ISTA Pharmaceuticals Inc. (ISTA)

[surf1944]

7:30AM ISTA Pharm reports 'positive', topline results from its Phase 2 clinical trial of BEPOSONE nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis (ISTA) 9.05 : According to the trial findings, BEPOSONE nasal spray showed highly statistically significant improvements compared to placebo in patients' nasal symptoms following exposure to one of the most potent seasonal allergy triggers, Mountain Cedar pollen. These improvements were seen as early as Day 1 of therapy and were sustained through the two-week treatment period. Statistically significant improvement was also seen for BEPOSONE within 15 minutes after dosing in a small subgroup of subjects who frequently evaluated their nasal symptoms for 4 hours after their first nasal spray dose. Further, safety data demonstrated BEPOSONE was well-tolerated as a nasal spray, with an adverse event profile similar to placebo and generally consistent with those observed with bepotastine besilate dosed as a nasal spray in prior clinical trials and with other antihistamine nasal sprays. "Based on these results and the positive Phase 2 results from our single-agent antihistamine nasal spray of bepotastine besilate, BEPOMAX, which were reported last year, we expect to complete some additional Phase 2 studies ahead of our Phase 3 pivotal program covering both products, slated to begin in 2013. BEPOSONE and BEPOMAX represent exciting potential expansions of our prescription allergy product line, currently focused on BEPREVE (bepotastine besilate ophthalmic solution) 1.5% for the treatment of ocular itching associated with allergic conjunctivitis."

[surf1944]

7:30AM ISTA Pharm announces issuance of U.S. patent for Prolensa (ISTA) 8.38 : Co announced that the United States Patent and Trademark Office has issued Patent No. 8,129,431 with claims covering PROLENSA (bromfenac ophthalmic solution), ISTA's once-daily topical nonsteroidal anti-inflammatory product for the treatment of ocular inflammation and pain following cataract surgery. The patent was issued to ISTA's licensor, Senju Pharmaceuticals Co. Ltd., and was granted a patent term adjustment that extends the patent life originally set to expire January 2024 to September 2025.

[Penny Roger$]

~ Thursday! $ISTA ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $ISTA ~ Earnings expected on Thursday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








http://stockcharts.com/h-sc/ui?s=ISTA&p=D&b=3&g=0&id=p88783918276&a=237480049




http://stockcharts.com/h-sc/ui?s=ISTA&p=W&b=3&g=0&id=p54550695994



~ Google Finance: http://www.google.com/finance?q=ISTA
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=ISTA#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=ISTA+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=ISTA
Finviz: http://finviz.com/quote.ashx?t=ISTA
~ BusyStock: http://busystock.com/i.php?s=ISTA&v=2


<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=ISTA >>>>>>



http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.

[mlkrborn]

ISTA Pharm board reiterates commitment to maximizing shareholder value through strategic review process (ISTA) 7.96 : In response to Valeant's withdrawal of its unsolicited proposal to acquire ISTA, ISTA's Board of Directors reiterated its commitment to maximizing shareholder value and said it will continue its previously announced review of all strategic options available. Vicente Anido Jr., President and Chief Executive Officer of ISTA, said, "ISTA remains committed to reviewing the full range of strategic options that are available to the Company. While we continue to make excellent progress and are pleased with the level of interest generated to date, it will take time to complete a thorough and thoughtful review. We repeatedly offered Valeant the opportunity to participate in our strategic review process on a level playing field with others, but it was clear Valeant was only interested in an approach that would have effectively excluded others. We informed Valeant that there were simply too many other companies that had indicated strong interest in ISTA for us to take that approach."

[mlkrborn]

ISTA Pharm: Valeant Pharmaceuticals (VRX) confirms its increased $7.50 bid for ISTA (ISTA) 7.27 : Valeant expressed its disappointment that the Board of Directors and management of ISTA have not been willing to meaningfully engage with Valeant on a timely basis to obtain the benefits of its proposal. "We do not understand why ISTA would not have already pursued discussions with us and provided due diligence access... Our proposal represents an attractive premium to ISTA's trading performance, and we believe it offers a compelling opportunity for shareholders in light of ISTA's ongoing operational challenges." Valeant calls on the Board of Directors of ISTA to engage in discussion with Valeant and to provide it with access to selected due diligence in order to enter into a transaction no later than January 31, 2012... See 1:26 comment for additional details.

