The above expenditures for contract research and development for our current and future drug candidates will vary from quarter-to-quarter depending on the status of our research and development projects. For example, we began clinical development of our neuraminidase inhibitor, peramivir, by starting the first clinical trial with an intravenous formulation during the first quarter of 2006. We also began the scale-up manufacturing required for validation of the manufacturing process for both peramivir and our lead product Fodosine™, BCX-1777, an inhibitor of the enzyme purine nucleoside phosphorylase (“PNP”). Fodosine™ is currently in various stages of clinical development in multiple oncology indications, including a Phase II trial in T-cell leukemia. As these trials progress and additional trials are started, our costs for clinical studies will increase significantly.
Changes in our existing and future research and development and collaborative relationships also will impact the status of our research and development projects. For example, in November 2005 we entered into a license agreement with Roche for the worldwide development and commercialization for our second PNP inhibitor, BCX-4208. In addition to an upfront payment plus an advance payment for some manufacturing we will perform, Roche has assumed financial responsibility for the future development costs associated with this program. In February 2006, we licensed Fodosine™ to Mundipharma for the development and commercialization of this drug in Europe, Asia and Australasia. In addition to the upfront payment of $10 million, Mundipharma will pay 50% of the clinical development costs we will incur for Fodosine™ on existing and planned clinical trials, but their portion shall not exceed $10 million.
Although we may, in some cases, be able to control the timing of development expenses, in part by accelerating or decelerating certain of these costs, many of these costs will be incurred irrespective of whether we are able to discover drug candidates or obtain collaborative partners for commercialization. As a result, we believe that quarter-to-quarter comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of future performance. If we fail to meet the research, clinical and financial expectations of securities analysts and investors, it could have a material adverse effect on the price of our common stock.
Research and development (“R&D”) expenses increased 112.6% to $11,190,000 in the three months ended June 30, 2006 from $5,263,000 in the three months ended June 30, 2005. The increase is primarily attributable to expenses for contract research and synthesis of compound related to the clinical development and manufacturing of our drug candidates, Fodosine™ and peramivir. We are currently in several additional clinical trials with Fodosine™ as compared to the same period in 2005 and we initiated clinical testing of peramivir late in the first quarter of 2006. In addition, we have also started the process of manufacturing validation for both Fodosine™ and peramivir. There was also an increase in compensation cost for the second quarter of 2006 compared to the second quarter of 2005, primarily related to the Company’s adoption of Statement No. 123R, which resulted in $337,000 of share-based compensation expense for the second quarter 2006, and the increase in headcount during 2006.
General and administrative expenses for the three months ended June 30, 2006 increased 90.4% to $1,384,000 as compared to $727,000 for the same period in 2005, primarily due to $420,000 of share-based compensation expense related to the adoption of Statement No. 123R, additional employment expenses related to an increase in personnel, and an increase in professional fees.
Interest income for the three months ended June 30, 2006 was $933,000, a 228.5% increase as compared to the same period in 2005. This increase was due to a higher average cash balance during the second quarter of 2006.
Results of Operations (six months ended June 30, 2006 compared to the six months ended June 30, 2005)
Collaborative and other research and development revenues increased to $2,330,000 for the six months ended June 30, 2006 compared to $99,000 for the six months ended June 30, 2005, due to the recognition of revenue related to our collaboration with Mundipharma for the development and commercialization of Fodosine™ in Europe and Asia. For this collaboration, we began recognizing the $10 million up front payment in February 2006, which will continue until it is fully recognized in October 2017. In addition, we began recognizing revenue during the first quarter of 2006 for clinical expenses that will be reimbursed by Mundipharma according to the terms of the collaboration.
R&D expenses increased 84.3% to $19,234,000 for the six months ended June 30, 2006 from $10,438,000 for the six months ended June 30, 2005. The increase is primarily attributable to expenses for contract research and synthesis of compounds related to the clinical development and manufacturing of our drug candidates, Fodosine™ and peramivir. We are currently in several additional clinical trials with Fodosine™ as compared to the same period in 2005 and we initiated clinical testing of peramivir late in the first quarter of 2006. In addition, we have also started the process of manufacturing validation for both Fodosine™ and peramivir. There was also an increase in compensation cost for the second quarter of 2006 compared to the second quarter of 2005, primarily related to the Company’s adoption of Statement No. 123R, which resulted in $516,000 of share-based compensation expense for the first half of 2006, and the increase in headcount during 2006.
