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| ISTA > SEC Filings for ISTA > Form 10-Q on 6-Nov-2007 | All Recent SEC Filings |
6-Nov-2007
Quarterly Report
This Quarterly Report on Form 10-Q contains forward-looking statements that have been made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995 and concern matters that involve risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. Discussions containing forward-looking statements may be found in the material set forth under "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Risk Factors" and other sections of this Quarterly Report on Form 10-Q. Words such as "may," "will," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential,"
"continue" or similar words are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Although we believe that our opinions and expectations reflected in the forward-looking statements are reasonable as of the date of this Quarterly Report on Form 10-Q, we cannot guarantee future results, levels of activity, performance or achievements, and our actual results may differ substantially from the views and expectations set forth in this Quarterly Report on Form 10-Q. We expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof to conform such statements to actual results or to changes in our opinions or expectations. Readers are urged to carefully review and consider the various disclosures made by us, which attempt to advise interested parties of the risks, uncertainties, and other factors that affect our business, including without limitation the disclosures made under the captions "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in this Quarterly Report on Form 10-Q and the audited financial statements and the notes thereto and disclosures made under the captions "Management Discussion and Analysis of Financial Condition and Results of Operations", "Risk Factors", "Consolidated Financial Statements" and "Notes to Consolidated Financial Statements" included in our Annual Report on Form 10-K for the year ended December 31, 2006. We obtained the market data and industry information contained in this Quarterly Report on Form 10-Q from internal surveys, estimates, reports and studies, as appropriate, as well as from market research, publicly available information and industry publications. Although we believe our internal surveys, estimates, reports, studies and market research, as well as industry publications, are reliable, we have not independently verified such information, and, as such, we do not make any representation as to its accuracy.
Overview
We are an ophthalmic pharmaceutical company. Our products and product candidates address the $3.2 billion U.S. prescription ophthalmic market and include therapies for inflammation, ocular pain, glaucoma, allergy and dry eye. We currently have three products for sale in the U.S.: Xibrom™ (bromfenac sodium ophthalmic solution) for the treatment of inflammation and pain following cataract surgery, Istalol® (timolol maleate ophthalmic solution) for the treatment of glaucoma, and Vitrase® (hyaluronidase for injection) for use as a spreading agent. We also have several product candidates in various stages of development. We have incurred losses since inception and had an accumulated deficit of $293.3 million through September 30, 2007.
Third Quarter Developments
We increased our net revenue by 92% in the third quarter of 2007, as compared to the third quarter of 2006.
During September 2007, we licensed exclusive North American rights to nasal dosage forms of bepotastine, an investigational product for the treatment of allergy symptoms, from Tanabe Seiyaku Co., Ltd. Under the terms of our license agreement with Tanabe, we have paid an upfront payment to Tanabe of $2.0 million, and will make additional payments based on achievement of development and approval milestones, and royalties on future product sales. We are responsible for all costs associated with developing nasal bepotastine for North America, including clinical trials, FDA filings, manufacturing, and, if the product is approved, marketing and sales activities. We also obtained the right to develop other nasal bepotastine products, including a fixed combination with a steroid, and a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.
Results of Operations
Three Months Ended September 30, 2007 and 2006
Net Revenue. Net revenue was approximately $15.9 million for the three months ended September 30, 2007, as compared to $8.3 million for the three months ended September 30, 2006. The increase in net revenue was primarily attributable to the continued growth of Xibrom and Istalol in the marketplace.
In addition to product revenues for the three months ended September 30, 2007 and 2006, we recorded license revenue of $69,000 in each of the three months ended September 30, 2007 and 2006, reflecting the amortization of deferred revenue recorded in December 2001 for the license fee payment made by Otsuka Pharmaceuticals Co., Ltd. in connection with the license of Vitrase in Japan for ophthalmic uses in the posterior region of the eye.
The following table sets forth our net revenue for each of our products for each of the three month periods ended September 30, 2007 and 2006 and the corresponding percentage change.
