SEC Company Response from Electromed, Inc. (ELMD) (CIK 0001488917) (ELMD) — Jun 16, 2010
Electromed, Inc. (ELMD) (CIK 0001488917)
Date: June 16, 2010 · CIK: 0001488917 · Accession: 0000897101-10-001297
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File numbers found in text: 333-166470
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CORRESP 1 filename1.htm June 16, 2010 VIA EDGAR AND FEDEX U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attn: Tim Buchmiller and Ruairi Regan Re: Electromed, Inc. Registration Statement on Form S-1 Filed May 3, 2010 File No. 333-166470 Dear Mr. Buchmiller: On behalf of Electromed, Inc. (the “Company”), we are responding to your comment letter, dated May 28, 2010, to Mr. Robert Hansen, Chairman and Chief Executive Officer of the Company, regarding the Company’s registration statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on May 3, 2010 (the “Form S-1”). A responsive Pre-Effective Amendment No. 1 to the Form S-1 (“Amendment No. 1”) has been filed concurrently herewith via EDGAR. We have also provided you and the other SEC Staff members listed at the end of this response letter with courtesy marked copies of Amendment No. 1 showing changes to the Form S-1 to assist in your review. For your convenience, we have repeated and numbered the comments from your letter in boldface print. The Company’s responses are provided below each comment. Prospectus Cover Page 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 price within that range, and other information that was left blank throughout the document. Response: The Company confirms that the preliminary prospectus that will be circulated will include all non-Rule 430A information, including the price range and related information based on a bona fide estimate of the public offering price within that range. 2. Please highlight the reference to the risk factors section. Refer to Item 501(b)(5) of Regulation S-K. 1 Response: The Company has cross-referenced the risk factors section in a more prominent manner in Amendment No. 1 by unitalicizing the font and by moving the cross-reference to precede the description of the offering price of the securities. Table of Contents 3. We note the first sentence in the paragraph that follows your table of contents cautioning investors that they “should rely only on the information contained in this prospectus.” Please consider whether this statement, in its current form, is consistent with your ability to use free writing prospectuses. Response: The Company has revised the identified language on the table of contents page of Amendment No. 1 to reflect that investors may rely on information in free writing prospectuses prepared by or on behalf of the Company. Summary Our Business Strengths, page 2 4. We note that this section provides a broad overview of the strengths of your business. Please balance your disclosure by providing an equally prominent overview of the material risks to and weaknesses in your business. Response: The Company has revised the Risk Factors section of the Summary on pages 3 and 4 of Amendment No. 1 to provide a more prominent overview of the material risks to and weaknesses in the Company’s business, which are described in more detail in the Risk Factors section. Risk Factors Our business financial condition and results of operations, page 10 5. With a view to disclosure, please: • tell us the location and identity of your principal distributors; and • tell us whether you have any agreements with these distributors and the nature of such agreements if any. Response: The Company advises the Staff that it has made sales in more than ten countries. Its principal international distributors are Compania Europea de Productos Medicos, S.L. (Spain), Linde Medicale, S.r.l. (Italy), and TKB International, Inc. (Japan). TKB International, Inc. serves as the Company’s exclusive distributor in Japan pursuant to a Distributorship Agreement entered into on December 1, 2007. The agreement has a three-year term and will automatically extend for an additional two-year term unless cancelled by either party with six months’ notice. Compania Europea de Productos Medicos, S.L. (“Medipro”) 2 serves as the Company’s exclusive distributor in Spain pursuant to an agreement dated March 18, 2008. The agreement had an initial two-year term and was automatically renewed for an additional two-year term as a result of Medipro meeting minimum sales requirements. The Company entered into a letter agreement with Linde Medicale, S.r.l. on January 30, 2009, pursuant to which it serves as the Company’s exclusive distributor in Italy. Although the agreement expired on June 30, 2009, the Company and the distributor have continued to operate under the terms of the agreement. The Company has not disclosed this information in the Form S-1 because it does not believe that the identity of its distributors or the terms of its distributor agreements would be material to investors. If our patents, page 19 6. We note that you pursue a policy of obtaining patents in key foreign countries. To the extent you do not seek patent protection in all countries in which you market your products, please disclose the material risks to your business of such a