SEC Company Response from ReShape Lifesciences Inc. (RSLS) (CIK 0001427570) (HIND) — Sep 8, 2016
ReShape Lifesciences Inc. (RSLS) (CIK 0001427570)
Date: Sept. 8, 2016 · CIK: 0001427570 · Accession: 0001193125-16-705718
AI Filing Summary & Sentiment
Referenced dates: August 31, 2016
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CORRESP 1 filename1.htm CORRESP September 9, 2016 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Amanda Ravitz Geoff Kruczek Caleb French Kate Tillan Tara Harkins Re: Obalon Therapeutics, Inc. Draft Registration Statement on Form S-1 Submitted August 4, 2016 CIK No. 0001427570 Ladies and Gentlemen: We are submitting this letter on behalf of Obalon Therapeutics, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated August 31, 2016 relating to the Company’s draft Registration Statement on Form S-1 (CIK No. 0001427570) confidentially submitted to the Commission on August 4, 2016 (the “Registration Statement”). The Registration Statement is being publicly filed concurrently herewith. The numbered paragraphs below correspond to the numbered comments in the Staff’s letter and the Staff’s comments are presented in bold italics. We have also enclosed with the copy of this letter that is being transmitted via overnight delivery five copies of the Registration Statement in paper format, which have been marked to show changes from the draft Registration Statement as originally submitted. In addition to addressing the comments raised by the Staff in its letter, the Company has revised the Registration Statement to update other disclosures, including the U.S. Food and Drug Administration’s (“FDA”) recent approval of its Obalon balloon system. Prospectus Summary, page 1 The Obesity Epidemic, page 1 1. Please revise to clarify what you mean by “medical costs associated with obesity.” If this phrase includes costs related to the effects of obesity, rather than merely related to U.S. Securities and Exchange Commission September 9, 2016 Page 2 the treatment for obesity, please revise to clarify. Also revise to clarify what portion of that amount relates to the treatment of obesity. The Company advises the Staff that the amount of medical costs associated with obesity as disclosed on pages 2, 83 and 85 of the Registration Statement reflects the medical costs related to the effects of obesity, which may include treatment costs. The amount was determined by comparing all medical expenditures attributable to obesity, including out of pocket expenses, third-party payer expenses and Medicaid, for people who are obese versus people who are not obese. The Company has been unable to find a reliable statistic to quantify the amount spent directly on obesity treatments. In response to the Staff’s comment, the Company has revised its disclosure on pages 2, 83 and 85 of the Registration Statement to clarify that the number disclosed reflects the national medical care costs of obesity-related illness in adults, including out of pocket expenses, third-party payer expenses and Medicaid. Our Solution, page 2 Favorable Safety Profile, page 2 2. Please reconcile your disclosure here that all the reported serious adverse device events from your product occurred when the product was not used according to approved labelling with your disclosure in the first full paragraph on page 16 which indicates that in one instance you could not obtain enough information to verify an injury’s cause. The Company respectfully advises the Staff that even in the instance in which the Company could not obtain enough information to verify the exact cause of injury as described on page 16 of the Registration Statement, the Company did have enough information in that instance to confirm that the product was not used in accordance with approved labeling. In response to the Staff’s comment, the Company has clarified the nature of the information it was unable to verify on page 16 of the Registration Statement. Simple and Convenient Placement, page 2 3. If you believe it is appropriate to highlight the fact that your product can be placed without anesthesia or an endoscopy, please also provide disclosure, such as that found on page 4, indicating that removal of your product does require an endoscopy and sedation. In response to the Staff’s comment, the Company has revised its disclosure on pages 3, 84 and 88 of the Registration Statement. Implications of Being an Emerging Growth Company, page 6 4. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your U.S. Securities and Exchange Commission September 9, 2016 Page 3 behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. In response to the Staff’s comment, the Company will provide to the Staff on a supplemental basis under separate cover copies of all written materials that the Company, or anyone authorized to do so on the Company’s behalf, presented to potential investors in reliance on Section 5(d) of the Securities Act of 1933, as amended. Summary Consolidated Financial Data, page 9 5. We note on page 10 and throughout the filing that you have presented pro forma adjustments relating to the automatic conversion of all the outstanding shares of your convertible preferred stock into common stock and ultimately the automatic