SEC Company Response from INSULET CORP (PODD) (CIK 0001145197) (PODD) — Jul 29, 2016
INSULET CORP (PODD) (CIK 0001145197)
Date: July 29, 2016 · CIK: 0001145197 · Accession: 0001157523-16-006325
AI Filing Summary & Sentiment
File numbers found in text: 001-33462
Referenced dates: June 30, 2016
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CORRESP 1 filename1.htm July 29, 2016 BY EDGAR AND FEDEX Mr. Martin James Senior Assistant Chief Accountant Office of Electronics and Machinery Division of Corporation Finance Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Insulet Corporation Form 10-K for the Fiscal Year Ended December 31, 2015 Filed February 29, 2016 Form 10-Q for the Quarterly Period Ended March 31, 2016 Filed April 29, 2016 File No. 001-33462 Dear Mr. James: Set forth below are the responses of Insulet Corporation (Insulet or the Company) to the staff’s letter of comment, dated June 30, 2016 (the Comment Letter), relating to disclosures in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2016. For convenience of reference, each paragraph below is numbered to correspond to the numbered comment set forth in the Comment Letter. Form 10-K for the Fiscal Year Ended December 31, 2015 Patents, page 7 1. Please tell us when your patents expire. See Regulation S-K Item 101(c)(1)(iv). Response: The issued United States patents referenced in our Form 10-K for the Fiscal Year Ended December 31, 2015 have expiration dates that range from 2020 through 2031. We respectfully acknowledge the Staff’s comments and we will include this information in future filings. Mr. Martin James July 29, 2016 Page 2 Government Regulation, page 9 2. Please tell us the nature of the FDA inspectional observations that you mention in the last sentence of the second paragraph on page 11. Response: The FDA inspectional observations received on December 11, 2015 identified issues in product design control, proper assessment of design changes and procedural opportunities in device acceptance which were all specifically related to the Field Safety Notification of July 2015. Insulet has worked closely with the FDA to address these observations. We have received no objections to date on the responses provided to the FDA and we are awaiting final closure from the FDA. Third-Party Reimbursement, page 13 3. Please tell us whether any material private third-party payers have declined to reimburse expenses for products like yours, other than in the “limited number of cases” that you mention in the second sentence of the third paragraph of this section. Response: In the United States, our products are generally reimbursed by third-party payors, and we bill those payors for products provided to patients. There are no material private third-party payors that have declined to reimburse expenses for our products for their overall covered lives population. As disclosed, in certain cases, some third-party payors have declined to reimburse us for a particular patient because such patient failed to meet its criteria, most often because the patient already received reimbursement for an insulin pump from that payor within the warranty period, which is generally four years, or because the patient did not meet their medical criteria for an insulin infusion device. Reimbursement may also be declined by specific employer self-insurance plans based on specific provisions within those individual plans. This represents a much smaller subset of our overall potential patient population and is not believed to be material to our business. Risk Factors, page 13 Our ability to grow our revenue, page 28 4. Please tell us the names of the customers mentioned in the third sentence of the second paragraph of this risk factor. Also provide us your analysis of whether these names must be disclosed per Regulation S-K Item 101(c)(1)(vii). Mr. Martin James July 29, 2016 Page 3 Response: The significant customers discussed in the risk factor that make up over 10 percent of consolidated revenue are Ypsomed Distribution AG, our exclusive European distributor, and RGH Enterprises, Inc., one of our distributors in the United States, for each of the years ended December 31, 2014 and 2015. For the year ended December 31, 2013, RGH Enterprises, Inc. represents the only customer with revenue in excess of 10 percent of consolidated revenues. We respectfully acknowledge the Staff's comment and, in future filings, we will disclose the names of those customers that comprise over 10% of the Company’s consolidated revenue, in accordance with the guidance in Item 101(c)(1)(vii). Management’s Discussion and Analysis, page 37 Results of Operations, page 39 5. Please tell us the amount of OmniPod revenue separate from the amount of revenue from your handheld Personal Diabetes Manager device during each period presented in this filing and in your Form 10-Q for the fiscal quarter ended March 31, 2016. Address in your response (1) whether these separate results provide clarification regarding your disclosure related to the effect of customer retention or new patient starts, and (2) whether the information is required to be disclosed per Regulation S-K Item 101(c)(1)(i) or as a trend per Regulation S-K Item 303. In this regard, we note your reference to your product lines on page 39. Response: We respectfully acknowledge the