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| NBY > SEC Filings for NBY > Form 10-Q on 14-Aug-2009 | All Recent SEC Filings |
14-Aug-2009
Quarterly Report
The following discussion of our financial condition and results of operations should be read together with our consolidated financial statements and related notes included in Part I, Item 1 of this report. This discussion contains forward-looking statements that involve risks and uncertainties. Words such as "expects," "anticipates," "targets," "goals," "projects," "intends," "plans," "believes," "seeks," "estimates," variations of these words, and similar expressions are intended to identify these forward-looking statements. As a result of many factors, such as those set forth under the section entitled "Risk Factors" in Part II, Item 1A and elsewhere in this report, our actual results may differ materially from those anticipated in these forward-looking statements Readers are cautioned that these forward-looking statements are only predictions based upon assumptions made that we believed to be reasonable at the time, and are subject to risks and uncertainties. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Except as required by law, we undertake no obligation to revise or update publicly any forward-looking statements.
Overview
We are a development stage biopharmaceutical company focused on developing innovative product candidates for the treatment or prevention of a wide range of infections in hospital and non-hospital environments. Many of these infections have become increasingly difficult to treat because of the rapid rise in drug resistance. We have discovered and are developing a class of non-antibiotic anti-infective compounds, which we have named Aganocide compounds. These compounds are based upon small molecules that are naturally generated by white blood cells when defending the body against invading pathogens. We believe that our Aganocide compounds could form a platform on which to create a variety of products to address differing needs in the treatment and prevention of bacterial and viral infections. In laboratory testing, our Aganocide compounds have demonstrated the ability to destroy all bacteria against which they have been tested. Furthermore, because of their mechanism of action, we believe that bacteria are unlikely to develop resistance to our Aganocide compounds.
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Alcon is responsible for all of the costs that it incurs in developing the products using the Aganocide compounds. We announced the clearance of an Investigational New Drug (IND) application submitted by Alcon to the FDA to permit the clinical development of Novabay's NVC-422 for infection of the eye. The IND clearance has triggered the immediate payment of the first milestone of $1,000,000 from Alcon to Novabay. The achievement of the milestones and product commercialization is subject to many risks and uncertainties, including, but not limited to Alcon's ability to obtain regulatory approval from the FDA and Alcon's ability to execute its clinical initiatives. Therefore, we cannot predict when, if ever, the milestones specified in the Alcon agreement will be achieved or when we will receive royalties on sales of commercialized product.
On March 25, 2009, we announced that we entered into an agreement with Galderma S. A. to develop and commercialize our Aganocide® compounds, which covers acne and impetigo and potentially other major dermatological conditions, excluding onychomycosis (nail fungus) and orphan drug indications. The agreement is exclusive and worldwide in scope, with the exception of Asian markets, , where we have has commercialization rights, and North America, where we have an option to exercise co-promotion rights. Galderma will be responsible for the development costs of acne and other indications, except in Japan, in which Galderman has the option to request that we share such development costs, and for the ongoing development program for impetigo, upon the achievement of a specified milestone. Galderma will also reimburse NovaBay for the use of its personnel in support of the collaboration. NovaBay retains the right to co-market products resulting from the agreement in Japan. In addition, NovaBay has retained all rights in other Asian markets outside Japan, and has right to promote the products developed under the agreement in the hospital and other healthcare institutions in North America. Galderma will pay to Novabay certain upfront fees, ongoing fees, reimbursements, and milestone payments related to achieving development and commercialization of its Aganocide® compounds. If products are commercialized under this agreement then NovaBay will receive royalties whose rates escalate as sales increase. Upon the termination of the agreement under certain circumstances, Galderma will grant NovaBay certain technology licenses which would require NovaBay to make royalty payments to Galderma for such licenses with royalty rates in the low- to mid-single digits.
