UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): December 14, 2007
Nabi Biopharmaceuticals
(Exact name of registrant as specified in its charter)
| Delaware | 000-04829 | 59-1212264 | ||
| State or other jurisdiction of incorporation |
Commission File Number | IRS Employer Identification No. |
12276 Wilkins Avenue Rockville, MD 20852
(Address of principal executive offices) (Zip code)
(301) 770-3099
(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 ( see General Instruction A.2. below):
| ¨ | 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)) |
Nabi Biopharmaceuticals
| Item 7.01. | Regulation FD Disclosure |
In connection with the Company’s investor conference call on December 14, 2007 sponsored by Bear Stearns, the Company intends to review the slides furnished as Exhibit 99.1.
The information in this Item 7.01 shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, and it shall not be incorporated by reference into any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing. Furthermore, the furnishing of the information included in this Item 7.01 is not intended to constitute a determination by the registrant that the information is material or that the dissemination of the information is required by Regulation FD.
| Item 9.01. | Financial Statements and Exhibits |
| Exhibit number |
Description | |
| 99.1 | Slides | |
The information included in the exhibits to this Current Report on Form 8-K is furnished pursuant to Items 7.01 and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing. Furthermore, the furnishing of the information included in these exhibits to this Report is not intended to constitute a determination by the registrant that the information is material or that the dissemination of the information is required by Regulation FD.
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.
| Nabi Biopharmaceuticals | ||||||||
| Date: December 14, 2007 | By: | /s/ Jordan I. Siegel | ||||||
| Jordan I. Siegel | ||||||||
| Senior Vice President, Finance and Administration | ||||||||
| Chief Financial Officer and Treasurer | ||||||||
Index of Exhibits
| Exhibit number |
Description | |
| 99.1 | Slides | |
 Leveraging Our Opportunity Bear Stearns Conference Call December 14, 2007 Exhibit 99.1 |
 2 Forward Looking Statements Certain matters Nabi will discuss today are forward-looking statements including statements about our use of proceeds from the sale of the Biologics SBU. You
can identify these forward-looking statements because they involve our
expectations, beliefs, projections, anticipations or other characterizations
of future events or circumstances. These forward-looking statements are
not guarantees of future performance and are subject to risks and
uncertainties that may cause actual results to differ materially from those in
the forward-looking statements as a result of any number of factors. These
factors include, but are not limited to, risks relating to our strategic
alternatives process and our ability to: successfully partner with third
parties to fund, develop, and manufacture our pipeline products, including NicVAX and our gram-positive infections products; obtain successful
clinical trial results; realize anticipated cost savings related to job elimination due to greater than anticipated severance-related costs or other factors; maintain a
sufficient cash balance and generate sufficient cash flow from milestone or
royalty payments to fund our development and commercialization activities;
attract and maintain the human and financial resources to bring to market
products in development; depend upon third parties to manufacture or fill our
products; achieve approval and market acceptance of our products; enter into
and maintain arrangements with third parties to market and sell our
products; manufacture NicVAX or other products; comply with reporting and payment obligations under government rebate and pricing programs; raise additional capital on acceptable terms, or at all; and re-pay our outstanding convertible senior notes when due.
Many of these factors are more fully discussed, as are other factors, in the
company's Annual Report on Form 10-K for the fiscal year ended December 31,
2006 and our Quarterly Report on Form 10-Q for the quarter ended September
29, 2007 filed with the Securities and Exchange Commission.
|
 3 Pipeline Update In Progress: Partner NicVAX — Planning for pivotal phase III trials 4514 & 4515 underway — Ongoing immunogenicity study, phase II 4513 — Active partnership discussions In Progress: Partner StaphVAX — Process development of PVL and alpha toxin vaccine components underway — Active partnership discussions In Progress: Transfer of Manufacturing Processes — NicVAX clinical material secured to end of phase III — Transfer from Biotest to a CMO supplier for Go to Market — StaphVAX phase I materials |
 4 NicVAX |
  5 Primary and Secondary Abstinence Measures Target Quit Date Target Quit Date 8 week abstinence immediately prior to 6 months Continuous abstinence to 6 months 6 Months 12 Primary End Point Continuous abstinence to 12 months Secondary End Point |
 6 0 2 4 6 8 10 12 14 16 18 20 22 24 26 Improve Antibody Response 28 30 32 34 36 38 40 42 44 46 48 50 52 Study Week 200 µg/Schedule 1 400 µg/Schedule 1 200 µg/Schedule 2 400 µg/Schedule 2 |
 7 Exceeding the Effect Threshold Drives Greater Abstinence Intent to Treat Population 6% 6% (n=6/98) (n=6/98) 11% 11% (n=2/19) (n=2/19) p=0.37 p=0.37 22% 22% (n=6/27) (n=6/27) p=0.011 p=0.011 12-Month 12-Month Continuous Continuous Abstinence Rates Abstinence Rates NicVAX 400 µg NicVAX 400 µg Below Threshold Below Threshold at at TQD TQD Placebo Placebo NicVAX 400 µg NicVAX 400 µg Above Threshold Above Threshold at at TQD TQD Schedule 2 Schedule 2 |
 8 0 5 10 15 20 25 30 35 40 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Time to 8-Week Sustained Abstinence (Weeks) Placebo Mid/Low (67%) Ab Top 33% Ab p=0.0021 Decide on Optimum Abstinence Measure |
 9 Claims Data on Secondary Benefits 0 5 10 15 20 25 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Study Week Placebo Mid/Low Ab Top Ab p=0.0023 |
 10 NicVAX Critical Milestones by Quarter 2008 2009 4514 Primary end point data at 6 months Immunogenicity Data Available Start of 4514 NicVAX launch 4Q12 Start 4515 4513 First patient dosed |
 11 Corporate Priorities • Develop and Partner NicVAX and StaphVAX • Complete the Strategic Alternatives Process • Maximize Shareholder Value: Share repurchase program underway |
 12 |