conversion of your outstanding preferred warrants to purchase common stock. We further note from pages F-43 and F-44 that all of the preferred stock is automatically converted into common stock upon the company’s sale of your common stock in a firm commitment underwritten public offering in which the per share is price is at least $4.29. Explain to us why you believe these pro forma adjustments related to the conversion of your preferred shares upon the initial public offering are factually supportable by confirming to us that you presently expect the offering to meet such conditions. If management subsequently concludes the conditions may not be satisfied, please revise the filing accordingly. As the Staff notes, per the terms of the Company’s certificate of incorporation, all shares of the Company’s outstanding convertible preferred stock will automatically convert to common stock immediately prior to the closing of the Company’s initial public offering, provided that the offering price per share in the Company’s initial public offering is at least $4.29 and the aggregate gross proceeds to the Company in such offering is at least $30.0 million. The Company currently expects the price and aggregate gross proceeds will meet such conditions. If at a future date, however, the Company determines that the price and proceeds may not meet such conditions, then the Company will seek consent from the holders of at least 67% of the outstanding preferred stock (representing the requisite percentage under the Company’s certificate of incorporation) to automatically convert all shares of convertible preferred stock to common stock, effectively immediately prior to the closing of the initial public offering. In such case, the Company will update the disclosure in the Registration Statement to note that the requisite 67% of preferred stock holders have consented to the automatic conversion of convertible preferred stock to common stock immediately prior to the closing of the initial public offering. With respect to the automatic conversion of preferred stock warrants to common stock warrants, the Company respectfully refers the Staff to its response to comment 6 below. U.S. Securities and Exchange Commission September 9, 2016 Page 4 6. Explain to us why you believe that the outstanding preferred stock warrants and other warrants will be ultimately converted into common stock upon the initial public offering and are directly attributable to the transaction and factually supportable. The Company advises the Staff that the treatment of outstanding warrants upon the initial public offering is determined pursuant to the terms of each warrant. Certain of the Company’s outstanding warrants to purchase preferred stock contain provisions pursuant to which they will automatically convert to warrants to purchase common stock immediately prior to the closing of the initial public offering, and the other warrants to purchase preferred stock contain provisions pursuant to which they will automatically be deemed to have been net exercised immediately prior to the closing of the initial public offering based on the initial public offering price per share. The Company has clarified on pages 8 and 138 of the Registration Statement that this treatment occurs pursuant to the terms of the warrants, each of which is filed as an exhibit to the Registration Statement. Risk Factors, page 11 7. Given your disclosure on pages 52 and 130, please revise to clarify whether you will be a controlled company under applicable exchange rules and, if so, whether that status creates material risks. Also revise your disclosure beginning on page 114, as appropriate. The Company advises the Staff that, following the consummation of the offering, it will not be a “controlled company” under Nasdaq Listing Rule 5615(c), as no individual, group or other company will hold more than 50% of the voting power for the election of the Company’s directors. The officers, directors and significant stockholders referred to on pages 53 and 133 of the Registration Statement would not collectively be considered a “group” for purposes of Nasdaq Listing Rule 5615(c), and no single individual or “group” of Company stockholders has greater than 50% of the voting power for the election of the Company’s directors. Use of Proceeds, page 56 8. Please revise to clarify what you mean by “commercialization” of your product. If that term includes multiple, discrete uses to which you will apply proceeds, such as expanding your domestic sales force and manufacturing facilities, as noted on page 71, please describe those uses separately. Also describe whether the amount of proceeds will be sufficient or whether you will require additional funds. In response to the Staff’s comment, the Company has revised its disclosure on page 57 of the Registration Statement. Dilution, page 60 9. Please expand the disclosure on page 61 to clarify how the numbers and percentages in the table on that page would change assuming the exercise of all outstanding warrants and options. In response to the Staff’s comment, the Company has revised its disclosure on page 64 of the Registration Statement. U.S. Securities and Exchange Commission September 9, 2016 