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| MIPI > SEC Filings for MIPI > Form 10-Q on 15-May-2007 | All Recent SEC Filings |
15-May-2007
Quarterly Report
Research and Development Expense. Research and development expense consists
of expenses incurred in developing and testing product candidates. These
expenses consist primarily of salaries and related expenses for employees, as
well as fees for consultants engaged in research and development activities,
fees paid to professional service providers for monitoring our clinical trials
and for acquiring and evaluating clinical trial data, costs of contract
manufacturing services and materials used in clinical trials, depreciation of
capital resources used to develop our product candidates and facilities costs.
We expense research and development costs as incurred. Certain research and
development activities are partially funded by NIH grants described above. All
costs related to such grants are included in research and development costs. We
believe that significant investment in product development is necessary and plan
to continue these investments as we seek to develop our product candidates and
proprietary technologies.
For the periods indicated, research and development expenses for our programs in
the development of Azedra, Onalta, Solazed, Zemiva and our other platform and
general R&D programs were as follows (in thousands):
Three months ended
March 31, March 31,
Program 2006 2007
Azedra and Ultratrace platform $ 931 $ 1,471
Onalta - 2,375
Solazed - 1,003
Zemiva 1,465 2,261
Other Platform and general R&D 1,672 2,575
Total $ 4,068 $ 9,685
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We in-licensed Onalta and Solazed in November 2006 and January 2007,
respectively.
We do not know if we will be successful in developing our drug candidates.
While we expect that expenses associated with the completion of our current
clinical programs would be substantial, we believe that such expenses are not
reasonably certain. The timing and amount of these expenses will depend upon the
costs associated with potential future clinical trials of our drug candidates,
and the related expansion of our research and development organization,
regulatory requirements, advancement of our preclinical programs and product
manufacturing costs, many of which cannot be determined with accuracy at this
time based on our stage of development. This is due to the numerous risks and
uncertainties associated with the duration and cost of clinical trials, which
vary significantly over the life of a project as a result of unanticipated
events arising during clinical development, including with respect to:
• the number of clinical sites included in the trial;
• the length of time required to enroll suitable subjects;
• the number of subjects that ultimately participate in the trials; and
• the efficacy and safety results of our clinical trials and the number of additional required clinical trials.
Our expenditures are subject to additional uncertainties, including the terms
and timing of regulatory approvals and the expense of filing, prosecuting,
defending or enforcing any patent claims or other intellectual property rights.
In addition, we may obtain unexpected or unfavorable results from our clinical
trials. We may elect to discontinue, delay or modify clinical trials of some
drug candidates or focus on others. A change in the outcome of any of the
foregoing variables in the development of a drug candidate could mean a
significant change in the costs and timing associated with the development of
that drug candidate. For example, if the FDA or other regulatory authority were
to require us to conduct clinical trials beyond those that we currently
anticipate, or if we experience significant delays in any of our clinical
trials, we would be required to expend significant additional financial
resources and time on the completion of clinical development. Additionally,
future commercial and regulatory factors beyond our control will evolve and
therefore impact our clinical development programs and plans over time.
Beyond our three lead drug candidates, we anticipate that we will select drug
candidates and research projects for further development on an ongoing basis in
response to the preclinical and clinical success, as well as the commercial
potential of such drug candidates.
General and Administrative Expense. General and administrative expense
consists primarily of salaries and other related costs for personnel in
executive, finance, accounting, information technology and human resource
functions. Other costs include facility costs not otherwise included in research
and development expense, legal fees relating to patent and corporate matters and
fees for accounting services.
Costs Related to Delays in Initial Public Offering. We expensed the costs
associated with the initial filing of our registration statement on Form S-1.
Our initial public offering, which was effective on February 1, 2007, was
delayed for a period in excess of 90 days, and as a result it was deemed an
aborted offering in accordance with Staff Accounting Bulletin Topic 5A. These
costs which total $2.2 million and
$720,000 are included in general and administrative expenses in the Statements
of Operations for the years ended December 31, 2005 and December 31, 2006,
respectively. We have capitalized costs associated with our subsequent offering
process as of December 31, 2006.
