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Financial Statements For the Year Ended

Key Takeaway: Financial Statements For the Year Ended December 31, 2004 March 22, 2005 Name of Listed Company: MEDICINOVA, INC. Listed Exchanges: Hercules, Osaka Ex. Code Number: 4875 Location of Head Office: California, U.S.A. (URL http://www.medicinova.com) Representative Officer: Tak

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Financial Statements For the Year Ended December 31, 2004
March 22, 2005
Name of Listed Company: MEDICINOVA, INC. Listed Exchanges: Hercules, Osaka Ex.
Code Number: 4875 Location of Head Office: California, U.S.A.
Representative Officer: Takashi Kiyoizumi, President & CEO
Date of Meeting of Board of Directors for Approving Financial Statements: March 22,
Interim Dividend System: N/A
Date of Annual Meeting of Shareholders: To be
System of trading unit of shares: Adopted (Unit: 1,000 shares)
1. The financial statements for the years ended December 31, 2004 and 2003 are prepared in accordance with accounting principles generally
accepted in the United States (U.S.). Unless otherwise noted, all amounts are expressed in U.S. dollars.
(1) Operating Results
Revenues Operating Loss Net Loss
Year ended December 31, 2004 490,282 (48,612,386 ) (48,272,603 )
Year ended December 31, 2003 (6,261,103 ) (6,209,130 )
Net Loss Net Loss Per Share Ratio of Net Loss to Stockholders Equity Ratio of Operating Loss to Total Assets Ratio of Operating Loss to Sales
Year ended December 31, 2004 (48,272,603 ) (159.23 ) 788.8 % 163.7 % 9,915.2 %
Year ended December 31, 2003 (6,209,130 ) (12.42 ) 218.2 % 173.5 %
ended December 31, 2004: N/A
Year ended December 31, 2003: N/A
Year ended December 31, 2004: 500,000 shares
Year ended December 31, 2003: 500,000 shares
Annual Dividend Per share Aggregate (annual) Dividends Paid Pay Out Ratio Ratio of Dividends to Stockholders Equity
Interim Dividend Year-end Dividend
Year ended December 31, 2004
Year ended December 31, 2003
(3) Financial Condition
Total Assets Stockholders Equity Equity Ratio (Ratio of equity to total assets) Stockholders Equity Per Share
%
As of December 31, 2004 53,768,595 7,669,122 14.3 15.34
As of December 31, 2003 5,631,309 4,569,882 81.2 9.14
2004: 500,000 shares
December 31, 2003: 500,000 shares
December 31, 2004: 0 shares
December 31, 2003: 0 shares
Net Cash Used in Operating Activities Net Cash Used in Investing Activities Net Cash Provided by Financing Activities Cash and Cash Equivalents at the Year-end
Year ended December 31, 2004 (13,546,476 ) (11,071,235 ) 59,178,340 38,801,328
Year ended December 31, 2003 (5,931,250 ) (1,065,716 ) 9,956,547 4,240,699
2. Financial Results Forecast for the
six months ending June 30, 2005 and the Year Ending December 31, 2005
Revenues Operating Loss Net Loss Annual Dividend Per Share
Interim Dividend Year-end Dividend
Interim Period (6 months) 42,200 (18,600,000 ) (17,000,000 )
Full Year 750,000 (40,900,000 ) (37,700,000 )
(Reference) Expected loss per share
(for full year): $0.39
Notes to use or disclosure of financial results forecast.
The above estimates are based on certain assumptions made by the Company s
management as of the date hereof. These assumptions are based on management s experience and perception of current conditions, trends, expected future developments and other factors believed to be appropriate in the circumstances. Such estimate
is subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of the Company, which may cause the Company s actual results to differ materially from the above estimates. These risks include the risk
factors detailed in the Company s Securities and Exchange Commission filings. Our independent auditors have not compiled or been involved in the preparation of the forecasted results for 2005. Accordingly, they assume no responsibility for the
accuracy or presentation of this information.
There is nothing to be noted regarding a corporate group because MEDICINOVA, INC. (hereinafter the Company, we, our or
us ) has no affiliated companies.
The Company aims at becoming a global pharmaceutical company specialized in acquiring, developing and selling innovative drugs for diseases and conditions
with no established effective treatment. In seeking and acquiring license to product candidates, the Company follows its basic policy that:
While there are no plans to do so in the foreseeable future, the Company will pursue maximization of stockholders value when it distributes profit.
However, the Company is still at the early stage of business development. It is our policy for the time being to retain earnings to appropriate them for the growth and development of the operations.
The Company may determine that it has become necessary and important to reduce the investing unit according to the future upward movement of the
Company s share price in order to encourage more investment by investors and to increase the liquidity of the Company s shares.
It is expected that the Company will continue to report net loss at least for the next several years. Accordingly, we believe that it is inappropriate to
use financial indices as business management targets of the Company for the time being. Moreover, we believe it is also inappropriate to use non-financial indices such as the development progress of product candidates as targets because they are not
established as standard indices.
The Company seeks to be a pioneer in developing and selling therapeutic drugs for diseases for which effective treatments have not been established. Major
The Company has acquired rights in various product candidates that are based on proven pharmacology, but have features distinct from existing treatments.
In developing these product candidates, the Company uses two different approaches: strategic core programs and partnering programs. We believe that these approaches enable us to diversify our development risks with respect to these product
candidates. The intention is to advance development of existing and future product candidates without excessive reliance on any single program and thereby to increase the likelihood of long-term success. Moreover, we believe that this dual pathway
development approach significantly enhances our ability to generate near-term revenue opportunities through
the partnering programs, and long-term sustained revenue opportunities through strategic core programs.