Quarter Ended Quarter Ended
$ millions September 30, 2007 September 30, 2006 % Change
Xibrom $ 11.3 $ 5.2 117 %%
Istalol 3.0 2.1 43 %%
Vitrase 1.5 0.9 67 %%
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Quarter Ended Quarter Ended
$ millions September 30, 2007 September 30, 2006 % Change
Other 0.1 0.1 0 %%
Total Net Revenue $ 15.9 $ 8.3 92 %%
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Gross margin and cost of products sold. Gross margin for the three months ended September 30, 2007 was 74%, or $11.7 million, as compared to 70%, or $5.7 million, for the three months ended September 30, 2006. The increase in gross margin as a percentage of net revenue is primarily due to the change in revenue mix, primarily driven by increased Xibrom sales. Historically, as an early stage commercial entity, we were not party to any wholesaler inventory management arrangements, but we anticipate going forward that we may enter into to such arrangements. We believe these arrangements, if entered into, could negatively impact our future net sales and gross margin.
Cost of products sold was $4.2 million for the three months ended September 30, 2007, as compared to $2.5 million for the three months ended September 30, 2006. Cost of products sold for the three months ended September 30, 2007 consisted primarily of standard costs for each of our commercial products, distribution costs, royalties, and other costs of products sold. The increase in cost of products sold is primarily the result of increased net product sales year over year.
We expect our gross margin for 2007 will be approximately 71% to 74%, subject to quarterly fluctuations based on revenue mix, and are currently tracking to the upper end of the range.
Research and development expenses. Research and development expenses were $8.1 million for the three months ended September 30, 2007, as compared to $8.0 million for the three months ended September 30, 2006. Included in research and development expenses for the third quarter ended September 30, 2007 was $3.0 million in milestone expense, including an upfront payment expense in the amount of $2.0 million associated with the licensing of the nasal dosage form of bepotastine from Tanabe. Our research and development expenses to date have consisted primarily of costs associated with the clinical trials of our product candidates, compensation and other expenses for research and development personnel, costs for consultants and contract research organizations and costs related to the development of commercial scale manufacturing capabilities for Vitrase, Istalol and Xibrom.
Generally, our research and development resources are not dedicated to a single project but are applied to multiple product candidates in our portfolio. As a result, we manage and evaluate our research and development expenditures generally by the type of costs incurred. We generally classify and separate research and development expenditures into amounts related to clinical development costs, regulatory costs, pharmaceutical development costs, manufacturing development costs, and medical affairs costs. In addition, we also record as research and development expenses any up front and milestone payments that have accrued to third parties prior to regulatory approval of a product candidate under our licensing agreements unless there is an alternative future use. For the three months ended September 30, 2007, approximately 24% of our research and development expenditures were for clinical development costs, 12% were for regulatory costs, 4% were for pharmaceutical development costs, 16% were for manufacturing development costs, 7% were for medical affairs costs and approximately 37% were for research and development related milestones, part of which was for an up front payment to in-license the nasal dosage form bepotastine.
Changes in our research and development expenses are primarily due to the following:
• Clinical Development Costs - Overall clinical costs, which include clinical investigator fees, study monitoring costs and data management, for the three months ended September 30, 2007 were $2.0 million as compared to $2.8 million for the three months ended September 30, 2006 or a decrease of $0.8 million. The decrease in clinical costs was primarily due to the timing of commencement and completion of various clinical trials.
• Regulatory Costs - Regulatory costs, which include compliance expense for existing products and other activity for pipeline projects, were $0.9 million for each of the three months ended September 30, 2007 and 2006.
• Pharmaceutical Development Costs - Pharmaceutical development costs, which include costs related to the testing and development of our pipeline products, for the three months ended September 30, 2007 were $0.3 million as compared to $0.4 million for the three months ended September 30, 2006 or a decrease of $0.1 million. The decrease is primarily due to the overall reduction in outside research expenses.
• Manufacturing Development Costs - Manufacturing development costs, which include costs related to production scale-up and validation, raw material qualification, and stability studies, were $1.3 million for each of the three months ended September 30, 2007 and 2006.
• Medical Affairs Costs - Medical affairs costs, which include activities that relate to medical information in support of our products, were $0.6 million for each of the three months ended September 30, 2007 and 2006.