Stock-Based Compensation Expense. Operating expenses include stock-based
compensation expense. Stock-based compensation expense results from the issuance
of stock-based awards, such as options and restricted stock to employees,
members of our Board of Directors and consultants in lieu of cash consideration
for services received. On January 1, 2006 we adopted SFAS No. 123(R) to account
for stock-based awards. We use the fair value method of accounting for all other
awards. Compensation expense for options and restricted stock granted to
employees and nonemployees is classified either as research and development
expense or general and administrative expense based on the job function of the
individual receiving the grant. These costs which total $692,000 and $408,000
are included in the Statements of Operations for the three months ended
March 31, 2006 and March 31, 2007, respectively. See discussion under "Critical
Accounting Policies and Estimates - Stock-Based Compensation."
Other (Expense) Income, Net. Other (expense) income, net includes interest
income and interest expense. Interest income consists of interest earned on our
cash, cash equivalents and short-term investments. Interest expense consists of
interest incurred on equipment leases and on debt instruments.
Redeemable Convertible Preferred Stock Dividends and Accretion of Issuance
Costs. Redeemable convertible preferred stock dividends and accretion of
issuance costs consists of cumulative, undeclared dividends payable on the
securities and accretion of the issuance costs and costs allocated to issued
warrants to purchase common stock. The issuance costs on these shares and
warrants were recorded as a reduction to the carrying value of the redeemable
convertible preferred stock when issued, and are accreted to redeemable
convertible preferred stock using the interest method through the earliest
redemption dates of each series of redeemable convertible preferred stock (A, B
and C) by a charge to additional paid-in capital and net loss attributable to
common stockholders. Upon the consummation of the initial public offering of the
Company which was closed by the SEC on February 7, 2007, the redeemable
convertible preferred stock automatically converted into common stock on a
33-for-1 basis and the cumulative but unpaid dividends (with limited exception)
converted into common stock based upon formulas established at each issuance
date of the securities. Accordingly, we no longer record dividends and accretion
on the redeemable convertible preferred stock.
Critical Accounting Policies and Significant Judgments and Estimates
As fully described in the "Management's Discussion and Analysis of Financial
Condition and Results of Operations" section of our Annual Report on Form 10-K
for the year ended December 31, 2006 and as discussed below, we consider our
critical accounting policies to be as follows. We refer the reader to our Annual
Report on Form 10-K for more information on these policies.
• Accrued expenses; and
• Income taxes
Stock-Based Compensation. In December 2004, the FASB issued SFAS 123 (revised
2004), "Share-Based Payment," which is known as SFAS 123(R) and replaces SFAS
123, "Accounting for Stock-Based Compensation," as amended by SFAS 148,
"Accounting for Stock-Based Compensation-Transition and Disclosure." SFAS 123(R)
requires public entities to recognize compensation expense for awards of equity
instruments to employees based on the grant-date fair value of the awards.
On January 1, 2006 we adopted SFAS No. 123(R) to account for stock-based
awards. We historically have not recorded stock-based compensation expense for
stock awards issued to employees with fixed terms and with exercise prices at
least equal to the fair value of the underlying common stock on the measurement
date. Effective January 1, 2006, we began recording compensation costs over the
vesting period for the unvested portion of the other awards issued after being
considered a public company, which would include awards granted after
November 8, 2005, using the grant date fair value. We will continue to record
compensation cost on awards issued prior to this date following the provisions
of APB Opinion No. 25, i.e. the prospective transition method under SFAS
No. 123(R) for the awards granted while not a public company. Compensation cost
for awards granted after January 1, 2006 will be accounted for under the fair
value method and recognized over the requisite service period.
We use the fair value method of accounting for all other awards. For stock
options granted to nonemployees, the fair value of the stock options is
estimated using the Black-Scholes valuation model. This model utilizes the
estimated fair value of the common stock and requires that, at the measurement
date of the award, which is usually the date services are completed, we make
assumptions with respect to the expected life of the option, the volatility of
the fair value of the common stock, risk free interest rates and expected
dividend yields of our common stock. Higher estimates of volatility and expected
life of the option increase the value of an option and the resulting expense.
