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
Date of
Report (Date of Earliest Event Reported): August 5, 2010
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, Maryland | 20852 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code: (301)
770-3099
Not
Applicable
(Registrant’s
name or former address, if change since last report)
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):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
2.02. Results of Operations and Financial Condition
On August
5, 2010, Nabi Biopharmaceuticals (the “Company”) issued a press release
announcing its results of operations for the three months ended June 26,
2010. A copy of the press release announcing these results is
furnished as Exhibit 99.1 to this report.
The
information in this Item 2.02 and the exhibit attached hereto shall not be
deemed to be “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934 (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 of 1933 or the Exchange Act, regardless of any general
incorporation language in such filing.
Item
9.01. Financial Statements and Exhibits
|
Exhibit
number
|
|
Description
|
|
99.1
|
|
Earnings
Press Release
|
SIGNATURE
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 thereunto
duly authorized.
|
NABI
BIOPHARMACEUTICALS
|
|
|
By:
|
/s/ Raafat E.F. Fahim,
Ph.D.
|
|
Raafat
E.F. Fahim, Ph.D.
|
|
|
President,
Chief Executive Officer and acting Chief
Financial
Officer
|
|
Date: August
5, 2010
Exhibit
99.1
 |
NEWS
RELEASE
|
Investor
Relations
301-770-3099
| www.nabi.com
FOR IMMEDIATE
RELEASE
Nabi
Biopharmaceuticals Announces Second Quarter 2010 Financial Results
Rockville, Maryland, August 5, 2010
– Nabi
Biopharmaceuticals (NASDAQ: NABI) today announced its second quarter financial
results for the three month period ended June 26, 2010. The Company
reported a net loss from continuing operations of $3.4 million, or $0.08 per
share, compared to a net loss of $5.8 million, or $0.11 per share, for the
period ended June 27, 2009.
Second
quarter revenue was $4.8 million reflecting revenue recognized from payments
received from GlaxoSmithKline Biologicals (GSK). This includes $3.9
million related to the $21.5 million upfront payment received at the close of
the PentaStaph sale in 2009 and the $40 million NicVAX upfront payment received
in the first quarter of 2010 as well as $0.9 million for services provided to
GSK under the PentaStaph agreement. Revenue from the PentaStaph and
NicVAX upfront payments are being recognized ratably over the expected term of
the Joint Steering Committees created under each of the agreements.
General
and Administrative expenses were $1.2 million for the quarter ended June 26,
2010 compared to $2.4 million in the prior year period. This decrease
reflects our efforts to decrease our expenses, lower legal and facilities costs
as well as an allocation of a portion of these costs to Cost of Services in the
2010 period. Research and Development expenses were $6.5 million in
the second quarter of 2010 compared to $3.4 million in 2009, reflecting costs of
the two NicVAX Phase III trials initiated in November 2009 and March 2010 as
well as manufacturing-related activities for NicVAX. We expect that
Research and Development expenses will continue to increase during the balance
of 2010.
For the
six months ended June 26, 2010, the Company’s net income from continuing
operations was $2.1 million, or $0.04 cents per share, compared to a net loss of
$12.9 million, or $0.25 cents per share, for the six months ended June 27,
2009. Revenue of $18.6 million was recognized for the six months
ended June 26, 2010 compared to no revenue for the comparable 2009
period. General and Administrative expenses for the current six-month
period were $3.0 million compared to $5.4 million in 2009 while Research and
Development expense was $12.4 million for the current six-month period compared
to $7.2 million for the 2009 period.
Net cash
provided by operating activities from continuing operations was $41.0 million
for the first six months of 2010 compared to $12.8 million of net cash used in
the first six months of 2009. The 2010 period included $56.3 million
received from GSK related to the PentaStaph and NicVAX
agreements. Cash, cash equivalents and marketable securities totaled
$118.0 million at June 26, 2010 compared to $119.0 million at the end of
2009. Cash provided by operating activities was offset by payments of
$35.8 million for common stock repurchases and $6.1 million for the repurchase
of the remaining balance of the 2.875% Convertible Senior Notes as well as our
operating expenses.
During
the second quarter of 2010, the Company repurchased 4.8 million shares of common
stock for a total of $27.2 million and subsequent to the end of the second
quarter, repurchased 563,194 additional shares for a total of $3.1 million
through July 30, 2010. As of that date, there were approximately 43
million shares outstanding and the share repurchase program had a remaining
balance available of $30.6 million.
Recent
and Upcoming Events
|
|
·
|
Completed
enrollment in first NicVAX Phase III trial, final data expected in the
fourth quarter of 2011
|
|
|
·
|
Expect
to complete enrollment in second NicVAX Phase III trial on schedule by
year end, final data expected in early
2012
|
|
|
·
|
Expect
to complete remaining PentaStaph milestones and collect $13 million in
payments by year end
|
“I am
very pleased with the progress we made in advancing the Phase III trials for
NicVAX,” said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi
Biopharmaceuticals. “We have completed enrollment in the first Phase
III trial and are making good progress in the second Phase III
trial. In addition, our financial position remains strong while we
continue to repurchase our stock to increase shareholder value.”
