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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
Jazz Pharmaceuticals plc
Response Received
17 company response(s)
High - file number match
SEC wrote to company
2009-07-29
Jazz Pharmaceuticals plc
Summary
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Company responded
2009-08-13
Jazz Pharmaceuticals plc
References: July 29, 2009
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Company responded
2009-09-15
Jazz Pharmaceuticals plc
References: July 29, 2009
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Company responded
2013-01-07
Jazz Pharmaceuticals plc
References: December 21, 2012
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Company responded
2013-01-22
Jazz Pharmaceuticals plc
References: December 21, 2012
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Company responded
2013-02-20
Jazz Pharmaceuticals plc
References: December 21, 2012 | February 13, 2013
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Company responded
2013-11-01
Jazz Pharmaceuticals plc
References: October 22, 2013
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Company responded
2013-11-15
Jazz Pharmaceuticals plc
References: October 22, 2013
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Company responded
2015-01-06
Jazz Pharmaceuticals plc
References: December 22, 2014
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2015-01-12
Jazz Pharmaceuticals plc
References: December 22, 2014
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Company responded
2015-02-02
Jazz Pharmaceuticals plc
References: December 22, 2014 | January 12, 2015
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Company responded
2016-11-14
Jazz Pharmaceuticals plc
References: October 31, 2016
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2018-11-14
Jazz Pharmaceuticals plc
References: November 8, 2018
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Company responded
2019-11-19
Jazz Pharmaceuticals plc
References: November 5, 2019
Summary
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Company responded
2019-12-20
Jazz Pharmaceuticals plc
References: November 5, 2019
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Company responded
2020-01-17
Jazz Pharmaceuticals plc
References: November 5, 2019
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2020-02-14
Jazz Pharmaceuticals plc
References: November 5, 2019
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Company responded
2025-07-29
Jazz Pharmaceuticals plc
References: July 17, 2025
Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
Jazz Pharmaceuticals plc
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-04-04
Jazz Pharmaceuticals plc
References: March 21, 2025
Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-02-20
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-11-05
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-12-11
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-11-08
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2016-12-07
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2016-10-31
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2015-02-03
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-12-22
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2013-12-09
Jazz Pharmaceuticals plc
Summary
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Company responded
2014-01-07
Jazz Pharmaceuticals plc
References: December 31, 2013
Summary
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Company responded
2014-01-14
Jazz Pharmaceuticals plc
References: January 9, 2014
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-10-22
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-03-08
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-02-13
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-12-21
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2009-12-22
Jazz Pharmaceuticals plc
Summary
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Company responded
2009-12-29
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-09-29
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2007-04-13
Jazz Pharmaceuticals plc
Summary
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Company responded
2007-05-21
Jazz Pharmaceuticals plc
References: April 13, 2007
Summary
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Company responded
2007-05-31
Jazz Pharmaceuticals plc
Summary
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Jazz Pharmaceuticals plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2007-05-15
Jazz Pharmaceuticals plc
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-08 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | 001-33500 | Read Filing View |
| 2025-07-29 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2025-07-17 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | 001-33500 | Read Filing View |
| 2025-04-04 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2020-02-20 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2020-02-14 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2020-01-17 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2019-12-20 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2019-11-19 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2019-11-05 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2018-12-11 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2018-11-14 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2018-11-08 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2016-12-07 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2016-11-14 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2016-10-31 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2015-02-03 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2015-02-02 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2015-01-12 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2015-01-06 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2014-12-22 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2014-01-14 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2014-01-07 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-12-09 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-11-15 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-11-01 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-10-22 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-03-08 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-02-20 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-02-13 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-01-22 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-01-07 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2012-12-21 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-12-29 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-12-22 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-09-29 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-09-15 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-08-13 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-07-29 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2007-05-31 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2007-05-21 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2007-05-15 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2007-04-13 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-08 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | 001-33500 | Read Filing View |
| 2025-07-17 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | 001-33500 | Read Filing View |
| 2020-02-20 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2019-11-05 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2018-12-11 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2018-11-08 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2016-12-07 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2016-10-31 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2015-02-03 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2014-12-22 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-12-09 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-10-22 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-03-08 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-02-13 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2012-12-21 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-12-22 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-09-29 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-07-29 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2007-05-15 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2007-04-13 | SEC Comment Letter | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-29 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2025-04-04 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2020-02-14 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2020-01-17 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2019-12-20 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2019-11-19 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2018-11-14 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2016-11-14 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2015-02-02 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2015-01-12 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2015-01-06 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2014-01-14 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2014-01-07 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-11-15 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-11-01 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-02-20 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-01-22 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2013-01-07 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-12-29 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-09-15 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2009-08-13 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2007-05-31 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
| 2007-05-21 | Company Response | Jazz Pharmaceuticals plc | Ireland | N/A | Read Filing View |
2025-08-08 - UPLOAD - Jazz Pharmaceuticals plc File: 001-33500
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 8, 2025 Philip Johnson Executive Vice President and Chief Financial Officer Jazz Pharmaceuticals plc Fifth Floor, Waterloo Exchange Waterloo Road Dublin 4, Ireland D04 E5W7 Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2024 File No. 001-33500 Dear Philip Johnson: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-07-29 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP jazzpharmaceuticals.com July 29, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Lynn Dicker Angela Connell Jessica Dickerson Tim Buchmiller Re: Jazz Pharmaceuticals plc Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-33500 Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to the comments received from the staff (the “Staff”) of the Securities and Exchange Commission by letter dated July 17, 2025 with respect to the above-referenced filing. For ease of reference, the Staff’s comments are reproduced below in italicized type followed by the Company’s response. Form 10-K for Fiscal Year Ended December 31, 2024 Item 1. Business Competition, page 22 1 . We note your disclosure that you have the right to receive a “meaningful royalty” from Hikma on net sales of the Hikma AG product. Please revise your future filings to disclose the royalty rate, or a royalty rate range not to exceed 10 percentage points, or explain to us why it would not be appropriate to do so. The Company acknowledges the Staff’s comment and respectfully advises the Staff that the Company believes that disclosure of the royalty rate from Hikma on net sales of the Hikma AG product (the “royalty rate”) (or in lieu thereof, a royalty rate range) is not required because disclosure of the royalty rate is neither material nor necessary for the protection of investors and moreover, it would not be appropriate for the Company to make such disclosure given the confidential nature of the royalty rate and an associated order of the U.S. District Court for the Northern District of California, as explained in more detail below. Disclosure of the royalty rate is neither material nor necessary for the protection of investors In the context of omitted disclosure, the U.S. Supreme Court has held that, to fulfill the materiality requirement, “there must be a substantial likelihood that the disclosure of the omitted fact would have been viewed by the reasonable investor as having significantly altered the ‘total mix’ of information made available.” TSC Industries v. Northway, Inc. , 426 U.S. 438, 449 (1976); Basic, Inc. v. Levinson , 485 U.S. 224 (1988). The Staff has advised against making materiality determinations through the application of any single quantitative formula, stating that both quantitative and qualitative factors must be taken into account. SEC Release No. SAB 99 (Aug. 12, 1999). Set forth below are the quantitative and qualitative factors the Company considered in making the determination that disclosure of the royalty rate (or in lieu thereof, a royalty rate range) would not significantly alter the “total mix” of information the Company makes available to investors. Quantitative analysis The Company respectfully advises the Staff that, for each of the fiscal year ended December 31, 2024 and the three months ended March 31, 2025, high-sodium oxybate authorized generic royalty revenue in the aggregate, including the Hikma AG product royalty revenue, comprised only approximately 5% of the Company’s total revenue. Furthermore, the Company currently expects the Hikma AG product royalty revenue, as a percentage of the Company’s total revenue, to decline in future years as narcolepsy patients continue to adopt lower sodium Xywav and the Company continues to diversify its product portfolio and revenue drivers (in particular, the Company’s diversification of total revenue away from high-sodium oxybate). Accordingly, the royalty revenues realized from Hikma on net sales of the Hikma AG product have not been, and are not currently expected to be, quantitatively material. Jazz Pharmaceuticals plc. registered in Ireland (company number 399192) Registered Office: Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland Directors: Bruce C. Cozadd - Chairman (USA), Jennifer Cook (USA), Patrick G. Enright (USA), Laura Hamill (USA), Patrick Kennedy, Heather Ann McSharry, Seamus Mulligan, Kenneth W. O’Keefe (USA), Anne O’Riordan, Norbert G. Riedel (DE), Mark Smith (USA), Rick E Winningham (USA) Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland T: +353.1.634.7800 F: +353.1.634.7850 jazzpharmaceuticals.com Qualitative analysis The Company respectfully advises the Staff that the Hikma royalty revenues relate to a high sodium oxybate AG product, which is essentially an authorized generic version of the Company’s Xyrem product. The Company no longer considers Xyrem one of its lead marketed products, as indicated in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Annual Report”), and the Company does not consider AG royalty revenues to be a material part of its business. As disclosed in the Annual Report, the Company’s oxybate commercial efforts are focused on educating patients and physicians about the lifelong impact of high sodium intake, and how the use of Xywav enables them to address what is a modifiable risk factor. As discussed above, the Company expects revenues from high sodium oxybate products to decrease as a percentage of the Company’s total revenue in future years as Xywav has become a standard of care for patients with narcolepsy and idiopathic hypersomnia and the Company continues to focus its commercial efforts on educating patients about the benefits of Xywav and on its other lead marketed products. Further, the Company’s operating plan assumes that Xywav, with 92% lower sodium compared to high-sodium oxybates (depending on the dose), a dosing titration option and an absence of a sodium warning, will remain the #1 branded oxybate treatment for narcolepsy (the position it held based on revenue in the first quarter of 2025). Moreover, the royalty rate, which the Company has disclosed is fixed, beginning in January 2024, for the duration of the Company’s agreements with Hikma, is only one factor that determines the amount of royalties the Company receives from Hikma; the amount of royalties the Company receives is dependent on the prices at which Hikma sells its AG product and the volume of such sales, neither of which is publicly disclosed by Hikma. Hikma’s plans for commercialization and distribution of its AG product are controlled by Hikma. In addition, and as disclosed in the Annual Report, the Company respectfully advises the Staff that Hikma’s election to sell the Hikma AG product (with royalties to be paid to the Company) for a total of up to four years beginning in January 2024 may be terminated by Hikma at any time in accordance with the notice provisions in the agreements between the parties. Relatedly, the Company also granted Hikma a license to launch its own generic high-sodium oxybate product. If Hikma elects to launch its own generic product, it will no longer have the right to sell the Hikma AG product and the Company will no longer be entitled to royalty payments from Hikma. As a result, in addition to not being material to the Company on an absolute or relative basis, any royalties that may be payable under the Company’s agreements with Hikma are also uncertain in amount and duration, and additional detail about one factor that may influence such speculative information would not alter the total mix of information useful to investors in evaluating the Company’s business or in making investment decisions. The Company provides substantial disclosure regarding oxybate revenues The Company’s existing disclosure with respect to oxybate revenues and the drivers thereof is substantial, and includes the quantitative and qualitative information that is material to investors. Such quantitative information includes: • product revenue information; • royalty revenue information; • Xywav patient numbers by indication; and • estimates with respect to patient populations. Such qualitative information includes: • the Company’s commercialization strategy for its oxybate products; • information about competition for the Company’s oxybate products; • the Company’s research and development strategy and progress; and • historical and anticipated trends with respect to oxybate product revenues and royalty revenues. Accordingly, the Company respectfully submits that additional disclosure regarding the Hikma royalty rate would not significantly alter the “total mix” of information made available to investors and there is not a substantial likelihood that a reasonable investor would consider the Hikma royalty rate important in making an investment decision. Indeed, the Company believes that investment decisions are based on the Company’s overall business strategy and performance rather than the Hikma royalty rate. In any event, the Company believes that protection of investors has been satisfied with the substantial disclosure that currently exists in the Annual Report regarding the Company’s oxybate revenues, including with respect to Hikma’s rights to sell the Hikma AG product and its own generic high-sodium oxybate product, and the potential time periods under which the Company would be entitled to royalty payments from Hikma for sales of the Hikma AG product. jazzpharmaceuticals.com The royalty rate is highly confidential and disclosure of such rate would cause competitive harm to the Company The Company treats its Hikma pricing and royalty revenue rate as highly confidential and has not disclosed this information publicly, nor widely disseminated it within the Company. Notably, in multidistrict litigation proceedings before the U.S. District Court for the Northern District of California (the “Court”) relating to patent litigation settlements the Company entered into with certain generic drug manufacturers who had filed abbreviated new drug applications for generic versions of Xyrem (“ANDA filers”), the Court has granted motions made by both the Company and Hikma to seal the pricing and royalty rates in authorized generic agreements between the Company and Hikma, as well as the Company’s agreements with certain other ANDA filers. The Company believes that disclosure of the Hikma royalty rate would permit counterparties to gain an advantage in their negotiations with the Company in ongoing and future license negotiations by demanding the same or better terms and would allow competitors to use those values to glean insight into the Company’s practices related to negotiating these or other types of commercial agreements, all of which could cause the Company substantial competitive harm to the detriment of its shareholders. The Company is separately supplementally providing the most recent such order, granted on July 10, 2025, to the Staff. In granting the Company’s and Hikma’s motions to seal the pricing and royalty rates, the Court found that public interest in these terms was outweighed by the risk of competitive harm. The Court also determined that the precise royalty rates were not critical to the public understanding of the litigation. Accordingly, such rates and prices have and will be redacted in the documents that are publicly available for such proceedings. In light of the foregoing, because disclosure of the royalty rate is neither material nor necessary for the protection of investors and disclosure with respect to the royalty rate that is more granular than the Company’s existing disclosure could cause competitive harm to the Company, the Company respectively advises the Staff that it believes it would not be appropriate for the Company to disclose the royalty rate (or in lieu thereof, a royalty rate range). Patents and Proprietary Rights, page 27 2. We note that Rylaze accounted for approximately 11% of your total net product sales for the fiscal year ended December 31, 2024. We further note from your disclosure on page 28 that you obtained your rights to Rylaze pursuant to a licensing agreement. Please either file the licensing agreement governing your rights to Rylaze as an exhibit to future filings or explain to us why you do not believe such exhibit is required. Refer to Item 601(b)(10) of Regulation S-K. The Company respectfully acknowledges the Staff’s comment and plans to file the above-referenced licensing agreement, subject to appropriate redactions for confidential information, as an exhibit with its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. * * * * * Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response letter to me at + 1 650 496 3777. Sincerely, /s/ Philip L. Johnson Philip L. Johnson Executive Vice President and Chief Financial Officer Jazz Pharmaceuticals plc cc: Bruce C. Cozadd, Chairman and Chief Executive Officer Neena Patil, Executive Vice President and Chief Legal Officer Patricia Carr, Senior Vice President and Chief Accounting Officer John Corrigan, KPMG Chadwick Mills, Cooley LLP Sarah Sellers, Cooley LLP
2025-07-17 - UPLOAD - Jazz Pharmaceuticals plc File: 001-33500
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 17, 2025 Philip Johnson Executive Vice President and Chief Financial Officer Jazz Pharmaceuticals plc Fifth Floor, Waterloo Exchange Waterloo Road Dublin 4, Ireland D04 E5W7 Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2024 File No. 001-33500 Dear Philip Johnson: We have reviewed your filing and have the following comments. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for the Fiscal Year Ended December 31, 2024 Item 1. Business Competition, page 22 1. We note your disclosure that you have the right to receive a "meaningful royalty" from Hikma on net sales of the Hikma AG product. Please revise your future filings to disclose the royalty rate, or a royalty rate range not to exceed 10 percentage points, or explain to us why it would not be appropriate to do so. Patents and Proprietary Rights, page 27 2. We note that Rylaze accounted for approximately 11% of your total net product sales for the fiscal year ended December 31, 2024. We further note from your disclosure on page 28 that you obtained your rights to Rylaze pursuant to a licensing agreement. Please either file the licensing agreement governing your rights to Rylaze as an exhibit to future filings or explain to us why you do not believe such exhibit is required. Refer to Item 601(b)(10) of Regulation S-K. July 17, 2025 Page 2 We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Lynn Dicker at 202-551-3616 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jessica Dickerson at 202-551-8013 or Tim Buchmiller at 202-551- 3635 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-04-04 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP [Letterhead of Wachtell, Lipton Rosen & Katz] April 4, 2025 VIA EDGAR U.S. Securities and Exchange Commission 100 F Street, N.E. Division of Corporation Finance, Office of Mergers & Acquisitions Washington, D.C. 20549 Attention: Shane Callaghan U.S. Securities and Exchange Commission Division of Corporation Finance, Office of Mergers & Acquisitions April 4, 2025 Page 2 Re: Jazz Pharmaceuticals Public Limited Company Chimerix, Inc. Schedule TO-T Filed March 21, 2025 Filed by Pinetree Acquisition Sub, Inc. and Jazz Pharmaceuticals Public Limited Company File No. 005-87690 Ladies and Gentlemen: On behalf of Pinetree Acquisition Sub, Inc. (“ Offeror ”) and Jazz Pharmaceuticals Public Limited Company (“ Jazz ” and, together with Offeror, the “ Filing Persons ”), we acknowledge receipt of the comment letter, dated April 1, 2025 (the “ Comment Letter ”), from the staff (the “ Staff ”) of the Securities and Exchange Commission (the “ SEC ”) concerning the above-captioned Schedule TO-T (the “ Schedule TO ”). We submit this letter on behalf of the Filing Persons in response to the Comment Letter. To facilitate the Staff’s review, we have reproduced the Staff’s comments in italics below. Our response then follows each of the Staff’s comments. Concurrently with this letter, the Filing Persons are filing Amendment No. 3 to the Schedule TO-T, which reflects revisions made to the Schedule TO in response to the comments of the Staff. Unless otherwise noted, the page numbers in the responses below refer to pages in the Offer to Purchase, dated March 21, 2025 (the “ Offer to Purchase ”), which is included as Exhibit (a)(1)(A) to the Schedule TO. Capitalized terms used but not defined herein have the meaning given to such terms in the Offer to Purchase. U.S. Securities and Exchange Commission Division of Corporation Finance, Office of Mergers & Acquisitions April 4, 2025 Page 3 Schedule TO-T filed March 21, 2025 Staff Comment No. 1 Procedures for Accepting the Offer and Tendering Shares, page 15 1. We note the following statement made on page 16: “All questions as to the validity, form, eligibility (including time of receipt) and acceptance for payment of any tender of Shares will be determined by us, in our sole discretion.” Please revise this statement to clarify that shareholders are not foreclosed from challenging your determination in a court of competent jurisdiction. Please also revise the last sentence of the penultimate paragraph on page 16 accordingly. Response : In response to the Staff’s comment, the Filing Persons have revised the disclosures on page 16 of the Offer to Purchase concerning the Procedures for Accepting the Offer and Tendering Shares. Staff Comment No. 2 Withdrawal Rights, page 17 2. See comment 1 above. We note the following statement made on page 18: “We will determine, in our sole discretion, all questions as to the form and validity (including time of receipt) of any notice of withdrawal and our determination will be final and binding.” Please revise this statement to clarify that shareholders are not foreclosed from challenging your determination in a court of competent jurisdiction. Response : In response to the Staff’s comment, the Filing Persons have revised the disclosures on page 18 of the Offer to Purchase concerning Withdrawal Rights. U.S. Securities and Exchange Commission Division of Corporation Finance, Office of Mergers & Acquisitions April 4, 2025 Page 4 Staff Comment No. 3 Source and Amount of Funds, page 27 3. We note the following statement on page 27: “Jazz and Purchaser currently have, and will have, available to them, through a variety of sources, including cash on hand, funds necessary for the payment of the aggregate Offer Price and the aggregate Merger Consideration and to satisfy all of their payment obligations under the Merger Agreement and resulting from the transactions contemplated thereby” (emphasis added). Please revise to state the other source(s) of payment if all or a portion of the aggregate Offer Price and the aggregate Merger Consideration will not be funded from Jazz and Purchaser’s available cash on hand. See Item 7 of Schedule TO and Item 1007(a) of Regulation M-A. Response : In response to the Staff’s comment, the Filing Persons have revised the disclosures on page 27 of the Offer to Purchase. * * * * * * If you have any questions, please do not hesitate to contact me at (212) 403-1343. Very truly yours, /s/ Mark Gordon Mark Gordon cc: Neena M. Patil EVP & Chief Legal Officer Jazz Pharmaceuticals Public Limited Company
2020-02-20 - UPLOAD - Jazz Pharmaceuticals plc
February 20, 2020
Bruce C. Cozadd
Chairman and Chief Executive Officer
Jazz Pharmaceuticals plc
Fifth Floor, Waterloo Exchange
Waterloo Road, Dublin 4
Ireland D04 E5W7
Re:Jazz Pharmaceuticals plc
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed February 26, 2019
File No. 001-33500
