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OPHTHALMOLOGY INNOVATION SUMMIT @ AAOOCTOBER 13, 2016
NASDAQ: PSDV NANCY LURKER, PRESIDENT & CEO
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.
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DELIVERING INNOVATION TO THE EYE
Focused on preventing blindness through proprietary sustained release drug technologies
3
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
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
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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
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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
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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
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TWO HIGHLY ATTRACTIVE PROGRAMS:
POSTERIOR SEGMENT UVEITIS WET AMD
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UVEITIS IS THE THIRD LEADING CAUSE OF PREVENTABLE BLINDNESS IN THE DEVELOPED WORLD
Source: The Ocular Immunology and Uveitis Foundation 10
UVEITIS IS INFLAMMATION OF THE UVEAL TRACT (IRIS, CILIARY BODY, CHOROID) OR ADJACENT STRUCTURES
Posterior Segment
Anterior Segment
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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
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)
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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 ADMINISTRATIONCOMPLETE
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 RECURRENCEONGOING
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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
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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
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SYSTEMIC MEDICATION SPARING @ 6 MONTHS
18.2% Medidur™: 8/44 still on
system medication
52.4% Sham: 11/21 still onsystemic medication
SYSTEMIC MEDICATION SPARING @ 12 MONTHS
18.2% Medidur™ still on system medication
52.4% sham patients still onsystemic 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
SAFETY ENDPOINT: IOP ELEVATION
IOP6 MONTH MEDIDUR
6 MONTH SHAM
6 MONTH DELTA
AS OFJULY 1,
2016MEDIDUR
AS OFJULY 1,
2016SHAM
AS OFJULY 1,
2016DELTA
> 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
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
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
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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 2017Study 006
Inserterclinical trial: 26 patients
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WET AGE-RELATED MACULAR DEGENERATION (AMD) IS A CHRONIC EYE DISEASE THAT CAUSES PROGRESSIVE VISION LOSS
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CAUSED BY ABNORMAL BLOOD VESSELS THAT LEAK FLUID OR BLOOD INTO THE MACULA (CENTRAL VISION)
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WET-AMD PROGRAM:DURASERT™ WITH TKI
US PREVALENCE
~1.2MPATIENTS
200,000NEW DX PER YEAR
2015 GLOBAL MARKET SIZE
$5.3B*
* Internal Market Research 24
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
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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
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FINANCIAL HIGHLIGHTS
CASH:
$29M AT JUNE 30 2016
NODEBT
34M SHARES
0.6M WARRANTS
5.1M OPTIONS
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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
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DELIVERINGINNOVATION
TO THE EYE 29
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