UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
June 11, 2008
Date of Report (Date of earliest event reported)
JAZZ PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
| Delaware | 001-33500 | 05-0563787 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File No.) | (IRS Employer Identification No.) |
3180 Porter Drive, Palo Alto, California 94304
(Address of principal executive offices, including zip code)
(650) 496-3777
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.05. Costs Associated with Exit or Disposal Activities.
On June 11, 2008, Jazz Pharmaceuticals, Inc. (the “Company”) committed to a plan of termination that will result in a work force reduction of 33 employees, primarily in research and development and administrative areas. The Company commenced notification of employees affected by the workforce reduction on June 11, 2008. Affected employees will be eligible to receive severance payments, payment by the Company of each affected employee’s COBRA premiums for up to three months and acceleration of the vesting of 25% of any restricted stock units previously granted to the affected employees. The Company will also provide outplacement assistance. The Company is undertaking the workforce reduction as part of its strategic decisions to reduce its emphasis on early-stage research and development activities, thereby reducing the Company’s research and development spending commitments and streamlining its administrative operations. The Company expects to complete the reduction in force by the end of the second quarter of 2008.
As a result of the reduction in force, the Company estimates that it will record a one-time severance-related charge of approximately $500,000 in the second quarter of 2008. Approximately $475,000 of this charge represents cash payments over the next three months for severance payments, COBRA premium payments and outplacement assistance payments, and approximately $25,000 of this charge represents a non-cash expense related to the accelerated vesting of restricted stock units. The severance-related charge that the Company expects to incur in connection with the reduction in force is subject to a number of assumptions, and actual results may differ. The Company may also incur other charges not currently contemplated due to events that may occur as a result of, or associated with, the restructuring plan.
This Item 2.05 contains forward-looking statements, including, but not limited to, statements related to the expected severance costs and related estimated severance-related charge, the timing for completion of the reduction in force, and the Company’s plans to focus on its commercial activities and on two of its later-stage product development programs. These forward-looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the development of the Company’s product candidates, including the risk that study or clinical trial results may require the Company to discontinue their development; risks related to the uncertain and time-consuming regulatory approval process; and risks related to the need for additional funds. These and other risk factors are discussed under the heading “Risk Factors” in the two resale registration statements filed on Form S-3 by Jazz Pharmaceuticals with the Securities and Exchange Commission on June 11, 2008. In addition, the Company’s restructuring costs may be greater than anticipated and the workforce reduction and any future workforce and expense reductions may have an adverse impact on the Company’s commercial and development activities. The Company undertakes no duty or obligation to update any forward-looking statements contained in this Item 2.05 as a result of new information, future events or changes in its expectations.
Item 8.01. Other Information.
On June 11, 2008, the Company issued a press release announcing certain development timeline updates and the matters described in Item 2.05 of this Form 8-K. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
| Number |
Description | |
| 99.1 | Press release, dated June 11, 2008, entitled “Jazz Pharmaceuticals Announces Development Timeline Updates” |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| JAZZ PHARMACEUTICALS, INC. | ||
| By: | /s/ Carol A. Gamble | |
| Carol A. Gamble | ||
| Senior Vice President, General Counsel | ||
| and Corporate Secretary | ||
Date: June 11, 2008
EXHIBIT INDEX
| Number |
Description | |
| 99.1 | Press release, dated June 11, 2008, entitled “Jazz Pharmaceuticals Announces Development Timeline Updates” |
Exhibit 99.1
Jazz Pharmaceuticals Announces Development Timeline Updates
PALO ALTO, Calif., June 11, 2008 /PRNewswire-FirstCall/ — Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that timelines for two of its development programs have been delayed. In addition, the company will reduce its emphasis on early-stage research and development activities and implement a workforce reduction. Jazz Pharmaceuticals’ sales and marketing activities will not be affected by these changes.
Clinical development will continue as previously disclosed for JZP-6, for which top-line results from the first of two Phase III clinical trials for the treatment of fibromyalgia syndrome are expected by the end of 2008. Jazz Pharmaceuticals recently announced completion of enrollment in this trial. Submission of a New Drug Application for JZP-6 is targeted for the fourth quarter of 2009. As previously disclosed, the ongoing Phase II trial of JZP-8, in development for the treatment of recurrent acute repetitive seizures, is also expected to be completed during 2008.
The company plans to complete additional pre-clinical activities prior to initiation of the Phase III program for JZP-7, its product candidate for the treatment of restless legs syndrome. As a result, the start of the Phase III program for JZP-7 will be delayed. The Phase II clinical development of JZP-4, Jazz Pharmaceuticals’ product candidate for the chronic treatment of epilepsy and bipolar disorder, will be delayed to allow further formulation development work to be completed. The Phase II trial for JZP-4 and the Phase III trials for JZP-7 and JZP-8 will proceed in 2009 with additional financing or development partners for the company.
“Reducing our overall R&D spending commitments and streamlining our administrative operations gives us additional flexibility in our requirements for future financing and we believe will shorten our timeline to reach profitability,” said Dr. Samuel Saks, the Chief Executive Officer of Jazz Pharmaceuticals. “We are actively seeking partners for several of our development programs. We have been pleased with the level of interest from potential partners and look forward to completing one or more development partnerships to help us bring these important therapies to the market as quickly as possible.”
In connection with these strategic decisions, Jazz Pharmaceuticals will reduce its workforce by 33 employees (8 percent), primarily in research and development and administrative areas. The company expects to record a charge of approximately $0.5 million related to the workforce reduction in the second quarter of 2008.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information see www.JazzPharmaceuticals.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the continued development of Jazz Pharmaceuticals’ development product candidates, the timing of clinical study activities, the completion or results of potential development partnerships and the estimated charge related to the workforce reduction. These forward-looking statements are based on the company’s current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals’ actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the development of Jazz Pharmaceuticals’ product candidates, including the risk that study or clinical trial results may require Jazz Pharmaceuticals to discontinue its development; risks related to the uncertain and time-consuming regulatory approval process; risks related to the need for additional funds; and the risk that Jazz Pharmaceuticals may not be successful in completing development partnerships. These and other risk factors are discussed under the heading “Risk Factors” in the two resale registration statements filed on Form S-3 by Jazz Pharmaceuticals with the Securities and Exchange Commission on June 11, 2008. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
# # #
Contacts:
BCC Partners on behalf of Jazz Pharmaceuticals, Inc.
Karen L. Bergman, 650-575-1509
Michelle Corral, 415-794-8662
Jazz Pharmaceuticals, Inc.
Matthew Fust, Chief Financial Officer
650-496-2800
investorinfo@jazzpharmaceuticals.com