General and administrative expenses for the six months ended June 30, 2006 increased 102.3% to $2,879,000 as compared to $1,423,000 for the same period in 2005, primarily due to $661,000 of share-based compensation expense related to the adoption of Statement No. 123R, additional compensation expense related to an increase in personnel, and an increase in professional fees primarily related to our recent collaborations.
Interest income for the six months ended June 30, 2006 was $1,818,000, a 287.6% increase as compared to the same period in 2005. This increase was due to a higher average cash balance during the second quarter of 2006 resulting from receipt of the upfront payments related to the Roche and Mundipharma collaborations.
Liquidity and Capital Resources
Cash expenditures have exceeded revenues since our inception. Our operations have principally been funded through public offerings and private placements of equity and debt securities. For example, during December 2005, we raised $30.0 million (approximately $29.9 million net of expenses) through a sale of 2,228,829 shares of our common stock. Other sources of funding have included the following:
| • | collaborative and other research and development agreements (such as the Roche, Mundipharma and Green Cross licenses); |
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| • | equipment lease financing; |
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| • | facility leases; |
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| • | research grants; and |
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| • | interest income. |
In addition, we have attempted to contain costs and reduce cash flow requirements by renting scientific equipment and facilities, contracting with other parties to conduct certain research and development and using consultants. We expect to incur additional expenses, potentially resulting in significant losses, as we continue to pursue our research and development activities, undertake additional preclinical studies and clinical trials of compounds which have been or may be discovered and as we validate the manufacturing process of our lead compounds. We also expect to incur substantial expenses related to the filing, prosecution, maintenance, defense and enforcement of patent and other intellectual property claims and additional regulatory costs as our clinical products advance through later stages of development.
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We invest our excess cash principally in U.S. marketable securities from a diversified portfolio of institutions with strong credit ratings and in U.S. government and agency bills and notes, and by policy, limit the amount of credit exposure at any one institution. These investments are generally not collateralized and mature within two years. We have not realized any losses from such investments.
We have financed some of our equipment purchases with lease lines of credit. In July 2000, we renegotiated our lease for our current facilities, which will expire on June 30, 2010. We have an option to renew the lease for an additional five years at the current market rate in effect on June 30, 2010 and a one-time option to terminate the lease on June 30, 2008 for a termination fee of approximately $124,000. The lease, as amended effective December 1, 2005 for a reduction of 7,200 square feet, requires us to pay monthly rent starting at $36,855 per month in December 2005 and escalating annually to a minimum of $41,481 per month in the final year, plus our pro rata share of operating expenses and real estate taxes in excess of base year amounts. As part of the lease, we have deposited a U.S. Treasury security in escrow for the payment of rent and performance of other obligations specified in the lease. This pledged amount is currently $132,000, which can be decreased by $65,000 annually throughout the term of the lease. Currently, we have approximately 3,600 square feet being subleased, which can be terminated with 30 days written notice.
We have not incurred any significant charges related to building renovations since 2001, but we currently have plans for some renovations and for the purchase of additional scientific equipment. Our anticipated capital expenditures for 2006 related to these items are not expected to exceed $1.5 million.
At December 31, 2005, we had long-term operating lease obligations, which provide for aggregate minimum payments of $533,904 in 2006, $486,119 in 2007 and $496,834 in 2008. These obligations include the future rental of our operating facility.
