Posterior Segment Company Showcase - Alimera Sciences at OIS@AAO 2016.
Presenter:
Dan Myers, CEO
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2. Hypertension
Daily systemic doses
Diabetes
Insulin Pump
Arthritis
Therapy, exercise and at home
medication
How Chronic Diseases are
Treated Today
Low patient burden,
continuous treatment
Bolus injections that last for 1-
3 months administered directly
to the eye by a physician, with
reinjection every 1-3 months.
Ophthalmologists have adopted a standard of care that is inconsistent with the way
their fellow physicians in other disciplines treat chronic diseases because their options
have been limited.
How DME is Treated Today
High patient burden,
intermittent treatment
22 Š 2016 Alimera Sciences, All Rights Reserved2
3. 33 Š 2016 Alimera Sciences, All Rights Reserved3
ILUVIEN is the only therapy that allows physicians
to consistently treat DME daily
5. Key DME Management Goals
55 Š 2016 Alimera Sciences, All Rights Reserved5
A dry macula Preservation of
vision &/or
improving sight
Reduction in
patient burden
1 2 3
6. Consistent Delivery With Sustained Effect
ILUVIENÂŽ Delivers Consistent Treatment
66 Š 2016 Alimera Sciences, All Rights Reserved6
Source:
(a) OZURDEXÂŽ data from European Medicines Agency Assessment Report
(b) ILUVIENÂŽ data from Phase III Clinical Trials (FAME)
7. Side effects of
steroids are known
⢠ILUVIEN brings
innovation to
ophthalmology
⢠Side effects are
mitigated by
applying the lowest
possible dose
⢠Real world evidence
indicates our
success
77 Š 2016 Alimera Sciences, All Rights Reserved7
HOWEVER
ILUVIEN is not the
steroid of yesterday
8. Location N° of eyes (pts) Follow-up IOP Change & management
Medisoft 2nd
data extract
results (13 sites in the UK)1 290
Eyes (258 pts)
Up to
763
days
a. IOP elevation >30 mmHg, 6.6%
b. Emergent IOP-lowering drops,
14.8%
c. Rate of trabeculoplasty, 0%
d. Rate of incisional surgery, 0%
IRISS 2nd
data extract
(37 units in UK, DE, PT)2 328
Eyes (292 pts)
Up to
763
days
a. IOP elevation >30 mmHg, 8.2%
b. Emergent IOP-lowering drops,
18.4%
c. Rate of laser trabeculoplasty, 0%
d. Rate of incisional surgery, 0.6%
ILUVIEN Real-World Data Studies
1. Bailey C. Alimera Sciences symposium at EURETINA 2015.
2. Chakravarthy U. Alimera Sciences Advisory Board held on March 12 2016 in Paris, France.88 Š 2016 Alimera Sciences, All Rights Reserved8
9. 99 Š 2016 Alimera Sciences, All Rights Reserved9
10. Financial Overview
As of 6/30/16
1010 Š 2016 Alimera Sciences, All Rights Reserved10
Q1 Q2
$7.2M
U.S.
$2.3M
International
$4.1M
U.S.
$1.7M
International
2016 Revenue Growth
(a) Includes Series A preferred stock and warrants, Series B
preferred stock, common stock warrants, stock options and
common stock.
Q2 2016 Revenue
$9.5M
Q2 2016 Gross Margin
94.2%
Q2 2016 Net Loss
($6.9M)
Cash & Cash Equivalents*
$42.0M
Debt Outstanding
$35M
* The number shown for Cash & Cash Equivalents is a pro-forma representation
including net cash raised of $25.4M in the Companyâs latest equity raise
Contrast how chronic diseases are treated in other disease states versus DME
Changed to yellow/blue in order to better flow through to next slide
Continue to explain it with visual
What are the three key goals to managing DME? Dry macula, check. Preservation of vision or improving sight, check. Reduction in burden of injections, check. Reduction in adverse events, herein lies the perception that ILUVIEN is an issue.
We have eliminated 3, but we have a rep due to being a steroid
This highlights how ILUVIEN works versus the others
Take home
Far right column, better outcomes than our approval studies (clinical trials)
We now have had 4000 patients with almost no incisional surgery
Take out columns 4/5
Contact column 4 Ken Green
References
1. Dupas B et al. Alimera Sciences symposium at EURETINA 2015; 2. Figueira J et al ARVO 2016: poster #3257; 3. Bailey C. Alimera Sciences symposium at EURETINA 2015; 4. Bailey et al RCOphth 2016: poster #101. 5. Chakravarthy U. Alimera Sciences advisory board held on March 12 2016 in Paris, France. 6. Taylor et al RCOphth 2016: poster #110.
Massin trial treatment groups
Two groups were defined in advance: Group 1 included patients having received previous treatment in the study eye with laser photocoagulation for DME at least 3 months prior to the screening visit and no previous treatment with intraocular anti-VEGF therapy (anti-VEGF considered inappropriate); Group 2 included patients previously treated in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and with past history of âĽ3 monthly anti-VEGF treatments.
In fact we have three prominent US physicians presenting on the concept on Sunday.