[mlkrborn]

ISTA Pharm sees 2012 revs of $180-195 mln vs. 195.6 mln CIQ Est; sees EPS of $0.28-0.36 vs. $0.35 consensus (ISTA) 6.99 -0.04 : Co announced during its 2012 Guidance and Pipeline Update webcast/conference call that it expects to achieve 2011 net revenues above $160 mln and expects to be profitable in 2011 for the second consecutive year on an adjusted cash net income basis, according to preliminary unaudited estimates. Co provided its 2012 revenue guidance and gave additional detail on income and cash. ISTA expects: 2012 net revenues will be ~$180-195 mln. 2012 adjusted cash net income will be $15 mln to $19 mln, or fully diluted earnings per share of $0.28-0.36, assuming 53 mln fully diluted shares. The co defines "adjusted cash net income" as the company's net income adjusted for the non-cash mark-to-market adjustments relating to warrants, plus non-cash interest expense and non-cash stock-based compensation. 2012 adjusted EBITDA (or adjusted cash net earnings (or income) before interest, taxes, depreciation and amortization) will be $25 mln to $29 mln. Year-end 2012 cash balance will be at least $100 mln. This amount is after any scheduled debt repayments and includes amounts drawn on ISTA's bank line plus reserves for XIBROM/BROMDAY royalties.

[surf1944]

Valeant Bid Opens Eyes On ISTA Pharmaceuticals' Value

http://seekingalpha.com/article/316760-valeant-bid-opens-eyes-on-ista-pharmaceuticals-value?source=yahoo

[$King]

ISTA @ 6.68

[mlkrborn]

Offer rejected; PPS up!
ISTA Pharm Board of Directors confirms rejection of unsolicited, non-binding proposal from Valeant (VRX) (ISTA) 6.83 +2.86 : Co confirmed today that it had received a letter on November 23, 2011 from Valeant Pharmaceuticals International (VRX) outlining an unsolicited, non-binding proposal to acquire all of the outstanding shares of ISTA for $6.50 per share in cash, subject to due diligence. ISTA also confirmed receipt of a letter from Valeant dated December 16, 2011 reaffirming its non-binding proposal. After careful deliberation, with the assistance of its financial and legal advisors, ISTA's Board of Directors had previously determined on December 13, 2011 that the non-binding proposal was grossly inadequate and not in the best interests of ISTA shareholders.

[formbeach]

PPS doubled in premarket

[Kenswift]

This is what all that insider buying as about.

Valeant Makes Public Its Interest In Buying ISTA Pharmaceuticals

Valeant Pharmaceuticals International Inc. (VRX) is proposing to acquire Irvine, Calif.-based ISTA Pharmaceuticals Inc. (ISTA), a pharmaceutical company with eye-care and allergy drugs, for $6.50 a share in cash.

Valeant said its proposed offer is worth about $327 million including net debt, and represents a premium of about 67% over ISTA's closing price Thursday of $3.89.

The Mississauga, Ont. drug company said ISTA rebuffed its initial overtures, made in early October, prompting Valeant to make a formal written proposal to ISTA's management on Nov. 23. It later reaffirmed the proposal, but said ISTA rejected it on Dec. 14. That led Valeant to publicly unveil its proposal Friday.

The offer will only remain in effect until Jan. 31, Valeant said.

It's been a busy last few months for Valeant in terms of acquisitions. It's buying Australia's iNova Pharmaceuticals and recently completed the purchase of Calgary's Afexa Life Sciences Inc. Both were friendly deals.