The Company continues to identify and acquire licenses for product candidates in the late pre-clinical or early clinical development stage. The Company
utilizes its industry contacts to identify and acquire product candidates with high potential and extensive pre-clinical or early clinical data from Japanese pharmaceutical companies, which is one of our
advantages over other specialty drug companies in the U.S. market. The Company is in active negotiations to acquire licenses for additional product
candidates, making the best use of this advantage. In pursuing licenses for product candidates, the Company conducts extensive examinations not only on the patent rights and therapeutic needs addressed, but also on the market opportunities, level of
competition and strategic fit with existing programs. We believe that risks inherent in drug invention and development will be mitigated by expanding and further diversifying of our pipelines of product candidates.
The Company intends to actively pursue strategic collaborations with
major biotechnological or pharmaceutical companies to draw on their expertise on development, pharmaceutical regulation and commercialization. The Company has made contact with several companies that have shown interest in its partnership program.
In the area of the strategic core programs, we will continue to seek additional licensors of product candidates, potential co-marketing partners and potential future licensees outside the U.S. market. Once favorable results are obtained in the
clinical trial stage for product candidates developed through these efforts, we will endeavor to realize a quick return on our investment.
While developing the existing product candidate portfolio, the Company have also carefully assembled a management team of leaders with extensive
experience in all aspects of the drug development process from acquisition of product candidates through commercialization. The management team will be further strengthened in the near future by adding selected leaders who will contribute to the
improvement of our core competencies and the fastest implementation of our development programs.
The Company must steadily carry out business strategies described in Section 2.5. In pursuing these strategies, the following risks may adversely effect
the business of the Company:
We are a specialty pharmaceutical company still in the development stage
with a limited operating history. We have incurred significant net losses since our inception. For the year ended December 31, 2003, we had a net loss of $6.2 million. For the year ended December 31, 2004, we had a net loss of $48.3 million,
including $34.3 million of non-cash stock-based compensation charges related to employee stock options and warrants issued to the founders. We expect annual net losses to increase over the next several years as we expand and incur significant
clinical development costs. These losses have reduced our stockholders equity, and, excluding the portion related to non-cash warrant-based compensation, will continue to reduce our stockholders equity and working capital. Development
expenses are expected to increase in connection with our planned clinical trials for product candidates and any other development projects that we may
initiate. In addition, the general and administrative expenses and expenses necessary to operate as a public company are also expected to increase. Consequently, it is expected that significant and incremental operating losses will be recorded for
the foreseeable future.
We have not received, and do not expect to
receive for at least the next several years, any revenues from the commercialization of our product candidates. To date, we have not earned any product revenue and have funded our operations primarily from private sales of our securities. The only
source of revenues of 2004 was from development management services rendered to Asahi Kasei Pharma Corporation and Argenes Inc., both Japanese pharmaceutical companies, in connection with their clinical development of pharmaceutical product
candidates. In 2003, we earned no revenues. The Company anticipates that it will continue to receive modest revenues for rendering consulting services. Prior to commercialization of a product candidate, consulting revenues, together with strategic
collaboration fees and upfront and milestone payments related to out-licensing will be our primary source of revenues. To obtain revenues from sales of product candidates, the Company must succeed, either alone or with third parties, in obtaining
regulatory approval for the development, manufacturing and marketing of drugs with market potential. There is a risk that we may not succeed in these activities or may not generate sufficient revenues to support continuing business operations or to
achieve profitability.
The Company has acquired several licenses to develop and sell product
candidates. Currently, the Company is a licensee for the following six compounds that are incorporated in the development of our seven product candidates.
We are obligated to develop and commercialize these product candidates in accordance with terms and conditions agreed with licensors. Fulfillment of
some or all of the terms and conditions of the license arrangements is dependent on numerous factors, including some factors that are beyond the control of the Company. These license arrangements may be terminated if we materially breach our
obligations thereunder and fail to correct the breach within a specified period of time. If any of the license agreements is terminated, then we would have no further rights to develop and commercialize the licensed product candidate. The
termination of any license agreement may significantly and adversely affect our business.
candidates are in the clinical development stage and require regulatory approval for commercial sale. The regulatory approval process is long, complex and costly. It often takes several
years to complete the clinical development necessary to commercialize a drug, and delays or failure may occur at any stage that may result in failure to
generate revenues from marketing and sales of products derived from product candidates. Of the large number of drug candidates being developed by pharmaceutical companies only a small percentage result in the submission of a new drug application to
the Food and Drug Administration (FDA), and even fewer are approved for commercialization. Interim results of clinical trials do not necessarily predict final results, and success in pre-clinical testing and early clinical trials does not ensure
that later clinical trials will be successful. A number of companies in the pharmaceutical industry have experienced significant setbacks in advanced clinical trials even after promising results in earlier trials. The Company may face the following
risks in connection with clinical trials:
To date, FDA has accepted Investigational New Drug (IND) applications for three of our seven product candidates. We are not
allowed to conduct human clinical trials in the United States on other five product candidates until IND applications are accepted and there is no assurance that FDA will give approval for these applications. The commencement of clinical trials may
be delayed for other reasons, including delays in:
Once a clinical trial has begun, it may be delayed, suspended or terminated due to a number of factors, including:
Many of these factors described
above may also ultimately lead to refusal of regulatory approval of a present or future product candidate. If the Company experiences delays in clinical trials, the commercial prospects for product candidates will be harmed and product revenues will
Since the Company s capacity and resources to develop new drugs are
Last updated: Mar 22, 2005