Staff's comment. Sales of the Personal Diabetes Manager (PDM) and other accessories (which accessories are typically packaged together with the PDM and sold collectively, not separately) represent less than six percent of consolidated sales for each of the periods presented in the Form 10-K for the year ended December 31, 2015 and for each of the periods presented in the Form 10-Q for the quarter ended March 31, 2016. With respect to the OmniPod system, more than 90 percent of the system revenue was from stand-alone sales of the OmniPod disposable device for each of the periods presented in the Form 10-K for the year ended December 31, 2015 and for each of the periods presented in the Form 10-Q for the quarter ended March 31, 2016. The remaining amount, which represents less than approximately 10 percent of system revenue, was attributable to sales of the PDM and other accessories. More specifically, revenue from the sales of the PDM and accessories were approximately $11.6M, $11.3M, and $14.2M for the years ended December 31, 2015, December 31, 2014, and December 31, 2013, respectively. Revenue from the sales of the PDM and accessories were approximately $2.5M and $2.8M for the quarters ended March 31, 2015 and March 31, 2016, respectively. PDM sales may be made for a variety of reasons including new patient starts and replacements made for existing customers after expiration of the original warranty period. Due to the relative insignificance of revenue attributable to the PDM, we do not believe the relative revenue between the OmniPod device and the PDM is meaningful to identifying or understanding trends or uncertainties that would have a material impact on our revenue, or provide clarification regarding the effect of customer retention or new patient starts. Furthermore, changes in PDM revenue in any given period may be from other factors such as customer mix, pricing, or new product offerings. As the PDM sales are not meaningful to trends, are within the same class of products as the OmniPod device, and are less than 10 percent of total consolidated revenue, we determined no additional disclosure was warranted in accordance with Regulation S-K Item 303 and Regulation S-K Item 101(c)(1)(i) for each of the respective periods. Mr. Martin James July 29, 2016 Page 4 6. Please tell us with specificity the nature and causes of the “ordering patterns” that led to the changes mentioned in this section and on page 27 of your Form 10-Q for the fiscal quarter ended March 31, 2016. Address in your response the effect of any minimum purchase obligations. Also tell us the magnitude of these changes and the offsetting factors disclosed in your “Revenue” discussion and analysis in the Form 10-K and Form 10-Q. In your response, please ensure that the extent of customer retention and the extent of your installed base growth in the relevant periods are clear. Response: During the twelve months ended December 31, 2014, our U.S. and international distributors built up a level of safety stock, among other reasons, we believe, to mitigate risk associated with potential production capacity restraints and their ability to meet end-user demand. During the first quarter of 2015, our U.S. distributors reduced days-on-hand inventory as we increased our production capacity and demonstrated the ability to supply high-quality product to meet customer demand. During the first and second quarters of 2015, the improved production capacity enabled our international distributor to reduce on-hand inventory levels to better manage their working capital and offset the financial impact of the strength of the U.S. dollar on their business. This change in ordering patterns was not driven by minimum purchase obligations and was not a result of changes in our customer retention or installed base growth. While we are unable to quantify the exact magnitude of the impact of the change in ordering patterns, we believe the factors driving the changes for both U.S. OmniPod and International OmniPod were disclosed in order of magnitude. That is, the increased U.S. OmniPod revenue was primarily driven by growth in installed base and the change in distributor ordering patterns was less significant, whereas the change in International OmniPod revenue was primarily a result of the unfavorable distributor ordering patterns in the first quarter of 2015 and the increase in installed base was less significant, but still an important factor. 7. We note your reference to a reduction in royalty revenue. Please tell us the total royalty revenue in each period presented and the nature of your business that generates royalty revenue. Response: Our consolidated revenue included royalty revenue of $3.5 million, $6.7 million and $6.9 million in the years ended December 31, 2015, December 31, 2014 and December 31, 2013, respectively. Our rights to incorporate the FreeStyle blood glucose meter into the OmniPod System are governed by a development and license agreement with Abbott Diabetes Care, Inc. (Abbott). Under the terms of this agreement, Abbott pays us a royalty for qualified new patient starts which is the primary driver of the royalty revenue recognized in each of the years presented. Due to changes in the structure of the arrangement over time, historic changes in royalty revenue have not necessarily