-By Carolyn King, Dow Jones Newswires; 416-306-2100; [e-mail]

[surf1944]

6:31AM ISTA Pharm's REMURA was highly effective but not statistically significantly better than placebo; PROLENSA statistically significant (ISTA) 3.79 : Co announced top-line results from the second of its two Phase 3 studies to evaluate the short-term safety and efficacy of two concentrations of REMURA in alleviating the signs and symptoms of dry eye disease. In the EAST study, REMURA was highly effective in treating a sign and symptom of dry eye but was not statistically significantly better than placebo in the entire patient cohort, a common outcome reported in studies testing other dry eye therapies. In both Phase 3 studies, safety data demonstrated REMURA was well-tolerated, with an adverse event profile similar to placebo. Co also announced statistically significant results from the Phase 3 clinical program for PROLENSA. In both Phase 3 studies, PROLENSA was statistically significantly better than placebo and met the primary efficacy endpoint of absence of ocular inflammation 14 days following surgery and the secondary efficacy endpoint of elimination of ocular pain one day post-surgery. There were no serious drug-related ocular or systemic adverse events.

[surf1944]

2. ISTA Pharmaceuticals Inc. (ISTA): Develops, and markets remedies for diseases and conditions of the eye in the United States. Market cap of $169.95M. Projected 5-year EPS growth at 25.00%. Price at $3.94. Net institutional shares purchased over the current quarter at 10.7M, which is 31.94% of the company's 33.50M share float.

18 High-Growth Smart Money Picks Trading Under $5

http://seekingalpha.com/article/292600-18-high-growth-smart-money-picks-trading-under-5?source=yahoo

[mlkrborn]

ISTA Pharmaceuticals Reports Second Quarter 2011 Financial Results
Date : 07/28/2011 @ 4:05PM
Source : MarketWire
Stock : ISTA Pharmceuticals (ISTA)
Quote : 4.945 -2.255 (-31.32%) @ 1:50PM

ISTA Pharmaceuticals Reports Second Quarter 2011 Financial Results
Ista Pharmaceuticals, Inc. (MM) (NASDAQ:ISTA)
Intraday Stock Chart

Today : Friday 29 July 2011
Click Here for more Ista Pharmaceuticals, Inc. (MM) Charts.

ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today reported financial results and progress on key milestones for the quarter ended June 30, 2011.

Second Quarter 2011 Highlights

* Second quarter 2011 net revenues were $37.1 million, an increase of 6% over the second quarter of 2010.



* Revenues for ISTA's ophthalmic solution for ocular itching associated with allergic conjunctivitis, BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%, almost doubled over the prior-year quarter, growing from $6.2 million to $12.2 million.



* In April 2011, ISTA announced positive, top-line results from its Phase 2 study of bepotastine besilate nasal spray for allergic rhinitis.



* Under generally accepted accounting principles in the United States (GAAP), net income for the second quarter ended June 30, 2011, was $12.8 million, or $0.25 per share, based on 50.2 million fully diluted shares, impacted primarily by a non-cash warrant valuation gain of $19.0 million resulting from a decrease in the Company's stock price in the quarter. On an adjusted cash basis, ISTA had a net loss of $4.2 million, or loss of $0.11 per share, based on 38.4 million shares outstanding.



"As a company, we consistently record 40% of our net revenues in the first half of the year and 60% in the second half. Our first half net revenues of $73.9 million clearly put us on track to achieve our 2011 annual revenue guidance of $175 million to $190 million," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "In the second quarter, as a result of a concentrated sales and marketing campaign during a rather severe spring allergy season, product revenues for BEPREVE, our prescription eye drops for ocular itching associated with allergic conjunctivitis, were up 97% over the prior-year quarter. We have established a solid second position behind the market leader with a product that brings fast, long-lasting relief to ocular allergy sufferers.

"Prior to the allergy season, we successfully converted more than 80% of the bromfenac franchise from twice-daily XIBROM™ to once-daily BROMDAY™ for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extractions. We discontinued XIBROM shipments in late February and refocused our selling efforts on BEPREVE. Midway into the second quarter, a generic competitor to twice-daily XIBROM was approved. While the sales force was dedicated to BEPREVE, our channel and managed care teams were working to strengthen our bromfenac franchise position within the ophthalmic non-steroidal anti-inflammatory drug (NSAID) market. Year-to-date June 2011, as compared to 2010, total prescriptions for ISTA's bromfenac franchise (BROMDAY and XIBROM) increased 6.5% and on a weekly basis, BROMDAY continues to capture share. While revenues for our bromfenac franchise were down in the second quarter over the prior-year quarter, now that the spring allergy season is over, our sales force is fully dedicated to building share with the only once-daily NSAID on the market. Overall, our commercial business has been highly effective this year and with recent managed care contract wins for both BEPREVE and BROMDAY, we have confidence that we can gain share in both the allergic conjunctivitis and NSAID markets in the second half."

