Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.
Presenter:
Nancy Lurker, President & CEO
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2. SAFE HARBOR STATEMENT
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this
release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that
address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of
the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or
implied in our forward-looking statements include uncertainties with respect to: our ability to obtain needed capital; our ability to achieve
profitable operations; potential declines in Retisert royalties; fluctuations in our operating results; further impairment of our intangible assets;
our ability to obtain marketing approvals for and successfully commercialize Medidur for posterior segment uveitis; performance by CROs,
vendors and investigators; timing of filing marketing approval applications for Medidur; acceptability of data to be filed in support of Medidur
marketing applications; maintenance of orphan designation for Medidur, potential off-label sales of ILUVIEN for posterior segment uveitis;
successful commercialization of, and receipt of revenues from, ILUVIEN for DME; Alimera’s ability to continue as a going concern; the effect of
pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of fluocinolone acetonide side effects; outcome of dispute
with Alimera on commercialization expenses; any exercise by Pfizer of its option with respect to the latanoprost product; our ability to develop
Tethadur to successfully deliver large biologic molecules and develop products using it; efficacy and future development of severe OA implant
by us; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to
market and sell products; the success of current and future license agreements; termination or breach of current license agreements; effects
of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations
and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability;
industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; effects
of potential U.K. exit from the EU; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other
factors described in our filings with the SEC. You should read and interpret any forward-looking statements in light of these risks. Should
known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results
and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-
looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation
to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results
expressed or implied in such statements will not be realized.
2
3. DELIVERING INNOVATION TO THE EYE
Focused on preventing
blindness through
proprietary sustained release
drug technologies
3
4. OUR HISTORY
More than 20 years of focus on eye diseases
Developed 3 FDA approved sustained release products
used for the posterior segment of the eye
Licensed ophthalmology products to Bausch & Lomb & Alimera
Medidur™ program for posterior uveitis approaching commercialization
Dario Paggiarino, M.D. appointed Chief Medical Officer on August 1, 2016
Nancy Lurker appointed President & CEO on September 15, 2016
4
5. NANCY LURKER: 25-YEAR CAREER
OF MAXIMIZING PHARMACEUTICAL ASSETS
Multiple
key launches
including
Plavix®, Detrol®
and Detrol LA®,
Ambien®, Reclast®
and Exforge®
Strong track
record of working
with R&D to
transition products
from the clinic to
commercialization
Expertise in
launch risk
mitigation
US and
International
markets
Led public
and private
companies
5
6. KEY PSIVIDA ATTRIBUTES
Proved sustained release injectable
drug technology for small molecules
Developed three approved branded
eye products
Fourth eye product in the pipeline with
commercial launch potential within 18 months/
EU; 24 months/US
Solid balance
sheet
Strong scientific
team
6
7. ILUVIEN™ FOR DIABETIC MACULAR EDEMA
(DME): PARTNERED WITH ALIMERA
Approvals
Approved for DME in US, 17 EUs
Payments
PSDV received over $55m to date
Revenues to PSDV
20% of any product profit
Lasts for
3 Years
ILUVIEN™
Licensed Product
7
8. DURASERT™: APPROVED TECHNOLOGY
FOR OCULAR DELIVERY
Long Duration
Up to 3 years from single injection minimizes
frequent monthly ocular injections; now focusing
on 6-month regimen
Proprietary Sustained Polymer Technology
Tailored to be bioerodible or non-erodible
Broadly Applicable
Can deliver many types of small molecule drugs
Strong Patent Estate
Issued patents covering technology and inserter
extend beyond 2027
Lasts for
3 Years
DURASERT™
Approved Technology
8
10. UVEITIS IS THE