Dear Mr. Cozadd:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-02-14 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP February 14, 2020 Via EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Mary Mast and Angela Connell Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2018 Filed February 26, 2019 Form 8-K dated August 6, 2019 File No. 001-33500 Dear Ms. Mast and Ms. Connell: Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to the comment received from the staff (the “Staff”) of the Securities and Exchange Commission by letter dated November 5, 2019 (the “Comment Letter”) and as discussed by the Staff with the undersigned and other representatives of the Company in subsequent telephone conversations. For ease of reference, the Staff’s original comment is reproduced below in italicized type followed by the Company’s response. Form 8-K dated August 6, 2019 Exhibit 99.1 Reconciliations of GAAP Reported to non-GAAP Adjusted Information, page 12 1. Your adjustment for upfront and milestone payments does not appear to be consistent with Question 100.01 of the Non-GAAP Compliance and Disclosure Interpretations (C&DI) as such payments would appear to represent normal, recurring cash operating expenses. Please revise your future filings to remove this adjustment or explain to us why it does not violate the C&DI. In response to the Staff’s comment and as discussed during subsequent telephone conversations with the Staff, beginning with the Company’s earnings release for the first quarter of 2020, the Company will no longer include adjustments for upfront and milestones payments when presenting its non-GAAP financial measures. * * * * * Please do not hesitate to contact me at +353 1 634 7818 if you have any questions or would like additional information regarding this matter. Sincerely, /s/ Patricia Carr Patricia Carr Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Bruce C. Cozadd, Chairman, Chief Executive Officer and Interim Principal Financial Officer Neena Patil, Senior Vice President and General Counsel Emer McGrath, KPMG Chadwick Mills, Cooley LLP
2020-01-17 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP www.jazzpharmaceuticals.com January 17, 2020 Via EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Mary Mast and Angela Connell Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2018 Filed February 26, 2019 Form 8-K dated August 6, 2019 File No. 001-33500 Dear Ms. Mast and Ms. Connell: On behalf of Jazz Pharmaceuticals plc (the “Company”), this letter is being transmitted to inform the staff of the Securities and Exchange Commission (the “Staff”) that the Company intends to respond to the Staff’s letter dated November 5, 2019 and subsequent oral comments regarding the Staff’s review of the above-referenced filings no later than February 3, 2020. Please do not hesitate to contact me at +353 1 634 7818 if you have any questions or would like additional information regarding this matter. Sincerely, /s/ Patricia Carr Patricia Carr Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Bruce C. Cozadd, Chairman, Chief Executive Officer and Interim Principal Financial Officer Neena Patil, Senior Vice President and General Counsel Emer McGrath, KPMG Chadwick Mills, Cooley LLP Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland p 353.1.634.7800 f 353.1.634.7850 Jazz Pharmaceuticals plc. Registered in Ireland (company number 399192). Registered Office: Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland. Directors: Bruce C. Cozadd – Chairman (USA), Paul L. Berns (USA), Patrick G. Enright (USA), Peter Gray, Heather Ann McSharry, Seamus Mulligan, Kenneth W. O’Keefe (USA), Anne O’Riordan (HK), Norbert G. Riedel, Ph.D (USA), Elmar Schnee (CH), Catherine A. Sohn (USA), Rick E Winningham (USA)
2019-12-20 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP December 20, 2019 Via EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Mary Mast and Angela Connell Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2018 Filed February 26, 2019 Form 8-K dated August 6, 2019 File No. 001-33500 Dear Ms. Mast and Ms. Connell: On behalf of Jazz Pharmaceuticals plc (the “Company”), this letter is being transmitted to inform the staff of the Securities and Exchange Commission (the “Staff”) that the Company intends to respond to the Staff’s letter dated November 5, 2019 and subsequent oral comment regarding the Staff’s review of the above-referenced filings no later than January 17, 2020. Please do not hesitate to contact me at +353 1 634 7818 if you have any questions or would like additional information regarding this matter. Sincerely, /s/ Patricia Carr Patricia Carr Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Bruce C. Cozadd, Chairman, Chief Executive Officer and Interim Principal Financial Officer Neena Patil, Senior Vice President and General Counsel Emer McGrath, KPMG Chadwick Mills, Cooley LLP Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland p 353.1.634.7800 f 353.1.634.7850 Jazz Pharmaceuticals plc. Registered in Ireland (company number 399192). Registered Office: Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland. Directors: Bruce C. Cozadd – Chairman (USA), Paul L. Berns (USA), Patrick G. Enright (USA), Peter Gray, Heather Ann McSharry, Seamus Mulligan, Kenneth W. O’Keefe (USA), Anne O’Riordan (HK), Norbert G. Riedel, Ph.D (USA), Elmar Schnee (CH), Catherine A. Sohn (USA), Rick E Winningham (USA)
2019-11-19 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP www.jazzpharmaceuticals.com November 19, 2019 Via EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Mary Mast and Angela Connell Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2018 Filed February 26, 2019 Form 8-K dated August 6, 2019 File No. 001-33500 Dear Ms. Mast and Ms. Connell: Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to the comment received from the staff (the “Staff”) of the Securities and Exchange Commission by letter dated November 5, 2019 (the “Comment Letter”). For ease of reference, the Staff’s comment is reproduced below in italicized type followed by the Company’s response. Form 8-K dated August 6, 2019 Exhibit 99.1 Reconciliations of GAAP Reported to non-GAAP Adjusted Information, page 12 1. Your adjustment for upfront and milestone payments does not appear to be consistent with Question 100.01 of the Non-GAAP Compliance and Disclosure Interpretations (C&DI) as such payments would appear to represent normal, recurring cash operating expenses. Please revise your future filings to remove this adjustment or explain to us why it does not violate the C&DI. In response to the Staff´s comment, the Company acknowledges Question 100.01 of the Non-GAAP Compliance and Disclosure Interpretations (“C&DIs”), as well as Rule 100(b) of Regulation G to which Question 100.01 relates. The Company respectfully advises the Staff that the Company has considered the foregoing guidance and believes that its presentation of non-GAAP financial measures that exclude selected upfront and milestone payments is not misleading. The Company respectfully advises the Staff that it does not consider the selected upfront and milestone payments that it excludes when presenting its non-GAAP financial measures to be normal and recurring in the manner contemplated by the Staff in Question 100.01 due to the nature, magnitude, variability of amount and lack of predictability as to occurrence and/or timing of such payments. The Company’s upfront and milestone payment obligations relate to arrangements that provide the Company with license or other rights (such arrangements, “Rights Acquisitions”), which payments may not recur with similar materiality or impact on operating results across reporting periods due to the highly variable nature of those payments, which variability may be impacted by the discretionary and opportunistic nature of new Rights Acquisitions by the Company as well as the level and timing of achievement of milestone events. The Company regularly reviews its upfront and milestone payment adjustments and currently applies a quantitative and qualitative assessment to determine whether it is appropriate to potentially exclude an upfront or milestone payment due to the magnitude and nature of such payment and/or the related Rights Acquisition agreement. Upfront or milestone payments that do not meet the above-mentioned Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland p 353.1.634.7800 f 353.1.634.7850 Jazz Pharmaceuticals plc. Registered in Ireland (company number 399192). Registered Office: Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland. Directors: Bruce C. Cozadd – Chairman (USA), Paul L. Berns (USA), Patrick G. Enright (USA), Peter Gray, Heather Ann McSharry, Seamus Mulligan, Kenneth W. O’Keefe (USA), Anne O’Riordan (HK), Norbert G. Riedel, Ph.D (USA), Elmar Schnee (CH), Catherine A. Sohn (USA), Rick E Winningham (USA) www.jazzpharmaceuticals.com quantitative and qualitative criteria are not excluded. Conversely, the upfront and milestone payments that are excluded under such criteria are more distinctive and substantial such that the Company does not view such payments as normal and recurring in the manner contemplated by the Staff in Question 100.01. Rather, the Company believes that adjusting for upfront and milestone payments that meet such criteria allows investors to more meaningfully compare the Company’s results from period to period and to identify operating trends in the Company’s business. Importantly, the Company also uses these same non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. Because these non-GAAP financial measures are important internal measurements for the Company’s management, the Company also believes that these non-GAAP financial measures are useful to investors since these measures allow for greater transparency with respect to key financial metrics the Company uses in assessing its own operating performance and making operating decisions. In an effort to ensure that the Company’s presentation of its non-GAAP financial measures is not misleading, the Company presents the most directly comparable GAAP financial measures with equal or greater prominence and includes disclosure explaining how these measures are used by management and why management believes they are useful to investors. In addition, consistent with Question 102.03 of the Non-GAAP C&DIs, the Company does not describe upfront and milestone payments as non-recurring, infrequent or unusual, or in other terms that mischaracterize the frequency of these payments. Finally, the Company clearly explains the limitations of its non-GAAP financial measures, including by explaining that such financial measures should not be considered in isolation or as a substitute for comparable GAAP measures, and should in any event be read in conjunction with the Company’s reported GAAP results. For the foregoing reasons, the Company respectfully advises the Staff that it believes that excluding selected upfront and milestone payments from its non-GAAP financial measures, as described above, does not violate Question 100.01. Further, the Company respectfully advises the Staff that it will continue to regularly review the appropriateness of its non-GAAP financial measures and related adjustments to ensure that such financial measures do not exclude normal, recurring, cash operating expenses necessary to operate its business. * * * * * Please do not hesitate to contact me at +353 1 634 7818 if you have any questions or would like additional information regarding this matter. Sincerely, /s/ Patricia Carr Patricia Carr Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Bruce C. Cozadd, Chairman, Chief Executive Officer and Interim Principal Financial Officer Neena Patil, Senior Vice President and General Counsel Emer McGrath, KPMG Chadwick Mills, Cooley LLP
2019-11-05 - UPLOAD - Jazz Pharmaceuticals plc
November 5, 2019
Bruce C. Cozadd
Chairman and Chief Executive Officer
Jazz Pharmaceuticals plc
Fifth Floor, Waterloo Exchange
Waterloo Road, Dublin 4
Ireland D04 E5W7
Re:Jazz Pharmaceuticals plc
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed February 26, 2019
Form 8-K dated August 6, 2019
File No. 001-33500
Dear Mr. Cozadd:
We have limited our review of your filings to the financial statements and related
disclosures and have the following comments.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 8-K dated August 6, 2019
Exhibit 99.1
Reconciliations of GAAP Reported to Non-GAAP Adjusted Information, page 12
1.Your adjustment for upfront and milestone payments does not appear to be consistent with
Question 100.01 of the Non-GAAP Compliance and Disclosure Interpretations (C&DI) as
such payments would appear to represent normal, recurring cash operating expenses.
Please revise your future filings to remove this adjustment or explain to us why it does not
violate the C&DI.
FirstName LastNameBruce C. Cozadd
Comapany NameJazz Pharmaceuticals plc
November 5, 2019 Page 2
FirstName LastName
Bruce C. Cozadd
Jazz Pharmaceuticals plc
November 5, 2019
Page 2
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Mary Mast at 202-551-3613 or Angela Connell at 202-551-3426 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2018-12-11 - UPLOAD - Jazz Pharmaceuticals plc
December 11, 2018
Bruce Cozadd
Chairman and Chief Executive Officer and Director
Jazz Pharmaceuticals plc
Fifth Floor, Waterloo Exchange
Waterloo Road, Dublin 4, Ireland
Re:Jazz Pharmaceuticals plc
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed February 27, 2018
File No. 001-33500
Dear Mr. Cozadd:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-11-14 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP November 14, 2018 Via EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Office of Healthcare & Insurance 100 F Street, N.E. Washington, D.C. 20549 Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2017 Filed February 27, 2018 Form 10-Q for the Quarterly Period Ended September 30, 2018 Filed November 6, 2018 File No. 001-33500 Ladies and Gentlemen: Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to the comment received from the staff (the “Staff”) of the Securities and Exchange Commission by letter dated November 8, 2018 (the “Comment Letter”). For ease of reference, the Staff’s comment is reproduced below in italicized type followed by the Company’s response. Form 10-Q for the Quarterly Period Ended September 30, 2018 Notes to the Condensed Consolidated Financial Statements 2. Disposition, page 11 1. Please provide us an analysis with reference to authoritative literature supporting your determination of a $.5 million loss on sale to TerSera of the assets related to Prialt. In particular, address how you considered the $30 million of payments subject to certain conditions that may be received in the future and the literature upon which you relied. In response to the Staff’s comment, the Company respectfully advises the Staff that the Company recognized a loss on disposal of the assets related to Prialt of $0.5 million based on the difference between the carrying amount of the assets sold and the total transaction price, net of direct selling costs. The Company referred to the guidance under Accounting Standards Codification (“ASC”) 610-20, Gains and Losses from the Derecognition of Nonfinancial Assets, which applies to gains or losses recognized upon the derecognition of a nonfinancial asset or an in substance nonfinancial asset if the transaction is not with a customer. ASC 610-20-32-2 states the following: When an entity meets the criteria to derecognize a distinct nonfinancial asset or a distinct in substance nonfinancial asset, it shall recognize a gain or loss for the difference between the amount of consideration measured and allocated to that distinct asset in accordance with paragraphs 610-20-32-3 through 32-6 and the carrying amount of the distinct asset. The amount of consideration promised in a contract that is included in the calculation of a gain or loss includes both the transaction price and the carrying amount of liabilities assumed or relieved by a counterparty. ASC 610-20-32-3 provides that an entity shall apply the guidance under ASC 606, Revenue from Contracts with Customers, in determining the transaction price. The total consideration for the Prialt assets sold to TerSera Therapeutics LLC (“TerSera”), as provided in the asset purchase agreement (as amended, the “APA”), was $80.0 million, of which $50.0 million was received at closing, and the Company is entitled to receive installment payments of $15.0 million on each of December 31, 2019 and December 31, 2020, or earlier under certain circumstances (the “installment payments”). The consideration is subject to reduction if certain events, as defined in the APA, occur. TerSera may also deduct from the installment payments certain expenses that it incurs as provided in the APA. Thus, an element of the total consideration is variable. In accordance with ASC 606-10-32-11, an entity shall include in the transaction price some or all of an amount of variable consideration only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company considered the likelihood of occurrence of the events that would result in adjustments to the total consideration and based on the Company’s assessment of the relevant facts, concluded that the likelihood of such events occurring is remote. In addition, the Company reviewed each item that could give rise to a claim for reimbursable expenses by TerSera and determined that the best estimate of the total amount of consideration that will be withheld to cover such expenses is $0.5 million. In addition, the Company considered the guidance in ASC 606-10-32-15 through ASC 606-10-32-17 related to the existence of a significant financing component in assessing whether the two $15.0 million installment payments should be adjusted for the effects of the time value of money. The Company concluded the APA does not contain a significant financing component as the consideration varies based on the nonoccurrence of future events that are not substantially within the control of the Company or TerSera. The Company concluded that the most likely amount of total consideration to be received under the APA is $79.5 million, which was included in the calculation of the gain or loss on derecognition of the Prialt assets. After subtracting the carrying amount of the assets held for sale as of the closing date and direct selling costs from the total transaction price, the resulting loss on disposal of the assets was $0.5 million. * * * * * Please do not hesitate to contact me at (650) 496-2654 if you have any questions or would like additional information regarding these matters. Sincerely, /s/ Karen J. Wilson Karen J. Wilson Senior Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Bruce C. Cozadd, Chairman and Chief Executive Officer and Director Matthew P. Young, Executive Vice President and Chief Financial Officer Suzanne Sawochka Hooper, Executive Vice President and General Counsel Ruaidhri Gibbons, KPMG Chadwick Mills, Cooley LLP
2018-11-08 - UPLOAD - Jazz Pharmaceuticals plc
November 8, 2018
Bruce Cozadd
Chairman and Chief Executive Officer and Director
Jazz Pharmaceuticals plc
Fifth Floor, Waterloo Exchange
Waterloo Road, Dublin 4, Ireland
Re:Jazz Pharmaceuticals plc
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed February 27, 2018
Form 10-Q for the Quarterly Period Ended September 30, 2018
Filed November 6, 2018
File No. 001-33500
Dear Mr. Cozadd:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment, we ask you to provide us with
information so we may better understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Form 10-Q for the Quarterly Period Ended September 30, 2018
Notes to Condensed Consolidate Financial Statements
2. Disposition, page 11
1.Please provide us an analysis with reference to authoritative literature supporting your
determination of a $.5 million loss on sale to TerSera of the assets related to Prialt. In
particular, address how you considered the $30 million of payments subject to certain
conditions that may be received in the future and the literature upon which you relied.
FirstName LastNameBruce Cozadd
Comapany NameJazz Pharmaceuticals plc
November 8, 2018 Page 2
FirstName LastName
Bruce Cozadd
Jazz Pharmaceuticals plc
November 8, 2018
Page 2
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Keira Nakada at 202-551-3659 or Jim Rosenberg at 202-551-3679 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2016-12-07 - UPLOAD - Jazz Pharmaceuticals plc
Mail Stop 4 546 December 7, 2016 Via E -mail Mr. Matthew P. Young Executive Vice President and Chief Financial Officer Jazz Pharmaceuticals plc Fourth Floor, Connaught House One Burlington Road Dublin 4 Ireland Re: Jazz Pharmaceuticals plc Form 10-K for the Year Ended December 31, 2015 Filed February 23 , 2016 File No. 001-33500 Dear Mr. Young : We have completed our review of your filing . We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff . Sincerely, /s/ Sharon M. Blume Sharon M. Blume Accounting Branch Chief Office of He althcare and Insurance
2016-11-14 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP November 14, 2016 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant Office of Healthcare and Insurance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Jazz Pharmaceuticals plc Form 10-K for the Year Ended December 31, 2015 Filed February 23, 2016 Form 8-K dated August 9, 2016 Filed August 9, 2016 Form 8-K/A dated July 12, 2016 Filed September 27, 2016 File No. 001-33500 Dear Mr. Rosenberg: Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission by letter dated October 31, 2016 (the “Comment Letter”). The following information is provided in response to the Staff’s comments included in the Comment Letter, which comments are reproduced below in italicized type. Please note that the headings and numbering set forth below correspond to the headings and numbering contained in the Comment Letter. Form 8-K filed August 9, 2016 Exhibit 99.1 Press Release dated August 9, 2016 Non-GAAP Financial Measures, page 5 1. You disclose that intangible asset amortization, upfront and milestone payments, and restructuring, transaction and integration related costs are not indicative of your core operating results, yet these items are readily associated with product acquisitions (through either business combination, asset acquisitions or in-licensing) and appear to be an integral part of your strategy to create shareholder value as disclosed on page 3 of your 2015 Form 10-K. In addition, it is unclear how share-based compensation is not indicative of your core operating results as it appears to be a continuing component of your compensation package to employees. Please provide us proposed revised disclosure to be included in future earnings releases explaining the reasons why your non-GAAP measures provide useful information to investors and analysts without referring to “core operating results.” The Company has considered the Staff’s comment and in connection therewith determined to revise its disclosure explaining the reasons why the Company’s non-GAAP measures provide useful information to investors and analysts, without referring to “core operating results” (the “Revised Usefulness Disclosure”), which Revised Usefulness Disclosure is underlined below and will be included in future earnings releases: “Non-GAAP Financial Measures To supplement Jazz Pharmaceuticals’ financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the company presents non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc (and the related per share measure) and its line item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (and the related per share measure) and its line item components exclude from reported GAAP net income (and the related per share measure) and its line item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (and the related per share measure), adjust for the tax effect of non-GAAP adjustments and, for the comparable 2015 periods, adjust for the amount attributable to noncontrolling interests. In this regard, the components of non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc, including non-GAAP cost of product sales, non-GAAP selling, general and administrative expenses and non-GAAP research and development expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income measure. The company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts. In particular, the company believes that each of these non-GAAP financial measures, when considered together with the company’s financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare the company’s results from period to period and to its forward-looking guidance, and to identify operating trends in the company’s business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the company’s financial performance. Jazz Pharmaceuticals’ management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the company’s business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals’ management, the company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the company’s condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the company may exclude for purposes of its non-GAAP financial measures; and the company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. Likewise, the company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. In this regard, the company modified the calculation of its non-GAAP income tax provision commencing in the second quarter of 2016 and accordingly, the income tax effect of the adjustments between GAAP reported and non-GAAP adjusted results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). For purposes of comparability, the non-GAAP income tax provision and the corresponding income tax adjustment to arrive at non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc (and the related per share measures) for the comparable 2015 periods are presented on the same basis. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.” Form 8-K/A filed September 27, 2016 Exhibit 99.4 Notes to Unaudited Pro Forma Condensed Combined Financial Statements Note 1: Basis of Presentation, page 5 2. You disclose that the identifiable intangible assets you acquired include in-process research and development, or IPR&D. You also disclose that your preliminary estimate of $1.8 billion in IPR&D relates to Vyxeos. In Note 1 to your financial statements in your June 30, 2016 Form 10-Q you indicate that in addition to Vyxeos, you acquired Celator’s proprietary technology platform, CombiPlex. Please tell us the preliminary fair value you attribute to CombiPlex and why you do not reflect amortization of this intangible asset in your pro forma statements of income given that CombiPlex appears to be an intangible asset used in research and development and not a separate IPR&D project. In response to the Staff’s comment, the Company respectfully advises the Staff that the Company determined it was appropriate to aggregate VyxeosTM and the CombiPlex® technology platform (the “Platform”) into a single unit of account in accordance with the guidance contained in the AICPA Accounting and Valuation Guide Assets Acquired to be Used in Research and Development Activities (the “Guidance”) based on relevant facts and circumstances as of the effective date (the “Acquisition Date”) of the Company’s acquisition (the “Acquisition”) of Celator Pharmaceuticals Inc. (“Celator”). As of the Acquisition Date, there were no products approved by any regulatory authority based on the Platform, and Vyxeos was the only product candidate in development based on the Platform. Accordingly, as no Platform-based product has received regulatory approval, the Platform itself is considered incomplete and therefore, an in-process research and development (“IPR&D”) asset. The Vyxeos IPR&D project is dependent on the Platform, as it consists of the combination of two compounds (for which the Company has no intellectual property rights) in a proprietary ratio defined by the Platform. Accordingly, the Platform and Vyxeos share the same characteristics with respect to the phase of development, the nature of activities and costs necessary to continue development, the risks, including regulatory approval, associated with further development and the requirement to transfer rights to the Platform with Vyxeos in a divestiture scenario. Vyxeos represented Celator’s only Platform-based activity as of the Acquisition Date. As a result, the Company determined that, in accordance with the Guidance, it was appropriate to aggregate Vyxeos and the Platform into a single unit of account and recognize the related IPR&D asset with a fair value of $1.8 billion. The Company did not identify any other intangible assets in the Acquisition. The Company did not reflect amortization in the pro forma statements of income included in the Form 8-K/A filed on September 27, 2016 as only IPR&D was acquired in the Acquisition. * * * * * Please do not hesitate to contact me at (650) 496-2654 if you have any questions or would like additional information regarding these matters. Sincerely, /s/ Karen J. Wilson Karen J. Wilson Senior Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Matthew P. Young, Executive Vice President and Chief Financial Officer Suzanne Sawochka Hooper, Executive Vice President and General Counsel Sean O’Keefe, KPMG Chadwick Mills, Cooley LLP
2016-10-31 - UPLOAD - Jazz Pharmaceuticals plc
Mail Stop 4 546 October 31, 2016 Via E -mail Mr. Matthew P. Young Executive Vice President and Chief Financial Officer Jazz Pharmaceuticals plc Fourth Floor, Connaught House One Burlington Road Dublin 4 Ireland Re: Jazz Pharmaceuticals plc Form 10-K for the Year Ended December 31, 2015 Filed February 23 , 2016 Form 8-K dated August 9 , 2016 Filed August 9 , 2016 Form 8 -K/A dated July 12, 2016 Filed September 27, 2016 File No. 001-33500 Dear Mr. Young : We have limited our review of your filing to the financial statements and related disclosures and have the following comments . In our comment s, we ask you to provide us with information so we may better unde rstand your disclosure. Please respond to these comments within 10 business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, pleas e tell us why in your response. After reviewing your response to these comments, we may have additional comments. Form 8 -K filed August 8, 2016 Exhibit 99.1 Press Release dated August 9, 2016 Non-GAAP Financial Measures, page 5 1. You disclose that intangible asset amortization, upfront and milestone payments, and restructuring, transaction and integration related costs are not indicative of your core operating results, yet these items are readily associated with product acquisition s (through either business combination, asset acquisitions or in -licensing) and appear to be an integral part of your strategy to create shareholder value as disclosed on page 3 of your 2015 Form 10 -K. In addition, it is unclear how share -based compensati on is not Mr. Matthew P. Young Jazz Pharmaceuticals plc October 31, 2016 Page 2 indicative of your core operating results as it appears to be a continuing component of your compensation package to employees. Please provide us proposed revised disclosure to be include d in future earnings releases explaining the reasons why your non -GAAP measures provide useful information to investors and analysts without referring to “core operating results.” Form 8 -K/A filed September 27, 2016 Exhibit 99.4 Notes to Unaudited Pro Forma Condensed Combined Financial Statements Note 1: Ba sis of Presentation, page 5 2. You disclose that the identifiable intangible assets you acquired include in -process research and development, or IPR&D. You also disclose that your preliminary estimate of $1.8 billion in IPR&D relates to Vyxeos. In Note 1 t o your financial statements in your June 30, 2016 Form 10 -Q you indicate that in addition to Vyxeos, you acquired Celator’s proprietary technology platform, CombiPlex. Please tell us the preliminary fair value you attribute to CombiPlex and why you do not reflect amortization of this intangible asset in your pro forma statements of income given that CombiPlex appears to be an intangible asset used in research and development and not a separate IPR&D project. We remind you that the company and its manageme nt are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. You may contact Mark Bru nhofer, Senior Staff Accountant, at (202) 551 -3638 or Sharon Blume, Accounting B ranch Chief, at (202) 551 -3474 if you have questions regarding the comment s. In this regard, do not hesitate to contact me at (202) 551 -3679 . Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant Office of Healthcare and Insurance