Dr. Anido continued, "In terms of progress on our new product pipeline, in April, we announced positive, top-line results from our Phase 2 study of bepotastine besilate nasal spray for allergic rhinitis. We're in discussions with the U.S. Food and Drug Administration (FDA) on the clinical study designs for a bepotastine besilate/steroid combination nasal spray and plan to initiate a Phase 2 trial either during the Mountain Cedar Pollen season later this year or during spring allergy season early next year. Our recently initiated Phase 3 studies for low-concentration BROMDAY are now fully enrolled. We plan to announce results from the low-concentration BROMDAY studies in fourth quarter of this year and launch the product in late 2012 or early 2013.

"In a separate press release today, we reported the preliminary results for the first of two Phase 3 efficacy and short-term safety trials for REMURA™ for dry eye (WEST study), which showed that while REMURA was highly effective in treating a sign and symptom of dry eye versus baseline, it was not statistically significantly better than placebo, a common outcome in dry eye clinical studies. REMURA achieved statistical significance against placebo in the sign of conjunctival staining in a key female patient sub-population with moderate dry eye disease. Armed with this data, we expect to amend the statistical plan to appropriately focus the EAST study. In the fourth quarter of this year, we expect to report the Phase 3 results from the REMURA EAST study, which now is fully enrolled but the database has not been locked. The EAST data will be combined with the results of the WEST study, and the full dataset will determine the next steps for this program."

Financial Results

Net revenues for the second quarter ended June 30, 2011, were $37.1 million, or an increase of 6% over the same period in 2010. Net revenue growth was driven primarily by strong demand for BEPREVE, for ocular itching associated with allergic conjunctivitis, and ISTALOL®, a beta-blocking agent for the treatment of glaucoma.

[mlkrborn]

ISTA $5.00

July 29, 2011, 10:22 a.m. EDT
Ista plunges 28% on study failure, downgrades



By Val Brickates Kennedy



BOSTON (MarketWatch) -- Shares of Ista Pharmaceuticals /quotes/zigman/89471/quotes/nls/ista ISTA -31.39% plunged 28% to $5.16 early Friday, the day after it released a disappointing quarterly-earnings report and poor preliminary results from a Phase III study for its ophthalmology drug Remura. As a result, Stifel Nicolaus on Friday lowered its rating of the stock to hold. RBC Capital, meanwhile, maintained its outperform rating, but lowered its price target to $12 from $15.

[surf1944]

ISTA Pharm ISTA Stifel Nicolaus Buy » Hold

Read more: http://www.breifing.com/investor/calendars/upgrades-downgrades/#ixzz1TV1rjw9s

[surf1944]

ISTA Pharmaceuticals Announces Conference Call and Webcast of Second Quarter 2011 Financial Results

Press Release Source: ISTA Pharmaceuticals On Friday July 15, 2011, 7:30 am EDT

IRVINE, CA--(Marketwire - 07/15/11) - ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA - News) today announced it will release second quarter 2011 financial results after the market closes on July 28, 2011. In conjunction, the Company will host a conference call at 4:30 p.m. Eastern Time to review the Company's commercial operations and provide pipeline updates.

Date: Thursday, July 28, 2011
Time: 4:30 p.m. Eastern Time

Conference call access:
Internet: www.istavision.com
Domestic dial-in: 866.804.6922
International dial-in: 857.350.1668
Passcode: 73568588

To access the 24-hour audio replay, U.S. and Canadian participants may dial 888.286.8010; international participants may dial 617.801.6888. The access code for the replay is 37743515. This conference call also will be webcast live and archived on ISTA's website until September 4, 2011.