Financial
Results Conference Call and Webcast Information
The
Company will host a live webcast at 4:30 p.m. EDT today to discuss these
results. The live webcast can be accessed at:
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=100445&eventID=3239288
(Due
to the length of this URL, it may be necessary to copy and paste this hyperlink
into your browser. Remove the space if one exists.) or via the Nabi
Biopharmaceuticals website at http://www.nabi.com.
If you do
not have Internet access, the U.S./Canada call-in number is 866-783-2139 and the
international call-in number is 857-350-1598. The passcode is
73163453. An audio replay will be available through August 13, 2010
for U.S./Canada callers at 888-286-8010 and for international callers at
617-801-6888. The replay passcode is 67247790.
The press release and an archived
version of the webcast will be available on the company’s website at http://www.nabi.com.
About
Nabi Biopharmaceuticals
Nabi
Biopharmaceuticals leverages its experience and knowledge in powering the immune
system to develop products that target serious medical conditions in the areas
of nicotine addiction and gram-positive bacterial infections. Nabi
Biopharmaceuticals is currently developing NicVAX®
(Nicotine Conjugate Vaccine), an innovative and proprietary investigational
vaccine for treatment of nicotine addiction and prevention of smoking relapse.
The company is headquartered in Rockville, Maryland. For additional information
about Nabi Biopharmaceuticals, please visit www.nabi.com
Forward-Looking
Statements
Statements
in this release that are not strictly historical are forward-looking statements
and include statements about products in development, results and analyses of
clinical trials and studies, research and development expenses, cash
expenditures, licensure applications and approvals, and alliances and
partnerships, among other matters. You can identify these forward-looking
statements because they involve our expectations, intentions, beliefs, plans,
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 ability to conduct and obtain successful results from our
two Phase III clinical trials for NicVAX; GSK’s failure to exercise its option
for and successfully commercialize NicVAX; GSK’s failure to successfully develop
and commercialize any future generation candidate nicotine vaccine utilizing our
intellectual property; our ability to commercialize NicVAX if GSK does not
exercise its option for NicVAX; our ability to raise sufficient new capital
resources to fully develop and commercialize NicVAX if GSK does not exercise the
NicVAX option; our ability to attract, retain and motivate key employees; our
ability to collect any further milestones and royalty payments under the PhosLo
and PentaStaph agreements; the ability to obtain regulatory approval for NicVAX
and any future generation candidate nicotine vaccine in the U.S. or other
markets; our ability to successfully contract with contract manufacturing
organizations for the manufacture and supply of NicVAX and the risk that these
organizations will not fulfill their obligations to us; our ability to comply
with reporting and payment obligations under government rebate and pricing
programs; and loss of full use of our net operating loss
carryforwards. Some of these factors are more fully discussed, as are
other factors, in our Annual Report on Form 10-K for the fiscal year ended
December 26, 2009 filed with the Securities and Exchange Commission. We do not
undertake to update any of these forward-looking statements or to announce the
results of any revisions to these forward-looking statements except as required
by law.
Nabi
Biopharmaceuticals
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In
thousands)
|
June 26,
|
December 26,
|
|||||||
|
2010
|
2009
|
|||||||
|
ASSETS
|
||||||||
|
Current
assets:
|
||||||||
|
Cash
and cash equivalents
|
$ | 32,454 | $ | 59,510 | ||||
|
Marketable
securities
|
71,206 | 59,489 | ||||||
|
Receivables
|
4,585 | 9,122 | ||||||
|
Prepaid
expenses and other current assets
|
1,455 | 1,572 | ||||||
|
Total
current assets
|
109,700 | 129,693 | ||||||
|
Marketable
securities
|
14,355 | - | ||||||
|
Property
and equipment, net
|
601 | 855 | ||||||
|
Other
assets
|
635 | 769 | ||||||
|
Total
assets
|
$ | 125,291 | $ | 131,317 | ||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 3,350 | $ | 1,735 | ||||
|
Accrued
expenses and other current liabilities
|
5,409 | 4,961 | ||||||
|
Deferred
revenue, current portion
|