We plan to finance our needs principally from the following:
| • | our existing capital resources and interest earned on that capital; |
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| • | payments under collaborative and licensing agreements with corporate partners; and |
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| • | lease or loan financing and future public or private financing. |
As of June 30, 2006, we had $74.7 million in cash, cash equivalents and securities. We believe that our currently available funds will be sufficient to fund our operations at least through 2007. However, this is a forward looking statement, and there may be changes that would consume available resources significantly before such time. Our long-term capital requirements and the adequacy of our available funds will depend upon many factors, including:
| • | the progress and magnitude of our research, drug discovery and development programs; |
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| • | changes in existing collaborative relationships; |
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| • | our ability to establish additional collaborative relationships with academic institutions, biotechnology or pharmaceutical companies and governmental agencies or other third parties; |
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| • | the extent to which our collaborators, including governmental agencies will share in the costs associated with the development of our programs or run the development programs themselves; |
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| • | our ability to negotiate favorable development and marketing strategic alliances for our drug candidates; |
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| • | the scope and results of preclinical studies and clinical trials to identify drug candidates; |
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| • | the scope of manufacturing of our drug candidates to support our preclinical research and clinical trials; |
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| • | the scope of validation for the manufacturing of our drug substance and drug products required for future NDA filings; |
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| • | competitive and technological advances; |
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| • | the time and costs involved in obtaining regulatory approvals; |
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| • | the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
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| • | our dependence on others for development and commercialization of our product candidates; and |
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| • | successful commercialization of our products consistent with our licensing strategy. |
To date, we have financed our operations primarily from sale of our equity securities and cash from collaborations and, to a lesser extent, interest. For the first six months of 2006, our average monthly cash burn from normal operations has been approximately $3.2 million. For the year, our cash, cash equivalents and securities balance has increased from $60 million as of December 31, 2005 to $74.6 million as of June 30, 2006, primarily due to cash received from collaborations, totaling approximately $31.8 million net of sublicense fees, less the monthly cash burn from operations.
In June 2006 the Department of Health and Human Services (“HHS”) issued a Request for Proposal (“RFP”) for the potential funding of companies with antiviral drugs in development for both seasonal and avian influenza. We believe our peramivir program meets substantially all of the requirements outlined in the RFP and therefore we submitted a proposal to HHS on July 20, 2006 and we hope to be considered a competitive candidate for some of the funding to be made available under the RFP. We have made certain commitments related to the advancement of peramivir for both our intramuscular and intravenous formulations so that we will be prepared to enter multiple Phase II trials during the 2006-2007 influenza season. We plan to be in several Phase II trials with peramivir using intravenous and intramuscular formulations for the 2006-2007 flu season and we are currently initiating the additional Phase I trials to support these planned Phase II trials.
In addition, on August 7, 2006, we announced that we had received a Special Protocol Assessment (“SPA”) letter from the U.S. Food and Drug Administration (“FDA”) for the initiation of a pivotal clinical trial of our lead anti-cancer compound Fodosine™. The SPA letter documents the agreement between the FDA and the Company regarding the trial design’s suitability to support regulatory approval. We expect to initiate a multicenter, open-label pivotal clinical trial later this year with the goal of enrolling 100 patients. In our original request, we estimated the number of patients required for this trial would be approximately 50, based on other similar trials completed by other companies.
As a result of the commitments we have made for the clinical development of both peramivir and Fodosine™, plus the ongoing validation of the manufacturing process for these drug candidates, we expect that our monthly cash used by operations will increase significantly during the second half of 2006 to a level which could eventually exceed $5 million per month during this time. We are hopeful that our proposal response for the RFP will be acceptable for funding, which would significantly offset this projected burn rate if and when it became effective. In addition, we expect to achieve one milestone related to our collaboration with Mundipharma in 2006 and we will continue to be reimbursed for our clinical development costs up to the $10 million defined in our agreement. We currently have a balance receivable of approximately $2 million for their portion of the funding related to the clinical development of Fodosine™.
As our clinical programs continue to grow and patient enrollment increases, our costs will increase. Our current and planned clinical trials plus the related manufacturing, personnel resources and testing required to support these trials will consume significant capital resources and will increase our expenses and our net loss.
Our monthly burn rate could vary significantly depending on many factors, including our ability to raise additional capital, the development progress of our collaborative agreements for our drug candidates, the amount of funding or assistance we receive from governmental agencies or other new partnerships with third parties for the development of our drug candidates in general and for peramivir specifically, the progress and results of our current and proposed clinical trials for our most advanced drug products, the progress made in the manufacturing of our lead products and the progression of our other programs.
