SEC Comment Letter for MINRAD INTERNATIONAL, INC. (CIK 0001121225) — Jul 28, 2005
MINRAD INTERNATIONAL, INC. (CIK 0001121225)
Date: July 28, 2005 · CIK: 0001121225 · Accession: 0000000000-05-039033
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File numbers found in text: 333-126359
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<DOCUMENT> <TYPE>LETTER <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> Mail Stop 6010 July 28, 2005 William H. Burns, Jr. Minrad International, Inc. 847 Main Street Buffalo, NY 14203 Re: Minrad International, Inc. Registration Statement on Form SB-2 File No. 333-126359 Dear Mr. Burns: We have reviewed your filing and have the following comments. Where indicated, we think you should revise your documents 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 SB-2 General 1. In your response letter, please state our comment and then explain each change that has been made in response to a comment. In addition, you should also reference each page number in which disclosure has been revised in response to a comment so that we can easily place your revised disclosure in its proper context. 2. 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. 3. We note that you have filed a confidential treatment request for certain of your exhibits. In that regard, please be advised that comments related to your request for confidential treatment will be delivered under separate cover. We will not be in a position to consider a request for acceleration of effectiveness of this registration statement until we resolve all issues concerning the confidential treatment request. 4. In your next amendment, please update the disclosure, including updated financial information, and in your Risk Factor section, as of a recent date practicable. 5. Please provide updated interim financial information in accordance with Item 310(g) of Regulation S-B. 6. Where applicable, please amend your transition report on Form 10- KSB for the three months ended December 31, 2004 and your Form 10- QSB for the quarter ended March 31, 2005 to comply with our comments on your Form SB-2. Registration Statement Cover Page 7. Although Form SB-2 does not contain a space to indicate that the securities are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act, please revise to include this disclosure. Prospectus Cover Page 8. Please revise the third line where you disclose the number of shares of common stock to say "up to 25,120,561 shares of common stock." Risk Factors, page 4 9. We note your statement that, "The risks and uncertainties described below are not the only ones facing our company. Additional risks and uncertainties may also adversely impair our business operations." Please eliminate or revise these sentences as they imply that there are other risks that the investors should consider before investing in your company when the risk factors section should list all of the risks key to an investment decision. "We are currently in a growth stage and may experience setbacks in both business . . . .," page 4 10. Please clarify how long you have been manufacturing and marketing inhalation anesthetics. 11. Please also clarify when you launched the SabreSource system, and explain how your operations in producing this system have been limited. Please provide examples to illustrate your point. "We have historically experienced operating losses and expect to continue to . . . .," page 5 12. To the extent possible, please quantify the significant up- front expenditures you have incurred in the production and marketing activities of your inhalation anesthetics and image guidance system products as well as the amount of revenue you have derived from the sale of these products to date. "We will need to raise additional capital to fulfill our business strategies. We may . . . .," page 5 13. We note your disclosure relating to the need to raise additional capital. To the extent possible, please quantify how much capital you intend to need or raise in the next 12 to 18 months. Please also provide similar disclosure in your Liquidity and Capital Resources section. 14. Please disclose how long you will be able to maintain your operations without obtaining additional funds. To the extent possible, please put your cash needs in a context by stating the amount of cash you currently have available to you and the average amount of cash you are using on a monthly basis. Please also provide similar disclosure in your Liquidity and Capital Resources section. 15. In addition, please note that each risk factor should discuss one risk. We note that the discussion in the last three sentences of this risk factor appear to be discussing two separate risks. More specifically, the separate risk that if you issued additional capital, the dilution consequences of such an issuance; and the separate risk of debt financing, which may involve unfavorable financial terms or significant restrictive covenants. Please revise this section such that each risk factor is presented separately. "The loss of the services of key personnel would adversely affect our business . . . .," page 6 16. Please identify the positions that each of William Burns and John McNeirney have with your company in this risk factor. 17. Please also briefly indicate the status of your conscious sedation program, including when you expect to complete the program. 18. In addition, please indicate if you maintain any key life insurance policies or employment agreements with these individuals. "We must hire and retain skilled technical and managerial personnel," page 6 19. To the extent that you have experienced problems hiring or retaining employees, please revise to disclose the problems and resulting consequences. "We depend on strategic partnerships and relationships," page 7 20. To the extent you have established any alliances with strategic partnerships and relationships that you believe are material to your business, please identify those partnerships and relationships in the Business section of your prospectus, please provide the material terms of any agreements you have with such partners. Please also file the agreements as exhibits to your registration statement. In the alternative, please provide an analysis as to why such agreements are not material to you. "We face competition in our industry, and many of our competitors have . . . .," page 7 21. Please explain to us the basis for your statement that you believe you are the only company with a real-time image guidance system with an accuracy of plus or minus 1 mm at a distance of 1 meter. Please also explain in greater detail how the accuracy of your system compares to that of your competitors` products. For example, do your competitors have products with greater or lesser accuracy than your guidance system? "We rely upon third-party manufacturers and suppliers, which puts us at risk for . . . .," page 7 22. To the extent you substantially rely on the services of any third party manufacturers or suppliers, please identify them in this risk factor and in your Business section, please provide the material terms of any agreements you have with such parties. Please also file any agreements you may have as exhibits to your registration statement. In the alternative, please provide us with an analysis as to why such agreements are not material to you. 23. We also note your statement that you rely on the continuing availability of certain specialty raw materials from a small number of suppliers. Please identify the raw materials you are referring to and also indicate the availability of these materials in general, other than from your selected suppliers. 