corporate presentation - seeking alpha...2017/04/29 · corporate presentation april 2017...

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.


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


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

!

http://www.lupus.org/about/statistics-on-lupus

https://www.niddk.nih.gov/health-information/health-topics/kidney-disease/lupus-nephritis/Pages/index.aspx

http://www.lupus.org/resources/15-questions-kidney-issues-and-lupus1


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


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.


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


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


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


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


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


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



PLACEBO PLACEBO


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


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


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


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


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


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%)


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


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


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


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


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.


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


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


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


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)


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


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



PLACEBO PLACEBO


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


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


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*


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


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


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


THANK YOU

http://www.auriniapharma.com/

corporate presentation - seeking alpha...2017/04/29 · corporate presentation april 2017...

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