policy. Response: In response to the Staff’s comment, the Company has revised the risk factor entitled “If our patents and other intellectual property rights do not adequately protect our products, we may lose market share to our competitors and be unable to operate our business profitably.” Please see page 18 of Amendment No. 1. Future sales of our common stock, page 21 7. Please address the warrants being issued to the underwriters as compensation for this offering in this risk factor. Response: The Company has revised the Form S-1 in response to the Staff’s comment. Please see page 20 of Amendment No. 1. Use of Proceeds, page 27 8. Please disclose the principal reasons for the offering. Response: The principal reasons for the offering are to provide Company shareholders liquidity in the public equity market and to raise cash to support the Company’s growth plan. The Company has revised the Use of Proceeds disclosure on page 25 of Amendment No. 1 to reflect the foregoing. 9. We note your disclosure in the fourth paragraph that you reserve the right to modify the use of proceeds for other purposes. You may reserve the right to change the allocation of proceeds provided you disclose the specific contingencies that would give rise to a change. See Instruction 7 to Item 504 of Regulation S-K. Please revise. Response: The Company has revised the Use of Proceeds disclosure on page 25 of Amendment No. 1 and the risk factor entitled “We have broad discretion in the use of the 3 proceeds of this offering and may apply the proceeds in ways with which you do not agree,” which begins on page 20 of Amendment No. 1, to indicate that the Company may modify its anticipated use of proceeds for contingencies such as the progress of its research and development activities, regulatory or competitive developments, and strategic opportunities. 10. Please reconcile your disclosure in this section with the disclosure in the fourth paragraph on page 36 that you expect to finance equipment purchases with proceeds of the offering. Also, revise the related risk factor on page 22, as applicable. Response: The Company has revised the Use of Proceeds disclosure on page 25 of Amendment No. 1 to state that it may use a portion of the proceeds from the offering to finance equipment purchases and other capital expenditures in the ordinary course of business. The Company has added similar language to the description of the offering on page 5 of Amendment No. 1 and the risk factor on page 20 of Amendment No. 1. Capitalization, page 28 11. Please revise to remove “cash and cash equivalents” from the table on page 28 since this is not part of your capitalization. Response: The Company has retained the “cash and cash equivalents” row in the capitalization table on page 26 of Amendment No. 1 for future pro forma disclosure of the proceeds from the offering. The Company has deleted the “Total capitalization” line item to avoid confusion on the part of the reader as to whether “cash and cash equivalents” are included in such amount. Dilution, page 29 12. Please revise your dilution disclosure to show dilution assuming exercise of the warrants being issued to the underwriters. Response: In response to the Staff’s comment, the Company has added disclosure in the Dilution section on page 27 of Amendment No. 1 to indicate that the dilution information excludes the impact of the exercise of the warrants to be issued to the underwriter in connection with this offering that will remain outstanding after this offering at an exercise price equal to 120% of the initial public offering price. Because the exercise price for such warrants will be greater than the initial public offering price, the exercise of such warrants would not result in any additional dilution to new investors in this offering. Management’s Discussion and Analysis, page 30 13. Refer to the last sentence of the last paragraph on page 30: 4 • Please disclose why Medicare reimbursement was temporarily suspended, include any appropriate risk factors disclosure if this could occur again; and • It appears from your disclosure on page 36 that the trademark lawsuit is expected to continue. To the extent that you reasonably expect that the continued litigation will have a material impact on income from continuing operations, by diverting the operational focus of management or otherwise, please provide the disclosure required by Item 303(a)(3)(ii) of Regulation S-K. Please also clarify why management’s attention to the trademark lawsuit significantly affected your sales given that you have a sales force and other distributors. Response: The temporary Medicare suspension was the result of unintentional noncompliance with state licensure requirements in two states in 2009. Consequently, between October 4, 2009 and December 4, 2009, all of the Company’s Medicare reimbursement payments were suspended. Although the temporary suspension delayed cash collections during the first six months of fiscal 2010, all Medicare claims have since been recovered following reinstatement on December 4, 2009. The risk factor on page 13 of Amendment No. 1, entitled “Our products could be subject to exclusion from Medicare, Medicaid and other government programs if we do not comply with all applicable standards for reimbursement,” discloses these facts and indicates that the Company’s business and results of operations could suffer if it is unable to maintain adequate compliance procedures that facilitate continuous eligibility for reimbursement. Please also see page 28 of Amendment No. 1. In response to the Staff’s comment, the Company advises the Staff that management does not expect the trademark litigation to have a material impact on income from continuing operations. In addition, the Company has added disclosure on page 28 of Amendment No. 1 to clarify why it believes the litigation affected its sales growth trend. 