Lauren Silvernail, CFO & VP Corporate Development to present at 2005 Thomas Weisel Partners Healthcare Conference on September 7, 2005 at 3:50 pm EST

Transcription

1 Lauren Silvernail, CFO & VP Corporate Development to present at 2005 Thomas Weisel Partners Healthcare Conference on September 7, 2005 at 3:50 pm EST

2 Forward Looking Statements Certain statements contained herein are forward-looking statements, (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, failure to achieve positive results in clinical trials, failure to receive market clearance from regulatory agencies, and those risks and uncertainties discussed in filings made by ISTA Pharmaceuticals, Inc. with the Securities and Exchange Commission.

3 A specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved products for serious diseases and conditions of the eye.

4 2005 Accomplishments Launch of Vitrase underway Approval of Xibrom March 05 IND for Ecabet Phase IIb March 05 IND for Reformulation Project April 05 Launch of Xibrom Q2 05 Publication of Vitrase Vitreous Hemorrhage Data Q3 05 Added strong ophthalmic steroid to pipeline Q3 05

5 Xibrom - Latest Addition to the Portfolio - Approved March 2005 by U.S. FDA for the reduction of ocular inflammation following cataract surgery Launched Q2 05 Target: ophthalmic surgeons, high volume prescribers of topical anti-inflammatory drugs Sales potential ~ $100M

6 Xibrom Overview 1st twice-daily (BID) ophthalmic NSAID All others are three or four times daily More potent than traditional NSAIDs Excellent safety profile Effective in clearing ocular inflammation In US clinicals 98% of patients treated with Xibrom were pain-free within 6 days

7 US Anti-Inflammatory Market 8.6MM TRx > $400 MM 24% 45% Combo Anti + Steroid (3.8MM) High Potency NSAID (1.5MM) (2.1MM) Low to Mid Potency (1.2MM) 17% 14% Xibrom

8 Xibrom Launch Targeted 10,000 ophthalmologists Sales force deployment: 70 sales reps Multiple presentations and publications Over 400 high prescribers of ophthalmic NSAIDS contacted prior to launch Over 90% agreed to use Xibrom in early experience trial Positive experiences reported

9 Xibrom: XFE (Xibrom First Experience) Trial MDs placed a minimum of 10 patients on Xibrom May & June, 2005 MDs rated Xibrom performance 400 MDs invited to participate 148 MDs reported to date (interim report) 1,589 patients experiences reported MDs reported that Xibrom met or exceeded expectations 98% of the time

10 Xibrom: Early Experience Program 148 Ophthalmologists: 1,589 Patients used Xibrom Very Satisfied: Exceeded Expectations Satisfied: Met All Expectations Dissatisfied: Met Some Expectations Very Dissatisfied: Did not meet Expectations Control of Inflammation 60 41% 84 58% 2 1.4% 0 0% Ease of use by patients % 28 19% % 0 0% Patients compliance with Xibrom % 41 28% % 0 0% Comfort upon Instillation 84 57% 61 41% 2 1.4% 0 0% Overall Safety Profile 79 54% 67 46% 0 0% 0 0% Were Your patients satisfied with Xibrom? 81 55% 67 45% 0 0% 0 0%

11 Xibrom: Early Experience Program 148 Ophthalmologists: 1,589 Patients used Xibrom I was impressed & believe Xibrom may replace the other NSAIDs in my practice I was satisfied & plan to continue using Xibrom in my practice I was a little dissatisfied, but will try Xibrom again to understand where it fits in my practice I will not use Xibrom again 58 39% 84 57% 5 4% 0 0% 100% will continue to use Xibrom

12 Xibrom Launch Results Visited over 80% high prescribers; Decile 9 & 10 visited multiple times Generated close to 1,100 TRxs in Week 7-4% market share and close to 5% market share for NRxs Positive response from physicians Physicians reporting multiple uses replacing other ophthalmic NSAIDS Well prepared for competitive response