Our research and development activities reflect our efforts to advance our product candidates through the various stages of product development. The expenditures that will be necessary to execute our development plans are subject to numerous uncertainties, which may affect our research and development expenditures and capital resources. For instance, the duration and the cost of clinical trials may vary significantly depending on a variety of factors including a trial's protocol, the number of patients in the trial, the duration of patient follow-up, the number of clinical sites in the trial, and the length of time required enrolling suitable patient subjects. Even if earlier results are positive, we may obtain different results in later stages of development, including failure to show the desired safety or efficacy, which could impact our development expenditures for a particular product candidate. Although we spend a considerable amount of time planning our development activities, we may be required to alter from our plan based on new circumstances or events or our assessment from time to time of a product candidate's market potential, other product opportunities and our corporate priorities. Any deviation from our plan may require us to incur additional expenditures or accelerate or delay the timing of our development spending. Furthermore, as we obtain results from trials and review the path toward regulatory approval, we may elect to discontinue development of certain product candidates in certain indications, in order to focus our resources on more promising candidates or indications. As a result, the amount or ranges of estimable cost and timing to complete our product development programs and each future product development program is not estimable.
Depending upon the progress of our clinical and pre-clinical programs, we expect our research and development expenses in 2007 will be approximately $28 to $30 million.
Selling, general and administrative expenses. Selling, general and administrative expenses were $11.3 million for the three months ended September 30, 2007, as compared to $9.2 million for the three months ended September 30, 2006. The $2.1 million increase in selling, general and administrative expenses in 2007 as compared to 2006 primarily results from higher sales and marketing expenses associated with the expansion of our sales force. Selling, general, and administrative expenses during the third quarter of 2007 and 2006 each include $0.7 million, respectively, in stock-based compensation expense.
We anticipate our selling, general and administrative expenses for 2007 will be approximately $44 to $48 million, excluding stock compensation expense which we estimate will be approximately $3 to $4 million for 2007.
Stock-based compensation. Compensation for stock options granted to non-employees has been determined in accordance with Statement of Financial Accounting Standards, or SFAS, No. 123(R), "Share-Based Payment" and Emerging Issues Task Force Consensus No. 96-18, "Accounting for Equity Instruments that are Issued to Other Than Employees for Acquiring or in Conjunction with Selling Goods or Services". Stock option compensation for non-employees is recorded as the related services are rendered and the value of compensation is periodically re-measured as the underlying options vest.
For the three months ended September 30, 2007 and 2006, we granted stock options to employees to purchase 52,600 shares of common stock (at a weighted average exercise price of $7.11 per share) and 24,800 shares of common stock (at a weighted average exercise price of $6.27 per share), respectively, equal to the fair market value of our common stock at the time of grant. We also issued 2,000 and 1,500 restricted stock awards for the three months ended September 30, 2007 and 2006, respectively, and included in stock compensation expense was $83,000 and $36,000 for the three months ended September 30, 2007 and 2006, respectively, related to these restricted stock awards.
Interest income. Interest income was each $0.7 million for the three months ended September 30, 2007 and the three months ended September 30, 2006, respectively.
Interest expense. Interest expense was $1.2 million for the three months ended September 30, 2007 and $1.0 million for the three months ended September 30, 2006. The increase is due in part to the amortization of the discount on the convertible notes offset by the change in the value of the derivative associated with the convertible notes.
We expect our net interest expense in 2007 will be approximately $2 to $3 million as a result of the interest on our senior subordinated convertible notes and interest on our revolving credit facility, offset by interest earned on our higher cash balances.
Nine Months Ended September 30, 2007 and 2006
Net Revenue. Net revenue was approximately $39.7 million for the nine months ended September 30, 2007, as compared to $20.7 million for the nine months ended September 30, 2006. The increase in net revenue was primarily attributable to the continued growth of Xibrom and Istalol in the marketplace.
