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Corporate Presentation
April 2017
www.auriniapharma.com
Forward-Looking Statements
2
Certain of the statements made in this presentation may constitute forward-looking information within the meaning of applicable Canadian securities lawand forward-looking statements within the meaning of applicable U.S. securities law. These forward-looking statements or information include, but arenot 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 data exclusivity in major markets, the expectation thatvoclosporin will be the only CNI with a label for LN, the expected progress of the AURION study; the anticipated commercial potential of voclosporin forthe treatment of LN; and anticipated interactions with the US Food and Drug Administration. 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 other things,assumptions about: the market value for the LN program; that another company will not create a substantial competitive product for Aurinia’s LNbusiness without violating Aurinia’s intellectual property rights; and the size of the LN market. Even though the management of Aurinia believes that theassumptions made and the expectations represented by such statements or information are reasonable, there can be 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 other factors which maycause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievementsexpressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlyingassumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks,uncertainties and other factors include, among others, the following: the market for the LN business may not be as estimated; and competitors may arisewith similar products.
Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not 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 willprove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly you should notplace 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 this presentation is qualifiedby this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and itsbusiness can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System forElectronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic DocumentGathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.
www.auriniapharma.com
Company Highlights
3
Clinical-stage biopharmaceutical company focused on the global nephrology and autoimmunity markets
Seasoned management team which led the development of Cellcept®, the standard of care in the treatment of lupus nephritis (LN)
Lead Program– Voclosporin is entering Phase III for the treatment of LN– a disease characterized by significant morbidity & mortality –drug achieved highest complete remission rate of any global LN study [49.4% (p<.001) at 48 weeks]
Large unmet medical need with readily available $1B+ market; extensive IP protection in the US as well as data exclusivity in major markets
www.auriniapharma.com
SLE & LN Overview & Symptomatology
4
1. Lupus Foundation of America website: http://www.lupus.org/about/statistics-on-lupus
2. NIDDK, Lupus Nephritis. https://www.niddk.nih.gov/health-information/health-topics/kidney-disease/lupus-nephritis/Pages/index.aspx. Accessed July 26, 2016.
3. Maroz N, Segal MS. Am J Med Sci. 2013;346(4):319-23. 4. Lupus Foundation of America, http://www.lupus.org/resources/15-questions-
kidney-issues-and-lupus1. Accessed July 26, 2016.
CENTRAL NERVOUS SYSTEM
Headaches, dizziness, memory disturbances,
vision problems, seizures, stroke,
or changes in behavior
LUNGS
Pleuritis, inflammation, or pneumonia
BLOOD
Anemia, decreased white cells, increased risk of
blood clots
HEART
Chest pains, heart murmurs
KIDNEYS
Inflammation
SLE is a chronic, complex and often disabling autoimmune disorder
Affects over 500K people in the US (mostly women)1
Highly heterogeneous, affecting range of organ &
tissue systems1
LN is an inflammation of the kidneys caused by SLE & represents a serious progression of SLE
Up to 60% of SLE patients develop LN2
Straightforward disease outcomes—early response correlates w/long term outcomes; measured by proteinuria2
Debilitating and costly, often leading to ESRD, dialysis, renal transplant, and death2
Severe LN progresses to ESRD within 15 years of diagnosis in 10% to 30% of patients3
Leakage of blood proteins into the urine (proteinuria) is clinical sign of LN4
NO FDA OR EMA APPROVED LN THERAPIES
Widespread
fatigue, fever, joint pain, muscle aches,
photosensitivity, rashes, hair loss, oral ulcers, anxiety & depression
!
www.auriniapharma.com
The Severity of Lupus Nephritis
5
Mok et al, Arthritis Rheum 2013
Standardized
mortality ratio
SLE patients w/renal damage and ESRD have 14-fold and >60-fold increased risk, of premature death, respectively
www.auriniapharma.com
Cost Burden of Lupus Nephritis
6
$0 $10,000 $20,000 $30,000 $40,000 $50,000 $60,000 $70,000
Asthma
Hypertension
Diabetes
COPD
Bipolar Disorder
Heart Disease
Rheumatoid Arthritis
Ulcerative Colites
Crohns Disease
SLE (no nephritis)
Lupus Nephritis
Average Annual Cost of Illness per Patient by Condition*
Medical Costs Absence Costs Short Term Disability
* Carls G, et al. J Occup Environ Med. 2009;51:66-79.
www.auriniapharma.com
Proteinuria Correlates with Long-Term Outcomes
7
8%
57%
87%
0%
20%
40%
60%
80%
100%
120%
Complete Remission Partial Remission No Response
LN patient survival without ESRD based on treatment response1
Not on Dialysis @ 10 years On Dialysis at 10 years
92%
43%
13%
1. Chen YE, et al. Clin J Am Soc Nephrol. 2008;3(1):46-53. Response = 50% reduction in proteinuria; Remission = proteinuria <.33 g/24 hrs..