2015-02-03 - UPLOAD - Jazz Pharmaceuticals plc
February 3, 201 5 Via E -mail Matthew P. Young Chief Financial Officer Jazz Pharmaceuticals PLC Fourth Floor, Connaught House One Burlington Road Dublin 4, Ireland Re: Jazz Pharmaceuticals PLC Form 10 -K for the Fiscal Year Ended December 31, 2013 Filed February 25 , 2014 Form 10 -Q for the quarterly period ended September 30, 2014 Filed November 4, 2014 File No. 001-33500 Dear Mr. Young : We have completed our review of your filings. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing s and the company may not as sert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing s to be certain that the filing s include the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Sharon Blume Sharon Blume Accounting Branch Chief
2015-02-02 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm Correspondence February 2, 2015 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporate Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2013 Filed February 25, 2014 Form 10-Q for the Quarterly Period Ended September 30, 2014 Filed November 4, 2014 File No. 001-33500 Dear Mr. Rosenberg: Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to the two additional oral comments received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) on January 26, 2015 relating to the Company’s response letter dated January 12, 2015 to the comment letter dated December 22, 2014 (the “Comment Letter”) regarding the comments of the Staff concerning the above-referenced filings. For your convenience, we have included a summary of the oral comments below and follow with our response. Amendment of Credit Facility and Term Loan Refinancing, page 21 Comment 1. With respect to comment 3 from the Comment Letter and the Company’s initial response thereto, please provide proposed disclosure to be included in future periodic reports that states that, in determining whether the January 23, 2014 second amendment to the credit agreement was a modification or a debt extinguishment, the 10% cash flow test (the “10% Test”) under ASC 470-50 was performed using the present value of cash inflows and outflows that included all principal increases and lender fees on the date of such amendment. In addition, please confirm to us that the outcome of this determination will not change the conclusion that was previously disclosed by the Company in its periodic reports. The Company confirms to the Staff that when the 10% Test is performed using the present value of the cash flows, which includes all principal increases and lender fees on the date of the January 23, 2014 second amendment to the credit agreement, to determine whether such amendment was a modification or a debt extinguishment, the outcome is the same as when the Company performed the 10% Test using the net method. Specifically, the Company in each case concluded that the January 23, 2014 second amendment to the credit agreement was a modification and not an extinguishment because the debt terms under the amended and the original credit agreement are not deemed to be substantially different. Under the approach to be disclosed in the Company’s future periodic reports, the Company performed the 10% Test as follows: • The 10% Test was performed for lenders that participated in the credit agreement both before and after the January 23, 2014 amendment by comparing present value of all cash flows, including principal increases and lender fees on the date of the amendment, under the original and the amended credit agreement, on a lender-by-lender basis. The U.S. Securities and Exchange Commission February 2, 2015 Page 2 Company’s credit agreement (both original and as amended) contains an option to prepay the term loans. The Company’s analysis was performed assuming exercise of the prepayment option in accordance with ASC 470-50-40-12(c). This analysis resulted in a change in present value of cash flows of less than 10% for each of the lenders. • Principal balances associated with new lenders to the credit agreement were considered new arrangements. In addition, in response to the Staff’s comment, the Company proposes to revise its disclosure, commencing with the Company’s annual report on Form 10-K for the year ended December 31, 2014, in substantially the form set forth below. The proposed changes to such disclosure (as compared to the disclosure in the quarterly report on Form 10-Q for the quarter ended September 30, 2014 (the “Form 10-Q”)) to address the Staff’s request for revised disclosure are underlined below: “The refinancing of the term loans involved multiple lenders who were considered members of a loan syndicate. In determining whether the refinancing was to be accounted for as a debt extinguishment or modification, we considered whether the lenders remained the same or changed and whether the change in debt terms was substantial. The debt terms would be considered substantially different if the present value of the cash inflows and outflows of the new term loans, including all principal increases and lender fees on the refinancing date, was at least 10% different from the present value of the remaining cash inflows and outflows of the original term loans, or the 10% Test. We performed a separate 10% Test for each individual lender participating in the loan syndication. For existing lenders who participated in the new term loans as part of the new loan syndicate, the refinancing was accounted for as a modification as the change in debt terms was determined to not be substantial using the 10% Test.” 13. Income Taxes, page 29 Comment 2. With respect to comment 4 from the Comment Letter and the Company’s initial response thereto, please provide us with proposed enhanced disclosure to clarify why the $202.0 million in upfront and milestone payments for the rights to JZP-110 and to defibrotide in the Americas were excluded from income before income tax provision in the calculation of the effective tax rate. In response to the Staff’s comment, the Company proposes to enhance its disclosure, commencing with the Company’s annual report on Form 10-K for the year ended December 31, 2014, in substantially the form set forth below. The proposed changes to such disclosure (as compared to the disclosure in the Form 10-Q) to address the Staff’s request for enhanced disclosure are underlined below: “After adjusting the income before income tax provision for the year ended December 31, 2014 by excluding a total of $202.0 million in upfront and milestone payments for rights to JZP-110 and to defibrotide in the Americas, which were acquired by subsidiaries of the Company in a non-taxable jurisdiction, the effective tax rate on the resulting income before income tax provision for 2014 was [X]%.” * * * * * U.S. Securities and Exchange Commission February 2, 2015 Page 3 The Company further acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in the filings; • Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filings; and • the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact me at (650) 496-2654 if you have any questions or would like additional information regarding these matters. Sincerely, /s/ Karen J. Wilson Karen J. Wilson Senior Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Matthew P. Young, Jazz Pharmaceuticals plc Suzanne Sawochka Hooper, Jazz Pharmaceuticals plc Sean O’Keefe, KPMG Chadwick Mills, Cooley LLP
2015-01-12 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm Correspondence Letter January 12, 2015 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporate Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2013 Filed February 25, 2014 Form 10-Q for the Quarterly Period Ended September 30, 2014 Filed November 4, 2014 File No. 001-33500 Dear Mr. Rosenberg: Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated December 22, 2014 (the “Comment Letter”) regarding the Staff’s review of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 (the “Form 10-K”) and the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 (the “Form 10-Q”). The following information is provided in response to the Staff’s comments included in the Comment Letter, which comments are reproduced below in italicized type. Please note that the headings and numbering set forth below correspond to the headings and numbering contained in the Comment Letter. Form 10-Q for the Quarterly Period Ended September 30, 2014 Notes to Condensed Consolidated Financial Statements 7. Debt Exchangeable Senior Notes, page 20 1. Tell us if there is a book-tax basis difference for the liability component of your exchangeable senior notes and if you recognized a deferred tax liability related to the difference and why or why not. The Company advises the Staff that it determines deferred taxes separately for each tax-paying component (i.e., an individual entity or group of entities that is consolidated for tax purposes) in each tax jurisdiction in accordance with ASC Topic 740-10-30-5. The $575.0 million principal amount of 1.875% exchangeable senior notes due 2021 (the “2021 Notes”) were issued by a 100% owned non-U.S. finance subsidiary (the “Issuer”) that is a tax resident in Ireland. The proceeds from the 2021 Notes were subsequently loaned to another 100% owned non-U.S. finance subsidiary that is also a tax resident in Ireland. Based on applicable Irish tax law, there is a book-tax basis difference related to the liability component of the 2021 Notes. The Company concluded that the basis difference is not a temporary difference because it is expected to reverse with no associated future tax consequences. Based on the foregoing, the Company has not recognized any associated deferred tax liability in its consolidated financial statements. U.S. Securities and Exchange Commission January 12, 2015 Page 2 2. It appears the exchangeable senior notes issued in August 2014 contain redemption features. Provide us your analysis that supports your conclusion that none of the redemption features are required to be bifurcated in accordance with ASC 815-15. Specifically address whether the debt involves a substantial discount in accordance with ASC 815-15-25-40 through 43. The 2021 Notes issued in August 2014 contain the following redemption features: • The holders of the 2021 Notes have the ability to require the Issuer to repurchase all or a portion of their 2021 Notes for cash in the event the Company undergoes certain fundamental changes, as defined in the indenture governing the 2021 Notes (the “Indenture”), at a repurchase price equal to 100% of the principal amount of the 2021 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. • In certain events of default, the holders of the 2021 Notes have the right to accelerate the payment of the 2021 Notes. Upon acceleration of the 2021 Notes under those circumstances, the Issuer will be required to repay 100% of the principal amount plus accrued and unpaid interest, if any. • Prior to August 15, 2021, the Issuer may redeem the 2021 Notes, in whole but not in part, subject to compliance with certain conditions, if the Issuer has, or on the next interest payment date would, become obligated to pay to the holder of any 2021 Note additional amounts as a result of certain tax-related events. Under those circumstances, the redemption price would be equal to 100% of the principal amount plus accrued and unpaid interest, including additional interest, if any, to, but excluding, the redemption date. • The Issuer also may redeem the 2021 Notes on or after August 20, 2018, in whole or in part, if the last reported sale price per ordinary share of the Company has been at least 130% of the exchange price (as defined in the Indenture) then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Issuer provides notice of redemption. Under those circumstances, the redemption price would be equal to 100% of the principal amount of the 2021 Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. In accordance with ASC 815-15-25-42, the Company evaluated the above redemption features under the four-step sequence as outlined below: Four-Step Test The 2021 Notes 1. Is the amount paid upon settlement (also referred to as the payoff) adjusted based on changes in an index (rather than simply being the repayment of principal at par, together with any unpaid accrued interest)? If yes, continue to Step 2. If no, continue to Step 3. No. The amount paid upon settlement is set at 100% of the principal amount plus accrued and unpaid interest and is not adjusted based on changes in an index. 2. Is the payoff indexed to an underlying other than interest rates or credit risk? If yes, then that embedded feature is not clearly and closely related to the debt host contract and further analysis under Steps 3 and 4 is not required. If no, then that embedded feature shall be analyzed further under Steps 3 and 4 as well as under the provisions of paragraphs 815-15-25-1 and 815-15-25-26. N/A U.S. Securities and Exchange Commission January 12, 2015 Page 3 3. Does the debt involve a substantial premium or discount? If yes, continue to Step 4. If no, in accordance with paragraphs 815-15-25-40 through 25-41, further analysis of the contract under paragraph 815-15-25-26 is required to determine whether the call (put) option is clearly and closely related to the debt host contract if paragraph 815-15-25-26 is applicable. No. The debt was issued at par and is redeemable at par. ASC 815-15-25-26 is not applicable since all of the redemption features are contingently exercisable and do not have a single interest rate underlying. Therefore, no analysis under paragraph 815-15-25-26 is required. 4. Does a contingently exercisable call or put accelerate the repayment of the contractual principal amount? If yes, the call or put is not clearly and closely related to the debt instrument. If not contingently exercisable, in accordance with ASC 815-15-25-40 through 25-41, further analysis of the contract under ASC 815-15-25-26 is required. N/A Based on the foregoing, the Company concluded that all of the redemption features are considered clearly and closely related to the debt host contract and are not required to be bifurcated in accordance with ASC 815-15. Amendment of Credit Facility and Term Loan Refinancing, page 21 3. Please provide us your analysis under ASC 470-50-40 supporting your conclusion that the January 23, 2014 second amendment to the credit agreement was a modification and not an extinguishment. On January 23, 2014, the Company entered into a second amendment to its credit agreement to provide for (i) a tranche of incremental term loans in the aggregate principal amount of $350.0 million, (ii) a tranche of new term loans (the “New Term Loans”) to refinance the $554.4 million aggregate principal amount of term loans previously outstanding under the credit agreement (the “Prior Term Loans”) in their entirety, and (iii) a $425.0 million revolving credit facility that replaced the prior $200.0 million revolving credit facility. The Company used the proceeds from the incremental term loans and $300.0 million of loans under the revolving credit facility, together with cash on hand, to finance the acquisition of control of Gentium S.p.A. The January 23, 2014 second amendment also reduced the interest rate margin on the Prior Term Loans by 25 basis points. The Company advises the Staff that in determining whether the January 23, 2014 second amendment of the credit agreement qualified as a modification of an instrument or a debt extinguishment, the Company looked to the guidance of ASC 470-50 Modifications and Extinguishments, which states that an exchange of debt instruments with substantially different terms is a debt extinguishment. In a case in which the terms of the debt instrument are changed or modified, if the effect on cash flow on a present value basis is less than 10%, the debt instruments are not considered to be substantially different and, therefore, there is no debt extinguishment. The Company performed an analysis to conclude that the present value of the cash flows under the January 23, 2014 second amendment was less than 10% different from the present value of the remaining cash flows under the terms of the original credit agreement. In performing the analysis for the purposes of applying the ASC 470-50 10% cash flow test (the “10% Test”), the Company used the net method, under which: • The cash flows related to the lowest common principal balance between the Prior Term Loans and the New Term Loans, including lender fees, were compared on a lender-by-lender basis. As the Prior Term Loans had previously been modified within one year of the January 23, 2014 second amendment without being deemed to be substantially different, the debt terms that existed prior to the first amendment to the credit agreement were used to determine whether the U.S. Securities and Exchange Commission January 12, 2015 Page 4 debt terms that exist after the January 23, 2014 second amendment were substantially different. The Company’s credit agreement (both original and as amended) contains an option to prepay the term loans. The Company’s analysis was performed assuming both the exercise and non-exercise of the prepayment option. The analysis performed assuming exercise of the prepayment option generated the smaller change in cash flow (which is used in the 10% Test), resulting in a 1.3% change in present value of cash flows. • Any principal in excess of a lender’s lowest common principal balance was treated as a new, separate debt issuance. • Any decrease in principal would have been treated as a partial extinguishment of debt under the net method. However, there were no decreases of principal as a result of the January 23, 2014 second amendment as no lender reduced their principal balance or withdrew from the facility. Based on the foregoing, the Company concluded that the January 23, 2014 second amendment of its credit agreement was a modification and not an extinguishment because the terms of the New Term Loans and the Prior Term Loans are not deemed to be substantially different. 13. Income Taxes, page 29 4. Please provide us your analysis under ASC 740-10-25 supporting your treatment of the $202.0 million in upfront and milestone payments for rights to JZP-110 and to defibrotide in the Americas as i) temporary differences or ii) differences that are not temporary. In response to the Staff’s comment, the Company advises the Staff that the rights to JZP-110 and to defibrotide in the Americas were acquired by subsidiaries incorporated in a non-taxable jurisdiction. Accordingly, the Company has treated the $202.0 million in upfront and milestone payments for rights to JZP-110 and to defibrotide in the Americas as differences that are not temporary because there are no associated tax consequences. * * * * * The Company further acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in the filings; • Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filings; and • the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact me at (650) 496-2654 if you have any questions or would like additional information regarding these matters. Sincerely, /s/ Karen J. Wilson Karen J. Wilson Senior Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Matthew P. Young, Jazz Pharmaceuticals plc Suzanne Sawochka Hooper, Jazz Pharmaceuticals plc Sean O’Keefe, KPMG Chadwick Mills, Cooley LLP
2015-01-06 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm Correspondence January 6, 2015 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporate Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2013 Filed February 25, 2014 Form 10-Q for the Quarterly Period Ended September 30, 2014 Filed November 4, 2014 File No. 001-33500 Dear Mr. Rosenberg: On behalf of Jazz Pharmaceuticals plc (the “Company”), this letter is being transmitted to inform the staff of the Securities and Exchange Commission (the “Staff”) that the Company intends to respond to the Staff’s letter dated December 22, 2014 regarding the Staff’s review of the above-referenced filings no later than January 20, 2015. Please do not hesitate to contact me at (650) 496-2654 if you have any questions or would like additional information regarding this matter. Sincerely, /s/ Karen J. Wilson Karen J. Wilson Senior Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Matthew P. Young, Jazz Pharmaceuticals plc Suzanne Sawochka Hooper, Jazz Pharmaceuticals plc Chadwick Mills, Cooley LLP
2014-12-22 - UPLOAD - Jazz Pharmaceuticals plc
December 22, 2014 Via E -mail Matthew P. Young Chief Financial Officer Jazz Pharmaceuticals PLC Fourth Floor, Connaught House One Burlington Road Dublin 4, Ireland Re: Jazz Pharmaceuticals PLC Form 10 -K for the Fiscal Year Ended December 31, 2013 Filed February 25 , 2014 Form 10 -Q for the Quarterly Period Ended September 30, 2014 Filed November 4, 2014 File No. 001-33500 Dear Mr. Young : We have limited our review to only your fi nancial statements and related disclosures and do not intend to expand our review to other portions of your documents . In our comments, we ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your response s to our comment s. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing s. Form 10 -Q for the Quarterly period Ended September 30, 2014 Notes to Condensed Consolidated Financial Statements 7. Debt Exchangeable Senior Notes , page 20 1. Tell us if there is a book -tax basis difference for the liability component of your exchangeable senior notes and if you recognized a deferred tax liability related to the difference and why or why not. Matthew P. Young Jazz Pharmaceuticals PLC December 22 , 2014 Page 2 2. It appears the exchangeable senior notes issued in August 2014 contain redemption features. Provide us your analysis that supports your conclusion that none of the redempti on features are required to be bifurcated in accordance with ASC 815 -15. Specifically address whether the debt involves a substantial discount in accordance with ASC 815 -15-25-40 through 43. Amendment of Credit Facility and Term Loan Refinancing , page 21 3. Please provide us your analysis under ASC 470 -50-40 supporting your conclusion that the January 23, 2014 second amendment to the credit agreement was a modification and not an extinguishment. 13. Income Taxes, page 29 4. Please provide us your analysis un der ASC 740 -10-25 supporting your treatment of the $202.0 million in upfront and milestone payments for rights to JZP -110 and to defibrotide in the Americas as i) temporary differences or ii) differences that are not temporary. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing s to be certain that the filin gs include the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comment, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing s; staff comment s or changes to disclosure in response to staff comment s do not foreclose the Commission from taking any action with respect to the filing s; and the compa ny may not assert staff commen ts as a defense in any proceeding initia ted by the Commission or any person under the federal securities laws of the United States. You may contact Lisa Vanjoske , Assistant Chief Accountant, at (202) 551 -3614 if you have any questions regarding the comment s. In this regard, do not hesitate to contact me at (202) 551-3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2014-01-14 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP VIA EDGAR 201 Redwood Shores Parkway Redwood Shores, CA 94065-1134 +1 650 802 3000 tel +1 650 802 3100 fax January 14, 2014 James R. Griffin +1 (650) 802-3150 James.griffin@weil.com U.S. Securities and Exchange Commission Division of Corporation Finance Office of Mergers and Acquisitions 100 F Street, N.E. Washington, DC 20549-3628 Attn: Mr. David L. Orlic, Special Counsel Re: Gentium S.p.A. Amendment No. 2 to Schedule TO Filed by Jazz Pharmaceuticals Italy S.r.l. and Jazz Pharmaceuticals Public Limited Company Filed January 7, 2014 File No. 005-81083 Dear Mr. Orlic: This letter is sent on behalf of Jazz Pharmaceuticals Public Limited Company (“Parent”) and Jazz Pharmaceuticals Italy S.r.l. (“Purchaser,” and, collectively with Parent, the “Filing Parties,” “we” or “our”), in response to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) communicated in its letter dated January 9, 2014 (the “Comment Letter”) regarding the above-referenced filing. Please note that the Filing Parties today filed with the Commission Amendment No. 5 to the Tender Offer Statement on Schedule TO (“Amendment No. 5”) reflecting the revisions set forth below. For ease of reference, the headings and numbers of the responses set forth below correspond to the headings and numbers in the Comment Letter, and we have set forth below, in bold, the text of the Staff’s comment prior to each response in the same order as presented in the Comment Letter. Amendment No. 2 to Schedule TO filed on January 7, 2014 Purpose of the Offer; Plans for the Company, page 42 1. Comment: “We note your response to prior comment 4. Disclosure now states that, under Italian law, there is not a “short-form” or “squeeze-out” merger available to cash out minority Mr. David L. Orlic January 14, 2014 Page 2 shareholders. However, disclosure goes on to state that Parent may seek to effect a squeeze-out of minority shareholders pursuant to an exchange of Parent ordinary shares for the Company’s equity interests through a merger or series of mergers of the Company with and into Parent or one or more of its subsidiaries. Please clarify this distinction. Please also disclose whether the permissible type of squeeze-out would be for cash, and whether the price could be more or less than the offer price. Please also disclose how any remaining U.S. shareholders would be treated in any second step transaction and whether they would be treated differently from all other shareholders.” Response: The Staff’s comment is noted. In response to the Staff’s comments, the Filing Parties have provided additional disclosure in Amendment No. 5 clarifying that, under Italian law, “short-form” or “squeeze out” mergers are not available where cash is received by the minority shareholders, but that such mergers are available where equity interests in Parent (or a subsidiary of Parent) are received by the minority shareholders. The Filing Parties have also added additional disclosure in Amendment No. 5 advising shareholders that the price to effect any such post-offer transactions, if any, may be more or less than the Offer Price. Furthermore, the Filing Parties advise the Staff that, under Italian law, it is not permissible to treat shareholders holding the same class of securities differently. Accordingly, U.S. shareholders could not be treated differently from other shareholders in any such transactions, as the Ordinary Shares are the only outstanding class of shares of Gentium. To address the Staff’s comments, the Filing Parties have amended and restated the disclosure in “Section 13. Purpose of the Offer; Plans for the Company” as set forth in Exhibit “A” attached hereto. 