[surf1944]

ISTA Pharmaceuticals Announces Company's Addition to Russell 3000 and NASDAQ Biotechnology Indexes

Press Release Source: ISTA Pharmaceuticals On Thursday June 16, 2011, 7:30 am EDT

IRVINE, CA--(Marketwire - 06/16/11) - ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA - News) has received notification it will join the Russell 3000® Index when Russell Investments reconstitutes its family of U.S. indexes on June 25, 2011.

The Russell Indexes capture the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization to create the Russell 3000® Index and the Russell Microcap® Index. Russell indexes are reconstituted annually and are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies.

Membership in the Russell 3000, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index, as well as the appropriate growth and value style indexes. The Russell 3000 also serves as the U.S. component to the Russell Global Index. Russell determines membership for its equity indexes primarily by objective, market capitalization rankings and style attributes.

In addition, ISTA announced the Company was added to the NASDAQ Biotechnology Index in late May.

[surf1944]

ISTA Pharm ISTA RBC Capital Mkts Outperform $8 » $15

Read more: http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm#ixzz1LOI1T8Tk

[surf1944]

7:34AM ISTA Pharm reports positive, topline results from its phase 2 clinical trial of Bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis (ISTA) 10.17 : co announces positive, topline results from its Phase 2 dose-ranging, environmental clinical trial of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. According to the trial findings, each of three concentrations of bepotastine besilate nasal spray showed statistically significant improvements compared to placebo in patients' nasal symptoms following exposure to Mountain Cedar pollen during the peak season for this allergen. These improvements were seen on day one of therapy and were sustained through the two-week treatment period. Further, safety data demonstrated bepotastine besilate was well-tolerated as a nasal spray, with an adverse event profile similar to placebo and consistent with those observed with bepotastine besilate dosed as a nasal spray in prior clinical trials and with other antihistamine nasal sprays.

[Adventurous]

Everything is looking great!

[surf1944]

ISTA Pharm ISTA RBC Capital Mkts Sector Perform $6 » $8

[surf1944]

4:03PM ISTA Pharm beats by $0.05, beats on revs; guides FY11 EPS below consensus, revs in-line (ISTA) 7.14 -0.08 : Reports Q4 (Dec) earnings of $0.14 per share, $0.05 better than the Thomson Reuters consensus of $0.09; revenues rose 49.4% year/year to $51.1 mln vs the $46.8 mln consensus. Co issues mixed guidance for FY11, sees EPS of $0.11-0.18 vs. $0.19 Thomson Reuters consensus; sees FY11 revs of $175-190 mln vs. $180.23 mln Thomson Reuters consensus.

[Adventurous]

BOOOOM - Called that bottom at 5.40 and now we're in the 7's!

[Adventurous]

Bingo...super nice pop! ISTA! Looking for much more over the long run!

[Adventurous]

Today's crash was all because of the market! I picked some up at 5.39! Looking for the rebound on Monday! Let the uptrend continue!

[Adventurous]

BUMP - ISTA doing well lately! Lots of potential here!

[TheBioTrader]

ISTA - Ascending Triangle on watch. This is a low float so watch out.

[sleepingGiants]

thats cool thanks

[kei]

http://finance.yahoo.com/q/ce?s=ISTA+Company+Events

i'm sorry...
the date is ----> november 2nd (not november 3rd)

http://biz.yahoo.com/cc/9/117539.html

[kei]

>>>I was asking because I'm waiting on a 510k decision.

hi :)

sorry, but i don't have an answer to your question.
i myself a new shareholder.

good luck to us :)

[sleepingGiants]

thank you

[kei]

hi :)

their earning report is coming on november 3rd (just 2 weeks away)
they had a great 2nd quarter report on august 4...since then, the price is going up steadily.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=55612634

price hystory:
http://finance.yahoo.com/q/hp?s=ISTA+Historical+Prices

no one knows how good or bad about their 3rd quarter, but so far, the company does look solid to me and they also have deep pipelines.

pipelines:
http://www.istavision.com/about/research-development.html

products:
http://www.istavision.com/products.html

[sleepingGiants]

not much buzz for FDA approval

[NORTH LAND]

Do you think the company announced the approval today, Saturday (Weekend), but was given the decision Friday?
I think a company has 48-hrs to announce the approval.
I'm surprised the fda would give a decision on the weekend.
I might be wrong; however.
I was asking because I'm waiting on a 510k decision.
Do you have any input?