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The collaboration with Roche for the worldwide development and commercialization of BCX-4208 provided an upfront payment plus an advance payment for specific manufacturing we will perform. We expect to fulfill our manufacturing obligation in the third quarter of 2006. The initial $30 million was recorded as a receivable on our balance sheet at December 31, 2005 and was received in January 2006. Roche will take over the development and pay all costs associated with this program. The agreement also provides for future event payments and royalties to be made by Roche upon the achievement of certain clinical, regulatory and sales events.
In February 2006, we licensed Fodosine™ to Mundipharma for the development and commercialization of this drug in Europe, Asia and Australasia. In addition to the upfront payment of $10 million which was received in February 2006, Mundipharma will pay 50% of the clinical development costs we will incur for Fodosine™ on existing and planned clinical trials, but their portion shall not exceed $10 million. In addition, Mundipharma will conduct additional clinical trials at their own cost up to a maximum of $15 million. The agreement also provides for future event payments and royalties to be made by Mundipharma upon the achievement of certain clinical, regulatory and sales events.
For the Roche and Mundipharma collaborations, we will owe sublicense payments to AECOM and IRL on all upfront, future event payments and royalties. For the first six months of 2006, we have paid approximately $8.2 million related to these agreements. The revenue from these agreements has been recorded as deferred revenue on our balance sheet and will be recognized over the remaining patent life of the related drug candidate. The payments to AECOM and IRL have been recorded as deferred assets on our balance sheet and will be recognized over the period of the related revenue recognition. Due to the nature of the potential milestones in our collaborations, it is difficult to predict if and when particular milestones will be achieved by us or our collaborators.
We expect that we will be required to raise additional capital to complete the development and commercialization of our current product candidates. Additional funding, whether through additional sales of securities or collaborative or other arrangements with corporate partners or from other sources, including governmental agencies in general and from the RFP specifically, may not be available when needed or on terms acceptable to us. The issuance of preferred or common stock or convertible securities, with terms and prices significantly more favorable than those of the currently outstanding common stock, could have the effect of diluting or adversely affecting the holdings or rights of our existing stockholders. In addition, collaborative arrangements may require us to transfer certain material rights to such corporate partners. Insufficient funds may require us to delay, scale-back or eliminate certain of our research and development programs.
Off-Balance Sheet Arrangements
As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities (“SPEs”), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. As of June 30, 2006, we are not involved in any material unconsolidated SPE or off-balance sheet arrangements.
Contractual Obligations
A summary of our obligations to make future payments under contracts existing as of December 31, 2005 is included in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2005. For the six months ended June 30, 2006, the Company has entered into various contracts in the ordinary course of business for several R&D related items, including manufacturing of various compounds, additional toxicology studies and clinical trials and has already paid for some of the obligations disclosed at December 31, 2005. The net effect of these changes was to increase the purchase obligations disclosed at December 31, 2005 by a total of approximately $8.2 million. These obligations could change during the course of the year depending on the status of each of our development programs.
For purposes of our disclosure of contractual obligations, purchase obligations include commitments related to clinical development, manufacturing and research operations and other significant purchase commitments.
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In addition to the contractual obligations disclosed, we have committed to make potential future “sublicense” payments to third-parties related to the in-licensing for some of our development programs. Payments under these agreements generally become due and payable only upon achievement of certain developmental, regulatory and/or commercial milestones. Because the achievement of these milestones is neither probable nor reasonably estimable, such contingencies have not been recorded on our balance sheet.
Critical Accounting Policies
We have established various accounting policies that govern the application of accounting principles generally accepted in the United States, which were utilized in the preparation of our financial statements. Certain accounting policies involve significant judgments and assumptions by management that have a material impact on the carrying value of certain assets and liabilities; management considers such accounting policies to be critical accounting policies. The judgments and assumptions used by management are based on historical experience and other factors, which are believed to be reasonable under the circumstances. Because of the nature of the judgments and assumptions made by management, actual results could differ from these judgments and estimates, which could have a material impact on the carrying values of assets and liabilities and the results of operations.
While our significant accounting policies are more fully described in Note 1 to our financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2005, we believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating our reported financial results and affect the more significant judgments and estimates that we use in the preparation of our financial statements.