2. Comment: “Disclosure states that Parent may seek to acquire any remaining outstanding equity interests by terminating the Depositary Agreement and purchasing the Ordinary Shares underlying the ADSs one year after any such termination pursuant to the terms of such agreement. However, disclosure elsewhere in the document states that, if Parent terminates the Depositary Agreement, ADS holders will receive one Ordinary Share in exchange for each ADS surrendered, and that, at any time after the expiration of one year from the date of termination, the Depositary may sell the Ordinary Shares underlying ADSs that have not been surrendered and hold uninvested the proceeds on behalf of holders. Please clarify this disclosure, and disclose, if true, that termination of the Depositary Agreement will only eliminate minority interests with respect to ADSs that are not surrendered.” Response: The Staff’s comment is noted. In response to the Staff’s comments, the Filing Parties have revised the disclosure to clarify the effect of the termination of the Depositary Agreement on holders of ADSs who exchange such ADSs for Ordinary Shares during the one-year period following termination of the Depositary Agreement, and those shareholders who retain their ADSs and do not exchange the ADSs for Ordinary Shares during such period. To address the Staff’s comment, the Filing Parties have amended and restated the disclosure in “Section 13. Purpose of the Offer; Plans for the Company” as set forth in Exhibit “A” attached hereto. Mr. David L. Orlic January 14, 2014 Page 3 3. Comment: “Disclosure states that the approach used to acquire the equity interests not tendered in the offer will in part be based on the percentage of the Company’s equity interests tendered into the offer. Please provide more details as to how the percentage of equity interests tendered into the offer will affect the determination as to the approach used to acquire the remaining equity interests. Please disclose any percentage thresholds which would determine any particular course of action. Finally, please disclose any other factors that will be weighed in making this determination.” Response: The Staff’s comment is noted. The Filing Parties advise the Staff that, while Parent’s current objective is to acquire all of the Ordinary Shares and ADSs in the Offer or otherwise, any determination by the Filing Parties as to whether or not they will ultimately acquire the equity interests of the Company that are not tendered pursuant to the Offer or in the subsequent offering period, and should they make such a determination, the timing and approach used, will be assessed after completion of the Offer and subsequent offering period. The Filing Parties have not determined any percentage or other thresholds that would result in them deciding to pursue the acquisition of any then-outstanding securities of the Company, the method for acquiring any such outstanding equity interests, or the timing thereof. Rather, the Filing Parties will take into account the percentage of equity interests of the Company outstanding following the completion of the Offer and the subsequent offering period in determining whether or not to seek to acquire such outstanding equity and interests and, if they determine to do so, the approach used to do so. To address the Staff’s comment, the Filing Parties have amended and restated the disclosure in “Section 13. Purpose of the Offer; Plans for the Company” as set forth in Exhibit “A” attached hereto. ---------------------------------------------------------------------------------------------------------------------------------------------------------- If you have any questions or would like further information concerning the Filing Parties’ responses to the Comment Letter, please do not hesitate to contact me at (650) 802-3150. Thank you for your time and consideration. Sincerely, /s/ James R. Griffin James R. Griffin, Esq. cc: Via E-mail Suzanne Sawochka Hooper, Esq. Keith A. Flaum, Esq. Jane Ross, Esq. Mr. David L. Orlic January 14, 2014 Page 4 Exhibit “A” 13. Purpose of the Offer; Plans for the Company. Purpose of the Offer. The purpose of the Offer is for Parent, through Purchaser, to acquire control of, and ultimately the entire equity interest in, the Company. The Offer is intended to facilitate the acquisition of all outstanding Ordinary Shares and ADSs, or, at a minimum, permit Parent to control a majority interest in the Company. The Company Board has approved the Tender Offer Agreement and the transactions contemplated thereby, including the Offer. The Company Board currently consists of seven members. Three of such directors have signed letters of resignation that will be effective as of the Acceptance Time. It is a condition to the Offer that the remaining four directors of the Company appoint three members to the Company Board as directed by Parent to fill the vacancies created by such resignations. Of the four remaining legacy directors of the Company, an additional three have signed letters of resignation effective as of the day after the Acceptance Time. Following the effectiveness of such additional resignations, Parent’s designees will hold three of the four seats of the Company Board and control the operations of the Company. The Company intends to call an ordinary meeting of the shareholders of the Company which, assuming the Offer closes prior to February 7, 2014, will be convened on February 24, 2014 (with a second call of February 25, 2014), and at such meeting Parent will be able to elect all members of the Company Board. Following such time, Parent will exercise effective control of the Company through its election of all of the members of the Company Board. Unless all of the outstanding Ordinary Shares and ADSs are tendered in the Offer or in the subsequent offering period and are purchased by Purchaser in accordance with the terms of the Offer to Purchase, Parent, together with Purchaser, will not acquire all of the equity interests of the Company, but will still control the Company through its election of all of the members of the Company Board. Parent has not determined whether it will seek to purchase any remaining outstanding Ordinary Shares and ADSs not tendered in the Offer or in the subsequent offering period, and Parent is not obligated to do so pursuant to the Tender Offer Agreement or under Italian law. Unless Parent makes the later decision to acquire the remaining equity interests of the Company following the Acceptance Time and the subsequent offering period, and until it actually does so, the minority shareholders of the Company will continue to be entitled to exercise the rights as shareholders provided to them under the Italian Civil Code. These rights include: • the right of a shareholder to challenge Company Board resolutions adopted in violation of applicable law or the bylaws of the Company, if they are detrimental to the shareholder’s rights (Article 2388 of the Italian Civil Code); Mr. David L. Orlic January 14, 2014 Page 5 • the right of a shareholder to file a complaint with the Company’s board of statutory auditors in the event the members of the Company Board breach their fiduciary duties: ¡ in such instance, the board of statutory auditors is required to give notice of such complaint at a meeting of shareholders of the Company; ¡ if the complaint is brought by shareholders representing at least 5% of the corporate capital, the board of statutory auditors is required to investigate the matters brought to its attention and report its findings and any proposed solutions to the shareholders of the Company at the shareholders’ meeting (Article 2408 of the Italian Civil Code); • the right of shareholders representing at least 5% of the voting shares of the Company to challenge a resolution of the shareholders’ meeting (Article 2377, paragraph 3, of the Italian Civil Code); • the right of shareholders representing at least 10% of the corporate capital to file a complaint to report any grounded allegation of serious irregularity in the management of the Company which may jeopardize the Company or any controlled companies (Article 2409 of the Italian Civil Code): ¡ in this case, the court can (i) order an inspection of the management of the Company and (ii) if the irregularities are proved, order interim measures and even remove the directors and statutory auditors from their office; • the right of shareholders representing at least 10% of the corporate capital to request that a shareholders’ meeting be convened by the directors and to establish the meeting agenda (Article 2367, paragraph 1, of the Italian Civil Code); • the right of shareholders representing at least 20% of the corporate capital to initiate a liability action against the directors of the Company (Article 2393-bis of the Italian Civil Code); • the right of shareholders representing at least 20% of the corporate capital to veto any waiver and/or settlement of the Company’s liability action against directors of the Company (Article 2393, paragraph 6, of the Italian Civil Code); and • the right of shareholders attending any shareholders’ meeting who represent at least one-third of the shares represented at the meeting to request that the meeting be postponed for up to 5 days if they are not sufficiently informed about the agenda (Article 2374 of the Italian Civil Code). Moreover, any shareholder of an Italian joint stock company that abstains from voting or votes against the matters contained in Article 2437 of the Italian Civil Code may withdraw from the Company and cause their Ordinary Shares to be purchased pursuant to the procedures set forth in the Italian Civil Code. Mr. David L. Orlic January 14, 2014 Page 6 Parent’s current objective is to acquire all of the Ordinary Shares and ADSs in the Offer or otherwise. However, any determination by Parent to seek to purchase any remaining outstanding Ordinary Shares and ADSs following the completion of the Offer and the subsequent offering period and, should it make such determination, the timing and approach used for any such purchase will be assessed by Parent after the completion of the Offer and the subsequent offering period based in part on the number of ADSs and Ordinary Shares tendered in the Offer and the subsequent offering period. Parent has not determined any percentage or other thresholds that would result in it deciding to pursue the acquisition of any remaining outstanding Ordinary Shares and ADSs, the method for acquiring any such outstanding equity interests, or the timing thereof. If Parent chooses to acquire any remaining outstanding equity interests of the Company following the completion of the Offer and the subsequent offering period, such purchases may be effected at prices higher or lower than the Offer Price. Under Italian law, there is not a “short-form” or “squeeze-out” merger available by which Parent may acquire for cash all of the remaining Ordinary Shares and ADSs held by the minority shareholders of the Company that do not tender into the Offer or the subsequent offering period. However, a “squeeze out” of the Company’s minority shareholders for equity interests in Parent (or a subsidiary of Parent) pursuant to an exchange of Parent ordinary shares (or equity interests of a subsidiary of Parent) for the Company’s equity interests through a merger or series of mergers of the Company with and into Parent or one or more of its subsidiaries is available under Italian law, such that such minority shareholders would then hold an equity interest in Parent (or a subsidiary of Parent). Under Italian law, holders of the same class of securities may not be treated differently in such a transaction. Accordingly, U.S. shareholders may not be treated differently from other shareholders in any such merger or mergers and, as a result, U.S. shareholders that do not tender into the Offer or the subsequent offering period will be entitled to the same merger consideration as other holders of Ordinary Shares in such transaction. Alternatively, as discussed in “Section
2014-01-07 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP Weil, Gotshal & Manges LLP VIA EDGAR 201 Redwood Shores Parkway Redwood Shores, CA 94065-1134 +1 650 802 3000 tel +1 650 802 3100 fax January 7, 2014 James R. Griffin +1 (650) 802-3150 James.griffin@weil.com U.S. Securities and Exchange Commission Division of Corporation Finance Office of Mergers and Acquisitions 100 F Street, N.E. Washington, DC 20549-3628 Attn: Mr. David L. Orlic, Special Counsel Re: Gentium S.p.A. Tender Offer Statement on Schedule TO Filed by Jazz Pharmaceuticals Italy S.r.l. and Jazz Pharmaceuticals Public Limited Company Filed December 23, 2013 File No. 005-81083 Dear Mr. Orlic: This letter is sent on behalf of Jazz Pharmaceuticals Public Limited Company (“Parent”) and Jazz Pharmaceuticals Italy S.r.l. (“Purchaser,” and, collectively with Parent, the “Filing Parties,” “we” or “our”), in response to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) communicated in its letter dated December 31, 2013 (the “Comment Letter”) regarding the above-referenced filing. Please note that the Filing Parties today filed with the Commission Amendment No. 2 to the Tender Offer Statement on Schedule TO (“Amendment No. 2”) reflecting, among other things, the revisions set forth below. For ease of reference, the headings and numbers of the responses set forth below correspond to the headings and numbers in the Comment Letter, and we have set forth below, in bold, the text of the Staff’s comment prior to each response in the same order as presented in the Comment Letter. Tender Offer Statement on Schedule TO filed on December 23, 2013 Until what time may I withdraw previously tendered Ordinary Shares or ADSs?, page S-vi Mr. David L. Orlic January 7, 2014 Page 2 Weil, Gotshal & Manges LLP 1. Comment: Please advise how you determined that March 24, 2014 is the proper date after which holders may withdraw tendered securities, if not yet accepted for payment. Refer to Section 14(d)(5) of the Securities Exchange Act of 1934. Response: The Staff’s comment is noted. In response to the Staff’s comment, the Filing Parties have revised the disclosure in the “Summary Term Sheet” and “Section 4. Withdrawal Rights” to reflect that holders may withdraw tendered securities after February 21, 2014, the date that is 60 days after the date of the original tender offer. Certain Information Concerning the Company, page 15 2. Comment: We note the disclaimer of responsibility for the accuracy or completeness of certain disclosure in the offering document. Disclaiming responsibility for disclosure in the offering document is inappropriate. Please revise. Response: The Staff’s comment is noted. The referenced language has been deleted from the first paragraph of “Certain Information Concerning the Company.” Tender Offer Agreement, page 23 3. Comment: The second paragraph in this section contains numerous statements which can be read to imply that the tender offer agreement does not constitute public disclosure under the federal securities laws. Please revise to remove any such potential implication. Response: The Staff’s comment is noted. The second paragraph in “Section 12. The Tender Offer Agreement; Other Agreements” has been amended and restated as follows to reflect the Staff’s comment: “The description of the Tender Offer Agreement in this Offer to Purchase has been included to provide you with information regarding its terms. The Tender Offer Agreement contains representations and warranties made by and to the parties thereto as of specific dates. The statements embodied in those representations and warranties were made for purposes of that contract between Parent, Purchaser and the Company and are subject to qualifications and limitations agreed by the parties in connection with negotiating the terms of that contract. In addition, certain representations and warranties were made as of a specified date, may be subject to a contractual standard of materiality different from those generally applicable to shareholders, or may have been used for the purpose of allocating risk between the respective parties rather than establishing matters as facts.” Purpose of the Offer; Plans for the Company, page 42 Mr. David L. Orlic January 7, 2014 Page 3 Weil, Gotshal & Manges LLP 4. Comment: Please disclose how the Parent, through Purchaser, intends to ultimately acquire the entire equity interest in Gentium. Please disclose the impact of being a majority security holder of this company from a corporate governance perspective. Please contrast this with the impact of acquiring the entire equity interest in Gentium. Response: The Staff’s comment is noted. In response to the first sentence of the Staff’s comment, the Filing Parties have added the following disclosure as the second paragraph of “Section 13. Purpose of the Offer; Plans for the Company” and of “Section 16. Appraisal Rights” disclosing the means by which Parent, through the Purchaser, may ultimately acquire the entire equity interest in Gentium. The Filing Parties advise the Staff that Parent has not made a determination at this time of how it intends to acquire any equity interests not tendered into the Offer and will not be able to do so until after the expiration of the Offer. “Under Italian law, there is not a “short-form” or “squeeze-out” merger available to cash out minority shareholders of the Company if Parent, through Purchaser, acquires less than all of the outstanding equity interests of the Company. However, Parent may seek to effect a “squeeze out” of the Company’s minority shareholders pursuant to an exchange of Parent ordinary shares for the Company’s equity interests through a merger or series of mergers of the Company with and into Parent or one or more of its subsidiaries. Alternatively, as discussed in “Section 7. Possible Effects of the Offer on the Market for Ordinary Shares and ADSs; Nasdaq Listing,” Parent may also seek to acquire any remaining outstanding equity interests of the Company through private transactions or by terminating the Depositary Agreement and purchasing the Ordinary Shares underlying the ADSs one year after any such termination pursuant to the terms of such agreement. The ultimate decision of how Parent and Purchaser will seek to acquire the equity interests not tendered in the Offer, if any, will be made following the Acceptance Time and the approach used will in part be based on the percentage of the Company’s equity interests tendered into the Offer.” In response to the second and third sentence of the Staff’s comment, the Filing Parties have added the following disclosure as the third and fourth paragraphs of “Section 13. Purpose of the Offer; Plans for the Company” to reflect intended corporate governance revisions to Gentium’s board structure pending the acquisition of all of the outstanding equity interests of Gentium and disclosing the material rights available to minority shareholders under Italian law. “The Company Board currently consists of seven members. Three of such directors have signed letters of resignation that will be effective as of the Acceptance Time. It is a condition to the Offer that the remaining four directors of the Company appoint three members to the Company Board as directed by Parent to fill the vacancies created by such resignations. Of the four remaining legacy directors of the Company, an additional three have signed letters of resignation effective as of the day after the Acceptance Time. Following the effectiveness of such additional resignations, Parent’s designees will hold three of the four seats of the Company Board and control the operations of the Company. The Company intends to call an ordinary meeting of the shareholders of the Company Mr. David L. Orlic January 7, 2014 Page 4 Weil, Gotshal & Manges LLP which, assuming the Offer closes prior to February 7, 2014, will be convened on February 24, 2014 (with a second call of February 25, 2014), and at such meeting Parent will be able to elect all members of the Company Board. Following such time, Parent will exercise effective control of the Company through its election of all of the members of the Company Board.” “Until such time that Parent is able to acquire all of the equity interests of the Company, the minority shareholders of the Company will continue to be entitled to exercise the rights as shareholders provided to them under the Italian Civil Code. These rights include: • the right of a shareholder to challenge Company Board resolutions adopted in violation of applicable law or the bylaws of the Company, if they are detrimental to the shareholder’s rights (Article 2388 of the Italian Civil Code); • the right of a shareholder to file a complaint with the Company’s board of statutory auditors in the event the members of the Company Board breach their fiduciary duties: • in such instance, the board of statutory auditors is required to give notice of such complaint at a meeting of shareholders of the Company; • if the complaint is brought by shareholders representing at least 5% of the corporate capital, the board of statutory auditors is required to investigate the matters brought to its attention and report its findings and any proposed solutions to the shareholders of the Company at the shareholders’ meeting (Article 2408 of the Italian Civil Code); • the right of shareholders representing at least 5% of the voting shares of the Company to challenge a resolution of the shareholders’ meeting (Article 2377, paragraph 3, of the Italian Civil Code); • the right of shareholders representing at least 10% of the corporate capital to file a complaint to report any grounded allegation of serious irregularity in the management of the Company which may jeopardize the Company or any controlled companies (Article 2409 of the Italian Civil Code): • in this case, the court can (i) order an inspection of the management of the Company and (ii) if the irregularities are proved, order interim measures and even remove the directors and statutory auditors from their office; • the right of shareholders representing at least 10% of the corporate capital to request that a shareholders’ meeting be convened by the directors and to establish the meeting agenda (Article 2367, paragraph 1, of the Italian Civil Code); Mr. David L. Orlic January 7, 2014 Page 5 Weil, Gotshal & Manges LLP • the right of shareholders representing at least 20% of the corporate capital to initiate a liability action against the directors of the Company (Article 2393-bis of the Italian Civil Code); • the right of shareholders representing at least 20% of the corporate capital to veto any waiver and/or settlement of the Company’s liability action against directors of the Company (Article 2393, paragraph 6, of the Italian Civil Code); and • the right of shareholders attending any shareholders’ meeting who represent at least one-third of the shares represented at the meeting to request that the meeting be postponed for up to 5 days if they are not sufficiently informed about the agenda (Article 2374 of the Italian Civil Code). Moreover, any shareholder of an Italian joint stock company that abstains from voting or votes against the matters contained in Article 2437 of the Italian Civil Code may withdraw from the Company and cause their Ordinary Shares to be purchased pursuant to the procedures set forth in the Italian Civil Code.” Certain Conditions of the Offer, page 43 5. Comment: All offer conditions, except those related to the receipt of government regulatory approvals necessary to consummate the offer, must be satisfied or waived at or before the expiration of the offer, not merely before acceptance of securities for payment. Please revise the language stating that conditions apply at or before the “Offer Closing.” Response: The Staff’s comment is noted. Parent (on behalf of itself and Purchaser) and Gentium have modified the Offer to Purchase to provide that for purposes of determining whether the conditions to the Offer (including the Minimum Condition) have been satisfied or whether there is a Permitted Minimum Condition Modification, references to “Acceptance Time” will instead reflect references to the “expiration of the Offer.” Accordingly, the first paragraph in “Section 14. Certain Conditions of the Offer” has been amended and restated as follows to reflect the Staff’s comment: “For the purposes of this Section 14, capitalized terms used but not defined herein will have the meanings set forth in the Tender Offer Agreement. Notwithstanding any other provisions of the Offer, in addition to (and not in limitation of) the rights and obligations of Purchaser to extend and/or amend the Offer at any time in its sole discretion (subject to the terms and conditions of the Tender Offer Agreement), Purchaser (i) will not be required to accept for payment or, subject to any applicable rules and regulations of the SEC (including Rule 14e-1(c) under the Exchange Act (relating to the obligation of Purchaser to pay for or return tendered Ordinary Shares and ADSs Mr. David L. Orlic January 7, 2014 Page 6 Weil, Gotshal & Manges LLP promptly after termination or withdrawal of the Offer)), pay for, and (ii) may delay the acceptance for payment of or, subject to the restriction referred to above, the payment for, any tendered Ordinary Shares and ADSs, in the event that at or prior to the scheduled expiration of the Offer (as it may be extended pursuant to terms of the Tender Offer Agreement):” 6. Comment: The Minimum Condition and Permitted Minimum Condition Modification cannot permissibly be determined with reference to the “Acceptance Time.” As noted above, all offer conditions, except those related to the receipt of government regulatory approvals necessary to consummate the offer, must be satisfied or waived at or before the expiration of the offer, not merely before acceptance of securities for payment. Please revise these provisions accordingly. Response: The Staff’s comment is noted. Parent (on behalf of itself and Purchaser) and Gentium have modified the Offer to Purchase to provide that for purposes of determining whether the conditions to the Offer (including the Minimum Condition) have been satisfied or whether there is a Permitted Minimum Condition Modification, references to “Acceptance Time” will instead be deemed to be references to the “expiration of the Offer.” The Offer to Purchase has accordingly been revised throughout to reflect the foregoing. Appraisal Rights, page 46 7. Comment: Please clarify the disclosure to explain the source of the uncertainty regarding withdrawal rights. Furthermore, please disclose whether there are means under applicable law to squeeze out minority shareholders in the event that you obtain more than the minimum number of Gentium shares, but less than 100 percent. Response: The Staff’s comment is noted. To address the Staff’s comment, the first two paragraphs of “Section 16. Appraisal Rights” have been amended and restated as follows: “Under Italian law, the holders of Ordinary Shares and ADSs who do not tender their Ordinary Shares or ADSs in the Offer will not have dissenters’ rights or appraisal rights in connection with the Offer. It is also doubtful whether under Italian law, upon delisting, holders of Ordinary Shares and ADSs may be entitled to exercise withdrawal rights with respect to such securities. Under Article 2437-Quinquies of the Italian Civil Code, shareholders who do not approve the resolution that leads to the delisting of the shares of an Italian “societa’ per azioni” (joint stock company) from a “regulated market” are entitled to withdraw from the company. The statute specifically refers to the listing of “shares” and does not mention the listing of ADSs or other types of securities, and refers
2013-12-09 - UPLOAD - Jazz Pharmaceuticals plc
December 9, 2013 Via E -mail Ms. Kathryn E. Falberg Executive Vice President and Chief Financial Officer Jazz Pharmaceuticals plc Fourth Floor Connaught House One Burlington Road Dublin 4 Ireland Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2012 Filed February 26, 2013 File No. 001 -33500 Dear Ms. Falberg : We have completed our review of your filing. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person u nder the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require . Sincerely, /s/ Andrew Mew Andrew Mew Accounting Branch Chief
2013-11-15 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP November 15, 2013 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporate Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2012 Filed February 26, 2013 Form 10-Q for the Quarterly Period Ended June 30, 2013 Filed August 6, 2013 Form 8-K dated August 6, 2013 Filed August 6, 2013 File No. 001-33500 Dear Mr. Rosenberg: Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated October 22, 2013 (the “Comment Letter”), regarding the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012 (the “2012 Form 10-K”), the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 (the “Q2 Form 10-Q”) and the Company’s Form 8-K dated August 6, 2013 (the “Form 8-K”). The following information is provided in response to the Staff’s comments included in the Comment Letter, which comments are reproduced below in italicized type. Please note that the headings and numbering set forth below correspond to the headings and numbering contained in the Comment Letter. Form 10-K for the Fiscal Year Ended December 31, 2012 Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Estimates Revenue Recognition, page 26 1. Please provide us proposed disclosure to be included in future periodic reports that explains the relative changes period over period of each of the items deducted from gross sales that you identify. In your disclosure please explain the underlying cause(s) as to why: • rebates increased from 6.0% of gross revenues in 2010 to 7.5% in 2011 and 8.0% in 2012 (clarifying the extent of the impact of the Affordable Care Act Medicaid rebate); • sales returns decreased from 2.1% of gross sales in 2010 to 0.8% in 2011 and then increased to 1.5% in 2012; and Fourth Floor, Connaught House, One Burlington Road, Dublin 4, Ireland p 353.1.634.7800 f 353.1.634.7850 Jazz Pharmaceuticals plc. Registered in Ireland (company number 399192). Registered Office: Fourth Floor, Connaught House, One Burlington Road, Dublin 4, Ireland. Directors: Bruce C. Cozadd - Chairman (USA), Paul L. Berns (USA), Patrick G. Enright (USA), Peter Gray, Heather Ann McSharry, James C. Momtazee (USA), Seamus Mulligan, Kenneth W. O’Keefe (USA), Norbet G. Riedel, Ph.D (USA), Catherine A. Sohn (USA), Rick E Winningham (USA) U.S. Securities and Exchange Commission November 15, 2013 Page 2 • chargebacks were near zero in 2010 and 2011 and in 2012 were 2.0% of gross revenues, and the expected effects of the cause(s) on future financial position and results of operations, as applicable. In response to the Staff’s comment, the Company proposes to enhance its critical accounting policies and significant estimates disclosure included in the Management’s Discussion and Analysis portion of its Annual Reports on Form 10-K, commencing with the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2013, to explain the period over period changes in each of the items deducted from gross product sales and to specifically address the underlying causes for such changes as well as the expected effects of those causes on the Company’s future financial position and results of operations, in each case as applicable. The revised disclosure will be made in substantially the form presented on Exhibit A hereto. In this regard, the Company will also prospectively include in its roll forward and accompanying discussion all of the items deducted from gross product sales, not just the most significant items deducted from gross product sales where the Company exercises judgment. The proposed disclosure included on Exhibit A hereto is based on the critical accounting policies and significant estimates disclosure included in the 2012 Form 10-K and therefore addresses gross product sales deductions for the years ended December 31, 2012, 2011 and 2010. Form 10-Q for the Quarterly Period Ended June 30, 2013 Management’s Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources, page 29 2. It is apparent from the accounts receivable balances presented on your balance sheets that your day’s sales outstanding, calculated based on the most recent quarter’s sales, increased from 37.0 days at both December 31, 2012 and 2011 to 49.2 days at June 30, 2013. Please provide us proposed disclosure to be included in future periodic reports that explains the underlying cause(s) for this increase and the expected effects of the cause(s) on future financial position and results of operations including any potential collectability or liquidity issues, as applicable. The Company acknowledges the Staff’s comment and respectfully advises the Staff that the days’ sales outstanding increased from 37.0 days at both December 31, 2012 and 2011 to 49.2 days at June 30, 2013 primarily due to a pre-negotiated change in payment terms with one large customer in connection with the elimination of a prompt payment discount, as disclosed on page 31 of the Q2 Form 10-Q. In response to the Staff’s comment, the Company has expanded its disclosure on page 32 of its Quarterly Report on Form 10-Q for