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To date, we have generated no revenue from product sales, and we have financed our operations and internal growth primarily through the sale of our capital stock, and the technology access fee from Alcon. We are a development stage company and have incurred significant losses since commencement of our operations in July 2002, as we have devoted substantially all of our resources to research and development. As of June 30, 2009, we had an accumulated deficit of $27.2 million. Our accumulated deficit resulted from research and development expenses and general and administrative expenses. We expect to continue to incur net losses over the next several years as we continue our clinical and research and development activities and as we apply for patents and regulatory approvals.
Recent Events
In April 2009, NovaBay announced an exclusive agreement with Professors Markus Nagl M.D. and Waldemar Gottardi, Ph.D. of the Medical University of Innsbruck, Austria that broadens NovaBay's intellectual property portfolio and could expand clinical opportunities and accelerate clinical timelines for the Aganocide compounds. Under the terms of the agreement, NovaBay gains access to clinical research, publications and patents on the uses of N-chlorotaurine (NCT), a natural antimicrobial produced by the body's white blood cells and the biological basis for NovaBay's Aganocides, in multiple disease indications.
In June 2009 we filed a shelf registration statement on Form S-3 registering up to $20,000,000 of our securities, which may be in the form of common stock, preferred stock, warrants or debt securities, or units comprising a combination of such securities. The shelf registration statement was declared effective in August 2009.
In July 2009, we announced that Alcon has begun treating patients in a Phase 2 clinical trial of NovaBay's patented lead Aganocide® compound, NVC-422, for viral conjunctivitis, a type of "pink eye."
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Critical Accounting Policies and Estimates Our condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States for interim reporting. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported revenues and expenses during the reporting periods. In preparing these condensed consolidated financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements giving due consideration to materiality. On an ongoing basis, we evaluate our estimates and judgments related to revenue recognition, income taxes, intangible assets, long-term service contracts and other contingencies. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Our significant accounting policies are more fully described in Note 2 of the Notes to Condensed Consolidated Financial Statements, included in Part I, Item 1 of this report, , and are also described in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2008. We have not materially changed these policies from those reported in our Annual Report on Form 10-K for the year ended December 31, 2008.
Results of Operations
Comparison of the Three and Six Months Ended June 30, 2008 and June 30, 2009
License and Collaboration Revenue
Total license and collaboration revenue was $2.4 million for the three months ended June 30, 2009, compared to $1.4 million for the three months ended June 30, 2008, and was $5.0 million for the six months ended June 30, 2009, compared to $2.9 million for the six months ended June 30, 2008. License and collaboration revenue consisted almost exclusively of amounts earned under the license and collaboration agreements with Alcon and Galderma for amortization of the upfront technology access fees, milestones, and other amounts that have been or will be reimbursed for the funding of research and development activities performed during the period. The upfront technology access fee of $10.0 million from Alcon is being amortized into revenue on a straight-line basis over the four year funding term of the agreement, through August 2010. The upfront fee of $1.0 million from Galderma is being amortized into revenue on a straight-line basis over the 20 month funding term of the agreement, through October 2010. The upfront technology access fee from KCI of $200,000 has been amortized on a straight-line basis over 18 months through December 2008.
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Research and Development
Total research and development expenses decreased by 39% to $1.4 million for the three months ended June 30, 2009 from $2.4 million for the three months ended June 30, 2008. Total research and development expenses decreased by 47% to $2.8 million for the six months ended June 30, 2009 from $5.2 million for the six months ended June 30, 2008. The decreases for each of the three and six month periods were primarily due to delayed research, development, and clinical expenses.
We expect to incur increased research and development expenses in the second half of 2009 and in subsequent years as we continue to increase our focus on developing product candidates, both independently and in collaboration with Alcon and Galderma. In particular, we expect to incur ongoing clinical, chemistry, and manufacturing expenses during the latter half of 2009 in connection with the common cold, dermatology, and catheter associated urinary tract infections programs.
General and Administrative
Total general and administrative expenses decreased by 24% to $1.2 million for the three months ended June 30, 2009 compared to $1.6 million for the three months ended June 30, 2008. Total general and administrative expenses decreased by 9% to $2.8 million for the six months ended June 30, 2009 compared to $3.0 million for the six months ended June 30, 2008. General and administrative expenses were lower overall for each of the three and six month periods due to decreased headcount and unfilled positions offset by increases in spending on legal costs and Sarbanes-Oxley implementation.