[kei]

http://finance.yahoo.com/news/ISTA-Pharmaceuticals-Receives-prnews-395117310.html?x=0&.v=1

[kei]

surf, good morning
going up nicely here...
do you think approval will come?
tia

[surf1944]

ISTA Pharmaceuticals Initiates Phase 3 Clinical Program for REMURA in Dry Eye Disease
- FDA Agrees to Special Protocol Assessment -

http://finance.yahoo.com/news/ISTA-Pharmaceuticals-prnews-1214950145.html?x=0&.v=1

[surf1944]

ISTA Pharmaceuticals (ISTA)
EV/Rev = 0.49

Current share price: $2.94

Ista is a company I've talked about before. Their primary product is XiBrom for the treatment of ocular pain and inflammation following eye surgery. The product lost exclusivity in January of this year but the company has yet to face any generic competition. The threat of generic competition is a real one, however, as Xibrom makes up over half of the company's revenues. As of the most recent quarter, operating cash flows were virtually zero.

Ista may have a rosier future, however. Total product sales year-over-year have increased 47% from 2009 to 2010. Furthermore, XiDay, a once daily version of Xibrom, faces a PDUFA date of October 16 and could allow Ista to maintain its XiBrom revenues. The company has several other treatments in the pipeline - including ecabet sodium and bromfenac for dry eye and T-Pred for inflammatory ocular conditions - but none have advanced beyond phase II trials yet.

Ista is covered by three research analysts with an average 'buy' rating and an average one year price target of $6.33/share.

http://seekingalpha.com/article/222299-five-potential-small-cap-biotech-bargains?source=yahoo

[surf1944]

ISTA Pharmaceuticals Initiates Clinical Development of Bepotastine Besilate Nasal Spray for the Treatment of Symptoms Associated with Seasonal Allergic Rhinitis

http://finance.yahoo.com/news/ISTA-Pharmaceuticals-prnews-2419683928.html?x=0&.v=1

[surf1944]

ISTA Pharmaceuticals to Present at the Jefferies 2010 Global Life Sciences Conference

http://finance.yahoo.com/news/ISTA-Pharmaceuticals-to-prnews-1003995520.html?x=0&.v=1

[surf1944]

7:34AM ISTA Pharm misses by $0.08, misses on revs; guides FY10 EPS below consensus, revs in-line (ISTA) 4.08 : Reports Q1 (Mar) loss of $0.20 per share, excluding a non-cash warrant valuation gain of $7.2 million, or $0.21 per share, $0.08 worse than the Thomson Reuters consensus of ($0.12); revenues rose 38.7% year/year to $28.3 mln vs the $28.9 mln consensus. Co issues mixed guidance for FY10, sees EPS of at least $0.02 vs. $0.05 Thomson Reuters consensus; sees FY10 revs of $147-165 mln vs. $150.83 mln Thomson Reuters consensus.

[surf1944]

ISTA Pharmaceuticals Announces Conference Call and Webcast of First Quarter 2010 Financial Results

Press Release Source: ISTA Pharmaceuticals, Inc. On Friday April 16, 2010, 8:00 am EDT
IRVINE, Calif., April 16 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA - News), today announced it will release first quarter 2010 financial results before market open on April 30, 2010. In conjunction, the Company will host a conference call at 10:00 a.m. Eastern Time to discuss these results and provide a pipeline update.


Date: Friday, April 30, 2010

Time: 10:00 a.m. Eastern Time


Conference call access:

Internet: www.istavision.com

Domestic dial-in: 800-591-6944

International dial-in: 617-614-4910

Passcode: 68237813


To access the 24-hour audio replay, U.S. and Canadian participants may dial 888-286-8010; international participants may dial 617-801-6888. The access code for the replay is 91982881. This conference call also will be webcast live and archived on ISTA's website until May 30, 2010.

[surf1944]

ISTA says FDA to review eye drug by Oct. 16
ISTA Pharmaceuticals says FDA to review once-daily eye inflammation treatment by Oct. 16

On Monday March 8, 2010, 5:54 pm EST
IRVINE, Calif. (AP) -- ISTA Pharmaceuticals Inc. said Monday the Food and Drug Administration will make a regulatory decision on the once-daily eye inflammation treatment XiDay by Oct. 16.