THIRD LEADING CAUSE OF
PREVENTABLE BLINDNESS
IN THE DEVELOPED WORLD
Source: The Ocular Immunology and Uveitis Foundation 10
11. UVEITIS IS
INFLAMMATION
OF THE UVEAL
TRACT (IRIS,
CILIARY BODY,
CHOROID) OR
ADJACENT
STRUCTURES
Posterior
Segment
Anterior
Segment
11
12. MEDIDUR PHASE III
PRODUCT FOR POSTERIOR SEGMENT UVEITIS
US
PREVALENCE
175,000
CASES
POTENTIAL
TO EXCEED
$100M*
ANNUAL REVENUE
5 YEARS AFTER LAUNCH
* Internal Market Research 12
13. MEDIDUR™ PHASE III
TREATMENT FOR POSTERIOR SEGMENT UVEITIS
SAME
DURASERT™
MICRO-INSERT
AS FDA APPROVED
ILUVIEN™
SAME DRUG AS
RETISERT™
AND ILUVIEN™
DELIVERS
FLUOCINOLONE
ACETONIDE
(CORTICOSTEROID)
13
14. MEDIDUR™ CLINICAL PROGRAM
Study 001 Phase III
clinical trial: 129 patients
Primary end-point:
Prevention of recurrence
Result:
p < 0.000000001
FIRST PHASE III TRIAL:
PREVENTION OF
RECURRENCE
COMPLETE
INSERTER TRIAL:
EASE OF
ADMINISTRATION
COMPLETE
Study 006 Phase III
clinical trial: 26 patients
Primary end-point:
Ease of administration
Result:
Positive usability
Study 005 Phase III
clinical trial: 150 patients
Primary end-point:
Prevention of recurrence
Enrollment status:
Complete by 4Q2016
SECOND PHASE III TRIAL:
PREVENTION OF
RECURRENCE
ONGOING
14
15. EFFICACY END-POINT: UVEITIS RECURRENCE
RATES AT 6 AND 12 MONTHS
6 MONTHS
RECURRENCE
18.4%
Medidur™ eyes
vs
78.6%
sham
Medidur™ eyes
3.9X
more likely to be
recurrence free
Primary
end-point
achieved
p < 0.000000001
12 MONTHS
RECURRENCE
27.6%
Medidur™ eyes
vs
85.7%
sham
Medidur™ eyes
5.1X
more likely to be
recurrence free
Evidence of
durable
response
15
16. VISUAL ACUITY GAIN (VS DAY 1)
VISION GAIN @ 12 MONTHS (≥15 LETTERS)
22.9%
Medidur™ treated
eyes gained
11.9%
sham eyes
gained
VISION GAIN @ 6 MONTHS (≥15 LETTERS)
22.9%
Medidur™ treated
eyes gained
7.3%
sham eyes
gained Medidur™
had positive
effect on
vision gain
16
17. SYSTEMIC MEDICATION SPARING @ 6 MONTHS
18.2%
Medidur™: 8/44 still on
system medication
52.4%
Sham: 11/21 still on
systemic medication
SYSTEMIC MEDICATION SPARING @ 12 MONTHS
18.2%
Medidur™ still on
system medication
52.4%
sham patients still on
systemic medication
SYSTEMIC MEDICATION SPARING
AT 6 AND 12 MONTHS
Medidur™
had significant
systemic sparing
medication
effect
*At baseline 50.3% of patients were on systemic meds (steroids, immuno-modulators, biologics)
17
18. SAFETY ENDPOINT: IOP ELEVATION
IOP
6 MONTH
MEDIDUR
6 MONTH
SHAM
6 MONTH
DELTA
AS OF
JULY 1,
2016
MEDIDUR
AS OF
JULY 1,
2016
SHAM
AS OF
JULY 1,
2016
DELTA
> 21 mm 27.6% 16.7% 10.9% 34.5% 26.2% 8.3%
> 25 mm 16.1% 4.8% 11.3% 21.8% 16.7% 5.1%
> 30 mm 10.3% 0% 10.3% 17.2% 11.9% 5.3%
Surgery 2.4% 0% 2.4% 4.6% 4.8% -0.2%
Difference
between Medidur™
and sham
decreases with time
*Inter-Ocular Pressure
18
19. AS OF JULY 1, 2016
45%
of phakic Medidur™
eyes had CS
9.5%
of phakic control
eyes had CS
SAFETY ENDPOINT: CATARACT SURGERY
At baseline
51%
of eyes
had already had
cataract surgery
(CS)
BY 6 MONTHS
9.5%
of phakic* Medidur™
eyes had CS
4.8%
of phakic control
eyes had CS
*Phakic = normal lens
19
20. EU MAA FILING UPDATE
Study 006
Inserter
clinical trial:
26 patients
Preparing
filing package
for MAA filing
in Q1 ʼ17
Study 001
Phase III
clinical trial:
129 patients
Primary
end-point:
Prevention of
Recurrence
20
21. FDA FILING UPDATE
Study 001
Phase III
clinical trial:
129 patients
Primary
end-point:
Prevention of
Recurrence
Study 005
Phase III
clinical trial:
150 patientsPreparing
filing package
for NDA filing
in 2H 2017
Study 006
Inserter
clinical trial:
26 patients
21
24. WET-AMD PROGRAM:
DURASERT™ WITH TKI
US PREVALENCE
~1.2M
PATIENTS
200,000
NEW DX PER YEAR
2015 GLOBAL
MARKET SIZE
$5.3B*
* Internal Market Research 24
25. WET-AMD PROGRAM:
DURASERT™ WITH TKI
CURRENT
TREATMENT
(ANTI-VEGF)
REQUIRES
INTRAVITREAL
INJECTIONS EVERY
4 WEEKS
OR MORE
LONG TERM
STUDIES SHOW
PROGRESSIVE
VISION LOSS
DESPITE
CONTINUED
ANTI-VEGF
THERAPY
25
26. DURASERT™ WITH TKI FOR WET-AMD
Tyrosine kinase inhibitors (TKIs) are antiangiogenic small molecules
known to inhibit both VEGF and PDGF, two factors involved in wet AMD
TKIs dual pharmacological action and sustained delivery could result in:
Improved vision and
Reduced frequency of intravitreal injections
TKI on market is effective in two non-clinical models
of wet AMD with Durasert™
IND-enabling studies with bioerodible Durasert™
underway now
26
28. ESTABLISH
CLEAR
OPERATING
PLAN
FOR CURRENT
FISCAL YEAR
END OF YEAR OBJECTIVES
ESTABLISH
THREE
YEAR
STRATEGIC
PLAN
STAY ON
TRACK FOR
US/EU
REGULATORY
FILINGS
EXPAND AND
ACCELERATE
WORK ON
COLLABORATIONS
TO MAXIMIZE
SUSTAINED
RELEASE
TECHNOLOGY
28