the period ended September 30, 2013, filed with the Commission on November 5, 2013 (the “Q3 Form 10-Q”), as reproduced below. The sentences that address the Staff’s request for disclosure with respect to the expected effects of the change in payment terms is underlined in the disclosure: U.S. Securities and Exchange Commission November 15, 2013 Page 3 “Net cash provided by operating activities of $204.4 million for the nine months ended September 30, 2013 related to net income of $161.0 million, adjusted for non-cash items of $100.7 million primarily related to intangible asset amortization, share-based compensation expense and the change in fair value of contingent consideration. This was partially offset by $57.3 million of net cash outflow related to changes in operating assets and liabilities which included an increase in accounts receivable of $37.6 million primarily related to a pre-negotiated change in payment terms under a long-term contract with one large customer in connection with the elimination of a prompt pay discount as well as the impact of income tax payments. The revised payment terms will continue to result in higher accounts receivable balances in future periods that will reduce net cash from operating activities in those periods. However, we do not anticipate that the change in payment terms will result in potential collectability difficulties nor do we expect that the change will materially impact our liquidity. Net cash provided by operating activities of $145.4 million for the nine months ended September 30, 2012 related to net income of $88.0 million, adjusted for non-cash items of $77.5 million primarily related to intangible asset amortization, acquisition accounting inventory fair value step-up adjustments and share-based compensation expense. This was partially offset by $20.1 million of net cash outflow related to changes in operating assets and liabilities.” The Company undertakes to continue to provide the expanded disclosure in future periodic reports, as applicable, in substantially the form included in the Q3 Form 10-Q as reproduced above. The Company also respectfully advises the Staff that, to the extent new or additional underlying reasons for changes in accounts receivable are material and determinable, the Company will provide disclosure similar in scope to the above in future periodic reports that elaborates on such reasons and the expected effects on the Company’s future financial position and results of operations. Form 8-K Filed August 6, 2013 Exhibit 99.1, Furnished 3. In the tables on the second and third to last pages of your earnings press release you present “reconciliation(s) of GAAP to non-GAAP adjusted information: certain line items and other information” that appear to be essentially non-GAAP statements of income. Please represent to us that you will remove this presentation from future earnings press releases or provide us proposed revised disclosure indicating why you believe that the presentation of each individual line-item is useful to investors as required by Item 10(e)(1)(i)(C) of Regulation S-K. Please see Instruction 2 to Item 2.02 of Form 8-K that indicates that the requirements of Item 10(e)(1)(i) of Regulation S-X apply to information furnished under Item 2.02 of Form 8-K and Question 102.10 of the Compliance & Disclosure Interpretations on Non-GAAP Financial Measures. In response to the Staff’s comment, the Company respectfully advises the Staff that, in designing the reconciliation tables that are the subject of the Staff’s comment (the “Reconciliation Tables”), the Company considered the Staff’s guidance in Question 102.10 of the Compliance & Disclosure Interpretations on Non-GAAP Financial Measures, and further acknowledges the Staff’s view that a full non-GAAP income statement is generally inappropriate given the undue prominence that may attach to the non-GAAP financial information. Accordingly, the Company designed the Reconciliation Tables with a view toward presenting selected non-GAAP financial measures in a format that does not represent a full income statement. Specifically, to make clear that the Company is not purporting to present a full non-GAAP income statement, the Company (i) removed the following captions, subtotals and line items from the tabular reconciliation of GAAP to non-GAAP adjusted information: “product sales, net,” “royalties and contract revenues,” “total operating expenses,” “net income,” all discontinued operations line items and U.S. Securities and Exchange Commission November 15, 2013 Page 4 both weighted-average ordinary shares line items; (ii) removed all underscores and double underscores from any and all amounts presented; and (iii) titled the Reconciliation Tables “Reconciliation of GAAP to Non-GAAP Adjusted Information—Certain Line Items and Other Information.” The Company also respectfully advises the Staff that it customarily presents guidance and historical results on a non-GAAP adjusted basis; specifically, adjusted net income and its components and related measures (including non-GAAP adjusted effective tax rate). As a result, the Company is required to provide reconciling information for each of these measures. As opposed to providing multiple, independent reconciliations for historical non-GAAP adjusted net income and its components (and related measures), the Company believes that the presentation of the required reconciling information in the form of the Reconciliation Tables strikes the appropriate balance between the concern underlying the Staff’s guidance in Question 102.10 of the Compliance & Disclosure Interpretations on Non-GAAP Financial Measures and the informational needs of the investor community. In fact, the Company began to provide historical reconciling information as presented in the Reconciliation Tables in response to requests from investors and analysts to allow them to more accurately model and track the Company’s financial performance. In response to such requests and in view of facilitating an accurate understanding of both the Company’s use of non-GAAP adjusted net income and its components and its financial performance as a whole, the Company believes that the Reconciliation Tables as they have been presented enhance the ability of investors to compare its results from period to period and allow for greater transparency with respect to key financial metrics the Company uses in making operating decisions. At the same time, the Company believes that the Reconciliation Tables as they have been presented avoid investor confusion between the Company’s GAAP financial information and its non-GAAP financial information and do not attach undue prominence to the non-GAAP financial measures. With the above said, in response to the Staff’s comment, to further distinguish the Reconciliation Tables from full income statement presentation and to more clearly differentiate the GAAP and non-GAAP financial measures, the Company has made certain modifications to the Reconciliation Tables and associated disclosures, as included in the Company’s third quarter 2013 earnings press release dated November 5, 2013 and furnished under Item 2.02 of the Company’s Form 8-K filed with the Commission on the same date (the “Q3 Earnings Release”). The presentation changes and enhanced disclosures are described below: • The Company has modified the titles of the Reconciliation Tables as follows: FROM: “Reconciliation of GAAP to Non-GAAP Adjusted Information—Certain Line Items and Other Information” TO: “Reconciliation of GAAP Reported to Non-GAAP Adjusted Information—Certain Line Items and Other Information” • The Company has changed the descriptive terminology in the Reconciliation Tables for GAAP and non-GAAP financial information as follows: FROM: “GAAP” and “Non-GAAP” TO: “GAAP Reported” and “Non-GAAP Adjusted” • The Company has increased the prominence of the GAAP information in the Reconciliation Tables by presenting the GAAP information in boldface type. U.S. Securities and Exchange Commission November 15, 2013 Page 5 • The Company has enhanced its non-GAAP financial measure disclosure, as included in the Q3 Earnings Release, to further emphasize the limitations of non-GAAP financial measures. The changes to such disclosure from that included in the Company’s second quarter 2013 earnings press release is underlined in the text reproduced below from the Q3 Earnings Release: “Non-GAAP Financial Measures To supplement Jazz Pharmaceuticals’ financial results and guidance presented in accordance with U.S. generally accepted accounting principles (“GAAP”), the company uses certain non-GAAP (also referred to as “adjusted” or “non-GAAP adjusted”) financial measures in this press release and the accompanying tables. The company believes that each of these non-GAAP financial measures is helpful in understanding its past financial performance and potential future results, particularly in light of the effect of various acquisition and divestiture transactions effected by the company during 2012. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures, and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Jazz Pharmaceuticals’ management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. Compensation of executives is based in part on the performance of the company’s business based on certain of these non-GAAP financial measures. In addition, Jazz Pharmaceuticals believes that the presentation of these non-GAAP financial measures is useful to investors because it enhances the ability of investors to compare its results from period to period and allows for greater transparency with respect to key financial metrics the company uses in making operating decisions, and also because the company’s investors and analysts regularly use them to model and track the company’s financial performance. Investors should note that these non-GAAP financial measures are not prepared under any comprehensive set of accounting rules or principles and do not reflect all of the amounts associated with the company’s results of operations as determined in accordance with GAAP. Investors should also note that these non-GAAP financial measures hav
2013-11-01 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm Correspondence November 1, 2013 VIA EDGAR United States Securities and Exchange Commission Washington, D.C. 20549 Attention: Jim B. Rosenberg, Senior Assistant Chief Accountant Division of Corporate Finance Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2012 Filed February 26, 2013 Form 10-Q for the Quarterly Period Ended June 30, 2013 Filed August 6, 2013 Form 8-K dated August 6, 2013 Filed August 6, 2013 File No. 001-33500 Dear Mr. Rosenberg: On behalf of Jazz Pharmaceuticals plc (the “Company”), this letter is being transmitted to inform the staff of the Securities and Exchange Commission (the “Staff”) that the Company intends to respond to the Staff’s letter dated October 22, 2013 with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 and the Company’s Form 8-K dated August 6, 2013, no later than November 15, 2013. Please do not hesitate to contact the undersigned at (650) 496-2654 if you have any questions or would like additional information regarding this matter. Sincerely, /s/ Karen J. Wilson Karen J. Wilson Senior Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Suzanne Sawochka Hooper, Jazz Pharmaceuticals plc Valerie Pierce, Jazz Pharmaceuticals plc Chadwick Mills, Cooley LLP
2013-10-22 - UPLOAD - Jazz Pharmaceuticals plc
October 22, 201 3 Via E-mail Ms. Kathryn E. Falberg Executive Vice President and C hief Financial Officer Jazz Pharmaceuticals plc Fourth Floor Connaught House One Burlington Road Dublin 4 Ireland Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2012 Filed February 26 , 2013 Form 10 -Q for the Quarterly Period Ended June 30, 201 3 Filed August 6, 201 3 Form 8 -K dated August 6, 2013 Filed August 6, 2013 File No. 001-33500 Dear M s. Falberg : We have limited our review of your filing s to your financial statements and related disclosures and do not intend to expand our review to other portions of your document s and have the following comment s. In our comment s, we ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within 10 business days by providing us the requested information or by advising us when you will provide the requested response . If you do not believe a comment appl ies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that key s your response s to our comment s. After reviewing the information provide d, we may raise additional comments and/or request that you amend your filing s. Ms. Kathryn E. Falberg Jazz Pharmaceuticals plc October 22, 201 3 Page 2 Form 10 -K for the fiscal year ended December 31, 2012 Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Estimates Revenue Recognition, page 26 1. Please provide us proposed disclosure to be included in future periodic reports that explains the relative changes period over period of each of the items deducted from gro ss sales that you identify. In your disclosure please explain the underlying cause(s) as to why: rebates increased from 6.0% of gross revenues in 2010 to 7.5% in 2011 and 8.0% in 2012 (clarifying the extent of the impact of the Affordable Care Act Medicaid rebate); sales returns decre ased from 2.1% of gross sales in 2010 to 0.8% in 2011 and then increased to 1.5% in 2012; and chargebacks were near zero in 2010 and 2011 and in 2012 were 2.0% of gross revenues , and the expected e ffects of the cause (s) on fu ture fi nancial position a nd res ults of operation s, as appl icable . Form 10 -Q for the quarterly period ended June 30, 2013 Management’s Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources, page 29 2. It is apparent from the accounts receivable balances presented on your balance sheets that your day’s sales outstanding, calculated based on the most recent quarter’s sales, increased from 37.0 days at both December 31, 2012 and 2011 to 49.2 days at June 30, 2013. Please provide us proposed disclosure to be included in future periodic reports that explains the underlying cause(s) for this increase and the expected e ffects of the cause (s) on fu ture fi nancial position a nd res ults of operation s including any poten tial collectability or liquidity issues , as applicable . Form 8 -K filed August 6, 2013 Exhibit 99.1 , Furnished 3. In the tables on the second and third to last pages of your earnings press release you present “reconciliation(s) of GAAP to non -GAAP adjusted information: certain li ne items and other information” that appear to be essentially non -GAAP statements of income. Please represent to us that you will remove this presentation from future earnings press releases or provide us proposed revised disclosure indicating why you bel ieve that the presentation of each individual line -item is useful to investors as required by Item 10(e)(1)(i)(C) of Regulation S -K. Please see Instruction 2 to Item 2.02 of Form 8 -K that indicates that the requirements of Item 10(e)(1)(i) of Regulation S -X apply to information Ms. Kathryn E. Falberg Jazz Pharmaceuticals plc October 22, 201 3 Page 3 furnished under Item 2.02 of Form 8 -K and Question 102.10 of the Compliance & Disclosure Interpretations on Non -GAAP Financial Measures. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing s to be certain that the filing s include the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the di sclosure in the filing s; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing s; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. You may contact Mark Brunhofer , Senior Staff Accountant , at (202) 551 -3638 or Andrew Mew , Accounting Branch Chief , at (202) 551 -3377 if you have questions regarding the comments . In this regard, do not hesitate to contact me at (202) 551 -3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2013-03-08 - UPLOAD - Jazz Pharmaceuticals plc
March 8 , 2013 Via E -mail Ms. Karen J. Wilson Vice President of Finance Jazz Pharmaceuticals plc 45 Fitzwilliam Square Dublin 2, Ireland Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2011 Filed February 2 8, 2012 File No. 001-33500 Dear Ms. Wilson : We have completed our review of your filings. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing s and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of th e United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing s to be certain that the filing s include the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely , /s/ Gus Rodriguez Gus Rodriguez Accounting Branch Chief
2013-02-20 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm CORRESP February 20, 2013 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporate Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2011 Filed February 28, 2012 File No. 001-33500 Dear Mr. Rosenberg: Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated February 13, 2013 (the “Comment Letter”), regarding the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 (the “Form 10-K”). We note that the Comment Letter was received in response to the Company’s previous letter that was submitted to the Staff on January 22, 2013 in response to the Staff’s comment letter dated December 21, 2012 (the “Prior Response Letter”). The following information is provided in response to the Staff’s comments included in the Comment Letter, which comments are reproduced below in italicized type. Please note that the headings and numbering set forth below correspond to the headings and numbering contained in the Comment Letter. Form 10-K for the Fiscal Year Ended December 31, 2011 Management’s Discussion and Analysis of Financial Condition and Results of Operations Business and Financial Overview, page 27 1. We acknowledge your response and proposed disclosure to our comment 10. We note that your research and development expense for the years ended 2011, 2010 and 2009 was 9.7%, 22%, and 32%, respectively, of total operating expenses. You also disclose that you expect future research and development expenses to increase. We believe your proposed disclosure lacks context without the amounts incurred for the periods presented. In this regard, in order to provide more insight into how you manage your R&D function, please revise your proposed disclosure to disclose the composition of the total R&D expense shown in the financial statements for each period presented. This can take a variety of forms but is mainly driven by how many projects are managed and how they are reported within the organization and may take the form, for example, of separate disclosure for each of your current three pathways (i.e. developing line extensions, generating additional clinical data for existing products and developing new product candidates). The Company acknowledges the Staff’s comment and respectfully advises the Staff that, as stated in the Prior Response Letter, the Company does not track total research and development costs separately for each of its development projects, nor does the Company track total research and development costs separately for each of its current three main categories of development projects. The Company further advises the Staff that while it tracks certain direct third-party costs on a project-by-project basis as way of monitoring external costs, such expenses represent only a portion of the total costs related to each project. Further, the Company does not accumulate internal research and development expenses, such as personnel costs and facility costs, on a specific project-by-project basis (or development category basis). The Company believes that disclosure of only the direct third-party costs that it tracks by each development program or category would not be meaningful to an investor’s investment decision with respect to the Company’s securities and could potentially be misleading. In this regard, the Company manages its research and development expenses based on its assessment of what development activities are important to the Company and have a reasonable probability of success, and by dynamically allocating and re-allocating resources accordingly. Fourth Floor, Connaught House, One Burlington Road, Dublin 4, Ireland p 353.1.634.7800 f 353.1.634.7850 Jazz Pharmaceuticals plc. Registered in Ireland (company number 399192). Registered Office: Fourth Floor, Connaught House, One Burlington Road, Dublin 4, Ireland. Directors: Bruce C. Cozadd - Chairman (USA), Paul L. Berns (USA), Patrick G. Enright (USA), James C. Momtazee (USA), Seamus Mulligan, Kenneth W. O’Keefe (USA), Catherine A. Sohn (USA), Rick E Winningham (USA) U.S. Securities and Exchange Commission February 20, 2013 Page 2 However, the Company does track its research and development expenses based on three main categories of expense: personnel costs; costs related to clinical study and other third-party outside services; and other costs. “Personnel” costs relate primarily to salaries, benefits and share-based compensation. “Clinical study and outside services” costs relate primarily to clinical studies performed by clinical research organizations, materials and supplies, and other third-party fees. “Other” costs primarily include overhead allocations consisting of various support and facilities-related costs. In response to the Staff’s comment, the Company proposes to include revised disclosure under the subheading “—Research and Development Expenses” in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s future periodic reports (commencing with the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012 (the “2012 Form 10-K”)) describing in further detail the nature of the Company’s research and development expenses and providing a breakout of its research and development expenses by major categories of expense as described above. As set forth in the Prior Response Letter, the Company respectfully advises the Staff that if and when the Company engages in one or more major research and development projects (or groups of related projects), the Company may begin to track all or a significant portion of its research and development expenses related to such projects (or group of related projects), in which case, the Company intends to provide enhanced disclosure regarding the determinable components of its research and development expenses allocable to such projects. The proposed disclosure, which would replace the proposed disclosure on page 8 of the Prior Response Letter, would be in substantially the following form: “Research and Development Expenses Research and development expenses consist primarily of personnel expenses, costs related to clinical studies and outside services, and other research and development costs. Personnel expenses relate primarily to salaries, benefits and share-based compensation. Clinical studies and outside services costs relate primarily to clinical studies performed by clinical research organizations, materials and supplies, and other third-party fees. Other research and development expenses primarily include overhead allocations consisting of various support and facilities-related costs. We do not track fully-burdened research and development expenses on a project-by-project basis. We manage our research and development expenses by identifying the research and development activities that we anticipate will be performed during a given period and then prioritizing efforts based on our assessment of what development activities are important to our business and have a reasonable probability of success, and by dynamically allocating resources accordingly. We also continually review our development pipeline projects and the status of their development and, as necessary, reallocate resources among our development pipeline projects that we believe will best support the future growth of our business. U.S. Securities and Exchange Commission February 20, 2013 Page 3 The following table provides a breakout of our research and development expenses by major categories of expense (in thousands): Year Ended December 31, 2012 2011 2010 Personnel expenses $ 10,432 $ 10,581 $ 11,422 Clinical studies and outside services 8,566 2,145 12,320 Other 1,479 1,394 1,870 Total $ 20,477 $ 14,120 $ 25,612 Research and development expenses increased by $6.4 million in 2012 compared to 2011 primarily due to increased clinical studies and outside services costs related to the generation of additional clinical data and the development of line extensions for existing products, and to a lesser extent, costs incurred to develop new product candidates that we acquired in the EUSA Acquisition and the Azur Merger. Personnel expenses and other research and development expenses in 2012 were consistent with prior year levels. Research and development expenses decreased by $11.5 million in 2011 compared to 2010 primarily due to lower clinical studies and outside services costs, and to a lesser extent, a decrease in personnel and other expenses. The decrease in 2011 was primarily due to our decision to discontinue the development of JPZ-6, our then product candidate for the treatment of fibromyalgia, as well as our discontinuation of certain research activities related to two line extension projects for existing products. A discussion of the risks and uncertainties with respect to our research and development activities, including completing the development of our product candidates, and the consequences to our business, financial position and growth prospects can be found in “Risk Factors” in Part I, Item 1A of this report.” Consistent with the Company’s response in the Prior Response Letter, the Company will also, commencing with the 2012 Form 10-K, supplement its disclosures in the overview section of “Management’s Discussion and Analysis of Financial Condition and Results of Operations” to include disclosure in substantially the following form. The below disclosure is based on the Company’s research and development projects as of the date hereof and would be updated to reflect the status of such projects as of the date of the future applicable periodic or annual report. “Our development pipeline projects currently include line extensions for existing products, the generation of additional clinical data for existing products, and clinical development of new product candidates. These projects include two clinical trials involving Erwinaze® (asparaginase Erwinia chrysanthemi): an ongoing pharmacokinetic clinical trial of the intravenous administration of Erwinaze in the United States and Canada; and a planned clinical trial including pharmacokinetic measures to evaluate the efficacy of Erwinaze in adolescents and young adults with ALL who are hypersensitive to E. coli-derived asparaginase, which is expected to begin in the second half of 2013. In addition, we are developing two product candidates, including a Phase I clinical trial in Europe of Asparec® (mPEG-r-crisantaspase), a pegylated recombinant Erwinia asparaginase for the treatment of patients with ALL with E. coli asparaginase hypersensitivity; and a Phase III clinical trial in Europe of Leukotac® (inolimomab), an anti-CD25 monoclonal antibody for the treatment of steroid-refractory acute graft vs. host disease. We expect that research and development expenses will be higher in 2013 compared to 2012 due to an expected increase in development activities and due to the inclusion of a full year of expense from the acquired Azur Pharma and EUSA Pharma businesses.” The Company respectfully advises the Staff that it has removed the reference to a New Drug Application (“NDA”) seeking approval of VersaclozTM (clozapine, USP) oral suspension for treatment-resistant schizophrenia from the description of its development pipeline projects, as such description appeared in the Prior Response Letter, because that referenced NDA was approved since the time of the Prior Response Letter. U.S. Securities and Exchange Commission February 20, 2013 Page 4 Notes to Consolidated Financial Statements Stock Based Compensation, page F-22 2. We acknowledge your response to our comment 3. Please provide us proposed disclosure to be included in future periodic reports that discloses your change in how you estimate expected volatility consistent with your response. Otherwise, please tell us where you made similar disclosure in your interim periodic reports. In response to the Staff’s comment, the Company proposes to revise the share-based compensation footnote in its filings, commencing with the 2012 Form 10-K, to include additional disclosure that explains the change in the Company’s approach to estimating expected volatility for share option grants in substantially the following form: “Prior to 2012, we used a blend of the historical volatility and implied volatility of our ordinary shares, as well as the historical volatility of a peer group, to determine expected volatility for share option grants, and we used the implied volatility of our ordinary shares for grants under our ESPP. We included consideration of the historical volatility of a peer group to estimate expected volatility for share option grants since the trading history of our ordinary shares was less than the expected term of the share options. Beginning in the year ended December 31, 2012, we rely only on a blend of the historical and implied volatilities of our own ordinary shares to determine expected volatility for share option grants because our trading history now exceeds the expected term of the share options. In addition, we use a single volatility estimate for each share option grant. The weighted average volatility is determined by calculating the weighted average of volatilities for all share options granted in a given year.” * * * * * The Company further acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in the filings; • Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filings; and • the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact me at (650) 496-2654 if you have any questions or would like additional information regarding these matters. Sincerely, /s/ Karen J. Wilson Karen J. Wilson Vice President, Finance and Principal Accounting Officer Jazz Pharmaceuticals plc cc: Kathryn E. Falberg, Executive Vice President and Chief Financial Officer Suzanne Sawochka Hooper, Executive Vice President and General Counsel Sean O’Keefe, KPMG Chadwick Mills, Cooley LLP
2013-02-13 - UPLOAD - Jazz Pharmaceuticals plc
February 1 3, 2013
Via E -mail
Ms. Karen J. Wilson
Vice President of Finance
Jazz Pharmaceuticals plc
45 Fitzwilliam Square
Dublin 2, Ireland
Re: Jazz Pharmaceuticals plc
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed February 2 8, 2012
File No. 001-33500
Dear Ms. Wilson :
We have reviewed your January 22, 2013 response to our December 21, 2012 letter and
have the following comments.