We expect that general and administrative expenses will increase during the second half of 2009 and in subsequent years due to increasing public company expenses and business development costs and our expanding operational infrastructure. In particular, we expect to incur increasing legal, accounting, investor relations, equity administration and insurance costs in order to operate as a growing public company.
Other Income (Expense), Net
Other income(expense), net decreased to $ (11,000) for the three months ended June 30, 2009 from $94,000 for the three months ended June 30, 2008. Other income/(expense), net decreased to ($1,000) for the six months ended June 30, 2009 from $257,000 for the six months ended June 30, 2008. This decrease was primarily attributable to the liquidation of short term investments in the fourth quarter of 2008, with repurchases of short term investments in February 2009 with lower rates of return which resulted in less interest income in the first six months of 2009. Interest income relates primarily to interest earned on cash, cash equivalents and investments in marketable securities. See "Note 3-Short Term Investments."
We expect that other income (expense), net will vary based on fluctuations in our cash balances and borrowings under equipment loans and the interest rate paid on such balances and borrowings.
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We have incurred cumulative net losses of $27.2 million since inception through June 30, 2009. We do not expect to generate significant revenue from product candidates for several years. Since inception, we have funded our operations primarily through the private placement of our preferred stock and our initial public offering. We raised total net proceeds of $12.6 million from sales of our preferred stock in 2002 through 2006. In October 2007, we completed our IPO in which we raised a total of $20.0 million, or approximately $17.1 million in net cash proceeds after deducting underwriting discounts and commissions of $1.4 million and other offering costs of $1.5 million.
In August 2006, we entered into a collaboration and license agreement with Alcon. Under the terms of this agreement, we received an up-front technology access fee of $10.0 million in September 2006. Additionally, we are entitled to receive semi-annual payments each January and July over the four year term of the agreement to support on-going research and development efforts. In both January and July 2007, we received a payment of $1.4 million to support the performance of research and development activities throughout 2007. The Alcon agreement also provides for milestone payments upon the achievement of specified milestones in each field of use and royalty payments upon the sale of commercialized products. The aggregate milestone payments payable in connection with the ophthalmic, optic and sinus fields are $19.0 million, $12.0 million and $39.0 million, respectively. In January 2009, we received $1.0 million for the non-rejection of an IND application related to its optic indication. However, we cannot predict when, if ever, future milestones specified in the Alcon agreement will be achieved or when we will receive royalties on sales of commercialized products.
During April 2007, we entered into a master security agreement to establish a $1.0 million equipment loan facility with a financial institution. The purpose of the loan is to finance equipment purchases, principally in the build-out of our laboratory facilities. Borrowings under the loan are secured by eligible equipment purchased from January 2006 through April 2009 and will be repaid over 40 months at an interest rate equal to the greater of 5.94% over the three year Treasury rate in effect at the time of funding or 10.45%. In April 2008, the agreement was extended through April 2009 , and as a result no further borrowings are permitted on this loan. There are no loan covenants specified in the agreement. As of June 30, 2009, we had an outstanding equipment loan balance of $658,095 carrying a weighted-average interest rate of 10.95%. The principal and interest due under the loan will be repaid in equal monthly installments through June 2011.
In March 2009, we entered into a license agreement with Galderma. Under the terms of the agreement, we have received an initial upfront payment of $1.0 million. In addition, Galderma will pay to Novabay certain upfront fees, ongoing fees, reimbursements, and milestone payments related to achieving development and commercialization of its Aganocide® compounds.
Cash and Cash Equivalents
As of June 30, 2009, we had cash, cash equivalents, and short-term investments of $10.7 million compared to $12.1 million at December 31, 2008.
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Cash Flows
The following table provides information regarding our cash flows and our
capital expenditures for the six months ended June 30, 2008 and 2009.