% o
f P
atie
nts
Rapid control & reduction of proteinuria in lupus patients may show a reduction in the need for dialysis1
www.auriniapharma.com
STANDARD THERAPY for PROLIFERATIVE LN
IV Cyclophosphamide 0.5-1g/m2 Monthly for 6 months
Proliferative LN: Give IV Methylprednisolone 0.5-1g/d for 1-3 days followed byOral Prednisone 1mg/kg/d ideal body weight, Maximum 80 mg/d, Taper Over Weeks
PLUS:
Oral MMF 2-3g/d for 6 months
PO Cyclophosphamide 1-1.5mg/kg/d, maximum 150 mg/d for 2-4 months
IV Cyclophosphamide 500 mg every 2 weeks for 3 months: LOW-DOSE-EURO-LUPUS REGIMEN
Or OrOr
24 week Partial Response & Complete Remission
Rates with Cyclophosphamide and MMF2
0%
10%
20%
30%
40%
50%
60%
Partial Response Complete RemissionCyclophosphamide MMF
9%
53%56%
% o
f P
atie
nts
8%
*
Results of the Aspreva Lupus Management Study (ALMS) showed that the majority of patients failed to achieve CR at 24 weeks for both of these first-line therapeutics2
A better solution is needed to improve renal response rates for LN
1. Hahn BH, et al. Arthritis Care Res (Hoboken). 2012;64(6):797-808.2. Appel GB, et al. J Am Soc Nephrol. 2009;20(5):1103-1112
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Drug Class Target Clinical Trial Status
Abatacept-BMS CTLA4-Ig CTLA4-B7 Phase 3- FAILED
Abatacept-ACCESS CTLA4-Ig CTLA4-B7 Phase 2- FAILED
Laquinamod Small Molecule Inflammation Phase 2- ENCOURAGING
Rituximab Monoclonal Antibody CD20 Phase 3- FAILED
Ocrelizumab Monoclonal Antibody CD20 Phase 3 - STOPPED
Sirukumab Monoclonal Antibody IL-6 Phase 2-FAILED
Bortezomib Proteasome Inhibitor Plasma Cells Phase 4- STOPPED
Anti-CD40 Ligand Monoclonal Antibody CD40 Ligand Phase 2- STOPPED
Tabalumab Monoclonal Antibody BLyS Phase 3- FAILED
Anti-TWEAK Monoclonal Antibody TWEAK Phase 2- FAILED
Recently Completed Clinical Trials in LN
Parikh et al JASN 2016
www.auriniapharma.com
Our Solution - Voclosporin - Key Benefits 1,2,3
1. Aurinia Data on file2. Busque S, et al. Am J Transplant. 2011;11(12):2675-2684 & AURA LV Data
3. AURA-LV Data on file
Voclosporin
Increased Potency vs. cyclosporine A,
allowing lower dosing
requirements 1
Limited inter & intra patient variability –
allowing flat dosing 1,3
Limited incidence of glucose intolerance
& diabetes at targeted doses vs.
