SEC Company Response from Jazz Pharmaceuticals plc (JAZZ) (CIK 0001232524) (JAZZ) — Aug 13, 2009
Jazz Pharmaceuticals plc (JAZZ) (CIK 0001232524)
Date: Aug. 13, 2009 · CIK: 0001232524 · Accession: 0001193125-09-174046
AI Filing Summary & Sentiment
File numbers found in text: 001-33500
Referenced dates: July 29, 2009
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CORRESP 1 filename1.htm SEC Response Letter August 12, 2009 VIA EDGAR AND FACSIMILE Mr. Jim B. Rosenberg Senior Assistant Chief Accountant United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 Washington, DC 20549 Re: Jazz Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2008 Form 10-K/A for the Fiscal Year Ended December 31, 2008 Form 10-Q for the quarterly period ended March 31, 2009 File Number: 001-33500 Dear Mr. Rosenberg: On behalf of Jazz Pharmaceuticals, Inc. (the “Company”), this letter is being transmitted in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), by letter dated July 29, 2009 (the “Comment Letter”), regarding (i) the Annual Report on Form 10-K for the fiscal year ended December 31, 2008, filed by the Company with the Commission on March 26, 2009 (the “Form 10-K”), (ii) Amendment No. 1 to the Form 10-K on Form 10-K/A, filed by the Company with the Commission on April 29, 2009 (the “Form 10-K/A”) and (iii) the Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2009, filed by the Company with the Commission on May 7, 2009 (the “Form 10-Q”). The text of the Staff’s comments has been included in this letter in italics for your convenience, and we have numbered the paragraphs below to correspond to the numbering of the Comment Letter. Form 10-K for the Year Ended December 31, 2008 Item 9A(T). Controls and Procedures Evaluation of Disclosure Controls and Procedures, page 67 1. We note your statement that “disclosure controls and procedures were sufficiently effective to provide reasonable assurance that the objectives of our disclosure control system were met.” Given the use of the word ‘sufficiently’, it remains unclear whether your chief executive officer and chief financial officer have concluded that your disclosure controls and procedures are effective. Please revise your disclosure to state, in clear and unqualified language, the conclusions reached by your chief executive officer and your chief financial officer on the effectiveness of your disclosure controls and procedures. Response: The Company acknowledges the Staff’s comment and will revise its disclosure, as requested, in future filings on Form 10-K and Form 10-Q as set forth below (blacklining reflects changes from the Company’s original disclosure): Evaluation of Disclosure Controls and Procedures We have carried out an evaluation, under the supervision, and with the participation of, management including our principal executive officer and acting principal financial officer, of our disclosure controls and procedures (as defined in Rule 13a-15(e)) of the Securities Exchange Act of 1934, as amended, or Exchange Act) as of the end of the period covered by this annual report on Form 10-K. Based on their evaluation, our principal executive officer and acting principal financial officer concluded that, subject to the limitations described below, our disclosure controls and procedures were effective to as of December 31, 2008. Limitations on the Effectiveness of Controls. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within an organization have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our principal executive officer and acting principal financial officer have concluded, based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were sufficiently effective to provide reasonable assurance that the objectives of our disclosure control system were met. We continue to implement, improve and refine our disclosure controls and procedures and our internal control over financial reporting. Notes to Consolidated Financial Statements Summary of Significant Accounting Policies Revenue Recognition Product Sales, Net, page F-11 2. Please revise to disclose the conditions under which you accept returns and the form of the return (i.e. credit issued, cash returned, product exchanged out of inventory for returned product). For product where you record revenue with the right of return and for which you exchange product out of inventory, disclose in your notes to financial statements how you account for your estimate of these returns at the time of sale of the product and how you account for returns at the date they are actually returned to you. Provide us an analysis supporting your accounting treatment with reference to the authoritative literature you rely upon to support your accounting. It also may be helpful to provide us an example showing the journal entries made. Response: The Company currently sells two commercial products, Xyrem® (sodium oxybate oral solution) and Luvox CR® (extended release fluvoxamine maleate capsules). The Company respectfully advises the Staff that the Company does not market any product for which the Company records revenue with the right of return and for which the Company exchanges product out of inventory. The Company relies