SEC Comment Letter for Emergent BioSolutions Inc. (EBS) (CIK 0001367644) (EBS) — Sep 11, 2006
Emergent BioSolutions Inc. (EBS) (CIK 0001367644)
Date: Sept. 11, 2006 · CIK: 0001367644 · Accession: 0000000000-06-043501
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File numbers found in text: 333-136622
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Mail Stop 6010 September 9, 2006 Fuad El-Hibri Chief Executive Officer Emergent BioSolutions Inc. 300 Professional Drive, Suite 250 Gaithersburg, Maryland 20879 Re: Emergent BioSolutions Inc. Registration Statement on Form S-1 Filed August 14, 2006 File No. 333-136622 Dear Mr. El-Hibri: We have reviewed your filing and have the following comments. Where indicated, we think you should re vise 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 deta iled as necessary in your explanation. In some of our comments, we may ask you to provi de us with information so we may better understand your disclosure. After reviewing th is information, we may raise additional comments. Please understand that the purpose of our re view 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 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 General 1. Please note that we have received your request for confidential treatment for certain of your exhibits. In that regar d, please be advised th at comments related to your request for confidential treatment w ill be delivered under separate cover. We will not be in a position to consider a request for acceleration of effectiveness Fuad El-Hibri Emergent BioSolutions Inc. September 9, 2006 Page 2 of this registration statement until we resolve all issues concerning the confidential treatment request. 2. Please provide updated interim financial in formation in accordance with Item 3- 12 of Regulation S-X. Comments Applicable to the Entire Prospectus 3. 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 re garding these materials. 4. Please note that when you file a pre- effective amendment containing pricing- related information, we may have additiona l comments. As you are likely aware, you must file this amendment prio r to circulating the prospectus. 5. Please note that when you file a pre-eff ective amendment that includes your price range, it must be bona fide. We interpre t this to mean your range may not exceed $2 if you price below $20 and 10% if you price above $20. Summary, page 1 6. In instances where you have stated that Bi oThrax is safe and effective, please revise to state that it is su fficiently safe and effective. 7. You indicate on page 1 that a study by th e Institute of Medicine supported the FDA ruling that BioThrax is safe and effective for the prevention of anthrax infection by all routes of exposure, including inhalation. Pl ease provide us a marked copy of this source to support your statement. 8. We note the statistical information you include on pages 2 and 76-77 regarding the data obtained from Frost & Sullivan. Please provide us with copies of this source in which you obtained the statistical figures. The copy should be marked to indicate the information supporting your statements. 9. If any of the data from Frost & Sullivan were derived from studies or reports that were performed on your behalf, please so indicate and file any appropriate third party consents. Our Business, page 1 10. We note that you have completed Phase I cl inical trials for your typhoid vaccine. Please tell us if the IND filed with th e FDA was filed by you or another party. Additionally, tell us the product name used in the IND that was filed. Fuad El-Hibri Emergent BioSolutions Inc. September 9, 2006 Page 3 11. Are you planning to conduct clinical trials for your hepatitis B therapeutic vaccine or Group B streptococcus vaccine in the US? Our Strategy, page 3 12. We note your summary of the primary goals for your company for the future. Please balance the discussion of your stra tegy in the summary with an equally prominent discussion of obstacles and risk s in implementing the stated goals. The Offering, page 5 13. Please revise to include disclosure rela ting to the rights which are being offered with the common stock. Risk Factors, page 8 14. Please include a separate risk factor disc losing the possibility that the issuance of the preferred stock purchase ri ghts might prevent a change in control in instances where some shareholders may believe the ch ange in control may be in their best interests. “We have derived substantially all of our re venue from sales of our . . . .,” page 8 15. Please revise your risk factor header and discussion to clearly state that BioThrax is currently your only product ava ilable for commercial sale. 16. Please revise to include a separate sta nd alone risk factor disclosing the ongoing legal proceedings and the effects they may have on your sales to the US government. “Our U.S. government contracts for BioThrax ® require annual funding . . . .,” page 9 17. This risk factor appears to be discussi ng three separate risks factors, the risks associated with Congressional appropria tions that the fundi ng of governmental programs are subject to; the risks permitting unilateral termination of