tacrolimus 2
Less cholesterolemia than cyclosporine A 1
0 2 4 6 80
100
200
300
400
500
600
Time (h)
Co
nce
ntr
atio
n (
ng/
mL)
VCSCsA
4.5
5.0
5.5
6.0
6.5
–10 0 10 20 30 40 50 60 70 80
Week
Drug therapy ends
Total Cholesterol (Study Isa05-25)Mean ±95% CI
VCS
CsA
0
5
10
15
20
Cas
es o
f n
ew o
nse
t d
iab
etes
(12
mo
nth
s)
Low conc. Mid conc.Voclosporin Tacrolimus
Mea
n t
ota
l ch
ole
ster
ol
10
Concentration (ng/mL)
0 10 20 30 40 50 600
10
20
30
40
50
60
70
80
90
100
r = 0.5
%C
NI
Concentration (ng/mL)0 250 500 750 1,000 1,250 1,500
0
25
50
75
100
%C
NI
r = 0.7
Concentration (ng/mL)
0 100 200 300 400 500 600 700 800 900
0
25
50
75
100
r = 0.8
%C
NI
www.auriniapharma.com
Voclosporin LN Clinical Program Overview
11
AURION (supportive proof of concept)
Single-arm, twin center exploratory study assessing predictive value of an early reduction in proteinuria in subjects receiving voclosporin + SoC in patients with active LN
AURA-LV (Phase IIB)
Study demonstrated that voclosporin added to SoC can increase the speed and rate of complete and partial remission in the presence of “extremely low physiological steroids levels”
• UPCR at week 8 is highly predictive of renal response at 24 & 48 weeks• Renal function remains stable and inflammatory markers continue to normalize
• Statistically significant higher CR, PR, time to CR/PR, UPCR reduction & SLEDAI score (non renal lupus) at 24 & 48 weeks; Achieved highest remission rates of any global LN study at 48 weeks• VCS well tolerated, AE, SAE and mortality consistent with other LN trials
AURORA (Phase III pivotal)
52-week global double-blind placebo controlled study to demonstrate that voclosporin added to SoC can increase overall renal response rates in the presence of extremely low steroids;
Primary endpoint: Renal response (or CR) at 52 weeks
www.auriniapharma.com
AURA Study Design: Phase IIB
12
Study was designed to evaluate whether voclosporin added to SoC can increase speed of and overall remission rates in the presence of extremely low steroids
VOCLOSPORIN 23.7 mg bid VOCLOSPORIN 23.7 mg bid
MMF 2 g + oral corticosteroids
VOCLOSPORIN 39.5 mg bid VOCLOSPORIN 39.5 mg bid
MMF 2 g + oral corticosteroids
PLACEBO PLACEBO
MMF 2 g + oral corticosteroids
Secondary endpoint
48 weeks
Primary endpoint
24 weeks
1:1
Ran
do
miz
ati
on
N=
26
5
20-25 mg/daily
15-20 mg/daily
10-15 mg/daily
5 mg/daily
2.5 mg/daily
Week 2 4 6 12 24 48
AURA - forced steroid taper
8
www.auriniapharma.com
AURA Key Inclusion Criteria & Outcome Measures
Indicative of highly active disease
KEY INCLUSION CRITERIA
Diagnosis of SLE according to ACR criteria
Biopsy proven LN [Class III, IV or Class V (alone or in combination w/Class III or
IV)]
Proteinuria of ≥1.5 mg/mgOR ≥2 mg/mg*
PRIMARY OUTCOME MEASURES
CR is defined as: Confirmed urinary protein/creatinine ratio of ≤0.5 mg/mg
Normal, stable renal function (≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%)
The proportion of subjects achieving complete remission (CR) at 24 weeks
KEY SECONDARY OUTCOMES
Partial Remission, Time to Remission, Time to Partial Remission, Durability of remission and extra-renal activity (SLEDAI) at 24 & 48 weeks
+
*≥2 mg/mg refers to Class V patients
Presence of sustained, low dose steroids (≤10mg prednisone from week 16-24)
No administration of rescue medications
13
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AURA: Renal Response (Remission) Rates at 24 & 48 weeks
Endpoint Treatment24
weeksOdds ratio
(95% CI)P-value*
48 weeks
Odds Ratio(95% CI)
P-value*
CompleteRemission
(CR)
23.7mg VCS BID 33% 2.03 (1.01, 4.05) p=.045 49% 3.21 (1.68, 6.13) p<.001
Control 19% NA NA 24% NA NA
Partial Remission
(PR)
23.7mg VCS BID 70% 2.33 (1.68, 6.13) p=.007 68% 2.34 (1.27, 4.33) p=.007
Control 49% NA NA 48% NA NA
14
*p-values are vs control group
First global trial in active LN to meet its primary endpoint; highest CR rates of any other global study in active LN
www.auriniapharma.com 15
23.7mg BID VCS demonstrates statistically significant renal response rates at 24 & 48 weeks
AURA: Improved Renal Response Over Time with Voclosporin
0%
10%
20%
30%
40%