13 Strong Franchise Behind Xibrom Product Indication Mkt Size ($M) Launch Date Istalol Glaucoma $170 Launched Vitrase Spreading Agent $50 Launched Xibrom Inflammation $250 Q2 05 Vitrase Vitreous $200 Approvable Hemorrhage Letter Vitrase Tobra/Pred Combo Inflammation $ Caprogel Hyphema $ Ecabet Diabetic Retinopathy Dry Eye $500 $ Strong Steroid Inflammation $

14 Istalol Product Overview Once daily beta blocker (timolol) for glaucoma Strong patent protection Better penetration through cornea Other beta-blockers are gel formulations or BID solutions Estimated U.S. market size: Glaucoma: $1.3 billion Ophthalmic beta-blockers: $170 million

15 Istalol Target Market Non-Selective Beta Blocker Market (3.7MM TRx for Timolol Products) 25% 45% Timolol Gels 2.2 TRx A/O 1.2 TRx Timolol Solutions 1.5 TRx 31% Data Source: IMS

16 Istalol Commercial Progress Now almost 1,700 TRxs per week and growing 3.5% NRx market share 1.24 bottles of Istalol dispensed per Rx Substitution rate is declining Expect further impact of 70 person sales force Modest revenues in 1H 05, improving 2H 05

17 Vitrase Product Overview Ovine hyaluronidase Strong patent protection Multiple uses Multiple vial configurations Estimated U.S. market size: Spreading agent: $50 million Vitreous hemorrhage: $200 million Diabetic retinopathy: $500 million Uses outside of ophthalmology Oncology Plastic surgery Pediatric surgery

18 Vitrase Activities Targeted to ophthalmic surgeons Over 400 accounts purchasing the product, new accounts added weekly Extensive reimbursement activities underway Multiple Continuing Medical Education programs ongoing Numerous publications both efficacy and safety papers for vitreous hemorrhage now published.

19 R&D Focus Xibrom line extensions Expand uses of Vitrase Reformulations- Tobra/Pred combo, strong steroid In-licensed products, e.g., ecabet

20 Tobra/Pred Combo Internally developed, IND filed Proprietary, patented formulation that mimics the composition of tears in an inflamed eye Combo includes most prescribed high potency steroid Phase III trial underway NDA filing early 06

21 US Anti-Inflammatory Market Tobra/Pred 45% 8.6MM TRx > $400 MM Combo Anti + Steroid (3.8MM) High Potency NSAID (1.5MM) (2.1MM) Low to Mid Potency (1.2MM) 17% 24% New Steroid 14% Xibrom

22 Ecabet Sodium Evaporative class of Rx dry eye treatments Mechanism of Action: Increases the quantity and quality of mucin produced by conjunctival goblet cells Mucin is a component of tear film that lubricates while retarding moisture loss from tear evaporation

23 Ecabet Sodium Phase IIb filed IND March 05 Started Q2 05 Completion 2H 05 Finalize endpoints of Phase III trials Pending results of Phase IIb, initiate Phase III trials Will conduct two US Phase III trials NDA filing expected in 07

24 Decreasing Risk Attractive Product Portfolio Profile Low Reward: Low Risk Vitrase Spreading Agent Istalol Tobra/Pred High Reward: Low Risk Strong steroid Xibrom Vitrase Vitreous Hemorrhage Ecabet Dry eye Low Reward: High Risk Caprogel Vitrase Diabetic Retinopathy High Reward: High Risk Increasing Reward

25 Product Launches Istalol Vitrase Strong steroid Xibrom line extensions Xibrom Tobra/Pred Vitrase Diabetic Retinopathy Ecabet sodium Targeting 1 new product intro every months

26 New Product Targets Mix between in-licensed and internal reformulation efforts Sales potential $ million Late-stage (at least Phase II) Fill gaps in the pipeline (e.g., antiinfectives, steroids, allergy)

27 Financial Snapshot Cash & Short-Term Investments, as of 6/30/05 $55.6 million Total Shares Outstanding, 6/30/ million Q2 05 operating expenses of $ 12.7 million, reflecting the sales force scale up and Xibrom launch expenses.

28 Summary Xibrom, Istalol and Vitrase on the market Commercial infrastructure in place Revenue ramp underway Ecabet, tobra/pred combo & strong steroid in late-stage development Searching for late stage products to add to the pipeline

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