Revenue Recognition
Our revenues have generally been limited to license fees, milestone payments, research and development fees, and interest income. Revenue is recognized in accordance with SAB No. 104 and EITF Issue 00-21. License fees, event payments, and research and development fees are recognized as revenue when the earnings process is complete and we have no further continuing performance obligations or we have completed the performance obligations under the terms of the agreement. Fees received under licensing agreements that are related to future performance are deferred and recognized as earned over an estimated period determined by management based on the terms of the agreement and the products licensed. For example, in the Roche and Mundipharma licenses agreements, we have determined to defer the upfront payments over the remaining life of the patents which are 17 years (through August 2023) and 12 years (through October 2017), respectively. In the event a license agreement contains multiple deliverables, we evaluate whether the deliverables are separate or combined units of accounting in accordance with EITF Issue 00-21. Revisions to revenue or profit estimates as a result of changes in the estimated revenue period are recognized prospectively.
Future event payments are recognized as revenue upon the achievement of specified events if (1) the event is substantive in nature and the achievement of the event was not reasonably assured at the inception of the agreement and (2) the fees are non-refundable and non-creditable. Any event payments received prior to satisfying these criteria are recorded as deferred revenue.
Significant direct costs incurred upon entering into a licensing arrangement, such as our sublicense fees to AECOM and IRL, are deferred and charged to expense in proportion to the revenue recognized. Under the guidance of EITF Issue 99-19, and EITF Issue 01-14, reimbursements received for direct out-of-pocket expenses related to research and development costs are recorded as revenue in the income statement rather than as a reduction in expenses.
Royalty revenue is recognized based on estimates of royalties earned during the applicable period and adjusted for differences between the estimated and actual royalties in the following period. If royalties can not be reasonably estimated, revenue is recognized upon receipt of royalty statements from the licensee. We have not received any royalties from the sale of licensed pharmaceutical products.
Research and Development Expenses
Major components of R&D expenses consist of personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by contract research organizations (CRO’s), materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. We charge these costs to expense when incurred, consistent with Statement of Financial Accounting Standards No. 2, Accounting for Research
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and Development Costs. These costs are a significant component of R&D expenses. Most of our manufacturing and our clinical and preclinical studies are performed by third-party CRO’s. We accrue costs for studies performed by CRO’s over the service periods specified in the contracts and adjust our estimates, if required, based upon our on-going review of the level of services actually performed by the CRO. We expense both our internal and external research and development costs as incurred. We expect our research and development expense to increase as we continue to develop our drug candidates.
Additionally, we have license agreements with third parties, such as AECOM and IRL that require maintenance fees or fees related to sublicense agreements. These fees are generally expensed as incurred unless they are related to revenues that have been deferred in which case the expenses will be deferred and recognized over the related revenue recognition period.
Accrued Expenses
As part of the process of preparing financial statements, we are required to estimate accrued expenses. This process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. The majority of our service providers invoice us monthly in arrears for services performed. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. To date, we have not adjusted our estimate at any particular balance sheet date in any material amount. Examples of estimated accrued expenses include:
| • | fees paid to contract research organizations in connection with preclinical and toxicology studies and clinical trials; |
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| • | fees paid to investigative sites in connection with clinical trials; |
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| • | fees paid to contract manufacturers in connection with the production of our raw materials, drug substance and drug products; and |
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| • | professional service fees. |
We base our expenses related to clinical trials on our estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and clinical research organizations that conduct and manage clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we will adjust the accrual accordingly. If we do not identify costs that we have begun to incur or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates.
Stock-Based Compensation
At June 30, 2006, we have two stock-based employee compensation plans, the Stock Incentive Plan (the “Plan”) and the Employee Stock Purchase Plan (the “ESPP”). Prior to January 1, 2006, we accounted for those plans under the recognition and measurement provisions of APB No. 25 and other related Interpretations, as permitted by Statement No. 123. No stock-based compensation cost related to the our employees was recognized in the Statements of Operations for any period ending prior to January 1, 2006, as all options granted had exercise prices equal to the market value of the underlying common stock on the date of grant. Effective January 1, 2006, we adopted the fair value recognition provisions of Statement No. 123R, using the modified prospective transition method. Under that transition method, total compensation cost of $1,176,673 ($1,131,139 of expense related to the Plan and $45,534 of expense related to the ESPP) was recognized during the first six months of 2006 and includes: (a) compensation cost for all share-based payments granted prior to, but not yet vested as of December 31, 2005, based on the grant date fair value estimated in accordance with the original provisions of Statement No. 123, and (b) compensation cost for all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value estimated in accordance with the provisions of Statement No. 123R. Results for prior periods have not been restated.