Six Months Ended
June 30,
(in thousands) 2008 2009
Cash provided by (used in):
Operating activities $ 5,283 ) $ (979 )
Investing activities 4,065 (2,979 )
Financing activities 275 (141 )
Capital expenditures (included in investing activities above) (493 ) (291 )
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Cash Used in Operating Activities
For the six months ended June 30, 2008 cash used in operating activities of $5.3 million was primarily attributable to our research and development and general and administrative expenses in running our company. For the six months ended June 30, 2009, cash used in operating activities was only $1.0 million, due to the receipt of milestone and other cash payments from collaborative agreements, which offset for the most part our research and development and general and administrative expenses.
Cash Used in (Provided by) Investing Activities
For the six months ended June 30, 2008, cash provided by investing activities of $4.1 million was attributable to sales or maturities of short-term investments (net of purchases) of $4.6 million and purchases of property and equipment of $493,000.
For the six months ended June 30, 2009, cash used in investing activities of $2.9 million was attributable to purchases of short-term investments of $2.7 million and purchases of property and equipment of $291,000.
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Cash Provided by( Used in) Financing Activities
Our financing activities provided cash of $275,000 in the six months ended June 30 2008. Our financing activities for the six months ended June 30, 2008 primarily consisted of $422,000 from borrowings under an equipment loan, offset by $131,000 in principal payments on an equipment loan and $18,000 in payments on capital leases.
Net cash used in financing activities of $141,000 for the six months ended June 30, 2009 was primarily attributable to the payments on the equipment loan and capital lease, offset by proceeds from stock issuances related to the exercise of stock options.
Net Operating Losses and Tax Credit Carryforwards
As of December 31, 2008 we had net operating loss carryforwards for both federal and state income tax purposes of $20.0 million. If not utilized, the federal and state net operating loss carryforwards will begin expiring at various dates between 2014 and 2027.
Current federal and California tax laws include substantial restrictions on the utilization of net operating loss carryforwards in the event of an ownership change of a corporation. Accordingly, our ability to utilize net operating loss carryforwards may be limited as a result of such ownership changes. Such a limitation could result in the expiration of carryforwards before they are utilized
Inflation
We do not believe that inflation has had a material impact on our business and operating results during the periods presented, and we do not expect it to have a material impact in the near future. There can be no assurances, however, that our business will not be affected by inflation.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
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Our commitments consist of an operating lease, a capital lease, and an equipment loan. The operating lease consists of payments relating to the lease for various laboratory and office space in one office building in Emeryville, California. This lease expires on October 31, 2015. Our commitment for a capital lease consists of the total payments due under one lease of laboratory equipment. The capital lease amount of $33,589 includes $1,482 of interest payments over the remaining term of the lease. Our commitment for the equipment loan consists of the total payments due under the loan facility of $725,001. This amount includes $66,906 of interest payments over the remaining term of the loan.
We expect the total cash, cash equivalents and short-term investments, along with committed funding under our license agreement from Alcon, will be sufficient to fund cash requirements for the next twelve months. However, we will need to raise additional capital or incur indebtedness to continue to fund our operations in the future. Our future capital requirements will depend on many factors, including:
• the scope, rate of progress and cost of our pre-clinical studies and clinical trials and other research and development activities;
• future clinical trial results;
• the terms and timing of any collaborative, licensing and other arrangements that we may establish;
• the cost and timing of regulatory approvals;
• the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;
• the effect of competing technological and market developments;
• the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and
• the extent to which we acquire or invest in businesses, products and technologies, although we currently have no commitments or agreements relating to any of these types of transactions.
We do not anticipate that we will generate significant product revenue for a number of years. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements, as well as through interest income earned on cash balances and short-term investments. To the extent that we raise additional funds by issuing equity securities, our shareholders may experience dilution. In addition, debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate one or more of our research or development programs or to obtain funds through collaborations for some of our technologies or product candidates that we would otherwise seek to develop on our own. Such collaborations may not be on favorable terms or they may require us to relinquish rights to our technologies or product candidates.
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