Stock-based compensation computed on awards to nonemployees is recognized over
the period of expected service by the nonemployee (which is generally the
vesting period). As the service is performed, we are required to update these
assumptions and periodically revalue unvested options and make adjustments to
the stock-based compensation expense using the new valuation. These adjustments
have resulted in stock-based compensation expense in addition to the amount
originally estimated or recorded as the deemed fair value of our stock has
increased over the last two years, with a corresponding increase in compensation
expense in the consolidated statements of operations in the periods of
re-measurement. Ultimately, the final compensation charge for each option grant
to nonemployees is unknown until the performance of services is completed. We
account for transactions in which services are received in exchange for equity
instruments based either on the fair value of such services received from
nonemployees or of the equity instruments issued, whichever is more reliably
measured. The two factors which most effect charges or credits to operations
related to stock-based compensation for nonemployee awards are the fair value of
the common stock underlying stock options for which such stock-based
compensation is recorded and the volatility of such fair value.
Results of Operations
Three Months Ended March 31, 2007 Compared to Three Months Ended March 31, 2006
Revenue - Research and Development Grants. Revenue increased by $166,000, or
204%, to $248,000 for the three months ended March 31, 2007 from $82,000 for the
three months ended March 31, 2006. The Company receives funding under various
Research and Development grants, the increase is primarily attributed to the
increased workload and reimbursable expenses for the first quarter of 2007.
Research and Development Expense. Research and development expense increased
$5.6 million, or 138%, to $9.7 million for the three months ended March 31, 2007
from $4.1 million for the three months ended March 31, 2006. The first quarter
of 2007 expense included $3.4 million of costs for the Onalta and Solezad
license agreements and technology transfer. Additionally, costs for the Phase II
clinical trials for Azedra and Zemiva increased $755,000 and preclinical costs
increased $356,000 over the first quarter of 2006. Also contributing to the
increase was $821,000 in additional compensation related expense, including
stock based compensation, due to growth in personnel hired throughout 2006.
As clinical sites are initiated and patients are enrolled in our clinical
programs, we anticipate incurring increased costs from professional service
firms helping to support the clinical program by performing independent clinical
monitoring, data acquisition and data evaluation. We also anticipate incurring
increased costs related to hiring of additional research and development and
clinical personnel and increased costs associated with production and
distribution of clinical trial material. We also expect that our research and
development expense will increase as we pursue the identification and
development of other product candidates, which we plan to fund through our own
resources or through strategic collaborations.
General and Administrative Expense. General and administrative expense
increased $171,000 or 5.89%, to $3.1 million for the three months ended
March 31, 2007 from $2.9 million for the three months ended March 31, 2006. The
major increases in 2007 were the reserve for prepaid expenses and other current
assets of $490,000, increased compensation related expense (excluding stock
based compensation) of $265,000, and increased professional services of
$176,000. These increases were offset by the reduction of $330,000 in costs
incurred in the three months ended March 31, 2006 for the postponed initial
public offering. Also offsetting the increase was a $564,000 decrease in stock
based compensation expense. Stock-based compensation decreased to $195,000 for
the three months ended March 31, 2007 compared to $759,000 for the three months
ended March 31, 2006, primarily due to a decrease in the estimated fair value of
our stock price in the second half of 2006.
Now that we have completed the initial public offering, we anticipate
greater general and administrative expenses, such as additional costs for
investor relations, increased costs for Sarbanes-Oxley compliance and other
activities associated with operating as a publicly-traded company. These
increases will also include the hiring of additional finance and administrative
personnel. In addition, we expect to continue to incur greater internal and
external business development costs to support our various product development
efforts, which can vary from period to period.
Other (Expense) Income, Net. Other (expense) income, net decreased $968,000
to $(920,000) for the three months ended March 31, 2007 from net other income of
$48,000 for the three months ended March 31, 2006. During the first quarter of
2007 and 2006, interest income was $526,000 and $166,000, respectively, and
interest expense was $1.4 million and $118,000, respectively. The increase in
interest income is a result of the increased investment funds available as a
result of the proceeds received following the initial public offering in
February 2007. The increase in interest expense of $1.3 million for the first
quarter of 2007 compared to the first quarter of 2006 was primarily due to the
$1.2 million of noncash interest expense resulting from the remaining
unamortized discount realized on the convertible notes which were converted to
common stock upon the completion of the initial public offering.