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As of June 30, 2006, there was approximately $10,008,033 of total unrecognized compensation cost related to non-vested employee stock option awards granted under the Plan and the ESPP. That cost is expected to be recognized as follows: $2,023,193 in the remainder of 2006, $3,173,165 in 2007, $2,344,415 in 2008, $1,822,830 in 2009, and $644,430 in 2010.
Under the fair value recognition provisions of Statement No. 123R, stock-based compensation cost is estimated at the grant date based on the fair value of the award and is recognized as expense over the requisite service period of the award. Consistent with the valuation method we used for disclosure-only purposes under the provisions of Statement No. 123, we use the Black-Scholes option pricing model to estimate fair value under Statement No. 123R. Determining the appropriate fair value model and the related assumptions for the model requires judgment, including estimating the life of an award, the stock price volatility, and the expected term. Compensation cost is recognized on a straight-line basis over the requisite service period.
Information Regarding Forward-Looking Statements
This filing contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These forward-looking statements can generally be identified by the use of words such as “may,” “will,” “intends,” “plans,” “believes,” “anticipates,” “expects,” “estimates,” “predicts,” “potential,” the negative of these words or similar expressions. Statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects are also forward-looking statements. Discussions containing these forward-looking statements are principally contained in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, as well as any amendments we make to those sections in filings with the SEC. These forward-looking statements include, but are not limited to, statements about:
| • | the initiation, timing, progress and results of our preclinical and clinical trials, research and development programs; |
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| • | the potential for funding from HHS for the clinical development of peramivir from the RFP; |
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| • | the further preclinical or clinical development and commercialization of our product candidates; |
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| • | the implementation of our business model, strategic plans for our business, product candidates and technology; |
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| • | our ability to establish and maintain collaborations with biotechnology or pharmaceutical companies and governmental agencies or other third parties; |
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| • | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
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| • | our ability to operate our business without infringing the intellectual property rights of others; |
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| • | estimates of our expenses, future revenues, capital requirements and our needs for additional financing; |
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| • | the timing or likelihood of regulatory filings and approvals; |
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| • | our financial performance; and |
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| • | competitive companies, technologies and our industry. |
These statements reflect our current views with respect to future events and BioCryst has no obligation to update or revise the statements. BioCryst cautions that you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in “Risk Factors.”
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You should read this discussion completely and with the understanding that our actual future results may be materially different from what we expect. We may not update these forward-looking statements, even though our situation may change in the future. We qualify all of our forward-looking statements by these cautionary statements.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
The primary objective of our investment activities is to preserve principal while maximizing the income we receive from our investments without significantly increasing our risk. We invest excess cash principally in U.S. marketable securities from a diversified portfolio of institutions with strong credit ratings and in U.S. government and agency bills and notes, and by policy, limit the amount of credit exposure at any one institution. Some of the securities we invest in may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, we schedule our investments to have maturities that coincide with our expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, we believe we have no material exposure to interest rate risk arising from our investments. Therefore, no quantitative tabular disclosure is provided.
Item 4. Controls and Procedures
We maintain a set of disclosure controls and procedures that are designed to ensure that information relating to BioCryst Pharmaceuticals, Inc. required to be disclosed in our periodic filings under the Securities Exchange Act is recorded, processed, summarized and reported in a timely manner under the Securities Exchange Act of 1934. We carried out an evaluation, under the supervision and with the participation of management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, 2006, the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed by BioCryst in the reports filed or submitted by it under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and include controls and procedures designed to ensure that information required to be disclosed by BioCryst in such reports is accumulated and communicated to the Company’s management, including the Chairman and Chief Executive Officer and Chief Financial Officer of BioCryst, as appropriate to allow timely decisions regarding required disclosure.
