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INSV > SEC Filings for INSV > Form 10-Q on 14-Aug-2012All Recent SEC Filings

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Form 10-Q for INSITE VISION INC


14-Aug-2012

Quarterly Report


Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The discussion in this Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of the federal securities laws that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. The cautionary statements made in this report should be read as applicable to all related forward-looking statements wherever they appear in this document. Our actual results could differ materially from those discussed herein. Factors that could cause or contribute to such differences include those discussed below under "Risk Factors," as well as elsewhere herein. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence or identification of unanticipated events.

The following discussion should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2011.

Overview

We are an ophthalmic product development company advancing ophthalmic pharmaceutical products to address unmet eye care needs. Our current portfolio of products is based on our proprietary DuraSite ® sustained drug delivery technology.

Our DuraSite sustained drug delivery technology is a proven synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. It enables topical delivery of a drug as a solution, gel or suspension and can be customized for delivering a wide variety of drug candidates. We have focused our research and development and commercial support efforts on the following topical products formulated with our DuraSite drug delivery technology. We may also utilize our DuraSite technology platform for the formulation of new ocular product candidates using either non-proprietary drugs or compounds originally developed by others for non-ophthalmic indications.

• AzaSite®(azithromycin ophthalmic solution) 1% is a DuraSite formulation of azithromycin, a broad spectrum ocular antibiotic approved by the U.S. Food and Drug Administration (FDA) in April 2007 to treat bacterial conjunctivitis (pink eye). It was commercialized in the United States by Inspire Pharmaceuticals, Inc. (Inspire) beginning in August 2007. The key advantages of AzaSite are a significantly reduced dosing regimen leading to better compliance and outcome, with a broad spectrum antibiotic, and a lowered probability of bacterial resistance based on high tissue concentration. On May 16, 2011, Merck & Co. (Merck) acquired Inspire and Inspire became a wholly-owned subsidiary of Merck. Merck is now responsible for commercializing AzaSite in North America. We receive a 25% royalty on net sales of AzaSite in North America.

• Besivance®(besifloxacin ophthalmic suspension) 0.6% is a DuraSite formulation of besifloxacin, a broad spectrum ocular antibiotic approved by the FDA in May 2009 to treat bacterial conjunctivitis (pink eye). An advantage of Besivance is a faster rate of resolution of the infection that may reduce the duration of the illness and reduce the chances of infecting others. Besivance was developed by Bausch & Lomb Incorporated (Bausch & Lomb) and launched in the United States in the second half of 2009. In 2011, Besivance was launched internationally in select countries. We receive a middle single-digit royalty on net sales of Besivance globally.

• AzaSite PlusTM (ISV-502) is a fixed combination of azithromycin and dexamethasone in DuraSite for the treatment of ocular inflammation and infection (blepharitis and/or blepharoconjunctivitis) for which there is no FDA approved indicated treatment. We completed a Phase 3 trial in November 2008 and AzaSite Plus was very well tolerated. Although efficacious, the trial did not achieve its primary clinical endpoint as defined by the previous protocol. We discussed the results of this trial with the FDA and determined a new development plan for this product candidate. In May 2011, we reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the design of a Phase 3 clinical trial of AzaSite Plus in patients with


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blepharitis. An SPA is a written agreement with the FDA that the study design and planned analysis of the sponsor's Phase 3 clinical trial adequately addresses the objectives necessary to support a regulatory submission. We initiated a new Phase 3 clinical trial for this product candidate in the fourth quarter of 2011.

• DexaSiteTM (ISV-305) is a DuraSite formulation of dexamethasone in development for the treatment of ocular inflammation. We have met with the FDA to discuss the development pathway for this product candidate. DexaSite is included in the Phase 3 clinical trial SPA for AzaSite Plus. Accordingly, we initiated a Phase 3 clinical trial for this product candidate in the fourth quarter of 2011.