government contracts; and the risk associated wi th specific procurement regulations in conducting business with the government. Pleas e ensure that each risk factor only discusses one risk factor and move the discussion pertaining to unilateral termination by the government to the risk factor entitled “Unfavorable provisions in government contracts may harm our business . . . .” on page 10 and the discussion regarding governmental oversight as a new separate risk factor. Fuad El-Hibri Emergent BioSolutions Inc. September 9, 2006 Page 4 “The pricing under our fixed price government contracts is based on . . . .,” page 1 0 18. If in the past your estimated costs were not accurate and therefore, you were not able to earn an adequate return on your contract, if such impact was material, please describe the incidence and furthe r describe the impact it had on your operations. “We have a limited operating history and may no t maintain profitability . . . .,” page 11 19. If there were any material factors that resulted in losses for the three months ended March 31, 2006, please explain. If these factors involved increased expenses that are likely to recur, please identify them and discuss their impact going forward. “We may need additional funding and may be unabl e to raise capital when . . . .,” page 12 20. You indicate that you are committed to substantial capital expenditures in connection with the expansion of your Lans ing, Michigan facility as well as for the planned build out of two buildings in Frederick, Maryland. Please quantify the approximate amount of expenditure you are committed for in connection with these expansions. Please provide similar in formation in the risk factor entitled “We have initiated a manufact uring facility expansion pr ogram. . . .” on page 13. “BioThrax and our immunobiotic product candida tes are difficult to . . . .,” page 13 21. If your financial condition has historically been materially impacted by lot failures, product recalls or other acceptance criteria, please describe the situation and further describe the imp act it had on your operations. “Disruption at, damage to or destruction of our manufacturing facilities . . . .,” page 14 22. If you have experienced any of the situati ons described in your bullet point list, please revise to describe the situation you experienced and the consequences. It may be necessary to include such discussi on as a separate risk factor discussion. “If third parties do not manufacture our product candidates in sufficient . . . .,” page 15 23. Please identify the third parties that manufactur e the supplies of your immunobiotic product candidates for your pr eclinical and clinical developments needs. If any of these parties have faile d to meet your preclinical and development needs, please discuss the failure and the effects of the failure. Fuad El-Hibri Emergent BioSolutions Inc. September 9, 2006 Page 5 24. Please identify the third party who provi des you with services related to your purification and fractionation of plas ma for your anthrax immune globulin candidate. “Our use of hazardous materials, chemicals, b acteria and viruses requires . . . .,” page 16 25. If you have been in violation of the envir onmental laws or been the subject of any investigations for violations in the past, pl ease revise to include this information. 26. Please state whether you currently have reas onably adequate insurance to insulate yourself from damage claims arising fr om your use of hazardous materials and quantify the extent of your insurance coverage. “We will not be able to commercialize our product candidates if our . . . .,” page 17 27. You indicate in the first full paragra ph following the bullet points that you anticipate that the FDA will not require you to conduct a Phase II clinical trial for the botulinum toxoid vaccine before pe rmitting you to initiate a donor stimulation program for your botulinum immune globu lin candidate. Please provide the basis for your believe that the FDA will not requ ire to conduct a Phas e II clinical trial related to your botulinum immune globulin candidate. “If we fail to achieve significant sales of Bi oThrax to customers in . . . .,” page 19 28. Please identify the potential customers you are targeting the BioThrax product. Please also identify the type of custom ers who are currently purchasing your BioThrax product, other than the U.S. government. 29. Please disclose when your new Lansing facility will be completed. “The commercial success of BioThrax and any products we develop…,” page 19 30. Please explain the meaning of the term “recombinant.” 