosporin
7
Altered functional group
on CsA
Impacts binding to the latch region on
Calcineurin
Voclosporin
N
HO
O
HN
N
OO
N
O
N
O
N O
NH
O
HN
O
N
O
HN
O
N
OMTT
Transplant
Auto-immune diseases
Antivirals
DiabetesHyper-lipidemia
Hyper-tension
Coronary heart
disease
MTT is a Common Way to Treat Complex Diseases
*Remission rates: CellCept®
vs. IVC after 6 months – ALMS
**Remission rates: multi-target therapy vs. IVC after 6 months –
Bao et al.
Data Suggest Multi-Targeted Therapeutic (MTT) Approach To LN
Will Yield Superior Results to either MMF or IVC Alone
8
Aspreva Lupus Management Study – ALMS (NEJM/JASN). Complete remission required presence of inactive urinary sediment**Bao Hao et al. J Am Soc Nephrol 19:2001-2010, 2008. IVC – Intravenous cyclophosphamide
Rem
issio
n/R
esp
on
se r
ate
20%
40%
60%
80%
100%
8.6%
53%
8.1%
56%
Partial
Response
Complete
Response
CellCept®IVC
6 Months
20%
40%
60%
80%
100%
50%40%
5%
40%
Partial
Response
Complete
Response
Multi-TIVC
6 Months
Rem
issio
n/R
esp
on
se
rate
(“multi-target” = CellCept® +CNI)
^MTT of Lupus Nephritis: A Prospective Randomized Controlled Multi-Center
Trial – (n=362)
40%
60%
80%
100%
38%
25%
38%
Partial
Response
Complete
Response
Multi-T(n=181)
IVC(n=181)
24 Weeks(multi-target = MMF + CNI)
46%
20%25%
p< .001
Japaneseregistration study:Tacrolimus-treated
patients experienced 15% rate of diabetes/ glucose intolerance^
^^Miyasaka et al. Mod Rheumatol. (2009) 19:606-615
^Liu et al. Annals of Internal Medicine 11 November 2014 doi:10.7326/P15-9000
AURION: Study Design
Primary analysis: Number of patients achieving each of the following biomarkers and the number of these patients who go on to achieve week 24 or week 48 remission.
Biomarkers:– 25% reduction in P/CR at 8 weeks– C3 normalization at 8 weeks– C4 normalization at 8 weeks– Anti-dsDNA normalization at 8 weeks
Secondary analyses: 24, 48 week outcomes, markers of SLE, PK/PD voclosporin in LN subjects
24 week
assessment
End of study
48 weeks Exploratory
Endpoint 8 weeks
Single Arm, Twin Centre Exploratory Study Assessing The Predictive Value Of An
Early Reduction In Proteinuria In Subjects Receiving Multi-Target Therapy With
Voclosporin 23.7 Mg BID, MMF Up To 2g Daily In Patients With Active Lupus Nephritis
AURION Data Release Ongoing at Upcoming Scientific Meetings:
- 7 patients to 24 weeks (June 2016)
- 10 patients to 24 weeks (Sept. 2016)
Voclosporin 23.7 mg bid Voclosporin 23.7 mg bid
MMF 1 - 2 g + oral corticosteroidsScreening
N = 10
0.00
1.00
2.00
3.00
4.00
5.00
1 (01-02) 2 (01-03) 3 (01-05) 4 (01-06) 5 (02-01) 6 (02-03) 7 (02-04)
UPCr Pre-Treatment to Week 24 (n = 7)
Pre-Treatment Week 24
10
AURION: 24 Week Data – First 7 Patients
Mean proteinuria reduction at 24 weeks is 54%*^ using voclosporin as a component of MTT
57% (4/10) have achieved a Complete Remission at 24 weeks as defined as a urinary protein creatinine ratio of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant steroid dose of less than 5mg/day.