upon the criteria set forth in paragraph 6 of Statement of Financial Accounting Standards No. 48, “Revenue Recognition When Right of Return Exists”, or Statement No. 48, to determine when and how to recognize revenue on product shipped with the right of return. The return policies and particular circumstances for each of the two products are described below. In the Company’s Form 10-K for the year ending December 31, 2009, the Company will describe its returns policy for both products. The Company respectfully advises the Staff that the Company did not disclose the conditions under which the Company accepts returns in its Form 10-K for the year ended December 31, 2008 (i) for Xyrem, because the returns of Xyrem in the United States are de minimus and because the Company does not record revenue on Xyrem sales outside the United States until the rights of return have lapsed or (ii) for Luvox CR, which the Company sells only in the United States, because since the launch of the product, the Company has not recorded revenue until the right of return has lapsed. The return policies for both products are described below. Xyrem (United States) The Company sells Xyrem in the United States to a single source specialty pharmaceutical distributor, Express Scripts Specialty Distribution Services, Inc., or SDS, a third party not related to the Company. As a condition of marketing approval of Xyrem in the United States, the United States Food and Drug Administration mandated in 2002 (and the requirement continues today) that the Company maintain a risk management program for Xyrem under which all Xyrem product sold by the Company in the United States must be shipped directly to patients through a central pharmacy. The Company ships its product on consignment to SDS (during consignment, title to the product remains with the Company). SDS removes product from consignment only when it is ready to ship the product to a patient; and SDS then ships the product directly to the patient. As noted on page F-11 of its Form 10-K for the year ended December 31, 2008, the Company recognizes revenue on sales of Xyrem to SDS upon transfer of title to SDS, which occurs only when SDS removes product from the Company’s consigned inventory at the SDS facility for shipment to a patient. The Company accepts returns from SDS of any product which both (i) has defects that are not reasonably susceptible to discovery upon receipt of the consigned product by SDS and (ii) is returned to SDS by patients. Based on the Company’s experience over a number of years (the Company acquired the rights to the product in mid-2005), product returns to SDS are extremely rare once product is shipped to patients. Beginning in 2008, the Company provides SDS with a credit for product returned by patients. For 2008, the Company issued credits totaling less than $20,000 for returned product. Based on the foregoing, the Company respectfully submits to the Staff that the Company’s method of recognizing revenue for Xyrem sales in the United States meets all the criteria in paragraph 6 of Statement No. 48. The Company respectfully advises the Staff that in its Form 10-K for the year ending December 31, 2009, the Company will disclose its return policy for Xyrem for sales in the United States, and that historically those returns have not been material. Xyrem (ex-United States) The Company sells limited quantities of Xyrem internationally to UCB Pharma Limited (Europe and certain other countries) and Valeant Canada Limited (Canada) under a license and distribution agreement with each of those third parties. The Company recognized revenue of $769,000, $306,000 and $127,000 from international sales of Xyrem during 2008, 2007 and 2006, respectively, to these third parties. The agreement with each party allows it a fixed period of time after delivery to inspect and reject shipments for failure to meet specifications. As noted on page F-11 of our Annual Report on Form 10-K, the Company recognizes revenue on its international sales when it is notified of customer acceptance, or when the time to inspect or reject the shipment has lapsed, if earlier. Thus, for international sales of Xyrem, the Company does not record revenue with the right of return. Luvox CR The Company sells Luvox CR only in the United States and accepts returns for expiring product only if the product is returned in its original packaging from the Company’s direct customers (wholesalers) within six months before or up to twelve months after product expiration, as noted on page F-11 of the Form 10-K. When product meeting these criteria is returned by wholesalers, the Company issues a credit based on the applicable historical purchase price of the returned product, as determined from its lot number. The credit issued can be applied against existing or future invoices. Because Luvox CR was launched relatively recently, the Company cannot reasonably estimate expected product returns of Luvox CR at the time of shipment as required under paragraph 6 of Statement No. 48. Therefore, the Company does not recognize revenue when it ships product to wholesalers. Instead, the Company recognizes revenue only when the product is