Please respond to this letter within 10 business days by providing the requested
information or by advising us when you will provide the requested re sponse. If you do not
believe the comment s apply to your facts and circumstances, please tell us why in your response.
Please furnish us a letter on EDGAR under the form type label CORRESP that key s your
response s to our comment s.
After reviewing the information you provide, we may have additional comments and/or
request that you amend your filing .
Form 10 -K for the Fi scal Year Ended December 31, 2011
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Business and Financial Overview, page 27
1. We acknowledge your response and proposed disclosure to our comment
10. We note that your res earch and development expense for the years ended 2011, 2010
and 2009 was 9.7%, 22%, and 32%, respectively, of total operating expenses. You also
disclose that you expect future research and development expenses to increase. We
believe your proposed disclo sure lacks context without the amounts incurred for the
periods presented. In this regard, in order to provide more insight into how you manage
your R&D function, please revise your proposed disclosure to disclose the composition
of the total R&D expense s hown in the financial statements for each period presented.
This can take a variety of forms but is mainly driven by how many projects are managed
and how they are reported within the organization and may take the form, for example, of
separate disclosure for each of your current three pathways (i.e. developing line
Ms. Karen J. Wilson
Jazz Pharmaceuticals plc
February 1 3, 2013
Page 2
extensions, generating additional clinical data for existing products and developing new
product candidates ).
Notes to Consolidated Financial Statements
Stock Based Compensation, page F -22
2. We acknowledge your response to our comment 3. Please provide us proposed
disclosure to be included in future periodic reports that discloses your change in how you
estimate expected volatility consistent with your response. Otherwise, please tell us
where you made similar disclosure in your interim periodic reports.
You may contact Sasha Parikh, Staff Accountant, at (202) 551 -3627 or Mark Brunhofer ,
Senior St aff Accountant, at (202) 551 -3638 if you have questions regarding the comment s. In
this regard, do not hesitate to contact me at (202) 551 -3679.
Sincerely,
/s/ Jim B. Rosenberg
Jim B. Rosenberg
Senior Assistant Chief Accountant
2013-01-22 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm SEC Response Letter January 22, 2013 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporate Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Jazz Pharmaceuticals plc Form 10-K for the Fiscal Year Ended December 31, 2011 Filed February 28, 2012 Form 10-Q for the Quarterly Period Ended September 30, 2012 Filed November 9, 2012 File No. 001-33500 Dear Mr. Rosenberg: Jazz Pharmaceuticals plc (the “Company”) is providing this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated December 21, 2012 (the “Comment Letter”), regarding the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 (the “Form 10-K”) and the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 (the “Form 10-Q”). The following information is provided in response to the Staff’s comments included in the Comment Letter, which comments are reproduced below in italicized type. Please note that the headings and numbering set forth below correspond to the headings and numbering contained in the Comment Letter. Form 10-K for the Fiscal Year Ended December 31, 2011 Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 58 1. Although you disclose the impact of volume increases separately from price increases on your product sales, you do not appear to discuss the underlying causes. Please provide us proposed revised disclosure to be included in future periodic reports that elaborates on why volume and prices changed. The Company acknowledges the Staff’s comment and in its future periodic reports, the Company will enhance its disclosures to include an indication of the underlying reasons for price and volume changes when such underlying reasons are material and determinable. With respect to the Staff’s request for proposed revised disclosure, although the Company believes that it has provided the information necessary to an understanding of changes in its results of operations in the Form 10-K and subsequent Quarterly Reports on Form 10-Q, the Company proposes the following revised disclosure as an example of how the Company would elaborate on the underlying reasons for volume and price changes in response to the Staff’s comment. The following sample revised disclosure elaborates on the increase in Xyrem product sales from 2010 to 2011: Fourth Floor, Connaught House, One Burlington Road, Dublin 4, Ireland p 353.1.634.7800 f 353.1.634.7850 Jazz Pharmaceuticals plc. Registered in Ireland (company number 399192). Registered Office: Fourth Floor, Connaught House, One Burlington Road, Dublin 4, Ireland. Directors: Bruce C. Cozadd - Chairman (USA), Paul L. Berns (USA), Patrick G. Enright (USA), James C. Momtazee (USA), Seamus Mulligan, Kenneth W. O’Keefe (USA), Catherine A. Sohn (USA), Rick E Winningham (USA) U.S. Securities and Exchange Commission January 22, 2013 Page 2 “Xyrem product sales increased in 2011 compared to 2010 primarily due to a higher average net selling price in the 2011 period resulting from price increases that we instituted in 2011 and, to a lesser extent, an increase in sales volume of 11% in 2011. Price increases were instituted based on market analysis. The increase in sales volume in the 2011 period was primarily driven by an increase in the average number of patients on Xyrem, which we believe resulted primarily from targeting newly identified physicians treating narcolepsy patients which led to a growing number of first time prescription fills, as well as increases over the 2010 period in the number of patients who continued to refill their Xyrem prescriptions as a result of our efforts to improve patient support services.” As noted above, to the extent the underlying reasons for price and volume changes disclosed in the Company’s future periodic reports are material and determinable, the Company will provide disclosure similar in scope to the above that elaborates on such reasons. Contractual Obligations, page 62 2. Please provide additional disclosure to be provided in future filings to quantify potential amounts relating to your milestones, royalty payments, and contractual payments that have been omitted from the table of contractual obligations or provide a cross reference to a discussion that is provided elsewhere in the filing if applicable. In response to the Staff’s comment, the Company proposes to revise the presentation of its contractual obligations in its future filings, commencing with the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012 (the “2012 Form 10-K”), to include additional disclosure that quantifies potential amounts that have been omitted from the table of contractual obligations, which revised disclosure will be made in substantially the form presented on Exhibit A hereto. Stock Based Compensation, page F-22 3. Please provide proposed disclosure to be provided in future periodic reports of the range of expected volatilities used as required by ASC 718-10-50-2(f)(2). In addition, tell us the name(s) of the peer group you use and how this peer group is similar to you in size, resources, and industry. Further, explain why you feel including the historic volatility of a peer group in your volatility analysis provides a better indicator than your historical volatility. In response to the Staff’s comment, the Company respectfully notes that, prior to 2012, the trading history of the Company’s common shares was less than the expected term of options granted to employees. In this regard, the common shares of the Company’s predecessor, Jazz Pharmaceuticals, Inc., did not commence trading until June 1, 2007. Accordingly, the Company supplemented its analysis of its historical and implied volatilities with the historical volatilities of common stock of peer companies over the period equal to the expected term of the options. The companies included in the peer group were as follows: Acorda Therapeutics, Inc.; Alkermes, Inc.; Auxilium Pharmaceuticals, Inc.; Depomed, Inc.; Enzon Pharmaceuticals, Inc.; Isis Pharmaceuticals, Inc.; ISTA Pharmaceuticals, Inc.; InterMune Inc.; The Medicines Company; Onyx Pharmaceuticals, Inc.; Questcor Pharmaceuticals, Inc.; Salix Pharmaceuticals, Ltd.; Santarus, Inc.; and ViroPharma Incorporated. The peer group companies each operated in the pharmaceutical industry, had annual revenues of less than $0.5 billion in their most recent fiscal year as reported in annual reports on Form 10-K filed with the Commission prior to December 31, 2011 (which compares to the Company’s annual revenue of $272 million for the year ended December 31, 2011), and had less than 1,000 employees (which compares to the Company’s 431 regular employees at February 21, 2012). U.S. Securities and Exchange Commission January 22, 2013 Page 3 The Company also respectfully advises the Staff that, beginning in the fiscal year ended December 31, 2012, the Company now relies only on historical and implied volatilities of its own common shares (including those of its predecessor, Jazz Pharmaceuticals, Inc.) since the Company has now accumulated a sufficient trading history to measure historical volatility over a period equal to the expected term of the options it grants to employees. The Company notes that ASC 718-10-50-2(f)(2) requires disclosure of the range of expected volatilities if different volatilities are used during the contractual term of a stock-based compensation award. In this regard, the Company respectfully advises the Staff that it does not use different volatilities during the expected term of an option and relies on a single volatility estimate that can be different for different option grants. In the Company’s future periodic reports, as applicable, the Company will include disclosure in substantially the following form to address this point: “We use a single volatility estimate for each option grant. The weighted average volatility is determined by calculating the weighted average of volatilities for all options granted in a given year.” Form 10-Q for the Quarterly Period Ended September 30, 2012 Notes to Consolidated Financial Statements 2. Business Combinations 4. On pages 11 and 12, you disclose your preliminary purchase price allocations for your Azur Merger and EUSA Acquisition, respectively. Please provide us proposed disclosure to be included in future periodic reports that: • Removes reference to a purchase price allocation as that is a construct of the purchase method. Under the acquisition method, assets acquired and liabilities assumed are generally recorded at fair value and goodwill is determined by the excess of the fair value of the consideration conveyed to the seller over the fair value of the net assets acquired. In this regard, you use the terms “purchase price” or “purchase price allocation” in your pro forma financial information reflecting the Azur Merger in your Form 8-K filed on February 28, 2012. • Specifically identifies which assets, liabilities or items of consideration are preliminary or provisional, the reasons why your initial accounting is incomplete and the nature and amount of any measurement period adjustments recognized during the reporting period as required by ASC 805-10-50-6. The Company acknowledges the Staff’s comment included in the first bullet point above and will revise its future periodic reports, as applicable, to replace all references to a purchase price allocation with references to the fair values of assets acquired and liabilities assumed in the Azur Merger and EUSA Acquisition under the acquisition method of accounting. The Company also acknowledges the Staff’s comment included in the second bullet point above and will revise its future periodic reports, as applicable, to specifically identify assets, liabilities and items of consideration which are preliminary or provisional, the reasons why its initial accounting is incomplete and the nature and amount of any measurement period adjustments recognized during the reporting period. The Company is currently in the process of evaluating whether any measurement period adjustments are required to be recorded in the fourth quarter of 2012 related to pre-acquisition contingencies, income taxes and residual goodwill. At the present time, the Company is not aware of any significant measurement period adjustments and expects to finalize its evaluation of the initial accounting for the Azur Merger and EUSA Acquisition as of December 31, 2012. The Company will provide updated disclosure in the 2012 Form 10-K, as applicable. In response to the Staff’s request for proposed disclosure to be included in future periodic reports that reflects the foregoing, the disclosures included in the final five paragraphs under each of the headings “–Merger with Azur Pharma” and “–Acquisition of EUSA Pharma” on pages 11 through 13 of the Form 10-Q would be replaced with the proposed disclosure substantially as set forth on Exhibit B hereto in the applicable future periodic reports, commencing with the 2012 Form 10-K, which assumes that the evaluation of the initial accounting for both the Azur Merger and the EUSA Acquisition will be complete and no measurement period adjustments to assets, liabilities or other items of consideration related to these transactions will be made. U.S. Securities and Exchange Commission January 22, 2013 Page 4 Merger with Azur Pharma, page 10 5. Regarding the $325 million in acquired developed technologies, please provide us disclosure to be provided in future periodic reports disaggregating the amount of total intangible assets acquired by name of each acquired technology and its estimated fair value. In response to the Staff’s comment, the Company will, commencing with the 2012 Form 10-K, revise its disclosure to disaggregate the amount of total intangible assets acquired to provide the name of each acquired technology and its estimated fair value. The proposed revised disclosure reflecting the foregoing is set forth on Exhibit B hereto under the heading “Merger with Azur Pharma.” Acquisition of EUSA Pharma, page 11 6. Regarding the $616.9 million in acquired developed technologies, please provide us disclosure to be provided in future periodic reports disaggregating the amount of total intangible assets acquired to provide the name of each acquired technology and its estimated fair value. In response to the Staff’s comment, the Company will, commencing with the 2012 Form 10-K, revise its disclosure to disaggregate the amount of total intangible assets acquired to provide the name of each acquired technology and its estimated fair value. The proposed revised disclosure reflecting the foregoing is set forth on Exhibit B hereto under the heading “Acquisition of EUSA Pharma.” 9. Shareholders’ Equity Shares and Additional Paid-In Capital, page 21 7. Please provide us proposed disclosure to be included in future periodic reports that clarifies where in your financial statements you recorded the $25.3 million paid on behalf of certain employees related to the net share settlement of exercised share options in connection with the Azur Merger. Please separately reference for us the authoritative literature you relied upon to support your accounting. In response to the Staff’s comment, the Company will, commencing with the 2012 Form 10-K, revise its future periodic reports, as applicable, to include substantially the following disclosure: “In 2012, we paid $25.3 million of income tax withholdings on behalf of certain employees of Jazz Pharmaceuticals, Inc. related to the net share settlement of exercised share options in connection with the Azur Merger. The number of shares issued to employees upon the net share settlement of the exercised share options was decreased by a number of shares having a total fair value on the date of the net share settlement equal to the amount of the income tax withholdings paid. The $25.3 million of income tax withholdings paid was recorded as a reduction to additional paid-in capital.” The Company also respectfully advises the Staff that it believes that the payment of minimum statutory income tax withholdings on behalf of the employees and issuing shares net of those withholdings is substantially similar to a direct repurchase of treasury stock from the employees. Therefore, consistent with the guidance in ASC Topic 505-30-30-8 for treasury stock purchased for retirement or for constructive retirement, the fair value of the shares retained by the Company equal to the amount necessary to satisfy the minimum statutory income tax withholdings was deducted from shareholders’ equity. U.S. Securities and Exchange Commission January 22, 2013 Page 5 14. Discontinued Operations, page 24 8. Please explain to us why you do not allocate a tax benefit to your discontinued operations when the disposed women’s health business was acquired in the Azur Merger and Azur historically reported a tax provision. Please reference for us the authoritative literature you rely upon to support your accounting. In response to the Staff’s comment, the Company respectfully advises the Staff that the Company allocates its tax provision between continuing operations and discontinued operations in accordance with ASC Topic 740-20-45-12 and Example 2 in ASC Topic 740-20-55-8. As a matter of background, the value of, and profit and the losses attributable to, the women’s health business were both prior to and after the Azur Merger substantially recognized and held outside of the United States in a non-taxable jurisdiction where a tax benefit is not available. During the three and nine months ended September 30, 2012, the women’s he
2013-01-07 - CORRESP - Jazz Pharmaceuticals plc
CORRESP
1
filename1.htm
Correspondence
January 7, 2013
VIA EDGAR
United States Securities and Exchange Commission
Washington, D.C. 20549
Attention:
Jim B. Rosenberg, Senior Assistant Chief Accountant
Division of Corporation Finance
Re:
Jazz Pharmaceuticals plc
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed February 28, 2012
Form 10-Q for the Quarterly Period Ended September 30, 2012
Filed November 9, 2012
File No. 001-33500
Dear Mr. Rosenberg:
On behalf of Jazz Pharmaceuticals plc (the “Company”), this
letter is being transmitted to inform the staff of the Securities and Exchange Commission (the “Staff”) that the Company intends to respond to the Staff’s letter dated December 21, 2012 with respect to the Company’s Form
10-K for the fiscal year ended December 31, 2011 and Form 10-Q for the quarterly period ended September 30, 2012, no later than January 22, 2013.
Please do not hesitate to contact the undersigned at (650) 496-2654 if you have any questions or would like additional information regarding this matter.
Sincerely,
/s/ Karen J. Wilson
Karen J. Wilson
Vice President, Finance and Principal Accounting Officer
Jazz Pharmaceuticals plc
cc:
Suzanne Sawochka Hooper, Jazz Pharmaceuticals plc
Valerie Pierce, Jazz Pharmaceuticals plc
Chadwick Mills, Cooley LLP
2012-12-21 - UPLOAD - Jazz Pharmaceuticals plc
December 21, 2012
Via E -mail
Ms. Karen J. Wilson
Vice President of Finance
Jazz Pharmaceuticals plc
45 Fitzwilliam Square
Dublin 2, Ireland
Re: Jazz Pharmaceuticals plc
Form 10 -K for the Fiscal Year Ended December 31, 2011
Filed February 28, 2012
Form 10 -Q for the Quarter ly Period Ended September 30, 2012
Filed November 9, 2012
File No. 001-33500
Dear Ms. Wilson :
We have reviewed your filing s and have the following comment s. In our comment s, we
ask you to provide us with information so we may better understand your disclosure.
Please respond to this letter within 10 business days by providing the requested
information or by advising us when you will provide the requested re sponse. If you do not
believe the comment s apply to your facts and circumstances, please tell us why in your response.
Please furnish us a letter on EDGAR under the form type label CORRESP that key s your
responses to our comment s.
After reviewing the information you provide, we may have additional comments and/or
request that you amend your filing .
Form 10 -K for the Fiscal Year Ended December 31, 2011
Management’s Discussion and Analysis of Financial Cond ition and Results of Operations
Results of Operations, page 58
1. Although you disclose the impact of volume increases separately from price increases on
your product sales, you do not appear to discuss the underlying causes. Please provide us
proposed revi sed disclosure to be included in future periodic reports that elaborates on
why volume and prices changed.
Ms. Karen J. Wilson
Jazz Pharmaceuticals plc
December 21, 2012
Page 2
Contractual Obligations, page 62
2. Please provide additional disclosure to be provided in future filings to quantify potential
amounts relating to y our milestones, royalty payments, and contractual payments that
have been omitted from the table of contractual obligations or provide a cross reference
to a discussion that is provided elsewhere in the filing if applicable.
Stock Based Compensation, page F-22
3. Please provide proposed disclosure to be provided in future periodic reports of the range
of expected volatilities used as required by ASC 718 -10-50-2(f)(2). In addition, tell us the
name(s) of the peer group you use and how this peer group is similar to you in size,
resources, and industry. Further, explain why you feel including the historic volatility of a
peer group in your volatility analysis provides a better indicator than your historical
volatility.
Form 10 -Q for the Quarter ly Pe riod Ended September 30, 2012
Notes to Consolidated Financial Statements
2. Business Combinations
4. On pages 11 and 12, you disclose your preliminary purchase price allocations for your
Azur Merger and EUSA Acquisition, respectively. Please provide us pro posed disclosure
to be included in future periodic reports that:
Removes reference to a purchase price allocation as that is a construct of the purchase
method. Under the acquisition method, assets acquired and liabilities assumed are
generally recorded at fair value and goodwill is determined by the excess of the fair
value of the consideration conveyed to the seller over the fair value of the net assets
acquired. In this regard, you use the terms “purchase price” or “purchase price
allocation” in your pro forma financial information reflecting th e Azur Merger in
your Form 8 -K filed on February 28, 2012.