50%
60%
Pat
ien
ts a
chie
vin
g C
R
Progression to Complete Remission
Control VCS 23.7mg BID
p=.045
p<.001
0%
10%
20%
30%
40%
50%
60%
70%
80%
Baseline 24 weeks 48 weeks
Progression to any Renal Response
Control VCS 23.7mg BID
p=.007
p=.007
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AURA: Pre-specified Analysis:Speed of Remission (renal response)
16
P-Value <0.001 for both LD-VCS and HD-VCS
VCS showed a statistically significant faster speed of remission compared to the control group
www.auriniapharma.com17
AURA Pre-specified Analysis: UPCR (mg/mg) (Mean ± SD) Over Time
0
1
2
3
4
5
6
7
8
9
10
Baseline Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24 Week 48 Week 50
UP
CR
(m
g/m
g)
Visit
UPCR (Mean ± SD) Over Time
p<.001
A statistically significant reduction in UPCR vs. patients in the control group; UPCR also remains stable after treatment stopped
www.auriniapharma.com18
AURA: Pre-specified Analysis:SELENA-SLEDAI Score 24 & 48 weeks
-4.5
-5.3
-6.3
-7.9
Mean Change from Baseline in SELENA-SLEDAI Score
Control Voclosporin 23.7 mg BID
p=.003
p<.001
VCS showed statistically significant reduction of SLEDAI score vs. patients in the control group
Mean Change from Baseline at 24 weeks Mean Change from Baseline at 48 weeks
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AURA Pre-specified Analysis:Anti-dS-DNA (Mean ± SD) Over Time
19
1.75
21.75
41.75
61.75
81.75
101.75
121.75
141.75
161.75
181.75
Baseline Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24 Week 48
dsD
NA
An
tib
od
y (I
U/m
L)
Visit
Anti-dsDNA (Mean ± SD) Over Time
p=.006
VCS showed statistically significant reduction of Ds-DNA antibody vs. patients in the control group
www.auriniapharma.com
AURA: Summary of TEAEs & Historical Comparison
20
1.Furie R. et al., Arthritis and Rheumatology, Vol. 66, No 2, February 2014
2. Appel GB, et al. J Am Soc Nephrol. 2009;20(5):1103-1112 – Aspreva Lupus Management Study (Induction)3.Mysler, E. et al., Arthritis and Rheumatism, Vol. 65, No 9, September 2013, 2368-2379
4. AURA-LV Study results – Aurinia data on file
Treatment Emergent Adverse Events(TEAE)*
*includes TEAES following treatment period
ControlN = 88n (%)
VCS 23.7 mg BID N = 89n (%)
VCS 39.5 mg BIDN = 88n (%)
Any TEAE 78 (88.6) 82 (92.1) 85 (96.6)
Any Serious TEAE 17 (19.3) 25 (28.1) 22 (25.0)
Any TEAE with Outcome of Death 4 (4.5) 10 (11.2) 2 (2.3)
Any Treatment-Related TEAE 15 (17.0) 45 (50.6) 55 (62.5)
Any Serious Treatment-Related TEAE 1 (1.1) 4 (4.5) 7 (8.0)
AURA-LV4
N=265(to Dec 18th/16)
ALMS Induction2
N=364Abatacept Study1
MMF N = 298Ocrelizumab Study3
N=378
SAE’s, Subjects, n (%) 59 (22.3%) (25.3%) 92 (30.9%) 107 (28.3%)
Serious Infections, Subjects n (%)
29 (10.9%) (10.9%) 58 (19.5%) 64 (16.9%)
Deaths, Subjects, n (%) 13 (4.9%) 14 (3.8%) 14 (4.7%) 14 (3.7%)
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AURA: Renal Function: eGFR (mL/min/1.73m²) over time
21
Renal function remains stable throughout treatment period; eGFR returns to baseline after 48 weeks
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AURA: Blood Pressure (BP) (Mean ± SD) over 48 weeks
22
80
90
100
110
120
130
140
150
160
Baseline Day 1 Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24
Syst
olic
Blo
od
Pre
ssu
re (
mm
Hg)
Visit
Systolic BP (Mean ± SD) Over Time
Week 48
50
60
70
80
90
100
110
Baseline Day 1 Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24 Week 48
Dia
sto
lic B
loo
d P
ress
ure
(m
mH
g)
Visit
Diastolic BP (Mean ± SD) Over Time
No significant difference in blood pressure over the 48-week treatment period
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AURA Top-line Safety Summary
23
1 Furie R. et al., Arthritis and Rheumatology, Vol. 66, No 2, February 2014
2 Appel GB, et al. J Am Soc Nephrol. 2009;20(5):1103-1112 – Aspreva Lupus Management Study (Induction)3.Mysler, E. et al., Arthritis and Rheumatixm, Vol. 65, No 9, September 2013, 2368-2379
The overall safety profile is consistent with other immunomodulators
No new safety signals were observed with the use of voclosporin in LN patients; voclosporin was well-tolerated