• BromSiteTM (ISV-303) is a DuraSite formulation of bromfenac in development for the treatment of post-operative inflammation and eye pain. We initiated a Phase 1/2 clinical trial for this product candidate in August 2010 and completed patient enrollment in December 2010. In the first quarter of 2011, we received positive top-line results from this study, which demonstrated the efficacy and safety of BromSite. In the third quarter of 2011, we completed an additional Phase 2 clinical trial to investigate the pharmacokinetics (PK) of BromSite in humans. We received positive top-line results that showed that the mean concentration of bromfenac in the aqueous humor of patients using BromSite was more than double compared to the currently available bromfenac eye product. We have discussed the design of the Phase 3 clinical trial with the FDA. We initiated a Phase 3 clinical trial for this product candidate in July 2012.

• ISV-101 is a DuraSite formulation with a low concentration of bromfenac for the treatment of dry eye disease. We filed an Investigational New Drug Application (IND) with the FDA for this product candidate in the first quarter of 2011. We anticipate a Phase 1/2 clinical trial for this product candidate, but no time period has been set.

Business Strategy.

Our business strategy consists of the following:

1. Develop our pipeline of ocular product candidates. We seek to identify new product candidates from proven drugs that can be improved by formulation in DuraSite, which substantially reduces the clinical risk in these product candidates. We plan to conduct preclinical and clinical testing of our portfolio product candidates.

2. Monetize our product candidates. At the appropriate time, we seek to partner with larger pharmaceutical companies to manufacture and market these products. Partnering agreements generally include upfront and milestone payments, as well as on-going royalty payments upon commercialization, payable to us.

Major Developments

Our major developments and events in 2012 included:

• As of July 24, 2012, we had 826 patients, out of 900 planned patients, enrolled in the AzaSite Plus/DexaSite Phase 3 clinical trial; and

• In July 2012, we initiated the BromSite Phase 3 clinical trial.


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Results of Operations

Revenues.

Our revenues for the three and six months ended June 30, 2012 and 2011 were:

                                    Revenues

                                 (in millions)



                                   Three months ended           Six months ended
                                        June 30,                    June  30,
                                  2012            2011          2012          2011
          AzaSite royalties     $     1.3       $     2.6     $    3.2       $  5.4
          Besivance royalties         0.5             0.3          0.9          0.4
          Other                        -              0.2           -           0.4

          Total                 $     1.8       $     3.1     $    4.1       $  6.2

For the three months ended June 30, 2012 and 2011, the decrease in AzaSite royalties was driven by a 50% decrease in AzaSite net sales by Merck. The increase in Besivance royalties was driven by an increase in net sales of Besivance by Bausch + Lomb. Revenues in the second quarter of 2011 also included $0.2 million from the amortization and recognition of international license fee payments for AzaSite.

For the six months ended June 30, 2012 and 2011, the decrease in AzaSite royalties was driven by a 40% decrease in AzaSite net sales by Merck. The increase in Besivance royalties was driven by an increase in net sales of Besivance by Bausch + Lomb. Revenues in the six months ended June 30, 2011 also included $0.2 million from the amortization and recognition of international license fee payments for AzaSite and $0.2 million from the sale of azithromycin to Merck under a supply agreement (the "Supply Agreement").

Research and development expenses.

Our research and development (R&D) expenses for the three and six months ended June 30, 2012 and 2011 were:

                              R&D Cost by Program

                                 (in millions)



                                     Three months ended           Six months ended
                                          June  30,                   June  30,
        Program                     2012            2011          2012          2011
        AzaSite Plus/DexaSite     $     2.2       $     0.2     $    4.2       $  0.3
        BromSite                        0.8             0.3          1.2          0.4
        New products and other          0.2             0.1          0.4          0.3
        Programs - non-specific         1.6             0.8          3.0          1.6

        Total                     $     4.8       $     1.4     $    8.8       $  2.6

For the three and six months ended June 30, 2012, our AzaSite Plus/DexaSite program expenses primarily related to costs for our Phase 3 clinical trial. As of June 30, 2012, we had 760 patients enrolled. Our BromSite program expenses primarily related to the costs of preparing for a Phase 3 clinical trial. Non-specific program costs, which comprised facility, internal personnel and stock-based compensation costs that are not allocated to a specific development program, increased primarily due to an increase in headcount as a direct result of the Phase 3 clinical trials for AzaSite Plus/DexaSite and the planned Phase 3 clinical trial for BromSite. In addition, we continue to incur R&D expense to develop new product candidates.