Specifically identifies which assets, liabilities or items of consideration are
preliminary or provisional, the reasons why your initial accounting is incomplete and
the nature and amount of any me asurement period adjustments recognized during the
reporting period as required by ASC 805 -10-50-6.
Merger with Azur Pharma, page 10
5. Regarding the $325 million in acquired developed technologies, please provide us
disclosure to be provided in future peri odic reports disaggregating the amount of total
intangible assets acquired by name of each acquired technology and its estimated fair
value .
Ms. Karen J. Wilson
Jazz Pharmaceuticals plc
December 21, 2012
Page 3
Acquisi tion of EUSA Pharma, page 11
6. Regarding the $616.9 million in acquired developed technologies, please provide us
disclosure to be provided in future periodic reports disaggregating the amount of total
intangible assets acquired to provide the name of each acquired technology and its
estimated fair value .
9. Shareholders’ Equity
Shares and Additional Paid -In Capital, page 21
7. Please provide us proposed disclosure to be included in future periodic reports that
clarifies where in your financial statements you recorded the $25.3 million paid on behalf
of certain employees related to the net share settlement of exercised share options in
conne ction with the Azur Merger . Please separately reference for us the authoritative
literature you relied upon to support your accounting.
14. Discontinued Operations, page 24
8. Please explain to us why you do not allocate a tax benefit to your discontinued operations
when the disposed women’s health business was acquired in the Azur Merger and Azur
historically reported a tax provision. Please reference for us the authoritative literature
you rely upon to support your accounting.
15. Income Tax, page 25
9. Please explain to us why you record a full valuation allowance against your US deferred
tax assets. In this regard , it appears that your US operations have been profitable since
2010 and th at you expect revenues to continue to grow and operating profits to continue
to be positive. In addition, in risk factors on pages 64 and 65 you disclose that you plan
to fully utilize the US net operating losses of Jazz Pharmaceuticals, Inc. prior to the ir
expiration and imply that the Azur Merger transaction with Jazz Pharmaceuticals, Inc. did
not result in an ownership change under Section 382 of the Internal Revenue Code
limiting your use of those net operating loss carryforwards.
Management’s Disc ussion and Analysis of Financial Condition and Results of Operations
Business and Financial Overview, page 27
10. Regarding your development pipeline activities, please provide us proposed disclosure to
be included in future periodic reports, that includes th e following for each of your
research and development projects:
The nature, objective, and current status of the project;
The costs incurred during each period presented and to date;
The nature of efforts and steps necessary to complete the project;
The ri sks and uncertainties associated with completing development;
Ms. Karen J. Wilson
Jazz Pharmaceuticals plc
December 21, 2012
Page 4
The extent and nature of additional resources that need to be obtained if current
liquidity is not expected to be sufficient to complete the project; and
Where a future milestone such as comple tion of a development phase, date of filing
an NDA with a regulatory agency, or approval from a regulatory agency can be
reliably determined, disclosure should be made.
If you do not maintain any research and development costs by project, disclose that fact
and explain why management does not maintain and evaluate research and development
costs by project. Provide other quantitative or qualitative disclosure that indicates the
amount of the company’s resources being used on the project .
Item 1A. Risk F actors, page 39
11. As a public company, your auditor is required by law to undergo regular Public Company
Accounting Oversight Board (PCAOB) inspections to assess its compliance with U.S.
law and professional standards in connection with its audits of financial statements fi led
with the SEC. The PCAOB, however, is currently unable to inspect the audit work and
practices of your auditor (see http://pcaobus.org/Internationa l/Inspections/Pages/
IssuerClientsWithoutAccessList.aspx ). As a result of this obstacle, investors in U.S.
markets who rely on your auditor’s audit reports are deprived of the benefits of PCAOB
inspections of auditors. Therefore, please provide us propose risk factor disclosure to be
included in future periodic reports that states this fact under a separate risk factor
heading. Explain that this lack of inspection prevents the PCAOB from regularly
evaluating your auditor’s audits and its quality control pro cedures.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing s to be certain that the filing s include s all information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding t o our comment s, please provide a written statemen t from the company
acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing s;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing s; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.
Ms. Karen J. Wilson
Jazz Pharmaceuticals plc
December 21, 2012
Page 5
You may contact Sasha Parikh, Staff Accountant, at (202) 551 -3627 or Mark Brunhofer ,
Senior St aff Accountant, at (202) 551 -3638 if you have questions regarding the comment s. In
this regard, do not hesitate to contact me at (202) 551 -3679.
Sincerely,
/s/ Jim B. Rosenberg
Jim B. Rosenberg
Senior Assistant Chief Accountant
2009-12-29 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm Acceleration Request December 29, 2009 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Jazz Pharmaceuticals, Inc. Form S-1 Registration Statement (File No. 333-163333) Ladies and Gentlemen: Jazz Pharmaceuticals, Inc. (the “Company”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1 to become effective at 4:00 p.m. Eastern Time on December 30, 2009 or as soon thereafter as is practicable. The Company hereby acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, JAZZ PHARMACEUTICALS, INC. By: /s/ Carol A. Gamble Carol A. Gamble Senior Vice President, General Counsel and Corporate Secretary cc: Bruce C. Cozadd, Chairman and Chief Executive Officer Philip J. Honerkamp, Vice President, Deputy General Counsel Chadwick L. Mills, Esq., Cooley Godward Kronish LLP
2009-12-22 - UPLOAD - Jazz Pharmaceuticals plc
Mail Stop 4720
December 22, 2009
Bruce C. Cozadd Chief Executive Officer Jazz Pharmaceuticals, Inc. 3180 Porter Drive Palo Alto, CA 94304
Re: Jazz Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed November 25, 2009
File No. 333-163333
Dear Mr. Cozadd:
We have limited our review of your filing to those issues we have addressed in
our comments. Where indicated, we think you should revise your document in response
to these comments. If you disagree, we w ill consider your explanation as to why our
comment is inapplicable or a revision is unneces sary. Please be as detailed as necessary
in your explanation. In some of our comme nts, we may ask you to provide us with
information so we may better understand your disclosure. After reviewing this
information, we may raise additional comments.
Please understand that the purpose of our re view 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 any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
1. In an equity line financing conducted as an indirect primary offering, the total
amount of securities issuable under the equity line agreement may represent
no more than one-third of your comp any’s public float at the time of
execution of the equity line agreement. It appears that you are attempting to
register approximately 50% of your una ffiliated public float. Please limit the
number of shares registered to one-thi rd of your public float or less.
2. Please expand your Risk Factor disclosure to include disclosu re related to the
following risks:
- The dilutive effect of the fo rmula or pricing mechanism;
Bruce C. Cozadd
Jazz Pharmaceuticals, Inc.
December 22, 2009
Page 2 of 3
- The likelihood that your company w ill have access to the full amount
available to you under the equity line agreement; and
- If Kingsbridge intends on engaging in short selling activities including
selling during the pricing period, a discu ssion of the effect of short selling
on your company’s market price.
3. We note that the cover page of your prospectus implies that Kingsbridge’s
obligations under the equity line agreement are transferrable. However, if
Kingsbridge can transfer its interest prior to the Regist rant’s exercise of a put,
then Kingsbridge is not irrevocab ly bound under the agreement, the
registration statement does not identify the proper se lling shareholder and the
registration statement may not cover sale s by the transferees of the shares.
Please remove the reference of tranferees from the registration statement. If
your investment agreement permits the transfer of the obligation, please withdraw your registration statement and renegotiate your agreement. You
can refile the registration statement af ter the agreement has been renegotiated.
* * *
As appropriate, please amend your regist ration statement in response to these
comments. You may wish to provide us w ith marked copies of the amendment to
expedite our review. Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information. Detailed cover
letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have provided all information investors require
for an informed investment decision. Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.
Notwithstanding our comments, in the even t the company requests acceleration of
the effective date of the pending registration statement, it should furnish a letter, at the
time of such request , acknowledging that:
should the Commission or the staff, acting purs uant to delegated authority, declare the
filing effective, it does not foreclose th e Commission from taking any action with
respect to the filing;
the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility
for the adequacy and accuracy of the disclosure in the filing; and
Bruce C. Cozadd
Jazz Pharmaceuticals, Inc.
December 22, 2009
Page 3 of 3
the company may not assert staff comments a nd the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement. We will act on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement. Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date.
Please contact Michael Rosenthall at 202-551-3674 or me at 202-551-3715 with
any questions.
S i n c e r e l y ,
Jeffrey P. Riedler
A s s i s t a n t D i r e c t o r
cc: Suzanne Sawochka Hooper Chadwick L. Mills Cooley Godward Kronish LLP Five Palo Alto Square 3000 El Camino Real Palo Alto, CA 94306 Fax: 650-849-7400
2009-09-29 - UPLOAD - Jazz Pharmaceuticals plc
Mail Stop 4720
September 29, 2009
Joan E. Colligan Acting Principal Financial Officer Jazz Pharmaceuticals, Inc. 3180 Porter Drive Palo Alto, CA 94304
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 Ms. Colligan: We have completed our review of your Form 10-K and related filings and have no
further comments at this time. S i n c e r e l y ,
J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r cc: Suzanne Sawochka Hooper Chadwick L. Mills Cooley Godward Kronish LLP Five Palo Alto Square 3000 El Camino Real Palo Alto, CA 94306 Fax: 650-849-7400
2009-09-15 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm Correspondence *FOIA Confidential Treatment Request* Confidential Treatment Requested by Jazz Pharmaceuticals, Inc. in connection with Annual Report on Form 10-K/A for the Fiscal Year Ended December 31, 2008 (File No. 001-33500) JAZZ-0001 September 15, 2009 VIA EDGAR AND FEDEX Mr. Michael Rosenthall Staff Attorney United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4720 Washington, DC 20549 Re: Jazz Pharmaceuticals, Inc. Form 10-K/A for the Fiscal Year Ended December 31, 2008 File Number: 001-33500 Dear Mr. Rosenthall: On behalf of Jazz Pharmaceuticals, Inc. (the “Company”), this letter is being submitted in response to an oral comment received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by Chad Mills of Cooley Godward Kronish LLP, the Company’s outside legal counsel, on September 11, 2009 (the “Comment”), regarding Amendment No. 1 on Form 10-K/A to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008, filed by the Company with the Commission on April 29, 2009. We note that the Comment was received in response to the Company’s previous letter that was submitted to the Staff on August 12, 2009 (the “Initial Response Letter”) in response to the Staff’s comment letter dated July 29, 2009 (the “Staff Letter”). The Comment is summarized in italics below, and the Company’s response follows. Comment Summary: We note the Company’s response to comment 4 of the Staff Letter. Please revise the Company’s draft disclosure for the Company’s 2010 proxy statement to specifically quantify the net sales, EBITDA and operating loss targets included in the Company’s corporate objectives for purposes of its annual bonus plan. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 Securities and Exchange Commission September 15, 2009 Page 2 *FOIA Confidential Treatment Request* Confidential Treatment Requested by Jazz Pharmaceuticals, Inc. in connection with Annual Report on Form 10-K/A for the Fiscal Year Ended December 31, 2008 (File No. 001-33500) JAZZ-0002 Company Response: In response to the Staff’s Comment, the Company has set forth in the below draft disclosure the specific net sales, EBITDA and operating loss targets included in the Company’s corporate objectives for purposes of the Company’s annual bonus plan. For the Staff’s convenience, the draft disclosure included in the Initial Response Letter with respect to comment 4 of the Staff Letter has been restated in its entirety below. As noted in the Initial Response Letter, this draft disclosure was prepared on the basis of a number assumptions and the actual disclosure for the Company’s 2010 proxy statement may therefore differ. Also as noted in the Initial Response Letter, the draft disclosure is being 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. The restated draft disclosure is as follows: Bonus Awards. Our Bonus Plan is designed to reward executive officers for attaining our corporate performance objectives as well as to reward them for their contributions to the achievement of those objectives. As set forth in our Bonus Plan, the target bonus levels for 2009 for our named executive officers were: 50% of the applicable annual base salary rate for Dr. Saks and Messrs. Cozadd and Myers; 40% of the applicable annual base salary rate for each of Ms. Gamble and Ms. Wissel; and between 10% and 30% of the applicable annual base salary rate for Ms. Colligan. Dr. Saks resigned his position with us effective April 3, 2009 and was therefore not eligible for a bonus under the Bonus Plan for 2009. For 2009, our corporate objectives for purposes of the Bonus Plan, approved by the Board of Directors in early 2009, were to: • obtain and publicly disclose top-line results for our second pivotal Phase III trial of JZP-6 (sodium oxybate) for the treatment of fibromyalgia during the third quarter of 2009, and submit a New Drug Application, or NDA, to the U.S. Food and Drug Administration for JZP-6 by December 31, 2009; • secure equity and nonequity financing sufficient to achieve our corporate objectives without the need for additional financing in 2010; • achieve total Xyrem and Luvox CR net sales of [*] and EBITDA from commercial operations of [*] in 2009; • achieve an operating loss of less than [*], measured by EBIDTA, by the end of the first quarter of 2009, and achieve breakeven on an operating basis, measured by EBIDTA, in the fourth quarter of 2009; and • ensure that employees are aligned with the corporate objectives and that our company operates in compliance will applicable laws and regulations. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 Securities and Exchange Commission September 15, 2009 Page 3 *FOIA Confidential Treatment Request* Confidential Treatment Requested by Jazz Pharmaceuticals, Inc. in connection with Annual Report on Form 10-K/A for the Fiscal Year Ended December 31, 2008 (File No. 001-33500) JAZZ-0003 Each of the executive officers is responsible for meeting our corporate objectives, and each objective was deemed important in determining the level of our performance during the year. Although the Compensation Committee did not set individual goals for individual executive officers, certain of the named executive officer’s responsibilities are more directly related to particular corporate objectives and were therefore given greater weight in the determination of the bonus amount paid to a named executive officer. Mr. Myers is responsible for all of our commercial operations, and our corporate objective related to achieving Xyrem and Luvox CR net sales and commercial EBIDTA targets were given greater weight in the determination of his bonus. Likewise, Ms. Wissel is responsible for our regulatory activities, and our corporate objective relating to completing the second pivotal Phase III trial of JZP-6 and the submission of an NDA for JZP-6 were given greater importance in her bonus determination. Similarly, Ms Gamble, along with Mr. Cozadd and Mr. Myers, is particularly responsible for the Company obtaining equity and nonequity financing, and their efforts in achieving this corporate objective had a greater impact on their bonus determination than it did for the other named executive officers. Nevertheless, in a small company such as ours, each executive is expected to contribute in significant ways to the achievement or most, if not all, of our corporate goals. In approving the corporate objectives for 2009, the expectation of our Board of Directors was that it would be highly unlikely that all of the corporate objectives would be achieved for the year. In this regard, the Board of Directors has historically approved corporate objectives that have been stretch objectives beyond those that would reasonably be expected to be attained in any given year, and our corporate objectives historically have not been achieved at the 100% level. Our Compensation Committee determines the size of the total bonus pool under the Bonus Plan, which is based primarily on our Board of Directors’ determination of our success in achieving our corporate objectives for the plan year. The Compensation Committee also determines the portion of the pool, if any, that will be allocated to the executive officers as a group and the bonuses for each of our executive officers and vice presidents. Our Chairman and Chief Executive Officer provide input to the Compensation Committee with respect to bonuses for executive officers and vice presidents. The Compensation Committee did not quantify or assign specific percentage criteria to the various corporate objectives under the Bonus Plan, but rather sought to approve a bonus payout that generally reflects our Board of Directors’ determination of the level of achievement of our corporate objectives, after taking into the account the corporate objectives deemed more important to our performance by the Board of Directors and the amount of cash available from our operations in determining whether, or how much, of a bonus could be paid. In the actual 2010 proxy statement, the Company would then describe the weighting, if any, given to each of the corporate objectives and the extent to which the goals were achieved, and how the extent of achievement was used to determine actual bonus awards. The Company further acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in the filings; CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 Securities and Exchange Commission September 15, 2009 Page 4 *FOIA Confidential Treatment Request* Confidential Treatment Requested by Jazz Pharmaceuticals, Inc. in connection with Annual Report on Form 10-K/A for the Fiscal Year Ended December 31, 2008 (File No. 001-33500) JAZZ-0004 • Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filings; and • the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact me at (650) 496-2611 if you have any questions or would like additional information regarding these matters. Sincerely, /s/ Philip J. Honerkamp Philip J. Honerkamp Vice President, Deputy General Counsel Jazz Pharmaceuticals, Inc. cc: Bruce C. Cozadd, Chairman and Chief Executive Officer Carol A. Gamble, Esq., Senior Vice President, General Counsel and Corporate Secretary Suzanne Sawochka Hooper, Esq., Cooley Godward Kronish LLP Chadwick L. Mills, Esq., Cooley Godward Kronish LLP CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83
2009-08-13 - CORRESP - Jazz Pharmaceuticals plc
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
2009-07-29 - UPLOAD - Jazz Pharmaceuticals plc
Via Facsimile and U.S. Mail
Mail Stop 4720
July 29, 2009
Joan E. Colligan
Acting Principal Financial Officer
Jazz Pharmaceuticals, Inc.
3180 Porter Drive
Palo Alto, CA 94304
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 Ms. Colligan:
We have reviewed your filings and have the following comments. In our
comments, we ask you to provide us with information to better understand your
disclosures. Where a comment requests you to revise disclosure, the information you
provide should show us what the revised disc losure will look like and identify the annual
or quarterly filing, as appli cable, in which you intend to fi rst include it. If you do not
believe that revised disclosure is necessary, explain the reason in your response. After
reviewing the information provided, we may raise additional comments and/or request
that you amend your filings.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filings. 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.
Form 10-K for the Year Ended December 31, 2008
Item 9A(T). Controls and Procedures
Evaluation of Disclosure Cont rols and Procedures, page 67
1. We note your statement that “disclos ure controls and procedures were sufficiently
effective to provide reasonable assurance that the objectives of our disclosure
control system were met.” Given the us e of the word ‘sufficiently’, it remains
unclear whether your chief executive offi cer and chief financial officer have
Joan E. Colligan
Jazz Pharmaceuticals, Inc. July 29, 2009 Page 2
concluded that your disclosure controls and procedures are effective . Please
revise your disclosure to state, in clear and unqua lified language, the conclusions
reached by your chief executive officer a nd your chief financial officer on the
effectiveness of your disclosure controls and procedures.
Notes to Consolidated Financial Statements
Summary of Significan t Accounting Policies
Revenue Recognition
Product Sales, Net, page F-11
2. Please revise to disclose the conditio ns under which you accept returns and the
form of the return (i.e. credit issue d, cash returned, produc t exchanged out of
inventory for returned product). For pr oduct 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 ho w you account for your estimate of these
returns at the time of sale of the prod uct 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.
Form 10-K/A for the Year Ended December 31, 2008
Item 10, page 2
3. Please revise your disclosure in this sect ion 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 discussi on of your nominating
committee, disclosure regarding the char ters of your board committees, and your
process, if any, for shareholder communications.
Compensation Discussion and Analysis
Bonus Awards, page 8
4. Your disclosure relating to the co rporate and individual goals does not
specifically identify these goals. Plea se provide draft di sclosure for your 2010
proxy statement describing these goals with more specificity. A description of the
goals is required regard less 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 achieveme nt was used to determine bonus awards.
Joan E. Colligan
Jazz Pharmaceuticals, Inc. July 29, 2009 Page 3
Form 10-Q for the quarterly period ended March 31, 2009
Notes to the Condensed Conso lidated Financial Statements
9. In-Licensing Agreements, page 13
5. Please explain to us how you determined that the $5 million increase to the Luvox
CR intangible asset was recoverable in light of the fact that you recorded an
impairment charge related to Luvox CR in December 2008.
* * * *
Please provide us the information request ed within 10 busine ss days or tell us
when you will provide us with a response. Pl ease furnish a cover le tter with your response
that keys your response to our comments. De tailed cover letters gr eatly facilitate our
review. Please furnish your letter on EDGAR under the form type label CORRESP.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filings to be certain that the filings include all information required
under the Securities Exchange Act of 1934 and that they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our co mments, please provide, in your letter, a
statement from the company acknowledging that:
• the company is responsible for the adequacy and accuracy of the disclosure in
the filings;
• staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking a ny action with respect to the filings;
and
• the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any pers on under the federal s ecurities laws of
the United States.
In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filings or in response to our comments on your filings.
Joan E. Colligan
Jazz Pharmaceuticals, Inc. July 29, 2009 Page 4
Please contact Vanessa Robe rtson, Staff Accountant, at (202) 551-3649 or Joel
Parker, Accounting Branch Chief, at (202) 551-3651 if you have any questions regarding
the processing of your response as well as any questions regarding comments on the
financial statements and related matters. You may contact Michael Rosenthall, Staff
Attorney, at (202) 551-3674 or Suzanne Haye s, Legal Branch Chief, at (202) 551-3675
with questions on any of the ot her comments. In this regar d, do not hesitate to contact
me, at (202) 551-3679.