There have been no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2006 that have materially affected, or are reasonably likely to materially affect, BioCryst’s internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. | Legal Proceedings: |
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| None |
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Item 1A. | Risk Factors: |
Our 2005 Annual Report on Form 10-K includes a detailed discussion of our risk factors. The risk factor below was disclosed on the Form 10-K and updates information as of June 30, 2006. It should be read in conjunction with all the risk factors and information disclosed in that Form 10-K.
If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our product candidates or continue our research and development programs.
To date, we have financed our operations primarily from sale of our equity securities and cash from collaborations and, to a lesser extent, interest. For the first six months of 2006, our average monthly cash burn from normal operations has been approximately $3.2 million. For the year, our cash, cash equivalents and securities balance has increased from $60 million as of December 31, 2005 to $74.6 million as of June 30, 2006, primarily due to cash received from collaborations, totaling approximately $31.8 million net of sublicense fees, less the monthly cash burn from operations.
In June 2006 the Department of Health and Human Services (“HHS”) issued a Request for Proposal (“RFP”) for the potential funding of companies with antiviral drugs in development for both seasonal and avian influenza. We believe our peramivir program meets substantially all of the requirements outlined in the RFP and therefore we submitted a proposal to HHS on July 20, 2006 and we hope to be considered a competitive candidate for some of the funding to be made available under the RFP. We have made certain commitments related to the advancement of peramivir for both our intramuscular and intravenous formulations so that we will be prepared to enter multiple Phase II trials during the 2006-2007 influenza season. We plan to be in several Phase II trials with peramivir using intravenous and intramuscular formulations for the 2006-2007 flu season and we are currently initiating the additional Phase I trials to support these planned Phase II trials.
In addition, on August 7, 2006, we announced that we had received a Special Protocol Assessment (“SPA”) letter from the U.S. Food and Drug Administration (“FDA”) for the initiation of a pivotal clinical trial of our lead anti-cancer compound Fodosine™. The SPA letter documents the agreement between the FDA and the Company regarding the trial design’s suitability to support regulatory approval. We expect to initiate a multicenter, open-label pivotal clinical trial later this year with the goal of enrolling 100 patients. In our original request, we estimated the number of patients required for this trial would be approximately 50, based on other similar trials completed by other companies.
As a result of the commitments we have made for the clinical development of both peramivir and Fodosine™, plus the ongoing validation of the manufacturing process for these drug candidates, we expect that our monthly cash used by operations will increase significantly during the second half of 2006 to a level which could eventually exceed $5 million per month during this time. We are hopeful that our proposal response for the RFP will be acceptable for funding, which would significantly offset this projected burn rate if and when it became effective. In addition, we expect to achieve one milestone related to our collaboration with Mundipharma in 2006 and we will continue to be reimbursed for our clinical development costs up to the $10 million defined in our agreement. We currently have a balance receivable of approximately $2 million for their portion of the funding related to the clinical development of Fodosine™.
As our clinical programs continue to grow and patient enrollment increases, our costs will increase. Our current and planned clinical trials plus the related manufacturing, personnel resources and testing required to support these trials will consume significant capital resources and will increase our expenses and our net loss.
Our monthly burn rate could vary significantly depending on many factors, including our ability to raise additional capital, the development progress of our collaborative agreements for our drug candidates, the amount of funding or assistance we receive from governmental agencies in general and under the RFP specifically, or other new partnerships with third parties for the development of our drug candidates in general and for peramivir specifically, the progress and results of our current and proposed clinical trials for our most advanced drug products, the progress made in the manufacturing of our lead products and the progression of our other programs. Our long-term capital requirements and the adequacy of our available funds will depend upon many factors, including:
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| • | the progress of our research, drug discovery and development programs; |
| | |
| • | changes in existing collaborative relationships; |
| | |
| • | our ability to establish additional collaborative relationships with academic institutions, biotechnology or pharmaceutical companies, governmental agencies or other third parties; |
| | |
| • | the extent to which our collaborators, including governmental agencies will share in the costs associated with the development of our programs or run the development programs themselves; |
| | |
| • | our ability to obtain funding for our peramivir program from the RFP issued by HHS; |
| | |
| • | our ability to negotiate favorable development and marketing alliances for our drug product candidates; |
| | |
| • | the magnitude of our research and development programs; |
| | |
| • | the scope and results of preclinical studies and clinical trials to identify drug product candidates and the costs of manufacturing drug product to support these studies and trials; |
| | |
| • | competitive and technological advances; |
| | |
| • | the time and costs involved in obtaining regulatory approvals; |
| | |
| • | the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
| | |
| • | our dependence on others for development and commercialization of our product candidates; and |
| | |
| • | successful commercialization of our products consistent with our licensing strategy. |
We will be required to raise additional capital to complete the development and commercialization of our current product candidates. Additional funding, whether through additional sales of securities or collaborative or other arrangements with corporate partners, governmental agencies or from other sources, may not be available when needed or on terms acceptable to us. The issuance of preferred or common stock or convertible securities, with terms and prices significantly more favorable than those of the currently outstanding common stock, could have the effect of diluting or adversely affecting the holdings or rights of our existing stockholders. In addition, collaborative arrangements may require us to transfer certain material rights to such corporate partners as described in the following risk factor related to collaborative relationships. Insufficient funds may require us to delay, scale-back or eliminate certain of our research and development programs.
