SEC Comment Letter for MEDICINOVA INC (MNOV) (CIK 0001226616) (MNOV) — Oct 28, 2004
MEDICINOVA INC (MNOV) (CIK 0001226616)
Date: Oct. 28, 2004 · CIK: 0001226616 · Accession: 0000000000-04-034707
AI Filing Summary & Sentiment
File numbers found in text: 333-119433
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<DOCUMENT> <TYPE>LETTER <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> Mail Stop 3-09 October 27, 2004 Takashi Kiyoizumi, M.D., Ph.D. President and Chief Executive Officer MediciNova, Inc. 4350 La Jolla Village Drive, Suite 950 San Diego, CA 92122 Re: MediciNova, Inc. Registration Statement on Form S-1 File Number 333-119433 Dear Dr. Kiyoizumi: We have reviewed your filing and have the following comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not raise additional comments. Please understand that the purpose of our review process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Form S-1 Comments Applicable to the Entire Prospectus 1. We note your statement in the exhibit list that you intend to apply for confidential treatment for certain of your exhibits. Please note that comments related to your request for confidential treatment will be delivered under separate cover. Please be advised that we will not be in a position to consider a request for acceleration of effectiveness of the registration statement until we resolve all issues concerning the confidential treatment request. 2. Please note that when you file a pre-effective amendment containing pricing-related information, we may have additional comments. 3. Please note that when you file a pre-effective amendment that includes your price range, it must be bone fide. We interpret this to mean that your range may not exceed $2 if you price below $20 and 10% if you price above $20. 4. Please provide us proofs of all graphic, visual or photographic information you will provide in the printed prospectus prior to its use, for example in a preliminary prospectus. Please note we may have comments regarding this material. 5. Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not complete lists. If our comments are applicable to portions of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. Table of Contents, page i 6. You should retain only the Table of Contents on this page. All other information should be disclosed after the Risk Factors section. Prospectus Summary, page 1 7. As you have chosen to include a summary of your strategy, please revise to include a discussion of the risks and obstacles you must address in implementing this strategy. Risks Affecting Our Business, page 2 8. Please revise this discussion so that it is in a bullet-point format. Risk Factors, pages 7-22 9. Your risk factor section is 16 pages long and contains a lot of duplicative information. Please reduce it to eliminate overlapping or duplicative information. For example, please note the following: * It appears that the risks discussed in the 3rd, the 6th, the 7th, and the 11th risk factors overlap relating to your ability to develop and commercialize a therapeutic drug successfully. Please consider combining these risk factors to reduce the redundancy. * It appears the risks discussed in the 18th and 19th risks factors discuss similar issues related to your reliance on third parties to manufacture your products. Please consider combining these risk factors to reduce the redundancy. * It appears that the risks discussed in the 22nd, 23rd and 24th risk factors discuss similar issues and risks related to protecting your proprietary risks. Please consider combining these risk factors to reduce the redundancy. * It appears the risks discussed in the 23rd and the 28th risks factors discuss similar risks related to your ability to obtain and maintain your patent protection and other proprietary rights. Please consider combining these risk factors to reduce the redundancy. * It appears the risks discussed in the 25th and 26th risk factors discuss similar risks related to litigation involving proprietary or the proprietary rights of others. Please consider combining these risks factors to reduce the redundancy. "Unless we are able to generate sufficient product revenue, we will continue . . . .," page 7 10. We note your disclosure that you received revenue from the performance of "development management services." Please describe what development management services you performed. 11. In addition, please identify to whom you provided these services to, and whether you expect to continue to provide such management services. "If we fail to develop and commercialize a therapeutic drug successfully, we . . . .," page 7 12. Please revise your risk factor heading to disclose that you have no products available for commercial sale. "The loss of any rights to develop and market any of our product candidates . . . .," page 7 13. Please identify the parties that you currently maintain any material license agreements with as well as the product candidates that you have licensed. "If we fail to identify and license or acquire product candidates, we will not be . . . .," page 8 14. Please revise your risk factor to disclose that you may not have the necessary funds or resources to complete acquisitions, and that if you are able to do acquisitions that you may not successfully integrate the acquired company or technology with your own. You should also highlight your lack of experience in identifying and completing acquisitions. "If we fail to obtain the capital necessary to fund our operations, we will be . . . .," page 9 15. Please divide this risk factor into two risk factors: one addressing the consequences of not obtaining sufficient capital and the other addressing the negative consequences of obtaining capital, such as dilution. It may be appropriate to combine the second risk factor with "If we raise additional capital in the future, your ownership in us could be diluted" on page 19. 16. If you do not raise the anticipated offering amount, please indicate how long you could continue to run your operations. We note your have provided for this disclosure in your Liquidity and Capital Resources discussion. "We will depend on strategic collaborations with third parties to develop and . . . .," page 10 17. Based on our reading of this risk factor and your Business section, it is unclear whether you have entered into any strategic collaboration with third parties to develop and commercialize any of your product candidates. Please revise your disclosure to clarify whether you have or have not. If you have not, please also indicate when you anticipate you would enter into such arrangements. "We rely on third parties to conduct our clinical trials and perform data . . . .," page 10 18. Please identify the third parties you rely on to conduct your clinical trials and perform data collection and analysis. Please also describe the material terms of any agreements you have with such entities in the Business section of your document. You should also file the agreements as exhibits. 19. Please indicate if any of the factors you have described in this risk factor have delayed, suspended or terminated any of your clinical trials. If so, please briefly describe the specific circumstances and how they impacted the Company. "If we are unable to attract, retain and motivate key management and scientific . . . .," page 11 20. Since most companies rely on their key personnel, clearly explain how this specific risk factor applies to your company. For example, identify the key personnel upon whom you are dependent and how you would be adversely affected if one or more of them left. 21. To the extent that you have experienced problems attracting and retaining key personnel in the recent past, please revise to describe these problems. Additionally, if any key employee has plans to retire or leave your company in the near future, please revise the discussion to disclose this information. 