Page 5 Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 66 Overview, page 66 10. Please revise to clarify why it was necessary to discontinue sales in Europe and Mexico to focus on developing and seeking domestic regulatory approval of your current product. In response to the Staff’s comment, the Company has revised its disclosure on page 68 of the Registration Statement. Results of Operations, page 69 11. Please revise your discussion of revenues throughout this section to discuss, and where possible quantify, the changes in your revenues resulting from changes in prices, changes in volume or a combination of both items. Please refer to Item 303 and the related instructions in Regulations S-K as well as SEC Interpretive Release No. 33-8350. The Company advises the Staff that fluctuations in revenue were nearly entirely a result of changes in the volume of its product sold. The Company has revised its disclosure on pages 71 and 72 of the Registration Statement to clarify this fact. Liquidity and Capital Resources, page 70 12. We note from disclosures on page F-10 that a significant portion of your revenue is derived from foreign sources. We also note on pages F-3 and F-27 that your balance sheet presents cash and cash equivalents of approximately $3.3 million and $4.3 million as of December 31, 2015 and June 30, 2016, respectively. Please revise your liquidity discussion in Management’s Discussion and Analysis in future filings, to the extent that you believe material, to disclose the amount of cash and cash equivalents as well as liquid investments held by foreign subsidiaries at each balance sheet date presented in your financial statements and quantify the amount that would not be available for use in the United States without incurring U.S taxes. Please further provide a discussion of any known trends, demands or uncertainties as a result of your policies of permanently reinvesting earnings outside the United States that are reasonably likely to have a material effect on the business as a whole or that may be relevant to your financial flexibility. Refer to Item 303(a)(1) of Regulation S-K. The Company respectfully advises the Staff that, to date, the Company has only sold its product outside of the United States. The Company’s sales have been primarily to its sole distributor in the Middle East, Bader Sultan & Bros. Co W.L.L. (“Bader”), and the Company has historically sold its product in Europe and Mexico as well. All sales to Bader and into Europe have been made, and the cash received from such sales has been held, by the Company, which is located in the United States. The only other entity with sales and the ability to generate cash was the Company’s Mexico subsidiary, which always generated losses and had negative cash flows. U.S. Securities and Exchange Commission September 9, 2016 Page 6 As of December 31, 2015, the Company had approximately $7,000 in cash held by two foreign subsidiaries. As of June 30, 2016, both of the Company’s foreign subsidiaries had been dissolved. As further described in the Company’s response to comment 29 below, both of the foreign subsidiaries were never profitable and had cumulative net losses and, accordingly, all of the cash previously held by the foreign subsidiaries would have been available for use in the United States without incurring U.S. taxes. The Company does not believe that the insignificant amount held by the foreign subsidiaries in the past has had or will have a material effect on its business. 13. Given the historical amounts of cash you have used for the periods disclosed in your financial statements and amounts in the table on page 74, please revise to clarify why you believe the $18.3 million of cash, cash equivalents and short-term investments you hold as of June 30, 2016 will not be sufficient for the next 12 months, absent the proceeds of this offering. The Company advises that Staff that it has recently received approval of its Obalon balloon system from the FDA, and therefore expects to incur substantial additional expenditures in the next 12 months in connection with the commercial launch of its product in the United States, including the development of a direct sales force and the expansion of its manufacturing facilities. In response to the Staff’s comment, the Company has revised its disclosure on pages 72 and 73 of the Registration Statement to clarify that, absent the proceeds from the initial public offering, it would likely be unable to completely fund its planned expenditures in the next 12 months, particularly those related to the commercial launch of its product. Contractual Obligations, page 74 14. Please revise to quantify the amounts subject to the contracts noted in the first full paragraph following the table. The Company advises the Staff that any future amounts that may become owed to the Company’s clinical trial sites, clinical supply manufacturing organizations or vendors for preclinical studies, research supplies and other services are contingent upon an underlying event occurring, such as patient visits, internal Company approval of additional preclinical studies and further research, and are not legally binding or enforceable contractual purchase obligations unde