dispensed to patients through prescriptions (this occurs only after wholesalers have repackaged and shipped the product to their pharmacy customers, who then repackage the product to fill prescriptions in smaller quantities to dispense to the patients). The Company does not accept product returns of product that have been dispensed to patients. Therefore, the Company’s estimate of a reserve for returns is zero. The Company respectfully advises the Staff that it will describe the return policy for Luvox CR in its Form 10-K for the year ending December 31, 2009. The Company previously sold two additional commercial products, Antizol and Cystadane, but all rights to those products were sold to third parties in August 2008 and March 2007, respectively. In each case, the third party assumed all liabilities for product returns subsequent to the effective dates of the purchase agreements. Form 10-K/A for the Year Ended December 31, 2008 Item 10, page 2 3. Please revise your disclosure in this section to meet the requirements of Item 407 of Regulation S-K including, but not limited to, discussion of the number of board meetings in the past year and director attendance, a discussion of your nominating committee, disclosure regarding the charters of your board committees, and your process, if any, for shareholder communications. Response: The Company respectfully advises the Staff that the Company has addressed, in its Form 10-K/A, the disclosures requirements of Part III of Form 10-K as such disclosure requirements relate to Item 407 of Regulation S-K. In particular: • the disclosures required by Item 407(a) are addressed under the caption “Independence of Jazz Pharmaceuticals’ Board of Directors” on page 27 of the Form 10-K/A; • the disclosures required by Item 407(c)(3) are addressed under the caption “Director Nominations” on page 4 of the Form 10-K/A; • the disclosures required by Items 407(d)(4) and (d)(5) are addressed under the caption “Audit Committee” on page 4 of the Form 10-K/A; • the disclosures required by Item 407(e)(4) are addressed under the caption “Compensation Committee Interlocks and Insider Participation” on page 20 of the Form 10-K/A; and • the disclosures required by Item 407(e)(5) are addressed under the caption “Compensation Committee Report” on page 20 of the Form 10-K/A. The Company also respectfully advises the Staff that the Company will address all of the applicable disclosure requirements of Item 407 of Regulation S-K in its definitive proxy statement for its next annual meeting of stockholders, as required by Schedule 14A. Compensation Discussion and Analysis Bonus Awards, page 8 4. Your disclosure relating to the corporate and individual goals does not specifically identify these goals. Please provide draft disclosure for your 2010 proxy statement describing these goals with more specificity. A description of the goals is required regardless of whether bonuses were paid under the plan. Additionally, confirm that you will discuss the extent to which these goals were achieved and how the extent of achievement was used to determine bonus awards. Response: In response to the Staff’s comment, the Company has prepared the following draft disclosure for its 2010 proxy statement regarding the criteria and methodology for determining potential bonus awards for the Company’s named executive officers for 2009. Please note that this draft disclosure was prepared on the basis of a number assumptions, including, without limitation: that the Company’s named executive officers for 2009 will be Bruce C. Cozadd, Samuel R. Saks (CEO during a portion of 2009), Robert M. Myers, Carol A. Gamble, Janne L.T. Wissel and Joan Colligan; that none of the foregoing, with the exception of Dr. Saks, will terminate employment prior to the payment of any bonus; that there will be no changes or modifications to the Company’s corporate objectives for purposes of the Company’s bonus plan during the remainder of 2009; and that bonuses were paid under the Company’s bonus plan for 2009 performance. Further, the Company’s Board of Directors or Compensation Committee could determine to take action or award bonuses on the basis of criteria or methodology not discussed below, in which case the actual disclosure for the Company’s 2010 proxy statement may differ. As a result, the following draft disclosure is provided solely to provide the Staff with draft disclosure that more specifically describes the goals used to determine bonus awards, which such specificity the Company confirms to the Staff will be reflected in the actual disclosure for the Company’s 2010 proxy statement (and regardless of whether bonuses are actually paid under the Company’s bonus plan). Finally, the Company confirms to the Staff that the 2010 proxy statement will discuss the extent to which the indicated goals were achieved, the relative weight assigned to each objective by the Board of Directors and the Compensation Committee, and how the extent of achievement was used to determine bonus awards, if any. The requested draft disclosure is as follows: Bonus Awards. Our Bonus Plan is designed to reward executive officers for attaining our corporate performance obj