*Indicates patient taking MMF at entry (failing MMF)
^ LOCF – subject withdrew from study at 8 weeks
^
*
-1.00
-0.50
0.00
0.50
1.00
1.50
2.00
2.50
3.00
3.50
4.00
UP
Cr
(mg/m
g)
Visit
UPCr Means and 95% Confidence Level Over Time
UP
Cr
(mg
/mg
)
*
*
11
LN Inflammatory markers are positively impacted after 24 weeks of MTT with voclosporin
eGFR assessed through CKD-EPI formula
Renal function is stable (as measured by eGFR) throughout the treatment period
C3 & C4 Improves after 24 weeks* of therapy, while renal
function as measured by CKD-EPI remains stable
0
20
40
60
80
100
120
140
160
eG
FR
(m
L/m
in/1
.73m
2)
Visit
eGFR Means and 95% Confidence Level Over Time*
0
10
20
30
40
50
60
70
80
90
C3C
3
mg/d
l
C3 – Baseline vs. Week 24*
Baseline 24 weeks
18% increase in mean
C3*
0
5
10
15
20
25
C4
C4
mg/d
l
C4 – Baseline vs. Week 24*
Baseline 24 weeks
37% increase in mean
C4*
*LOCF for subject 7 – subject withdrew from study at 12 weeks
One subject (subject 4) out of 7 required multiple dose interruptions of MMF and voclosporin for hypertension, anemia, community acquired pneumonia eventually maintained on lower dose of voclosporin therapy
Another (subject 7) failed to respond adequately to drugs and was withdrawn from therapy at week 12
Otherwise combination well tolerated
No unexpected safety signals
24 week Safety/tolerability utilizing voclosporin
as a component of Multitargeted Therapy (MTT)
12
AURION – 24 week Top-Line Data Summary -
Encouraging
13
24 week AURION data appears to support the hypothesis that MTT utilizing voclosporin has the potential to improve LN disease activity
AURION efficacy data is encouraging:
– 57% (4/7) of patients in remission at 24 weeks as measured by urinary protein creatinine ratio of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant steroid dose of less than 5mg/day
– 54% mean reduction in proteinuria (including LOCF data)
– Mean C3/C4/anti-dsDNA trending towards normalization
Safety profile is encouraging while renal function remains stable (as measured by eGFR/CKD-Epi)
AURA (Aurinia Urinary - protein Reduction in Active nephritis) : Enrolment Complete – 24 week data available Q3/2016
14
Voclosporin 39.5 mg bid
MMF 2 g + oral corticosteroids
1:1
:1 R
and
om
izat
ion
N
=26
5
1º Endpoint 24 weeks - Complete remission (confirmed UPCr ≤ 0.5 and eGFR
within 20% baseline value)
Voclosporin 23.7 mg bid
Voclosporin 39.5 mg bid
End of study 48 weeks - Durability of remission, 48 week outcomes, extra-renal lupus activity (SLEDAI
MMF 2 g + oral corticosteroids
MMF 2 g + oral corticosteroids
Voclosporin 23.7 mg bid
Placebo Placebo
20-25mg/day
15-20mg/day
10-15mg/day
5mg/day
10mg/day
2.5mg/day
Week 2 4 6 12 24 48
AURA - Forced Steroid taper30 mg/day
40 mg/day
50 mg/day
60 mg/day
8
Study design aims to demonstrate rapid,
sustained complete remission in the
presence of extremely low steroids
Commercial Potential of Voclosporin for the Treatment of LN Could Be Substantial
Total US SLE/Lupus Population ~.5 – 1.5M^^
~200K
~300K
Not diagnosed,
not in the
healthcare
system
SLE patient population
(non-renal)
