SEC Comment Letter for OccuLogix, Inc. (CIK 0001299139) — Sep 13, 2004
OccuLogix, Inc. (CIK 0001299139)
Date: Sept. 13, 2004 · CIK: 0001299139 · Accession: 0000000000-04-029334
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File numbers found in text: 333-118204
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<DOCUMENT> <TYPE>LETTER <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> MAIL STOP 03-06 September 13, 2004 Elias Vamvakas, Chief Executive Officer OccuLogix, Inc. 5280 Solar Drive, Suite 100 Mississauga, Ontario Canada L4W 5M8 RE: OccuLogix, Inc. Registration Statement on Form S-1 Commission File No. 333-118204 Filed on August 13, 2004 Dear Mr. Vamvakas: 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. General 1. Please confirm that any preliminary prospectus you circulate will include all non-Rule 430A information. This includes the price range and related information based on a bona fide estimate of the public offering within that range. Also note that we may have additional comments after you include this information. 2. Please fill in the blanks in your document so that we may continue our review. 3. If you intend to include any graphics in the prospectus, please submit them for our review. 4. Please minimize the use of technical medical terminology or other words or phrases that may be unfamiliar to the average investor in the Summary and Risk Factors section. See Updated Staff Legal Bulletin No. 7 (CF). In addition, if you include technical terms in the body of your prospectus, please concisely explain these terms where you first use them in the discussion. For example, we note terms such as rheopheresis, apheresis, BCVA, FRCSC, morphometry, and electrophysiological function. 5. Please provide an objective support for the following statements: * our RHEO System is the only Dry AMD treatment to target what we believe to be the underlying cause of AMD rather than its symptoms (pages 1 and 38); and * RHEO Therapy is currently the only Dry AMD therapy that ... appears to improve vision in some patients (page 2). 6. We note the statistics you attribute to various third parties throughout the prospectus including, among others, the following: * Dry AMD afflicts approximately 13.0 to 13.5 million people in the United States, representing approximately 85% to 90% of all AMD cases (pages 1, 38, and 40); * approximately 15 million people in the United States suffer from AMD (pages 2 and 39); * the Category 3 and the Category 4 Dry AMD population ... represents approximately 54% of the total U.S. Dry AMD patients, or currently approximately 8 million people (page 2); * the prevalence of AMD increases sharply with age, from 18% among people 65 to 74 years of age to 47% among people 85 years and older (page 39); and * the prevalence of AMD among a selected sample of U.S. residents aged 65 and older was 27% in 1999 (page 39). Please supplementally provide us with copies of the materials that support the statistics cited, clearly marking the relevant sections. In addition, please tell us whether those third parties have consented to your use of their data and whether any of the reports were prepared specifically for your use. 7. News articles report that your treatment could be launched in the second half of 2005. See e.g. TLC Subsidiary Files For IPO In Canada, The Globe and Mail, Sep. 1, 2004, at B11; TLC Spinoff Files For Share Offering, The Globe and Mail, Aug. 14, 2004, at B2. This appears to be inconsistent with the disclosure in the prospectus that you would not generate significant revenues until late 2006. Please supplementally advise if you or your affiliates provided such information to the market or media. Prospectus Cover Page 8. Disclose that your major shareholder, TLC Vision Corporation, currently holds 65.8% of your outstanding shares and plans to sell ______ shares in this offering. 9. The underwriter should be aware of the staff`s long-standing and unchanged position that the term "Sole Book-Runner" should be removed from the cover page. Please comply. You may, however, include this language on the back cover page. Prospectus Summary - Page 1 10. Please provide independent support for your belief that poor microcirculation and the gradual build-up of cellular waste material contribute to the development of Dry AMD and for the efficacy of your process. 11. Clarify that to date you have received results for 36 patients in the MIRA-1 clinical trial, one third of which are in the placebo group. 12. Quantify what you mean by "worse than legal driving vision" and the degree to which vision improved in 58% of the patients. Discuss the extent to which you have established whether improvements are long term, as well as short term. 13. Briefly describe the extent of the affiliation of the registrant with TLC Vision Corporation. 14. In the forepart, please briefly describe the status of your products` regulatory approval, and state that you do not expect to generate revenues in the United States or materially increase sales in Canada until late 2006, at the earliest. 