The drug is a once-per-day version of Xibrom, a drug that is already on the market but is intended to be used twice a day.

XiDay, like Xibrom, is aimed at treating eye inflammation following cataract surgery.

ISTA said the FDA is still considering the company's request for a shorter, six-month, priority review.

ISTA reported Xibrom net sales of $81.1 million for the year ended December 31, 2009.

Shares of ISTA rose 6 cents to $3.89 in after-hours trading after rising 10 cents, or 2.7 percent, to close at $3.83 during the regular trading session.

[surf1944]

ISTA Pharm ISTA RBC Capital Mkts Sector Perform $7 to $6

[surf1944]

ISTA Pharmaceuticals Announces 2010 Financial Guidance
ISTA Expects 2010 Net Revenue of $147 to $165 Million
Company Anticipates 2010 Operating Income of $8 to $10 Million

Press Release Source: ISTA Pharmaceuticals, Inc. On Tuesday February 9, 2010, 9:00 am
IRVINE, Calif., Feb. 9 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced financial guidance for the full year 2010. The Company expects net revenue will be approximately $147 to $165 million. In addition, ISTA's management anticipates reporting its first profitable year in 2010, with earnings per share for the full year expected to be at least $0.02, excluding any mark-to-market adjustments relating to warrants.

"2010 will mark ISTA's transition from a young development company to a financially independent commercial organization," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "By offering products with differentiated value propositions for both the physician and the patient and building a strong and motivated commercial team, we will have achieved this milestone five years after launching our first product, Istalol, which was closely followed by the launch of our flagship product, Xibrom. As we look to 2010 and beyond, Bepreve, Xibrom, XiDay, bepotastine nasal spray, and bromfenac for dry eye stand out as our long-term growth drivers, and we are excited about ISTA's future."

2010 Financial Outlook in Detail


We expect our net revenue for 2010 will be approximately $147 to $165 million. We continue to assume there will not be a generic competitor to Xibrom in 2010. We expect sales from our Xibrom franchise (including XiDay, assuming U.S. Food and Drug Administration (FDA) approval) to be in the range of $95 to $105 million and anticipate sales from Bepreve will be at least $20 million. As in previous years, our net sales are seasonal, with first quarter net sales typically being the lowest of the year and less than the prior quarter.
We expect our gross margin in 2010 will be in the range of 74% to 76%.
We expect R&D expenses to be approximately 18% to 22% of net revenue, depending upon the progress of our clinical programs. In 2010, we will focus our development activities on our bromfenac formulation as a treatment for dry eye disease and our nasal bepotastine formulation for nasal allergies. During 2010, we anticipate initiating our full-scale Phase 3 clinical program in dry eye disease, as well as the long-term safety study required by the FDA in advance of a New Drug Application (NDA) filing. To maximize our bepotastine franchise, we will complete our formulation work for bepotastine nasal and anticipate initiating the clinical program with this product as a treatment for nasal allergies in 2010.
We expect SG&A expenses for 2010 to be approximately 48% to 52% of net revenue.
We expect our operating income for 2010 will be $8 to $10 million.
We expect our net income for 2010 will be at least $1 million, or earnings per share of $0.02, excluding any mark-to-market adjustments relating to warrants. Once we are profitable, we expect our fully diluted common shares, including our outstanding shares of common stock, warrants and stock options on a treasury stock basis, will be approximately 49 million shares.
We expect our business to generate $6 to $10 million in cash in 2010.

As previously announced on February 1, 2010, the Company will issue full financial results for 2009 after market close on February 23, 2010. In conjunction, ISTA will host a conference call to discuss the 2009 results, as well as review the 2010 guidance and the Company's product development pipeline. Information for the call and webcast are available at www.istavision.com.

Xibrom (bromfenac ophthalmic solution)® 0.09%, Istalol® (timolol maleate ophthalmic solution) 0.5%, Bepreve™ (bepotastine besilate ophthalmic solution) 1.5%, and XiDay™ (bromfenac ophthalmic solution) are trademarks of ISTA Pharmaceuticals.