LN patient population,
elevated proteinuria
Other products used for Lupus
(United States)*
Estimated
Price/year (in US)*
Rituxan® ~$27,000/year
CellCept® (branded 2012) ~$12,000/year
Benlysta® ~$35,000^/year*
*plus infusion costs
Competitor Pricing per LN patient per year
*Datamonitor SLE- Stakeholder insights
^Biotrends – Launch trends - Benlysta®
*IMS Data
^^LFA estimates
15
*Projection based on IMS-NDTI data includes both renal
(65%) and non renal (35%) Lupus patients
**Internal Aurinia projections
Average Annual Cost of Illness Per Patient ***
$0 $10,000 $20,000 $30,000 $40,000 $50,000 $60,000
SLE nephritis
Renal failure
Crohn's disease
Systemic lupus eurythematosus
Ulcerative colitis
SLE without nephritis
Rheumatoid arthritis
Heart disease
Bipolar disorder
Chronic obstructive pulonary disease
Diabetes
Hypertension
Asthma Medical costs
Absence costs
Short term
disability costs$14,909
$64,195
$22,427
$35,687
$25,921
$25,215
$21,161
$19,530
$17,860
$15,407
$14,079
$10,125
$8,907
*** Journal of Occupational and Environmental Medicine, Volume 51, Number 1, January 2009
The Economic Burden of Patients Suffering from Lupus
Nephritis Can Exceed $60K/year
16
0
10000
20000
30000
40000
50000
60000
70000
SLE (without LN) LN
20
05
US
D
Direct and Indirect Costs of SLE (without LN) and LN*
Inpatient Emergency
Outpatient Rx
Absenteeism Short-term disability
Total = $21,161
Total = $64,195
Indirect
Indirect
Direct
Direct
*Carls et al.,JOEM., Volume 51, No. 1, January 2009
**Li T, et al. Arthritis Rheum. 2009;61(6):755-763.
***Does not include cost of transplant
$0
$20,000
$40,000
$60,000
$80,000
$100,000
$120,000
1 2 3 4 5
Me
an
An
nu
al M
ed
ical C
osts
Year Since Initial Diagnosis
LN with ESRD (n = 156)
LN without ESRD (n = 333)
LN (n = 489)
SLE without LN (n = 1,809)
SLE (n = 2,298)
Reference (n = 2,298)
Mean Annual Medical Costs Associated with
Lupus with and without Nephritis**
NASDAQ - AUPH
******
Although the cost to treat LN can be greater than other autoimmune diseases the treatment objectives are remarkably similar:
– Crohn’s Disease / Psoriatic Arthritis / Multiple Sclerosis:
Induce/maintain remission – avoid destructive flares leading to permanent tissue damage
Decrease frequency of hospital and ambulatory care visits
Limit long-term disability
Reduce overall steroid burden
Improve QoL and wellbeing of the patients
In LN physicians are trying to avoid, dialysis, renal transplantation and death
Voclosporin pricing potential should be considered within
the context of other autoimmune diseases
17
$10K
$20K
$30K
$40K
$50K
$60K
$70K
$80K
An
nu
al W
AC
Price
*
200K 250K 300K 350K 400K
Estimated Prevalence
BENLYSTA® – nrSLE
ENBREL® – PsA
STELARA® – PsA
GILENYA™ – MS
TECFIDERA™ – MS
450K
CIMZIA® – CD
500K
TYSABRI® – CD
~LN
*WAC price from Analysource – Calculated as per package insert for indication
.
LN is Less Common than other Autoimmune
Diseases and can have a higher
Pharmacoeconomic Burden
HUMIRA® – CD
REMICADE® – CD
COPAXONE® – MS
AUBAGIO® – MS
Management with track record of industry success & extensive expertise and focus on lupus nephritis
Well-capitalized, efficient public entity (NASDAQ: AUPH TSX: AUP)
– 32.3 million shares outstanding, 5.9 mil warrants
Solid safety and proof of concept package
– > 2,000 patients treated with voclosporin to date >> well characterized safety profile
– Same multi-target therapy (MTT) approach used in transplantation
– Strong clinical evidence to support CNI efficacy as part of MTT
– Supportive 8-week Proof of Concept - AURION
Large and well-defined market opportunity
– Renal lupus has significant unmet medical need with an extremely high pharmaco-economic burden
– Growing market projected to exceed $3B^ in value by the end of this decade
– Robust IP protection with likelihood of data exclusivity in major markets
Investment Summary
18
AURA LV enrollment
complete N=265
Q1 / 2016 Q2 / 2016 Q3 / 2016 Q4 / 2016
AURION 8-Week data
collection/ enrollment
complete
AURA LV 24-week
1° data read-out
AURION 24-Week
data
collection/release
FDA End Ph.II
meeting*
*Following positive AURA results
^Data Monitor
FDA Fast Track
designation