Included in net revenues for the nine months ended September 30, 2007 and 2006, we recorded license revenue of $0.2 million in each of the nine months ended September 30, 2007 and 2006, reflecting the amortization of deferred revenue recorded in December 2001 for the license fee payment made by Otsuka Pharmaceuticals Co., Ltd. in connection with the license of Vitrase in Japan for ophthalmic uses in the posterior region of the eye.
The following table sets forth our net revenue for each of our products for each of the nine month periods ended September 30, 2007 and 2006 and the corresponding percentage change.
Nine Months Ended Nine Months Ended
$ millions September 30, 2007 September 30, 2006 % Change
Xibrom $ 28.1 $ 12.0 134 %
Istalol 7.7 5.7 35 %
Vitrase 3.7 2.8 32 %
Other 0.2 0.2 0 %
Total Net Revenue $ 39.7 $ 20.7 92 %
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Gross margin and cost of products sold. Gross margin for the nine months ended
September 30, 2007 was 74%, or $29.3 million, as compared to 68%, or $14.1
million, for the nine months ended September 30, 2006. The increase in gross
margin as a percentage of net revenue is primarily due to the change in revenue
mix. Cost of products sold was $10.4 million for the nine months ended
September 30, 2007, as compared to $6.7 million for the nine months ended
September 30, 2006. Cost of products sold for the nine months ended
September 30, 2007 consisted primarily of standard costs for each of our
commercial products, distribution costs, royalties, and other costs of products
sold. The increase in cost of products sold is primarily the result of increased
net product sales year over year.
Research and development expenses. Research and development expenses were $20.2 million for the nine months ended September 30, 2007, as compared to $17.2 million for the nine months ended September 30, 2006. The increase in research and development expenses for the nine months ended September 30, 2007 was primarily the result of an increase in clinical development costs, which include FDA filing fees, clinical investigator fees, study monitoring costs and data management costs, due to the completion of the Xibrom QD once-daily Phase III studies, the completion of the Bepreve™ (bepotastine ophthalmic solution) Phase II/III study, the completion of the ecabet sodium Phase IIb confirmatory study and the recording of milestone expense in the amount of $3.0 million, which included a $2.0 million upfront payment associated with the licensing of the nasal dosage form of bepotastine from Tanabe.
For the nine months ended September 30, 2007, approximately 39% of our research and development expenditures were for clinical development costs, 14% were for regulatory costs, 4% were for pharmaceutical development costs, 19% were for manufacturing development costs, 9% were for medical affairs costs and approximately 15% was for research and development related milestones, part of which was for an up front payment to in-license the nasal dosage form of bepotastine.
Changes in our research and development expenses are primarily due to the following:
• Clinical Development Costs - Overall clinical costs, which include clinical investigator fees, study monitoring costs and data management, for the nine months ended September 30, 2007 were $7.9 million as compared to $5.2 million for the nine months ended September 30, 2006 or an increase of $2.7 million. The increase in clinical costs in 2007 was primarily due to the completion of the Xibrom QD once-daily Phase III clinical trials, completion of the ecabet sodium Phase IIb confirmatory study and completion of the Bepreve™ (bepotastine ophthalmic solution) Phase II/III clinical trials.
• Regulatory Costs - Regulatory costs, which include compliance expense for existing products and other activity for pipeline projects, were $2.7 million for the nine months ended September 30, 2007 as compared to $3.0 million for the nine months ended September 30, 2006 or a decrease of $0.3 million. The decrease in regulatory costs for the nine months ended September 30, 2007 was primarily due to the allocation of FDA fees to inventory.
• Pharmaceutical Development Costs - Pharmaceutical development costs, which include costs related to the testing and development of our pipeline products, for the nine months ended September 30, 2007 were $0.9 million as compared to $1.2 million for the nine months ended September 30, 2006 or a decrease of $0.3 million. The decrease is primarily due to the overall reduction in outside research expenses.
• Manufacturing Development Costs - Manufacturing development costs, which include costs related to production scale-up and validation, raw material qualification, and stability studies, for the nine months ended September 30, 2007 were $3.8 million as compared to $3.6 million for the nine months ended September 30, 2006 or an increase of $0.2 million. The increase is primarily attributable to the allocation of production costs to capitalized inventory as a function of the scale up of activities associated with the increase in the number of commercial products during 2007 as compared to 2006.