14. We note that your revenues increased significantly in each period presented as compared to the previous year and that the increase was primarily due to increases in sales of SmartVest Systems. In light of the material increases in revenues, your MD&A disclosure does not provide a thorough analysis that provides readers a view of the company through the eyes of management. When individual line items disclosed in your statements of operations significantly fluctuate in comparison to the comparable prior period, please quantify, and disclose the nature of each item that caused the significant change. For example, please quantify each material factor (i.e. such as volume changes by type of product, number of SmartVest Systems sold for neuro-muscular diseases, etc.), disclose separately the effect on operations attributable to each factor causing the aggregate change from year to year and disclose the nature of or reason for each factor causing the aggregate change. The analysis should reveal underlying material causes of the factors described and any future impact on operating results. Please incorporate the above comment to all of the disclosures in the analysis of your results of operations in 5 MD&A and revise as necessary. See Item 303 of Regulation S-K and SEC Release No. FR-72 for guidance. Response: In response to the Staff’s comment, the Company has added disclosure within the MD&A on pages 31 and 32 of Amendment No. 1, regarding the amounts and reasons behind sales volume changes of its SmartVest System for the 2008 and 2009 fiscal years. The Company has further disclosed that changes in sales prices for the SmartVest System have had a nominal impact on revenue in the comparable periods, which it believes provides a reader with adequate information to assess the Company’s sales trends. The Company has also considered the Staff’s comments in preparing the MD&A for the nine months ended March 31, 2010 and 2009. Critical Accounting Policies and Estimates, page 31 General 15. The following comments on critical accounting policies and estimates contained in Management’s Discussion and Analysis should also be considered, if applicable, in the notes to your financial statements. Response: The Company acknowledges the Staff’s comment and has indicated any changes made to the financial statement notes in connection with its responses to comment nos. 16 –24 below. Revenue Recognition and Allowance for Doubtful Accounts, page 31 16. We see that you provide medical devices and services directly to patients and the majority of your transactions are with third-party payers. Please tell us how you considered the guidance in FASB ASC Topic 954 — Health Care Entities in determining your accounting for revenue and receivables. In addition, tell us how you considered whether you should report revenue and receivables net rather than gross, less a provision for discounts. Response: The Company is a medical device manufacturer whose revenues are entirely from product sales and contain no service revenues. The Company’s sales are made directly to the end users of its products and the Company does not enter into any direct contractual relations with third-party payers. The Company has reviewed the scope of ASC Topic 954, which applies to either of the following health care entities: (1) those whose principal operations consist of providing health care services and that derive all or almost all of their revenues from the sale of goods or services; or (2) those whose principal operations consist of the planning, organization, and oversight of the foregoing entities. ASC 954-10-15-1B describes the applicability of this topic to health care entities and does not include medical device companies. As such, the Company does not believe that ASC Topic 954 applies. Because the Company does not fall under ASC 954, it is unaware of any requirements to separately disclose discounts off its gross selling price. 6 17. We refer to your disclosure that revenues are recorded at amounts estimated to be received. Please revise to clarify how you estimate amounts to be received under reimbursement arrangements with third-party payers. In addition, disclose whether your adjustments to amounts previously billed have been material. Please disclose the “many contingencies” in the reimbursement process discussed on page 30 and indicate how these impact your revenue recognition. The amount of contractual allowances with third party payers should also be disclosed for each period. Response: In response to the Staff’s comment, the Company has modified