24. Please indicate if your suppliers currently meet your supply and manufacturing requirements. Additionally, if difficulties in obtaining needed supplies have ever caused a material delay or disruption to your business, please discuss in this risk factor. "Business interruptions beyond our control have occurred in the past and may take . . . .," page 8 25. Please further provide the details of the business interruption experienced at the Bethlehem facility, including how long the interruption was and how much damage the company experienced from a financial point of view. Please also indicate the amount of the claim you filed and how much you expect to receive from your insurance carrier and when you expect to receive the full amount, if at all. "We face significant risks associated with our international operations, which . . . .," page 8 26. Please identify each foreign country where you conduct your business, if such country represents a material portion of your business. If you determine such a market in a particular country is not material, please provide us with a detailed explanation as to why such markets are not material to you and therefore, require no additional disclosure. 27. We note your statement that you have recently experienced adverse effects on the sales of inhalation anesthetics in Venezuela as a result of restrictions of the Venezuelan government on the repatriation of the United States dollar. Please quantify how much of a financial impact such restrictions had on your operations. For example, quantify how much of a decrease you experienced in revenues from your sales in the Venezuelan market. Please also provide similar information regarding your sales in the Middle East. 28. Additionally, please also explain your distribution and selling efforts in both Venezuela and the Middle East. For example, do you directly sell to customers in these markets or do you sell through third parties? Additionally, please explain what specific Middle Eastern countries you sell your products to in this risk factor. 29. We note the disclosure you include in the bullet points of this risk factor. It appears each of these factors warrant separate discussion as risk factors. Please consider adding a risk factor discussion for each of the items listed in the bullet point section of this section. To the extent you do not believe each factor warrants separate discussion, please supplementally explain to us why. "Failure to obtain regulatory approval for our products in the future may . . . .," page 10 30. Please identify the foreign governmental agencies in which you are planning on seeking approvals for your products. 31. Please explain what cGMP standards mean. "We are subject to environmental regulations, and any failure to comply may . . . .," page 11 32. Please indicate if you maintain any insurance coverage with respect to any environmentally hazardous materials you manufacture or distribute. If so, please also disclose the coverage amount as well as any limitations of the insurance coverage. "We became public by means of a reverse merger, and as a result we are subject . . . .," page 12 33. Please briefly describe in this risk factor the operations conducted by the company prior to the reverse merger. 34. Please present the discussion concerning the risks associated with the fact that no security analysts of major brokerage firms and securities institutions sold your stock in a public offering as a separate risk factor with its own heading. Please also discuss in further details the consequences stemming from the risk you have identified. "We have recently been in default under obligations with various service . . . .," page 12 35. Please disclose the time period in which you defaulted. In addition, if material, please identify the providers that you had defaulted payment on. Please also quantify the amount you had defaulted on and how much you continue to owe to such vendors or lenders. You should also include a brief discussion of the financial arrangements you made with these vendors and whether you are currently meeting your obligations under these terms. 36. Please also indicate if you these vendors are continuing to provide you with services or supplies. If not, please indicate from whom you are currently receiving your needed services and/or supplies and how you intend to pay for these services or supplies. "We incur significant costs as a result of being a public company," page 12 37. Please revise your heading to add a consequence of you incurring significant costs. "If we are not able to adequately protect our intellectual property, we may not be . . . .," page 13 38. Please identify the patents for each material product as well as the expiration date for each patent. Please also provide similar information with respect to the foreign counterparts that protect your product, including the country and agency providing the approval for your product in foreign markets. "We have a concentration of stock ownership and control," page 14 39. Please revise the heading to add a consequence to you having a concentration of stock ownership and control. 40. Please provide the number of your shareholders holding a high concentration of your common stock, including their identity and their relationship with you, other than as majority stockholders. "Our stock price may be volatile because of factors beyond our control and you . . . .," page 15 41. Please disclose the price range of your common stock during the most recent two fiscal years and interim period. For example, the high and low price during this period. In addition, if any known factors are suspected of causing the volatility, please explain identify these factors and describe the suspected impact on your stock price. "We may experience future sales of large amounts of common stock by existing . . . .," page 15 42. Please revise to include the number of your presently outstanding shares, the number that is freely tradable and the number that is subject to Rule 144. "We are subject to penny stock regulations and restrictions, page 15 43. Please disclose the price per share of your common stock as of a recent date. "We have not paid and have no plans to pay cash dividends, page 16 44. Please revise this risk factor heading and discussion to clarify investors will only see a return on their investment if the value of the shares appreciates. Selling Shareholder Table, page 20 45. For each selling shareholder that is not a natural person or publicly registered company, please revise to disclose the natural person having voting and dispositive rights. 46. If any selling shareholders are registered broker-dealers, please revise to identify such parties as underwriters. The only exception to this position is if the selling shareholder received the shares as underwriting compensation. 47. If any of the selling shareholders are affiliates of broker- dealers, please revise to state that the selling shareholder received the shares in the ordinary course of business and has no agreement to directly or indirectly engage in a distribution of the shares. If a selling shareholder is not able to make such representations, then revise to identify such selling shareholder as an underwriter. Plan of Distribution, page 26 48. We note your disclosure that "selling shareholder" includes transferees, pledges, donees or other successors. Please note that in the event the shares covered by this prospectus are transferred in