Selling, general and administrative expenses. Selling, general and administrative expenses were $35.8 million for the nine months ended September 30, 2007, as compared to $28.9 million for the nine months ended September 30, 2006. The $6.9 million increase in selling, general and administrative expenses in 2007 as compared to 2006 primarily results from higher sales and marketing expenses associated with the expansion of our sales force. Selling, general, and administrative expenses during the 2007 and 2006 periods include $2.4 million and $2.0 million, respectively, in stock-based compensation expense.
Stock-based compensation. For the nine months ended September 30, 2007 and 2006, we granted stock options to employees to purchase 1,004,629 shares of common stock (at a weighted average exercise price of $7.62 per share) and 793,924 shares of common stock (at a weighted average exercise price of $6.64 per share), respectively, equal to the fair market value of our common stock at the time of grant. We also issued 105,291 restricted stock awards and 81,180 restricted stock awards for the nine months ended September 30, 2007 and 2006, respectively, and included in stock compensation expense was $221,000 and $83,000 for the nine months ended September 30, 2007 and 2006, respectively, related to these restricted stock awards.
Interest income. Interest income was $1.5 million for the nine months ended September 30, 2007, as compared to $1.3 million for the nine months ended September 30, 2006. The increase in interest income was primarily attributable to higher cash balances as a result of our receipt of $40.0 million in net proceeds from the issuance of senior subordinated convertible notes during 2006, the interest earned on the restricted cash and higher rates of return as compared to 2006.
Interest expense. Interest expense was $3.1 million for the nine months ended September 30, 2007, as compared to $1.2 million for the nine months ended September 30, 2006. The increase in interest expense was primarily attributable to the interest on the outstanding amounts under our credit facility, the amortization of the deferred financing costs, the amortization of the discount and the change in the value of the derivative associated with the issuance of $40.0 million in senior subordinated convertible notes and the interest recorded on these outstanding senior subordinated convertible notes.
Liquidity and Capital Resources
As of September 30, 2007, we had approximately $55.8 million in cash, cash equivalents and short-term investments, $3.2 million of restricted cash, which supports a letter of credit issued as security for interest payments on our outstanding senior subordinated convertible notes, and working capital of $41.5 million. Historically, we have financed our operations primarily through sales of our debt and equity securities. Since March 2000, we have received gross proceeds of approximately $281.7 million from sales of our common stock and the issuance of promissory notes and convertible debt.
Under our revolving credit facility, we may borrow up to the lesser of $10.0 million or 66.67% of our unrestricted cash, cash equivalents and net receivables. As of September 30, 2007, we had $2.5 million available for borrowing under the credit facility. All outstanding amounts under the credit facility bear interest at a variable rate equal to the lender's prime rate plus 0.5%, which is payable on a monthly basis. The credit facility also contains customary covenants regarding operations of our business and financial covenants relating to ratios of current assets to current liabilities and is collateralized by all of our assets with the exception of our intellectual property. As of September 30, 2007, we were in compliance with all of the covenants under the credit facility. All amounts owing under the credit facility will become due and payable on March 31, 2008.
In April 2006, we entered into a credit arrangement whereby we may borrow up to $1.2 million to finance the purchase of certain capital equipment. The outstanding amounts under this arrangement will become due and payable ratably over three years from the purchase date of the equipment. As of September 30, 2007, $0.7 million was outstanding under this arrangement.
Additionally, in June 2006, we issued an aggregate of $40.0 million in principal amount of our senior subordinated convertible notes, bearing 8% interest per annum payable quarterly in cash in arrears which began October 1, 2006. The notes mature in June 2011 and are convertible, at any time following their issuance, into shares of our common stock at a conversion price of $7.63 per share, subject to certain adjustments and limitations set forth therein.
For the nine months ended September 30, 2007, we used $22.7 million of cash for operations principally as a result of the net loss of $28.4 million, the net change in operating assets and liabilities of $2.2 million, offset by the recording of $2.4 million in stock based compensation and the recording of $0.9 million in depreciation and amortization. For the nine months ended . . .
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