15. Expand the second paragraph on page 2 to clarify the extent to which therapies for wet AMD have received FDA approval. 16. We note the advantages of your RHEO System described in "Our Solution" subsection. In order to provide a more balanced disclosure, please identify the disadvantages of your systems including the possible side effects and briefly discuss the significant risks related to the investment in your company. 17. You indicate that you are "currently" identifying multi-facility health care service providers and also seeking to establish Medicare reimbursement for RHEO Therapy. In an appropriate section, please describe the status of any contact or negotiation. Considering the fact that you do not have FDA approval to commercialize the product and that sales in the US will not begin until late 2006, please describe how much you are focusing on such marketing activities. 18. You state that MIRA-1 follows ten years of successful clinical trials and studies on Rheopheresis conducted outside United States. Please clarify if your RHEO System has been put in clinical trial for ten years outside the United States. Disclose if your system has been approved in foreign countries for commercial use. 19. On page 3, you state that AMA in January 2003 established an insurance billing code that accurately characterizes the RHEO Therapy procedure and that Medicare currently covers and pays for other FDA- licensed services billed with this code only when performed in a hospital outpatient setting. Please clarify what procedures the new insurance billing code covers, and disclose if there is a therapy similar to RHEO that is currently performed to outpatients. Also, since you are years away from FDA approval, delete multiple discussions on medical reimbursement. We note the bottom of page 1. 20. Under the caption "our solution," briefly describe the process you use to filter the blood. Also disclose what constitutes "an initial course of RHEO Therapy." 21. In an appropriate section, please describe your business in Canada. Describe the status of regulatory approval by the Canadian government, and disclose whether the product and services are commercially provided to AMD patients. 22. If you have a website, please provide the internet address here or in your business section. See Item 101(e) of Regulation S-K. 23. Under the caption "Corporate Information," disclose the extent to which your officers and directors also hold positions with TLC Vision. Summary Historical and Pro Forma Consolidated Financial Data - Page 6 24. The table references footnote (1) but does not include an explanatory footnote. Please revise or advise. Risk Factors - Page 8 25. In the beginning of this section, please add a risk factor disclosing that your auditor raised substantial doubt about your ability to continue as a going concern. Also, provide your most recent working capital and shareholder equity figures. We do not know whether we will be able to increase our revenues... - Page 8 26. Revise this caption to make clear that you have had losses every year since you began operations, and quantify in the risk factor your revenues for each of the three most recent years, rather than 1998 and 1999. Also quantify the extent of your accumulated deficit. Alternatively, move the first risk factor on page 14 to this location. 27. You state that the focus of your operations in recent years has shifted towards the ongoing pivotal trial, MIRA-1. Please briefly discuss your business prior to this change. 28. Also state that since July 2002, your only customer has been OccuLogix, L.P., an affiliated party. We may be unable to complete MIRA-1... - Page 8 29. We note that MIRA-1 is currently being conducted at seven treatment centers in the US and Canada and that your relationship with these contract research organizations could be terminated before MIRA-1 is completed. In your business section, please name these contract research organizations, describe the terms of any agreements entered into with these centers - including the compensation you agreed to pay - and file the agreements as exhibits. RHEO Therapy is based on a model that has not achieved... - Page 10 30. Please confirm if FDA initiated any actions, other than the directive requiring IDE and the fine against your founder. Disclose the amount of fine paid by Dr. Davis. Supplementally provide us with any directive or order issued by FDA against you or your affiliates. If Dr. Davis continues to be employed in any capacity, expand to disclose. 31. You state that the activities of the Rheotherapy Center engendered opposition in certain segments of the eye care community. Please provide more details. RHEO Therapy may produce adverse side effects... - Page 13 32. Please describe any side effects observed during MIRA-1 or any other known side effects. We may face future product liability claims... - Page 13 33. Please disclose your insurance policy coverage. Conflicts of interest... - Page 15 34. Disclose that these three individuals make up a majority of your board of directors. Future sales of our common stock could reduce our stock price - Page 17 35. Please disclose the average exercise price of your outstanding options and warrants. Use of Proceeds - Page 21 36. We note that you will use $20.4 million to $21.4 million of the net proceeds to build your infrastructure and to facilitate the commercialization of RHEO System. Please discuss in more detail how this amount will be used and break down this amount in more detailed items. Dilution - Page 23 37. Please update this section to reflect the numbers of your most recent financial statement. 