In previous studies (other indications), >2000 patients have been treated with voclosporin with no abnormal or unexpected SAE’s—this remains the case upon review of the AURA data
Safety beyond 24 weeks Control N = 88n (%)
VCS23.7 mg BID N = 89 (n %)
Any Serious Adverse Event 1 (1.1)^ 2 (2.2)
Malignancies 1 (1.1)^ 0 (0)
Deaths 3 (3.4)* 0 (0)
^Malignancy (metastatic melanoma) occurred following treatment period*3 deaths occurred following the treatment period (after week 50)
13 deaths have been reported in the AURA study: pattern is consistent with other global Active LN
studies1,2,3
11 of 13 deaths occurred at sites with compromised access to standard of care and all deaths were
determined to be unrelated to study treatment; no dose-dependent relationship was observed
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AURA: Conclusions
24
EFFICACY
23.7mg BID voclosporin demonstrated a statistically significant:
Higher CR vs. the control group at weeks 24 (p=.045); & 48 (p<.001)
Higher PR (50% reduction in UPCR over baseline) at weeks 24 & 48 (p=.007 & p=.002)
Faster time to CR (UPCR ≤ 0.5mg/mg) (p=.002)
Faster time to PR (p=.001)
Reduction in UPCR (both FMV & 24hr urine) at weeks 24 (p<.01) & 48 weeks (p<.001)
Reduction in SLEDAI at 24 (p=.003) & 48 weeks (p<.001)
First therapeutic agent to meet ALL KEY 24 & 48 week pre-specified secondary endpoints in global clinical trial for active LN
SAFETY
No new safety signals were observed with the use of VCS in LN patients & voclosporin was well-tolerated
Across indications, >2200 patients have been treated with VCS with no abnormal or unexpected SAEs
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AURION: Study Design
25
Single-arm, twin center exploratory study assessing predictive value of an early
reduction in proteinuria in subjects receiving voclosporin (23.7 mg BID) + SoC in
patients with active LN
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 urinary protein creatinine ratio (UPCr) 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
SCREENINGVOCLOSPORIN 23.7 mg bid VOCLOSPORIN 23.7 mg bid
MMF 1 – 2 g + oral corticosteroids
N = 10
Exploratory
endpoint, 8 weeks
24 week
assessmentEnd of study,
48 weeks
C3, complement 3; C4, complement 4; anti-dsDNA, anti-double-stranded DNA.
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AURION & AURA Predictive Response at 24 & 48 weeks
26
Biomarker AURION AURA
Week 24 Week 48 Week 24 Week 48
25% reduction in week 8 UPCR
sensitivity 71% 75% 100% 91%
specificity 33% 24% 30% 31%
C3 Normalizationsensitivity 29% 25% 15% 22%
specificity 100% 75% 82% 88%
C4 Normalizationsensitivity 29% 25% 40% 30%
specificity 100% 75% 90% 91%
Anti-dsDNANormalization
sensitivity 57% 50% 13% 18%
specificity 100% 50% 54% 50%
UPCR at week 8 is highly predictive of renal response at 24 & 48 weeks
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AURION: eGFR (CKD-EPI: Mean ± SE)Safety Population (All patients)
0
10
20
30
40
50
60
70
80
90
100
110
Baseline Week 2 Week 4 Week 8 Week 12 Week 24 Week 36 Week 48 Week 50
eGFR
Renal function remains stable through 48 weeks
VCS completed at 48 weeks
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AURION: Role of Biomarkers as Predictors of Remission
28
25% Reduction in UPCR from baseline offers high sensitivity, but low specificity
C3 and C4 normalization offer low sensitivity and high specificity; Anti-dsDNA offers little
additional information
Post-hoc analysis of AURA demonstrates similar results
Future studies in LN utilizing predictive biomarkers should consider both 25%
reduction in UPCR andC3/C4 normalization
www.auriniapharma.com
Voclosporin—Potential to Address LN Critical Need
29
Control of Active Disease
Rapid Disease Control
Lower Steroid Burden
Convenient Treatment Regimen
LN Critical NeedVoclosporin
(based on top-line AURA 48-week results)
www.auriniapharma.com
Overview of Regulatory discussions
30
Voclosporin has FDA Fast-track designation
Pursuant to regulatory interactions, we are conducting a single Phase III trial (AURORA) to serve as basis for regulatory submissions in major markets—US, Europe, and Japan