31. To the extent that there have been repo rts of any material side effects from BioThrax or any of your products in devel opment, please revise to include this information. “We have a small marketing and sales group. If we are unable to expand . . . .,” page 21 32. To the extent known, please disclose th e projected time frame of your hiring the additional marketing personnel and the approximately how many employees you plan to hire. Fuad El-Hibri Emergent BioSolutions Inc. September 9, 2006 Page 6 33. If you have had problems attracting or retaining qualified marketing and sales employees, please revise to describe the problems you have experienced. “We face substantial competition…,” page 21 34. Much of the detail included in this disc ussion is more approp riate for the Business section. Please revise the discussion to include a level of detail that helps readers understand the risk and consequences. Move the detailed discussion to the Business section. “Legislation and contractual provisions limiting or restricting liability . . . .,” page 23 35. You indicate that you have applied to th e Department of Homeland Security for liability protection for sales of BioThra x. Please disclose when you submitted the application and when you expect to h ear from the Department of Homeland Security. “Product liability lawsuits could cause us to incur substantial liabilities . . . .,” page 24 36. You indicate that the lawsuits claim da mages resulting from personal injuries allegedly suffered because of the BioThrax vaccination. Please specify what type of personal injuries the lawsuits claims arose from the use of your BioThrax vaccination. Additionally, disclose the amount of damages they are seeking. “If we fail to attract and keep senior mana gement and key scientific. . . .,” page 27 37. If you have experienced difficulties hiring or retaining employees, please describe these difficulties. Similarly, if you have r eason to expect that you may experience difficulties due to shortages of qualified people or other reasons, please discuss these expectations and the conditions that create the expectations. “We rely on property and equipment owned by the Department of Defense . . . ., page 28 38. Please disclose the fee you currently pa y to the government for use of their equipment, if such amount is material. “If third parties on whom we rely for clinical trials do not perform as . . . .,” page 33 39. Please identify the third parties on whom you “heavily” rely for the successful execution of your clinical trials. To the extent you have any agreements with such parties, please describe the agreements in your Business section and file the agreement as an exhibit. If you do not believe such agreements are material to you, please provide us with a detailed an alysis explaining why you do not believe such agreements are material to you. Fuad El-Hibri Emergent BioSolutions Inc. September 9, 2006 Page 7 40. You indicate that you expect to rely on the data from the development efforts of CDC, assuming CDC consents to such use and the study is completed. Please expand your disclosure by describing how frequent your contact with the CDC is and what information you are privy to, if any. 41. Please remove the discussi on relating to your plans to expand your internal clinical development and regulatory capabi lities and the risk that you may not be able to recruit appropriate ly trained personnel to your infrastructure to a new separate risk factor discussion. “We may fail to protect our intellectual pr operty rights, which would . . . .,” page 33 42. To the extent you are aware that you have any intellectual proper ty that is being infringed upon or that you have been notif ied of a third party's belief that you are infringing on their intellectual property, pleas e revise to disclose the situation and potential consequences. 43. Please disclose who has the obligations to take necessary actions to protect patents under your license and collaborati on agreements. If you do not have the obligation to take action, do you have the ri ght to take necessary actions if the other party does not? “If we infringe or are alleged to infringe intellectual property ri ghts . . . .,” page 35 44. If you or your collaborators were ever require d to pay license fees or royalties, or both as a result of patent infringement cl aims or to avoid potential claims, please so indicate and provide a desc ription of the circumstances. “Fuad El-Hibri, our president, chief executive officer and chairman of . . . .,” page 37 45. Please revise your risk factor heading to include the fact that Mr. El-Hibri will also control the outcome for the election of directors. We note you have provided this disclosure in your risk factor discussion. “If you purchase shares of our common stock in this offering, you will . . . .,” page 38 46. Please revise this risk factor to state th at shareholders will co ntribute ___% of the total amount to fund BioSolutions bu t will own only ___% of the shares outstanding. Fuad El-Hibri Emergent BioSolutions Inc. September 9, 2006 Page 8 “A significant portion of our total outstanding shares are restricted from . . . .,” page 39 47. Please disclose the total number of shares that will available for immediate sale in the market. Please also disclose the percen tage that the shares will represent of your total outstanding shar es after the offering. 48. Please also disclose the total amount bene ficially owned by Mr . El-Hibri and the percentage that his shares represent of your total outstanding after the offering. We note you have provided this information in the risk factor entitled “Fuad El- Hibri, our president, chief executive o fficer and chairman . . . .,” page 37. 49. Please indicate how many s