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For the three and six months ended June 30, 2011, program expenses primarily consisted of non-specific program costs which comprised facility, internal personnel and stock-based compensation costs that are not allocated to a specific development program. Our AzaSite Plus/DexaSite program expenses primarily related to costs to prepare for the new Phase 3 clinical trial. Our BromSite program expenses primarily related to the Phase 1/2 clinical trial that was initiated in August 2010.

General and administrative expenses.

General and administrative expenses for the three months ended June 30, 2012 and 2011 were $1.4 million and $1.5 million, respectively. In the 2011 period, the Company incurred higher legal expenses pertaining to patent litigation with the Regents of the University of California and Sandoz, Inc. General and administrative expenses for the six months ended June 30, 2012 and 2011 were $2.8 million.

Cost of revenues.

Cost of revenues for the three months ended June 30, 2012 and 2011 were $0.2 million and $0.4 million, respectively. Cost of revenues for the six months ended June 30, 2012 and 2011 were $0.5 million and $0.9 million, respectively. Cost of revenues were primarily comprised of royalties accrued for third parties, including Pfizer. For the six months ended June 30, 2011, cost of revenues also included $0.2 million for the cost of the azithromycin supplied to Merck under the Supply Agreement.

Interest expense and other, net.

Interest expense and other, net, for the three months ended June 30, 2012 and 2011 was an expense of $2.5 million and $2.6 million, respectively. Interest expense and other, net, for the six months ended June 30, 2012 and 2011 was an expense of $4.9 million and $5.1 million, respectively. These expenses are primarily related to interest on our secured notes payable.

Change in fair value of warrant liability.

Change in fair value of warrant liability was income of $0.2 million and $1.2 million, respectively, for the three and six months ended June 30, 2012. The income resulted from a decrease in the fair value of our warrant liability that was previously valued as of March 31, 2012 and December 31, 2011, respectively, and revalued as of June 30, 2012. The decrease in fair value was primarily driven by a decrease in our stock price.


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Liquidity and Capital Resources

In recent years, we have financed our operations primarily through private placements, debt financings and payments from corporate collaborations. At June 30, 2012, our cash and cash equivalents and short-term investments were $2.1 million and $15.5 million, respectively. It is our policy to invest our cash and cash equivalents and short-term investments in highly liquid securities, such as interest-bearing money market funds, treasury and federal agency notes. The current uncertain credit markets may affect the liquidity of such money market funds or other cash investments.

Net cash used in operating activities was $8.8 million and $4.3 million for the six months ended June 30, 2012 and 2011, respectively. The increase primarily resulted from $4.2 million of costs incurred for our AzaSite/DexaSite Phase 3 clinical trial.

Net cash provided by investing activities was $9.0 million and $3.0 million for the six months ended June 30, 2012 and 2011, respectively. In 2012 and 2011, we converted short-term investments to cash and cash equivalents.

For the six months ended June 30, 2012 and 2011, we undertook no financing activities.

Recent Accounting Pronouncements

In May 2011, the Financial Accounting Standards Board issued Accounting Standards Update No. 2011-04 ("ASU 2011-04"), Fair Value Measurement - Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRS. The amendments in this update will ensure that fair value has the same meaning in U.S. GAAP and in IFRS and that their respective fair value measurement and disclosure requirements are the same. This update is effective prospectively for interim and annual periods beginning after December 15, 2011. We adopted ASU 2011-04 effective January 1, 2012. The adoption of this amendment did not materially impact our consolidated statement of financial position or results of operations.


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