Comprehensive package of clinical data to date submitted and reviewed by the Division of Pulmonary, Allergy & Rheumatology at FDA, European Medicines Agency (EMA) and Pharmaceutical & Medical Devices Agency (PMDA) in Japan
www.auriniapharma.com
AURORA Study Design: Phase III-nearly identical to AURA
31
52-week global double-blind placebo controlled study to demonstrate that voclosporin added to SoC can increase overall renal response rates in the presence of extremely
low steroids;Primary endpoint: Renal response (or CR) at 52 weeks – data expected late 2019
VOCLOSPORIN 23.7 mg bid VOCLOSPORIN 23.7 mg bid
MMF 2 g + oral corticosteroids
PLACEBO PLACEBO
MMF 2 g + oral corticosteroids
Primary endpoint
52 weeks
Secondary endpoint
24 weeks
1:1
Ran
do
miz
ati
on
N~
32
0
20-25 mg/daily
15-20 mg/daily
10-15 mg/daily
5 mg/daily
2.5 mg/daily
Week 2 4 6 12 24 52
Forced steroid taper
8
Con
tin
uation
Stu
dy
Treatment arm
Control arm
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Commercial Prospects for Voclosporin
32
Treated LN Population*
Quality of diagnosis by referring physicians*
In US and EU, 1 in 5 lupus nephritis patients are thought to be undiagnosed due to referring physicians being inefficient and inaccurate in diagnosing the condition.
Current proportionof controlled vs
uncontrolled pts*
Controlled Poorly controlled Active disease
When surveyed, physicians would use this product for both maintenance and induction phases
58% 25% 17%
Frequency of visit* Every 3 months Every 1-2 months > Once a month
Current treatment*Hydroxychloroquine, MMF, and steroids are most commonly used in the largest shares of patients.
Satisfaction*Only 18% of physicians were very satisfied or extremely satisfied with currently available therapies ability to achieve a CR within 6 months
125 – 200K 175 – 250K
InductionMaintenance
*Aurinia market research conducted in 2016 with ~700 Rheumatologists and Nephrologist across Europe and the United States
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LN Cycle of Disease Process & Flare Rates*
33
INDUCTION
MAINTENANCE
FLARE REMISSION
IVC or MMF with high dose steroids
MMF or AZA
steroidtaper
steroidtaper
~ 700 Rheumatologists & Nephrologists Surveyed across US
& EU
Mean Frequency of LN Flare
~ every 14 months
*Aurinia market research conducted in 2016 with ~700 Rheumatologists and Nephrologist across Europe and the United States
Destructive Cycle of LN Frequency of LN Flares*
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Potential Peak Sales by Market
34
Initial estimates of Voclosporin peak sales yield global opportunity in excess
of $1billion
Japan population and competitive market offers smaller opportunity
EU population likely larger than US however pricing opportunity is more limited
US market will provide most opportunity
Population, pricing potential and physician adoption of treatment support strong sales prospects
• Over $80millionJapan
• Over $300millionEU
• Over $1billionUS
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Milestones
Q1 2017
Q1 2017
Q2 2017
Japanese Phase I ethno bridging study results
AURA-LV 48-week top-line secondary endpoint results
Initiation of Phase III program - AURORA
Outcome of EMA & PMDA discussions
Q1 2017
AURION 48-week results
35
Q2 2017
Q2 2017
AURA-LV 48-week full data scientific & medical presentations
www.auriniapharma.com
Investment Summary
36
MANAGEMENT WITH TRACK RECORD OF SUCCESS & EXTENSIVE EXPERTISE IN LN
Positive PoC and Phase IIB study results
SOLID CLINICAL DOSSIER
Extremely high pharmaco-economic burdenLN patients appear to be readily assessable and
easily identified by specialty treaters
LARGE AND WELL-DEFINED MARKET OPPORTUNITY >$1B
>2,200 patients treated with voclosporin to date (across indications)
well-characterized safety profile
Positive interactions with regulatory authoritiesOnly one Phase III clinical trial required by the FDA
prior to a NDA submission
STRONG CASH POSITION
~$200M as of March 31, 2017
#1203-4464 Markham Street • Victoria BC V8Z 7X8
www.auriniapharma.com
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