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds: |
| |
| None |
| |
Item 3. | Defaults Upon Senior Securities: |
| |
| None |
| |
Item 4. | Submission of Matters to a Vote of Security Holders: |
| (a) | The Company’s annual meeting of stockholders was held on May 17, 2006. |
| | |
| (b) | Messrs. Bennett, Biggar, Horovitz and Steer were elected as directors for three-year terms expiring in 2009. Messrs., Bugg, Gordon, Higgins, Featheringill, Sherrill, and Spencer and Ms. Seidenberg continue as directors. |
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| (c) | Motion before stockholders: |
1. Election of four directors as follows -
| Name | | Votes For | | Abstentions/ Withheld | |
|
| |
| |
| |
| J. Claude Bennett, M.D. | | 26,005,139 | | 1,049,731 | |
| Stephen R. Biggar, M.D., Ph.D. | | 26,003,804 | | 1,051,066 | |
| Zola P. Horovitz, Ph.D. | | 23,244,705 | | 3,810,165 | |
| Randolph C. Steer, M.D. Ph.D. | | 26,005,793 | | 1,049,077 | |
2. Approval of the Stock Incentive Plan
| | | Votes For | | Votes Against | | Abstentions/ Withheld |
| | |
| |
| |
|
| | | 15,627,202 | | 1,328,145 | | 98,449 |
3. Ratification of Ernst & Young, LLP
| | | Votes For | | Votes Against | | Abstentions/ Withheld |
| | |
| |
| |
|
| | | 26,315,798 | | 712,490 | | 26,582 |
Item 5. | Other Information: |
| | |
| None |
| | |
Item 6. | Exhibits: |
| | |
| a. | Exhibits: |
| Number | | Description |
|
| |
|
| 3.1 | | Composite Certificate of Incorporation of Registrant. Incorporated by reference to Exhibit 3.1 to the Company’s Form 10-Q for the second quarter ending June 30, 1995 dated August 11, 1995. |
| 3.2 | | Bylaws of Registrant as amended December 15, 2005. Incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K filed December 16, 2005. |
| 4.1 | | Rights Agreement, dated as of June 17, 2002, by and between the Company and American Stock Transfer & Trust Company, as Rights Agent, which includes the Certificate of Designation for the Series B Junior Participating Preferred Stock as Exhibit A and the form of Rights Certificate as Exhibit B. Incorporated by reference to Exhibit 4.1 to the Company’s Form 8-A dated June 17, 2002. |
| 10.1 | | Stock Incentive Plan, as amended and restated effective March 7, 2006. |
| 31.1 | | Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 31.2 | | Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 32.1 | | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| 32.2 | | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
# Confidential treatment granted. |
& Management contracts. |
* Confidential treatment requested. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on this 9th day of August, 2006.
| BIOCRYST PHARMACEUTICALS, INC. |
| |
| |
| /s/Charles E. Bugg |
|
|
| Charles E. Bugg, Ph.D. |
| Chairman and Chief Executive Officer |
| |
| /s/Michael A. Darwin |
|
|
| Michael A. Darwin |
| Chief Financial Officer (Principal Financial and Accounting Officer), Secretary and Treasurer |
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