22. In addition, please discuss any aspects of your business that make you less attractive than other companies to potential employees. "We may not be able to continue to exploit the services of outside scientific . . . .," page 12 23. Describe briefly the rights that your outside and clinical advisors have to publish data and information. "We will need to increase the size of our organization, and we may encounter . . . .," page 12 24. To the extent you can, please quantify the extent of your growth and expansion and the time period to which you refer in this risk factor. Relying on third party manufacturers may result in delays in our clinical trials . . . .," page 13 25. Please indicate if these parties currently meet your manufacturing requirements. "Materials necessary to manufacture our products may not be available on . . . .," page 13 26. Please identify the suppliers that you or your manufacturers substantially rely on for the production of the compounds you need for preclinical and clinical purposes. To the extent you have any formal agreements with them, please provide the material terms of the agreements and file the agreements as exhibit to your document. If you do not have any long term agreements, please disclose this information and disclose when any short-term supply agreements expire. 27. If difficulties in obtaining needed supplies has ever caused a material delay or disruption to your business, please discuss. "Our success depends upon our ability to protect our intellectual property . . . .," page 14 28. Please describe your patents for any key products and the expiration date of such patents. In your Business section, provide an expanded discussion to include the number of patents you have, the number of patent applications you have filed as well as the number of patents licensed to you. 29. In addition, with respect to patents you obtained from third parties, please disclose who has the obligations to take necessary actions to protect patents under your license agreements. If you do not have the obligation to take action, do you have the right to take necessary actions if the other party does not? "Confidentiality agreements with employees and others may not adequately . . . .," page 15 30. If your business has been materially and adversely affected by the disclosure of proprietary information, please discuss the situation and its consequences. If our competitors develop and market products that are more effective than . . . .," page 17 31. If you are aware of any specific competition, products in development or new products that your competitors provide or will soon provide, disclose these competitive threats and the potential impact of these products or product introductions on your business. Also, you should consider naming your most relevant competitors whose business activities could have a material adverse effect on your prospects or business going forward. If there are too many competitors to name, please disclose the approximate number of competitors in your target markets. "Rapid technological change could make our products obsolete," page 17 Health care reform measures could adversely affect our business," page 18 "We will incur increased costs as a result of recently enacted and proposed . . . .," page 20 32. As currently written, these risk factors could apply to any issuer or offering. See Item 503(c) of Regulation S-K. While we understand that the risks you describe in this subsection are risks the company encounters because it is in the drug development business, you should state how this risk relates specifically to your company. "Consumers may sue us for product liability, which could result in substantial . . . .," page 17 33. Please disclose the amount of your insurance coverage, or in the alternative, please indicate if you believe such coverage amount is reasonably adequate to insulate you from potential product liability claims. "If our stockholders sell substantial amounts of our common stock after this . . . .," page 20 34. Please disclose the number of shares that are subject to lock-up agreements. 35. In addition, please revise to include information about the registration rights agreement described on page 64 pursuant to which additional shares of common stock could be registered for resale by shareholders. "As a new investor, you will experience immediate and substantial dilution in . . . . ," page 20 36. Please revise this risk factor to explain that investors who purchase shares will: * Pay a price per share that substantially exceeds the value of your assets after subtracting its liabilities; and * Contribute ___% of the total amount to fund the company but will own only ___% of the outstanding share capital and ___% of the voting rights. "We have never paid dividends on our capital stock, and we do not . . . .," page 22 37. Please be advised that so far as the risk to investors is concerned, this risk states that you will not pay dividends, which is not a risk by itself to investors. Clearly state that readers should not rely on an investment in your company if they require dividend income and an income to them would only come from any rise in the market price of your stock, which is uncertain and unpredictable Information Regarding Forward-Looking Statements, page 23 38. We note your statement that you the information derived from third party sources "do not guarantee the accuracy or completeness of the information" and that you have "not verified independently the data and make no representation as to the accuracy of the data." It is not appropriate to disclaim liability for statements included in your registration statement. Please revise to delete this language. Use of Proceeds, page 24 39. Please disclose the approximate amount and timing of the proceeds you plan to use for the purposes you list in this section, including how much you anticipate spending of each of your leading product candidates. Please also indicate where in the drug development process you expect to be after the expenditure of these proceeds. 40. Please disclose more specific information as to the use of working capital. For example, will you acquire new product candidates, or expand your facilities? Management`s Discussion and Analysis of Financial Condition, page 28 Research and Development Expense, page 28 41. Please refer to the Division of Corporation Finance "Current Issues and Rulemaking Projects Quarterly Update" under section VIII - Industry Specific Issues - Accounting and Disclosure by Companies Engaged in Research and Development Activities. You can find it at the following website address: <http://www.sec.gov/divisions/corpfin/cfcrq032001.htm>. Please disclose the following information for each of your major research and development projects: * The costs incurred during each period presented and to date on the project; * The nature, timing and estimated costs of the efforts necessary to complete the project; * The anticipated completion dates; * The risks and uncertainties associated with completing development on schedule, and the consequences to operations, financial position and liquidity if the project is not completed timely; and finally * The period in which material net cash inflows from significant projects are expected to commence. To the extent that information requested above is not known or estimable, disclose that fact and the reason why it is not known. 4