been indicative of trends in new patient starts or other related metrics. Mr. Martin James July 29, 2016 Page 5 Item 8. Financial Statements Note 2. Summary of Significant Accounting Policies Segment Reporting, page 53 8. Please revise future filings to report revenues from external customers for each product and service or each group of similar products and services unless it is impracticable to do so. If providing the information is impracticable, disclose that fact. Refer to ASC 280-10-50-40. Response: We respectfully acknowledge the Staff's comment. In future filings we will report within our segment footnote disclosure revenues from external customers for each product and service or each group of similar products and services. Specifically, in future filings, we will include within the segment footnote disclosure revenues for U.S. OmniPod, International OmniPod, and Drug Delivery as presented in our Results of Operations section of our Form 10-Q for the period ended March 31, 2016. 9. In future filings, please disclose the geographic information relating to revenues and long-lived assets required by ASC 280-10-50-41 unless it is impracticable to do so. This includes disclosing revenues from external customers attributed to the U. S. and attributed to all foreign countries from which you derive revenues. If revenues from external customers attributed to an individual foreign country are material, disclose those revenues separately. Also disclose the basis for attributing revenues from external customers to individual countries. Refer to ASC 280-10-50-41. Response: We respectfully acknowledge the Staff's comment. In future filings we will disclose within our segment footnote disclosure information relating to revenues and long-lived assets required by ASC 280-10-50-41. Goodwill, page 53 10. You disclose that you operate in one segment and you have a single reporting unit as you do not have segment managers and you do not review discrete financial information below consolidated results on a regular basis. Please tell us about how you applied ASC 350-20-35-33 through 35-37 in determining that you had only one reporting unit. Mr. Martin James July 29, 2016 Page 6 Response: In concluding that the Company only has one reporting unit in accordance with ASC 350-20-35-33 through 35-37, we: · identified the components that constitute a business within our single operating segment, · evaluated the financial information that is made available for the components, · evaluated our management reporting structure to identify segment management, and · evaluated whether segment management reviews the operating results of the components on a regular basis. Components that constitute a business As of December 31, 2015, the Company had four components that engage in business activities from which it may earn revenue and incur expenses; specifically U.S. OmniPod, International OmniPod, Drug Delivery, and Neighborhood Diabetes (Neighborhood) defined as follows: OmniPod – U.S. The Company is engaged in the development, manufacture and sale of the OmniPod System, an innovative, discreet and easy-to-use continuous insulin delivery system for people with insulin-dependent diabetes. The Company began commercial sale of the OmniPod System in the United States in 2005 and sells the OmniPod System in the United States through direct sales to customers and through distribution partners. OmniPod – International The OmniPod System is currently available in multiple countries in Europe and in Canada. In Europe, the OmniPod System is sold through an exclusive distribution partner, Ypsomed Distribution AG. In July 2015, the Company executed an asset purchase agreement with GlaxoSmithKline whereby the Company acquired assets associated with the Canadian distribution of the Company’s products and the Company assumed the distribution, sales, marketing, training and support activities for the OmniPod system in Canada. Drug Delivery The Company partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the subcutaneous delivery of pharmaceuticals. Neighborhood The Company acquired Neighborhood, a distributor of medical supplies for the treatment of diabetes, in June 2011. The main operations of the distribution business included order intake, customer support, sales, distribution and billing. The acquisition provided the Company with additional products, customers and bandwidth in these areas. This expertise was strategic to the Company as it was anticipating the launch of its second generation OmniPod and believed the additional infrastructure was needed to support a successful launch. As further outlined in our response to question #13 below, the acquisition of Neighborhood had specific benefits that supported the core OmniPod business. Mr. Martin James July 29, 2016 Page 7 Availability and Utilization of Discrete Financial Information As of December 31, 2015, revenue was measured and reported for U.S. OmniPod, International OmniPod, Drug Delivery, and Neighborhood. A measure of profit by component is not made available to, nor used by, the Chief Operating Decision Maker (CODM, as identified below) or his direct reports. The only discrete financial information at the component level that is reviewed by the CODM and direct reports is revenue (see separate discussion of Neighborho