13,068 | 18,447 | ||||||
|
2.875%
convertible senior notes, net
|
- | 5,951 | ||||||
|
Current
liabilities of discontinued operations
|
2,207 | 2,816 | ||||||
|
Total
current liabilities
|
24,034 | 33,910 | ||||||
|
Deferred
revenue
|
36,631 | - | ||||||
|
Total
liabilities
|
60,665 | 33,910 | ||||||
|
Stockholders'
equity:
|
||||||||
|
Convertible
preferred stock
|
- | - | ||||||
|
Common
stock
|
6,315 | 6,278 | ||||||
|
Capital
in excess of par value
|
367,319 | 365,841 | ||||||
|
Treasury
stock
|
(86,665 | ) | (50,267 | ) | ||||
|
Other
comprehensive income (loss)
|
8 | (20 | ) | |||||
|
Accumulated
deficit
|
(222,351 | ) | (224,425 | ) | ||||
|
Total
stockholders' equity
|
64,626 | 97,407 | ||||||
|
Total
liabilities and stockholders' equity
|
$ | 125,291 | $ | 131,317 | ||||
Nabi
Biopharmaceuticals
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In
thousands, except per share amounts)
|
For the Three Months Ended
|
For the Six Months Ended
|
|||||||||||||||
|
June 26,
|
June 27,
|
June 26,
|
June 27,
|
|||||||||||||
|
2010
|
2009
|
2010
|
2009
|
|||||||||||||
|
Revenue:
|
||||||||||||||||
|
Revenue
|
$ | 4,849 | $ | - | $ | 18,590 | $ | - | ||||||||
|
Operating
expenses:
|
||||||||||||||||
|
Cost
of service
|
615 | - | 1,285 | - | ||||||||||||
|
General
and administrative expenses
|
1,196 | 2,355 | 2,965 | 5,445 | ||||||||||||
|
Research
and development expenses
|
6,525 | 3,440 | 12,435 | 7,206 | ||||||||||||
|
Operating
income (loss)
|
(3,487 | ) | (5,795 | ) | 1,905 | (12,651 | ) | |||||||||
|
Interest
income
|
67 | 83 | 91 | 270 | ||||||||||||
|
Interest
expense
|
(45 | ) | (136 | ) | (187 | ) | (497 | ) | ||||||||
|
Other
income (expense), net
|
59 | 40 | 265 | 24 | ||||||||||||
|
Net
income (loss)
|
$ | (3,406 | ) | $ | (5,808 | ) | $ | 2,074 | $ | (12,854 | ) | |||||
|
Basic
income (loss) per share
|
$ | (0.08 | ) | $ | (0.11 | ) | $ | 0.04 | $ | (0.25 | ) | |||||
|
Diluted
income (loss) per share
|
$ | (0.08 | ) | $ | (0.11 | ) | $ | 0.04 | $ | (0.25 | ) | |||||
|
Basic
weighted average shares outstanding
|
44,377 | 50,974 | 46,456 | 51,094 | ||||||||||||
|
Diluted
weighted average shares outstanding
|
44,377 | 50,974 | 46,691 | 51,094 | ||||||||||||
Nabi
Biopharmaceuticals
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In
thousands)
|
For the Six Months Ended
|
||||||||
|
June
26,
|
June
27,
|
|||||||
|
2010
|
2009
|
|||||||
|
Cash
flow from operating activities:
|
||||||||
|
Net
income (loss) from continuing operations
|
$ | 2,074 | $ | (12,854 | ) | |||
|
Adjustments
to reconcile net income (loss) from continuing operations to
net cash provided by (used in) operating activities from
continuing operations:
|
||||||||
|
Depreciation
and amortization
|
220 | 255 | ||||||
|
Accretion
of discount on convertible senior notes
|
99 | 306 | ||||||
|
Share-based
compensation
|
1,102 | 904 | ||||||
|
Other
|
(4 | ) | 6 | |||||
|
Changes
in assets and liabilities:
|
||||||||
|
Receivables
|
4,538 | - | ||||||
|
Prepaid
expenses and other assets
|
240 | (426 | ) | |||||
|
Accounts
payable, accrued expenses and other
|
1,509 | (1,035 | ) | |||||
|
Deferred
revenue
|
31,252 | - | ||||||
|
Net
cash provided by (used in) operating activities from continuing
operations
|
41,030 | (12,844 | ) | |||||
|
Net
cash (used in) provided by operating activities from discontinued
operations
|
(609 | ) | 4,488 | |||||
|
Net
cash provided by (used in) operating activities
|
40,421 | (8,356 | ) | |||||
|
Cash
flow from investing activities:
|
||||||||
|
Proceeds
from sales and maturities of marketable securities
|
64,516 | 22,836 | ||||||
|
Purchases
of marketable securities
|
(90,560 | ) | - | |||||
|
Proceeds
from sales of property and equipment
|
50 | - | ||||||
|
Capital
expenditures
|
(2 | ) | - | |||||
|
Net
cash provided by (used in) investing activities
|
(25,996 | ) | 22,836 | |||||
|
Cash
flow from financing activities:
|
||||||||
|
Proceeds
from issuance of common stock for employee benefit plans
|
412 | 297 | ||||||
|
Purchase
of common stock for treasury
|
(35,843 | ) | (3,466 | ) | ||||
|
Repurchase
of convertible senior notes
|
(6,050 | ) | (10,091 | ) | ||||
|
Net
cash used in financing activities
|
(41,481 | ) | (13,260 | ) | ||||
|
Net
increase (decrease) in cash and cash equivalents
|
(27,056 | ) | 1,220 | |||||
|
Cash
and cash equivalents at beginning of period
|
59,510 | 106,438 | ||||||
|
Cash
and cash equivalents at end of period
|
$ | 32,454 | $ | 107,658 | ||||
# #
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