Full prescribing information for Bepreve™ is available on ISTA Pharmaceuticals' website at http://www.istavision.com/pdf/Bepreve_insert.pdf

Full prescribing information for Xibrom™ is available on ISTA Pharmaceuticals' website at www.istavision.com/pdf/XibromPI_XIB553.pdf

Full prescribing information for Istalol® is available on ISTA Pharmaceuticals' website at www.istavision.com/pdf/Istalol_Full_PI-ISL274.pdf

[surf1944]

1:26AM ISTA Pharm issues upside FY09 revenue guidance (ISTA) 3.74 : Co issues upside guidance for FY09 (Dec), sees FY09 (Dec) revs of $110.6 mln vs. $108.60 mln First Call consensus. Growth of its Xibrom 0.09% and Istalol 0.5% franchises, in addition to initial orders for ISTA's treatment for allergic conjunctivitis, Bepreve 1.5%, led to the 33% increase in revenue as compared to 2008 net revenue.

[surf1944]

ISTA Pharmaceuticals Submits Supplemental New Drug Application to the FDA for Once-Daily XiDay(TM)

Press Release Source: ISTA Pharmaceuticals, Inc. On Thursday December 17, 2009, 4:01 pm

IRVINE, Calif., Dec. 17 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the Company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery. ISTA currently markets Xibrom™ (bromfenac ophthalmic solution) 0.09%, which is an eye drop labeled for use twice-daily, beginning 24 hours after cataract surgery. If approved, ISTA plans to market the once-daily product under the brand name XiDay™.

ISTA filed the XiDay sNDA electronically in eCTD format. Pending FDA validation of the electronic file in the coming days and timely acceptance of the filing by the FDA, ISTA expects a standard review of six months from date of receipt.

Xibrom™ (bromfenac ophthalmic solution

Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the product in the U.S. in 2005. Xibrom is the 2009 year-to-date dollar market share leader in the U.S. ophthalmic non-steroidal anti-inflammatory market. ISTA reported Xibrom net sales of $55.1 million for the nine-month period ended September 30, 2009.

Xibrom currently is labeled as an eye drop used twice-daily beginning 24 hours after cataract surgery. Xibrom has not been approved by the FDA as a once-daily treatment. ISTA's sNDA filing requests the Agency approve a change to bromfenac ophthalmic solution's label to reflect its efficacy as a once-daily treatment in this patient population.

[surf1944]

7:31AM ISTA Pharm highlights Bepreve clinical data at the 2009 annual meeting of the American College of Allergy, Asthma & Immunology (ISTA) 4.56 : Co announces additional results from their Bepreve 1.5% Phase 3 clinical studies. These results were presented in poster sessions at the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology in Miami Beach, FL. In a poster presentation titled, "Treatment of Ocular Itching with Bepotastine Besilate Ophthalmic Solution 1.5% for Subjects with More Severe Itching Response in a Conjunctival Allergen Challenge Clinical Model of Allergic Conjunctivitis," integrated results from two Phase 3 studies demonstrated Bepreve 1.5% was as effective in suppressing ocular itching in patients with more severe itching as in patients with all grades of ocular itching. A total of 157 patients were enrolled in two 7-week, masked, randomized, placebo-controlled CAC clinical studies. 113 patients exhibited bilateral ocular itching grades greater than or equal to 3 at screening during study visit 2. Individuals were assessed at 15 minutes, 8 hours, or 16 hours following instillation at study visits spaced 2 weeks apart during the enrollment period. The difference in mean itching grades for the more severely affected subjects was within plus or minus 0.1 unit of the differences for the entire intent-to-treat population

[surf1944]

4:10PM ISTA Pharm misses by $0.02, beats on revs; guides FY09 revs in-line (ISTA) 4.03 +0.32 : Reports Q3 (Sep) loss of $0.03 per share, $0.02 worse than the First Call consensus of ($0.01); revenues rose 47.6% year/year to $32 mln vs the $27.6 mln consensus. Co issues in-line guidance for FY09, sees FY09 revs of $106-109 mln vs. $103.69 mln consensus.