S i n c e r e l y ,
J i m B . R o s e n b e r g
Senior Assistant Chief
Accountant
2007-05-31 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm Acceleration Request May 31, 2007 Re: Jazz Pharmaceuticals, Inc. Common Stock Registration Statement on Form S-1 No. 333-141164 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Dear Sir/Madam: In connection with the proposed offering of the above-captioned securities, we, as representatives of the several underwriters, hereby join with the request of Jazz Pharmaceuticals, Inc. (“the Company”) that the effective date of the above-captioned Registration Statement be accelerated so that the same will become effective on May 31, 2007, at 4:00 p.m. Eastern Daylight Time, or as soon as practicable thereafter. The following is supplemental information supplied under Rule 418(a)(7) under the Securities Act of 1933: (i) Date of preliminary prospectus: May 17, 2007 (ii) Dates of Distribution: May 17, 2007, through the date hereof (iii) Number of prospective underwriters to whom the preliminary prospectus was furnished: 4 (iv) Number of prospectuses so distributed: approximately 8,194 (v) Number of prospectuses distributed to others, including the Company, the Company’s counsel and independent accountants, and underwriters’ counsel: approximately 205 (vi) We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934. Very truly yours, MORGAN STANLEY & CO. INCORPORATED Acting severally on behalf of themselves and the several Underwriters By: /s/ Bryan W. Andrzejewski Name: Bryan W. Andrzejewski Title: Executive Director [Underwriters Acceleration Request]
2007-05-21 - CORRESP - Jazz Pharmaceuticals plc
CORRESP 1 filename1.htm Correspondence Letter Chadwick L. Mills (650) 843-5654 cmills@cooley.com VIA EDGAR AND FEDEX May 21, 2007 Division of Corporation Finance Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attn: Ms. Tabatha Akins Ms. Lisa Vanjoske Ms. Mary K. Fraser Mr. Jeffrey P. Riedler RE: Jazz Pharmaceuticals, Inc. Form S-1 Registration Statement File No. 333-141164 Ladies and Gentleman: On behalf of Jazz Pharmaceuticals, Inc. (the “Company”), we are hereby supplementally responding to a comment delivered by Ms. Tabatha Akins telephonically on May 18, 2007 with respect to Amendment No. 3 to the Registration Statement referenced above (the “Amendment”). Our understanding of the comment as relayed by Ms. Akins is as follows: Please clarify why the Company has not recorded an accrual with respect to the legal proceedings referenced in Note 19 to its consolidated financial statements in accordance with paragraphs 8 and 37 of Statement of Financial Accounting Standards No. 5, Accounting for Contingencies (“SFAS 5”). Please clarify when settlement talks with the U.S. Attorney began as it is not clear from your disclosure. In response to the foregoing comment by the Staff of the Securities and Exchange Commission (the “Staff”), the Company supplementally advises the Staff that it considered the relevant provisions of SFAS 5 in issuing its consolidated financial statements as of and for the period ending March 31, 2007 included in the Amendment and determined that it was not appropriate to record a liability associated with the legal proceedings referenced in Note 19 of the Company’s consolidated financial statements. Paragraph 8 of SFAS 5 provides that: “An estimated loss from a loss contingency (as defined in paragraph 1) shall be accrued by a charge to income if both of the following conditions are met: a. Information available prior to issuance of the financial statements indicates that it is probable that an asset has been impaired or a liability has been incurred at the date of the financial statements. It is implicit in this condition that it must be probable that one or more future events will occur confirming the fact of the loss. FIVE PALO ALTO SQUARE, 3000 EL CAMINO REAL, PALO ALTO, CA 94306-2155 T: (650) 843-5000 F: (650) 849-7400 WWW.COOLEY.COM Securities and Exchange Commission May 21, 2007 Page Two b. The amount can be reasonably estimated.” Paragraph 37 of SFAS 5, in relevant part, states the following: “The condition for accrual in paragraph 8(a) would be met if an unfavorable outcome is determined to be probable. If an unfavorable outcome is determined to be reasonably possible but not probable, or if the amount of loss cannot be reasonably estimated, accrual would be inappropriate, but disclosure would be required by paragraph 10 of this Statement.” In assessing the status of the legal proceedings referenced in Note 19 of its consolidated financial statements, the Company determined, as of the date of the filing of the Amendment, that accrual would be inappropriate because an unfavorable outcome, while reasonably possible, was not probable. According to paragraph 3(a) of SFAS 5, a future event is deemed “probable” if “the future event or events are likely to occur.” The settlement discussions disclosed in the prospectus and Note 19 of the Company’s consolidated financial statements were the result of ongoing discussions with the office of the Assistant U.S. Attorney for the Eastern District of New York regarding the subpoenas issued to the Company and Orphan Medical in April 2006 and the indictment of the physician who had previously been a speaker for Orphan Medical, and for a short time, the Company. The potential civil and criminal penalties of approximately $20.5 million discussed as part of this potential settlement represent only one component of a comprehensive, global settlement arrangement that the Company believes will be necessary to resolve these matters. As of the date of the Amendment, there had been no resolution by the Company’s Board of Directors approving any offer to settle or settlement of these matters, nor had the Company received settlement documents that it could recommend to its Board of Directors for approval. Reaching a comprehensive settlement of these matters will involve the resolution of several significant issues still being negotiated and which have not been agreed upon. These include, without limitation, the following: • the terms and conditions of the potential corporate integrity agreement, which have not yet been proposed by the Office of Inspector General, U.S. Department of Health and Human Services and may purport to impose conditions on the Company’s operations which are unacceptable; • the terms, conditions and language of the civil settlement agreement, an incomplete, preliminary draft of which has been forwarded to the Company without the input or approval of all relevant government agencies; FIVE PALO ALTO SQUARE, 3000 EL CAMINO REAL, PALO ALTO, CA 94306-2155 T: (650) 843-5000 F: (650) 849-7400 WWW.COOLEY.COM Securities and Exchange Commission May 21, 2007 Page Three • the terms, conditions and language of proposed documents relating to a possible criminal resolution, preliminary drafts of which have been received by the Company and which contained significant, disputed content that has not been revised; • the specific statements, including statements which may be adverse to the Company’s interest, to which the Orphan Medical would be required to allocute in court as part of the final resolution of this matter; • the timing and conditions under which Orphan Medical could be excluded from participation in federal healthcare programs, which could limit the ability of the Company to effectively market its products; and • continuing negotiations over language in the plea documents in an effort to ensure that the presiding court accepts the proposed resolution. The Company believes that the failure to resolve these multiple outstanding issues in an acceptable manner would result in the Company or the government refusing to settle these matters on the terms currently being negotiated, including the terms relating to proposed amount of civil and criminal penalties. In such event, the outcome of these matters, including the amount of any potential financial liability, would not be reasonably predictable or estimable by the Company. Since the Company can not, at this time, determine that the favorable resolution of the outstanding issues associated with the settlement resolutions is likely, the Company can not determine that any loss associated with this contingency is probable. As a result, the Company believes that under the principles set forth in SFAS 5, disclosure of the loss contingency is appropriate but accrual of any associated loss is not. The Company further supplementally advises the Staff that very general discussions regarding a possible financial settlement of these matters commenced in 2007. Specifically, in January 2007, the Company, its counsel, and representatives from the U.S. Attorney’s Office commenced discussions regarding the government’s assessment of potential damages associated with these matters. In March 2007, the Company’s counsel and representatives from the U.S. Attorney’s Office held additional discussions in which the broad parameters of a potential settlement were discussed. Because if its proposed initial public offering, the Company urged representatives from the U.S. Attorney’s Office to help it reach settlement of these issues in a timely fashion, and on May 2, 2007, the U.S. Attorney provided the Company with draft documents relating to the settlement of potential criminal liability, including a non-prosecution agreement, a criminal Information and criminal plea. The Company has responded to these drafts with respect to multiple terms it deemed unacceptable. Representatives of the U.S. Attorney’s Office have not provided the Company with revised drafts of these agreements and have not indicated that certain of the issues identified by the Company are resolvable on terms the Company would find acceptable. On May 4, 2007, the U.S. Attorney provided the Company with an incomplete, preliminary draft civil settlement agreement, which had not been approved by the Office of Inspector General, U.S. Department of Health and Human Services. The Company has provided preliminary comments on this draft, but has not yet received a draft approved by all relevant government agencies, nor a draft responding to its preliminary comments. As noted above, the Company has yet to receive a draft of a proposed corporate integrity agreement. FIVE PALO ALTO SQUARE, 3000 EL CAMINO REAL, PALO ALTO, CA 94306-2155 T: (650) 843-5000 F: (650) 849-7400 WWW.COOLEY.COM Securities and Exchange Commission May 21, 2007 Page Four ***** As previously indicated to the Staff, the Company currently intends to request that the Registration Statement be declared effective as of approximately May 30, 2007. As previously noted, in connection with its request for acceleration of effectiveness, the Company will furnish the acknowledgement letter requested from the Staff by letter dated April 13, 2007. Please do not hesitate to contact me at (650) 843-5654, Suzanne Sawochka Hooper at (650) 843-5180 or John Geschke at (650) 843-5757 if the Staff requires any additional information prior to acceleration of effectiveness or if there is anything that we or the Company can do to facilitate your review. Best regards, /s/ CHADWICK L. MILLS Chadwick L. Mills cc: Samuel R. Saks, M.D., Jazz Pharmaceuticals, Inc. Carol A. Gamble, Esq., Jazz Pharmaceuticals, Inc. Suzanne Sawochka Hooper, Esq., Cooley Godward Kronish LLP John M. Geschke, Esq., Cooley Godward Kronish LLP Bruce Dallas, Esq., Davis Polk & Wardwell FIVE PALO ALTO SQUARE, 3000 EL CAMINO REAL, PALO ALTO, CA 94306-2155 T: (650) 843-5000 F: (650) 849-7400 WWW.COOLEY.COM
2007-05-15 - UPLOAD - Jazz Pharmaceuticals plc
Mail Stop 6010
May 15, 2007
Samuel R. Saks, M.D.
Chief Executive Officer
Jazz Pharmaceuticals, Inc.
3180 Porter Drive
Palo Alto, California 94304
Re: Jazz Pharmaceuticals, Inc.
Amendment No. 2 to Form S-1 Registration Statement
File No. 333-141164
Dear Dr. Saks:
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.
Prospectus Summary – page 1
1. In the carryover paragraph at the top of page 3 you refer to “proof of concept clinical trials.” Please explain what this term refers to.
Samuel R. Saks, M.D.
Jazz Pharmaceuticals, Inc. May 15, 2007 Page 2
Management’s Discussion and Analysis of Financ ial Condition and Results of Operations, page
46
Critical Accounting Policies and Significant Judgments and Estimates, page 42
Stock-Based Compensation, page 55
Change in Accounting Principle – Stock Based Compensation Under SFAS 123R, page 56
Common Stock Fair Value, page 57
2. With respect to prior comment number twenty six, please expand your disclosures here to:
a. Quantitatively disclose how the enterprise value was estimated and changed at each valuation date.
b. Tell us, and elaborate on how the “comparison group utilized for the market approach was modified to reflect business developments at comparable companies” was considered in your reassessment of the estimated valuation.
c. Once you can reasonably estimate the IPO price, qualitatively and quantitatively discuss each significant factor contributing to the difference between each valuation and the estimated IPO price. See paragraph 182(b) of the AICPA Practice Aid.
3. Please refer to your response to our prior comment number twenty seven. Because you state that you used the assistance of an independent valuation specialist, we still believe that naming the expert and including a consent is required. Please revise your disclosure to name the expert and make reference to them in the “Experts” section of the document and provide the written consent this independent valuation specialist, or revise your disclosure to remove all references to the independent valuation specialist. Refer to Securities Act Rule 436. This comment also applies to our prior comment number 40.
4. Disclose the intrinsic value of vested and unvested options outstanding based on the estimated IPO price as required by paragraph 180 of the AICPA Practice Aid.
14. Stock-Based Compensation, page F-27
5. Refer to your response to our prior comment 42. Please demonstrate how you determined that the companies considered were comparable given your size and stage of
Samuel R. Saks, M.D.
Jazz Pharmaceuticals, Inc. May 15, 2007 Page 3
development. Tell us the names of the companies that you considered in your analysis. This comment also applies to our prior comment number 26.
* * * * *
As appropriate, please amend your registration statement in response to these comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cover letter with your amendment that keys your responses to our comments and provides any requested supplemental information. Detailed cover letters greatly facilitate our review. We may have additional comments after reviewing your amendment and responses to our comments.
You may contact Tabatha Akins at 202-551-3658 or Lisa Vanjoske at 202-551-3614 if
you have questions regarding comments on the financial statements and related matters. Please contact Mary K. Fraser at 202-551-3609 or me at 202-551-3610 with any other questions.
R e g a r d s ,
J e f f r e y P . R i e d l e r
A s s i s t a n t D i r e c t o r
Cc: Suzanne Sawochka Hooper, Esq.
Cooley Godward Kronish LLP
Five Palo Alto Square
3000 El Camino Real
Palo Alto, California 94306-2155
2007-04-13 - UPLOAD - Jazz Pharmaceuticals plc
Mail Stop 6010
April 13, 2007
Samuel R. Saks, M.D.
Chief Executive Officer
Jazz Pharmaceuticals, Inc.
3180 Porter Drive
Palo Alto, California 94304
Re: Jazz Pharmaceuticals, Inc.
Form S-1 Registration Statement
File No. 333-141164
Dear Dr. Saks:
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.
Comments applicable to the entire filing
1. We note that your filing contains numerous omissions throughout the prospectus which relate to the offering price range or the number of shares you will sell. These omissions include but are not limited to:
• Summary Financial Data
• Use Of Proceeds
• Capitalization • The Option Grants Table
• Shares Eligible For Future Sale
• The Principal Stockholders Table
Samuel R. Saks, M.D.
Jazz Pharmaceuticals, Inc. April 13, 2007 Page 2
• Dilution • Description of Capital Stock
Rule 430A requires you to include this information in your filing based upon an estimate of the offering price within a bona fide range you disclose on the cover page and based upon an estimate of the number of shares you will sell. We consider a bona fide range to be $2 if the price is under $20 and 10% if it is above $20. You should include the required information in an amendment prior to circulating a “red herring” prospectus.
2. Please confirm that your filing contains all of the graphic, photographic or artistic materials you intend to include in the prospectus. If not, provide us with copies of all the materials you intend to include in the prospectus prior to its printing and use. Please also note that all textual information in the graphic material should be brief and comply with the plain English guidelines regarding jargon and technical language.
3. Comments on your application for confidential treatment will follow under separate cover. We will not consider a request for acceleration of effectiveness of the registration statement until any comments we may have on the application are resolved.
4. In a number of places in your document you have used technical jargon that is not likely to be understood by your readers. Technical ja rgon should not appear in the forefront of
the prospectus. Accordingly, please replace the jargon with an explanation in plain English. If you cannot convey these ideas without jargon, please explain what the jargon means at the first place the terms appear. Here are some examples of the type of disclosure that need to be replaced:
• Fast-acting formulation of a Benzodiazepine
• Refractory
• Dopamine agonist
5. Throughout your document you have used a number of acronyms that are not likely to be familiar to your readers. The use of acronyms is a convenience for the writer, but it forces readers to learn a new vocabulary in order to understand the disclosure in your document. Please delete all of the acronyms except those which can be commonly found in general interest publications. Examples of acronyms that should be deleted include:
• API
• RSCs
• FMS
• RLS
Samuel R. Saks, M.D.
Jazz Pharmaceuticals, Inc. April 13, 2007 Page 3
• AED
• PHAST
6. Throughout the registration statement you make statements such as “when we obtain regulatory approval of Luvox CR” (see, for example, page 33) suggesting that you own Luvox CR. However, you also indicate in a number of places that Solvay must obtain approval of Luvox Cr. Please revise the disclosure throughout the document to clearly identify the rights and obligations that each of you and Solvay possess in regard to this product candidate.
Prospectus Summary – page 1
7. We note that while you have two currently marketed products, only one of them is mentioned in the summary. Please revise the summary to identify both marketed products and indicate that portion of your revenues attributable to each of them.
8. Please revise the last bullet on page 1 to briefly describe the requirements set forth in the “approvable letter” that Solvay must satisfy in order to obtain FDA approval for this product. A more detailed discussion should be provided in the “Business” section.
9. In the last bullet on page 1, you say that in January of 2007, you acquired the “U.S. marketing rights” to Luvox CR from Solvay Pharmaceuticals, Inc. Please be more specific about what you obtained from Solva y. Also, please briefly explain what your
obligations under this agreement are. The disclosure, as currently written, appears to imply that you own Luvox.
10. In the carryover paragraph at the top of page 3 you refer to your “lifecycle management activities.” Please revise the discussion to explain what this term refers to.
11. Please expand the last bullet on page 4 to quantify the amount of your net losses.
Risk Factors – page 8
The FDA may not approve Luvox CR for marketing in the United States, which could have a
material adverse effect on our business, financial condition, results of operations and growth
prospects. – page 8
12. Please revise and expand the risk factor to quantify the potential adverse impact on you. For example, how much did you spend to acquire the marketing rights? What are your financial obligations under the agreement?
Samuel R. Saks, M.D.
Jazz Pharmaceuticals, Inc. April 13, 2007 Page 4
Our only product candidate currently in Phase III clinical trials is JZP-6 for the treatment of
FMS…. – page 8
13. In the body of the risk factor you refer to “a risk management program similar to the one we use for Xyrem.” At this point in the prospectus, a reader will have no idea what you are referring to. Please revise the risk factor to briefly, but clearly, explain what a risk management program is and why such a program would make it difficult for you to “effectively supply the FMS market.”
Many of our product candidates are in preclinical or early-stage clinical trials. A failure to prove
that our product candidates are safe and effective in clinical trials would require us to
discontinue their development, which could materially and adversely affect our business,
financial condition, results of operations and growth prospects. – page 9
14. Please refer to the reference in the subheading to your product candidates in “early-stage clinical trials.” The disclosure in the summary discussing the status of your product development activities does not identify any ongoing clinical trials. Please revise pages 1 and 2 to briefly describe your ongoing early=phase trials.
We depend on one central pharmacy distributor for Xyrem sales in the United States and the loss
of that distributor or its failure to distribute Xyrem effectively would adversely affect sales of
Xyrem. – page 11
15. Please identify the pharmacy you rely on and describe the steps you have taken to ensure that you will not lose its services. It does not appear that you have filed this agreement as an exhibit to the registration statement and its material terms are not discussed in this document. Please file the agreement as an exhibit and revise the business section to include a discussion of its material terms.
Xyrem cannot be advertised directly to consumers, which could limit sales. – page 14
16. Please expand the last sentence to identify the products that compete with Xyrem. Also, tell us why you say that the competing products “may not be subject to” the advertising limitations and pre-review requirements. If the competing products are not subject to these requirements you should say so clearly. Without the information about competing products, a reader will not be able to adequately evaluate the risk and its potential adverse consequences.
We face substantial competition from companies with greater resources than we have. – page 15
Samuel R. Saks, M.D.
Jazz Pharmaceuticals, Inc. April 13, 2007 Page 5
17. In the second sentence of the risk factor you indicate that your product candidates will face competition from existing generic and branded products. Please identify the principal competitors and products or treatments for each of your existing and most developed product candidates. Also, discuss, for each product, how you intend to compete with the existing products or treatments. Investors need an adequate factual context for evaluating this risk.
Sales of our products in the United States may be adversely affected by consolidation among
wholesale drug distributors and the growth of large retail drug store chains. – page 23
18. The body of the risk factor contains the first reference to your product, Antizol, in the prospectus. Readers will not know anything about this product, so you will need to explain what it is, what it is used for and how much it contributes to your revenue. You should also quantify the information in the risk factor to the extent practicable. Without an adequate factual context, readers will not be able to evaluate the risk and its potential adverse consequences.
Our principal stockholders and management own a significant percentage of our stock and will
be able to exercise significant influence over matters subject to stockholder approval. – page 29
19. Please disclose the percentage of shares that will be owned by management subsequent to the offering.
20. Please expand the risk factor to address the issue of management entrenchment.
Use of Proceeds – page 33
21. Please revise the bullets to be more specific about the amount of proceeds you intend to use for each identified purpose. Where a bullet contains more than one identified purpose, you should disclose the amount to be used for each. The revised disclosure should also be more specific about how far along in the development process the proceeds will take you. If you will need substantial amounts of additional funds to commercialize the products, you should discuss the amounts of additional funds that will be required and your anticipated sources of funding for the remainder of the development.
22. Please expand the bullet list to include a bullet disclosing the amount of proceeds you expect to use for expenses associated with the U.S. Attorney’s investigation of Orphan Medical’s promotion of Xyrem.
Samuel R. Saks, M.D.
Jazz Pharmaceuticals, Inc. April 13, 2007 Page 6
Management’s Discussion and Analysis – page 43
Management’s Discussion and Analysis of Financ ial Condition and Results of Operations, page
43
In-Process Research and Development, page 53
23. Clarify here, and in the financial statements, the amount of in-process research and development attributed to each acquired project. You indicate that 71% of the total expense relates to an expanded label indication for Xyrem.
Critical Accounting Policies and Significant Judgments and Estimates, page 48
Revenue Recognition, page 48
Product Sales, Net, page 49
24. Your disclosure states that “significant judgment is inherent in the selection of assumptions” with respect to revenue dilution items. Please revise your disclosure to enhance your discussion of the estimates of items that reduce gross revenue such as payment discounts, wholesaler and specialty distributor fees, government chargebacks
and rebates, and other allowances and discounts to include the following:
a. Disclose the nature and amount of each accrual at the balance sheet date and the effect that could result from using other reasonably likely assumptions than what you used to arrive at each accrual such as a range of reasonably likely amounts or other type of sensitivity analysis.
b. Disclose the factors that you consider in estimating each accrual such as historical return of products, levels of inventory in the distribution channel, estimated remaining shelf life, price changes from competitors and introductions of generics and/or new products.
c. To the extent that information you consider in b) is quantifiable, disclose both quantitative and qualitative information and discuss to what extent information is from external sources (e.g., end-customer prescription demand, third-party market research data comparing wholesaler inventory levels to end-customer demand). For example, in discussing your estimate of product that may be returned, consider disclosing and discussing, preferably by product and in tabular format, the total amount of product (in sales dollars) that could be potentially be returned as of the balance sheet date and disaggregated by expiration period.
Samuel R. Saks, M.D.
Jazz Pharmaceuticals, Inc. April 13, 2007 Page 7
d. If applicable, discuss any shipments made as a result of incentives and/or in excess of your customer’s ordinary course of business inventory level. Discuss your revenue recognition policy for such shipments.
e. A roll forward of the accrual for each estimate for each period presented showing the following:
1. Beginning balance,
2. Current provision related to sales made in current period,
3. Current provision related to sales made in prior periods,
4. Actual returns or credits in current period related to sales made in current period,
5. Actual returns or credits in current period related to sales made in prior periods, and
6. Ending balance.
f. In your discussion of results of operations for the period to period revenue comparisons, discuss the amount of and reason for fluctuations for each type of reduction of gross revenue (i.e. product returns, chargebacks, customer rebates and other discounts and allowances) including the effect that changes in your estimates of these items had on your revenues and operations.
UCB Agreement, page 49
25. Please revise your disclosure to include a statement as to whether there has been any change in the expected performance period during each of the periods presented in your financial statements.
Stock-Based Compensation, page 50
Change in Accounting Principle – Stock Based Compensation Under SFAS 123R, page 51
Common Stock Fair Value, page 52
26. Provide the disclosures recommended by paragraph 182 of the AICPA Practice Aid Valuation of Privately Held-Company Equity Securities Issued as Compensation.
27. It appears you have you relied on the valuation and methodology of an independent valuation specialist for the value of your stock. Please revise your disclosure to name the expert and make reference to them in the “Experts” section of the document and provide the written consent this independent valuation specialist. Refer to Securities Act Rule 436 and footnote 60 of the AICPA Practice Aid.
Samuel R. Saks, M.D.
Jazz Pharmaceuticals, Inc. April 13, 2007 Page 8
Accrued Expenses, page 53
28. Please provide the disclosures contemplated by the penultimate paragraph of Section 501.14 of the Codification of Financial Reporting Policies.
Contractual Obligations, page 60
29. Based on your disclosure in your statement of cash flows, it appears that interest payments are and will continue to be a significant cash outflow for the Company. We believe the inclusion of interest payments in the contractual obligations table will provide investors increased transparency of your cash flow. Please revise your contractual obligations table to include interest. Refer to Financial