38. Expand to disclose the reorganization transactions that are reflected in this information. Also, clearly disclose how the "shares purchased" and "total consideration" columns will change if you assume exercise of all outstanding warrants and options. Unaudited Pro Forma Condensed Consolidated Financial Data - Page 24 39. The information your present here may be confusing to investors, as the pro forma adjustments are not clearly referenced to footnotes describing the assumptions you made. If your intent was to provide investors with a summary of the reorganized company on a pro forma basis, then move the section to follow the selected financial data table, present only the pro forma statements of operation and balance sheet columns with the accompanying introductory paragraphs and refer the reader to the detailed information presented on pages F-50 through F-58. Otherwise, replace the current disclosure with the detailed pro forma information currently included on page F-50 through F-58. Management`s Discussion and Analysis of Financial Condition and Results of Operations - Page 29 40. We note that all of your revenue is generated from sales to OccuLogix, L.P., an affiliate of yours, and OcculLogix, L.P. derive its revenue from sales to yet another related party. Identify the related parties to which you refer in the carryover paragraph at the bottom of page 29. Please disclose the sales of products and services related to Rheotherapy by you and your affiliates to end users who are not related to you. Cost of Sales - Page 30 41. Quantify the amounts paid to Messrs. Stock and Brunner under the agreements. Operating Expenses - Page 30 42. It appears that the majority of your G&A expenses are for compensation. Expand to discuss in more detail separately. Results of Operations - Page 31 43. To better explain cash flows from operations, please revise to discuss significant changes to the components of working capital - i.e., individually significant changes in line items. For example, we note that inventories increased $75 thousand or 40% over the past quarter while sales decreased significantly. Please address the impact on your working capital. 44. When you cite changes in components of working capital - for example, receivables, inventory, payables, and accruals - in explaining changes in cash flows from operations, please explain the reasons for the changes. For example, explain why you continue to build inventories when sales have fallen off. 45. You attribute your 73% decrease in revenue to the SARS outbreak in Toronto in 2003. Please discuss if your products and RHEO treatment is fully commercialized in Canada. Have you acquired all the regulatory approvals? Are third parties such as insurance companies or government health programs covering the costs of the treatments? If so, why was the revenue so low and what do you expect the future trend will be? 46. Please break down "general and administrative expenses" and "other (expenses) income" in more detailed items and quantify them. 47. We note that it appears that more than 80% of the options granted in 2003 went to three individuals. Expand to discuss, and provide additional information. 48. On page 30, you state that the clinical regulatory expenses will remain relatively constant until MIRA-1 and the clinical trials are complete. However, we note that the same expenses increased 116% in the three months ended March 31, 2004. Please clarify what the level of spending would be in the near future. If you have made any commitment to spend certain amounts on clinical trial when you received funding from TLC Vision and Diamed, please disclose in detail. 49. Please disclose OccuLogix, L.P.`s revenue and net profit for the periods discussed in this section. 50. We note that you attribute decreased revenue for the first quarter in 2004 to lower patient volumes due to the SARS outbreak. Quantify in the year-end revenues the extent to which sales declined in the second half of 2003. 51. We note that the 51% decrease in general and administrative expenses in year 2002 was due to a reduction in the number of staff. Please describe in more detail the facts underlying the downsizing that occurred during the time and disclose the numbers of employees before and after the incident. Liquidity and Capital Resources - Page 32 52. You state that the estimated net proceeds of this offering will be sufficient to fund your operations and other demands and commitments until late 2006. Please discuss in detail the basis of this statement. Describe and quantify, from the ma