Redeemable Convertible Preferred Stock Dividends and Accretion of Issuance
Costs. Redeemable convertible preferred stock dividends and accretion of
issuance costs increased $413,000 to $1.4 million for the three months ended
March 31, 2007 from $954,000 for three months ended March 31, 2006. This
increase was primarily attributable to accelerated amortization of issuance
costs of $1.3 million being included in accretion during the first quarter of
fiscal 2007 and partially offset by reduced dividends of $593,000 for the first
quarter of 2007 compared to the first quarter of 2006. The acceleration and the
reduced dividends are a result of the preferred stock being converted to common
stock on February 1, 2007 following the initial public offering. Upon completion
of the initial public offering no redeemable convertible preferred stock is
outstanding, and, accordingly, there will be no further accrual of dividends or
accretion of issuance costs on these shares.
Liquidity and Capital Resources
On February 1, 2007, the Company's initial public offering of 5,000,000
shares of its common stock registered on the registration statement of Form S-1,
as amended (Registration No. 333-129570) was declared effective by the SEC. All
registered shares were sold at the initial public offering price of $14.00 per
share. Certain warrants were exercised upon the initial public offering. Net
proceeds to the Company were approximately $62.6 million after deducting
underwriting discounts and commissions and estimated offering expenses totaling
approximately $7.4 million. We intend to use our cash to fund Zemiva and Azedra
clinical trials and research and development activities for our pre-clinical new
product candidates, debt repayment as debt becomes due, and general corporate
purposes, including capital expenditures and working capital. To date, we have
used a portion of the net proceeds of the initial public offering consistent
with our intent discussed immediately above.
Prior to our IPO, we have financed our business primarily through the
issuance of equity securities, revenues from government grants, debt financings
and equipment leases. Through December 31, 2006, we had received net cash
proceeds of $49.3 million from the issuance of shares of preferred and common
stock, $15.2 million from issuance of convertible notes payable, $5.0 million
from a note payable, and $4.3 million from government grants. At March 31, 2007,
we had $63.2 million in cash and short term investments available to finance
future operations. Our cash and cash equivalents are held at two financial
institutions to reduce our concentration risk. Management believes that the
financial institutions it uses are of high credit quality. Since our inception,
we have generated significant operating losses in developing our product
candidates. Accordingly, we have historically used cash in our operating
activities, and for the three months ending March 31, 2007 we used approximately
$8.4 million to fund these activities. As we continue to develop our product
candidates and begin to incur increased sales and marketing costs related to
commercialization of our future products, we expect to incur additional
operating losses until such time, if any, as our efforts result in commercially
viable products.
Based on our operating plans, including our contractual obligations as
outlined below, we believe that the proceeds from our initial public offering,
together with our existing cash resources and government grant funding will be
sufficient to finance our planned operations into, but not through, the second
quarter of 2008. However, over the next several years, we will require
significant additional funds to conduct clinical and non-clinical trials,
achieve regulatory approvals and, subject to such approvals, commercially launch
Azedra, Onalta and Zemiva. Our future capital requirements will depend on many
factors, including the scope of progress made in our research and development
activities and our clinical trials. We may also need additional funds for
possible future strategic acquisitions of businesses, products or technologies
complementary to our business. If additional funds are required, we may raise
such funds from time to time through public or private sales of equity or from
borrowings. Financing may not be available to us on acceptable terms, or at all,
and our failure to raise capital when needed could materially adversely impact
our growth plans and our financial condition and results of operations. If
available, additional equity financing may be dilutive to holders of our common
stock and debt financing may involve significant cash payment obligations and
covenants that restrict our ability to operate our business.
Recently Issued Accounting Standards
In September 2006, the FASB issued SFAS No. 157, "Fair Value Measurement"
(SFAS 157). SFAS 157 defines fair value, establishes a framework for measuring
fair value and expands fair value measurement disclosures. SFAS 157 is effective
for financial statements issued for fiscal years beginning after November 15,
2007. We are currently evaluating whether adoption of SFAS 157 will have an
impact on our financial statements.
In February 2007, the FASB issued SFAS No. 159, "The Fair Value Option for
Financial Assets and Financial Liabilities-Including an amendment of FASB
Statement No. 115" ("SFAS No. 159"). SFAS No. 159 permits entities to choose to
measure many financial instruments and certain other items at fair value. SFAS
No. 159 is effective for fiscal years beginning after November15, 2007. We are
in the process of evaluating the effect of SFAS No. 159 on our consolidated
. . .
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